PAGENO="0001" HEARING AID INDUSTRY $1 HEARINGS BEFORE THE PERMANENT SUBCOMMITTEE ON INVESTIGATIONS OF THE COMMITTEE ON GOVERNMENT OPERATIONS UNITED STATES SENATE NINETY-FOURTH CONGRESS SECOND SESSION PURSUANT TO SECTION 5, SENATE RESOLUTION 363, 94TH CONGRESS APRIL 1 AND 2, 1976 Printed for the use of the Committee on Government Operations ~ ( / U.S. GOVERNMENT PRINTING OFFICE 7~ 9 4 WASHI~G1ON 1977 PAGENO="0002" COMMITTEE ON GOVERNMENT OPERATIONS JOHN L. McCLELLAN, Arkansas HENRY M. JACKSON, Washington EDMUND S. MUSKIE, Maine LEE METCALF, Montana JAMES B. ALLEN, Alabama LAWTON CHILES, Florida SAM NUNN, Georgia JOHN GLENN, Ohio RICHARD A. WEGMAN, Chief Counsel and Staff Director PERMANENT SUBCOMMITTEE ON INVESTIGATIONS HENRY M. JACKSON, Washington, Chairman JOHN L. McCLELLAN, Arkansas JAMES B. ALLEN, Alabama SAM NUNN, Georgia LAWTON CHILES, Florida JOHN GLENN, Ohio CHARLES H. PERCY, Illinois JACOB K. JAVITS, New York WILLIAM V. ROTH, JR., Delaware BILL BROCK, Tennessee RICHARD A. WEGMAN, Chief Counsel and Staff Director CHARLES H. PERCY, Illinois JACOB K. JAVITS, New York WILLIAM V. ROTH, JR., Delaware BILL BROCK, Tennessee LOWELL P. WEICKER, JR., Connecticut HOWARD J. FELDMAN, Chief Counsel DOROTHY Fosnicn, Professional Staff Director STUART M. STATLER, Chief Counsel to the Minority RUTH YOUNG WATT, Cider Clerk ROLAND L. CRANDALL, Staff Editor (II) PAGENO="0003" CONTENTS Page Appendix 169 Testimony of- Bicksier, Ralph J., hearing aid purchaser, Santa Clara, Calif 24 Brennan, John C., hearing aid purchaser, Laurel, Md~__ 24 Burke, Carol, former employee of hearing aid dealer, Los Angeles, Calif - 100 Byrne, Maurice, former assistant attorney general, Louisville, Ky_. 117 Fortner, M. L., hearing aid dealer and president of the National Hear- ing Aid Society 135 Giglia, Vincent, chairman of the Consumer Affairs Committee of the National Hearing Aid Society - 135 Glasscock, Dr. Michael, assistant clinical professor of otolarynology, Vanderbilt University, Nashville, Tenn 73 Heisse, Dr. John W., otolaryngologist, Burlington, Vt 135 Hodges, Joseph, staff counsel, Florida State Department of Health and Rehabilitative Services - 117 Holloway, Dr. Rufus M., otolaryngologist, Orlando, Fla 67 Malavey, Mohan Rao, audiologist, Ear Medical Clinic, San Jose, Calif 24 Rickenberg, Herbert E., audiologist, director, hearing and speech, United Hospital, Newark, N.J 135 Rose, Dr. Darrell E., director, audiology section, Mayo Clinic, Rochester, Minn 4 Ruben, Dr. Robert J., chairman and professor, Department of Otorhinolaryngology, Albert Einstein College of Medicine, Yesiva University, New York, N.Y 73 Simmons, F. Blair, M.D., chairman, Division of Otolaryngology, Stanford School of Medicine, Stanford, Calif 73 Intro- duced EXHIBITs on Appears rage on page 1. Code of Ethics of the American Speech and Hearing Associa- tion 14 14 2. Final Report to the Secretary of HEW on Hearing Aid Health Care, prepared by HEW Intradepartmental Task Force on Hearing Aids 18 (`) 3. Letter dated March 14, 1974, from Anthony DiRocco, execu- tive secretary, National Hearing Aid Society, to John C. Brennan, Laurel, Md 37 37 4. Memorandum dated March 18, 1976, from Jonathan Cottin to hearing aid ifie re Beltone Hearing Aid Service, San Jose, Calif - 43 43 4A. Memorandum dated March 25, 1976, from Howard S. Marks to hearing aid case file re John C. Brennan 43 44 5. Affidavit of Dr. Robert J. Kramer 43 45 6. Affidavit of Stephen D. Gannaway 43 47 7. Affidavit of Linda L. Morrison 43 48 8. Affidavit of Dr. Robert A. Merrell, Jr 43 50 9. Memorandum dated February 11, 1976, from Jonathan Cottin to hearing aid file, re Wynn E. Walters, Florida hearing aid dealer 43 51 10. Complaint filed by the State of Florida against Wynn E. Walters 43 52 11. Deposition of Linda Morrison, August 1, 1975, in the Circuit Court, Seventh Judicial Circuit of Florida 43 (`) 1 May be found in the files of the subcommittee. (III) PAGENO="0004" Iv Intro- duced on Appears page on page 12. Deposition of Robert A. Merrell, Jr., M.D., June 4, 1975, in the Circuit Court, Seventh Judicial Circuit of Florida__ 43 (1) 13. Affidavit of Elda Mae Sewell 43 53 14. Affidavit of Arthur Spar, M.D 43 54 15. Memorandum dated March 18, 1976, from Jonathan Cottin to hearing aid case file re Elda Mae Sewell 43 54 16. Affidavit of Susan A. Toaz 43 55 17. Affidavit of Rena McKenzie 43 56 18. Affidavit of Anne Dow 43 57 19. Memorandum dated March 26, 1976, from Howard S. Marks to hearing aid case file re Victor H. Claprood 43 59 20. Indictment and conviction .of Victor P. Claprood in the circuit court in and for Sarasota County, Fla -- 43 59 21. Affidavit of Thaddeus Macy Crumpler 43 60 22. Affidavit of Francis I. Catlin, M.D 43 62 23. Memorandum dated March 12, 1976, from Jonathan Cottin to hearing aid case file re Thaddeus Macy Crumpler 43 63 24. Confirmation copies of Western Union mailgrams sent to * several hearing aid dealers 43 64 25. Latter dated November 11, 1975, to Hon. Alexander M. * Schmidt, Commissioner, Food and Drug Administration from Senator Charles H. Percy, together with reply dated January 2, 1976 87 87 26. Telegram dated March 30, 1976, to Senator Charles Percy from J. R. Anderson, M.D., president, American Council of Otolaryngology ~0 90 27. Transcript of testimony of Edith May Leonard before the grand jury of the county of Los Angeles, State of Cali- fornia 101 101 28. Mailgrams to Sanford D. Gertz, Studio City, Calif., and Dr. Emilio H. Marquez, Los Angeles, Calif.. 112 112 29. Indictment of Dr. Emilio H. Marquez and Sanford D. Gertz, et al. by the superior court of California for the county of Los Angeles 112 (`) 30. Disposition of the Emilio H. Marquez case by the superior court of California, county of Los Angeles 112 (1) 31. Disposition of the Sanford D. Gertz case by the superior court of California, county of Los Angeles 112 (1) 32. Accusation against Emilio H. Marquez, M.D., Los Angeles, Calif. before the Department of Health of the State of California 112 (1) 33. Accusation against Emilio H. Marquez, M.D., before the Board of Medical Examiners, Department of Consumer Affairs, State of California 112 (1) 34. Accusation against Sanford D. Gertz before the Department of Health, State of California 112 (1) 35. Accusation against Sanford D. Gertz before the Hearing Aid Dispeners Examining Committee of the Board of Medical Examiners, State of California 112 (1) 36. Letter dated February 17, 1976, from Stephen V. Wilson, Assistant U.S. attorney, Central District of California, to Roy F. Nilsson, Program Officer, Social Security Adminis- tration re proposed prosecution of Emilio H. Marquez, M.D. and Sanford D. Gertz, et al 112 (1) 37. Staff Study entitled "State Licensing Laws and Training Requirements for Hearing Aid Dealers" 119 (1) 38. Report of the Consumers' Advisory Council, Commonwealth of Kentucky, with attachments 121 (1) 39. Rules of the State of Florida, Department of Health and Rehabilitative Services re Dispensing hearing Aids 131 (1) 40. Documentation of the efforts of J. E. Hodges, Office of General Counsel, Division of Health, Jacksonville, Fla., to alert the Federal Trade Commission to the violations of hearing aid dealer and manufacturer in the Florida Keys.. 131 (1) 1 May be found in the files of the subcommittee. PAGENO="0005" V Intro~ thiced on Appears rage on page 41. Letter dated November 10, 1975, to all Hearing Aid Fitters! Dispensers, from Victor N. Thompson, president, Washing- ton Hearing Aid Society, Inc 142 142 42. Memorandum dated March 1, 1976, to Luke M. Fortner, president, NHAS, from Vincent J. Giglia, chairman, Con- sumer Affairs Committee, re Consumer Protection Plan_ - 151 169 42A. Model licensing bill for hearing aid specialists by the National Hearing Aid Society 151 (1) 43. Certificate of Certification by the National Hearing Aid Society 151 (1) 44. A report to the National Hearing Aid Society and the Hearing Aid Industry Conference, April 1971, prepared by Market Facts, Inc 151 (1) 45. A national survey of the hearing aid delivery system in the United States dated November 21, 1974, by Payne & Payne, consultants 151 169 46. Reprint from the winter 1976 issue of "Audecibel," the official publication of the National Hearing Aid Society, entitled "Financially Motivated Clinical Audiologists Open Attack on Otolaryngologists" 151 (1) 47. Reprints from the 1975 summer issue of "Audecibel," the official publication of the National Hearing Aid Society entitled "History Explodes `Prescription' Theory" by A. P. Mynders and "Why Fitting a Hearing Aid Is An Art, Not a Science" By Alfred R. Dunlavy 151 (1) 48. Statement of the American Council of Otolaryngology given by Harry W. McCurdy, M.D., executive director, and Aram Glorig, M.D., consultant, presented to the DHEW Intradepartmental Task Force on Hearing Aids, May 7, 1975 1.51 198 49. Pamphlet "Guidelines for Medical Clearance" published for the use of members of the National Hearing Aid Society__ 151 201 50. Letter dated January 23, 1976, to all NHAS members, from M. L. Fortner, president re NHAS medical clearance policy and rental/purchase option plan 151 203 51. Copy of the NHAS presentation to the HEW task force__ 151 (`) 52. Letters from several better business bureaus re hearing aid complaints 151 (1) 53. Letter dated October 22, 1975, to Larry G. Alkire, public affairs manager, Beltone Electronics Corp., from Frank E. MeLauglin, Office of Consumer Affairs, DHEW 151 204 54. Letter dated October 30, 1975, to Richard Fralick, public affairs director, National Hearing Aid Society, from Karen S. Blumenberg, consumer program specialist, National Retired Teachers Association 151 205 55. Summary of complaint reports from better business bureaus 151 205 56. Statement of the National Hearing Aid Society before a U.S. Senate committee, September 10 and 11, 1973 151 (1) 57. National Hearing Aid Society publication entitled "The Elimination of the Hearing Aid Specialist" 151 (1) 58. Reprint from the fall 1975 issue of Audecihel, National Hearing Aid Society publication entitled "Audiology Licensing Infringes on Licensing of Hearing Aid Specialists and Their Rights To Practice, Too" by Richard A. Kitch - 151 (1) 59. National Hearing Aid Society paper entitled "Critical Issues in the Hearing Health Care Delivery System, January 1976" 151 (1) 60. Comments and legal memorandum of the National Hearing Aid Society on the proposed trade regulation rule for the hea.ring aid industry before the Federal Trade Commission, February 27, 1976 151 (1) 1 May be found In the files of the subcommittee. PAGENO="0006" VI Intro- duced on Appears page on page 61. National Hearing Aid Society's response to the Permanent Subcommittee on Investigations "Staff Study of State Licensing Laws and Training Requirements for Hearing Aid Dealers" 151 209 62. Correspondence between the Permanent Subcommittee on Investigations and the National Hearing Aid Society re four-point consumer protection program 154 (1) 63. Congressional Research Service report on the Payne & Payne study of the hearing aid delivery system 159 159 Hearing dates- April 1, 1976 1 April 2, 1976 99 1 May be found in the files of the subcommittee. PAGENO="0007" HEARING AID INDUSTRY THURSDAY, APRIL 1, 1976 U.S. SENATE, PERMANENT SUBCOMMITTEE ON INVESTIGATIONS OF THE CoMMIrrIIE ON GOVERNMENT OPERATIONS, Washington, D.C. The subcommittee met at 10 a.m., in room 3302, Dirksen Senate Office Building, under authority of section 5, Senate Resolution 363, agreed to Marôh 1, 1976, Hon. Charles H. Percy presiding. Members of the subcommittee present: Senator Charles H. Percy, Republican, Illinois. Members of the professional staff present: Howard J. Feldman, chief counsel; F. Keith Adkinson, assistant counsel; Stuart M. Statler, chief counsel to the minority; Jonathan Cottin, investigator to the minority; and Ruth Y. Watt, chief clerk. Senator PERCY. The subcommittee will come to order. [Member of the subcommittee present at time of convening: Senator Percy.] [The letter of authority follows:] U.S. SENATE, COMMITTEE ON GOVERNMENT OPERATIONS, SENATE PERMANENT SUBCOMMITTEE ON INVESTIGATIONS, Washington, D.C. Pursuant to Rule 5 of the Rules of Procedure of the Senate Permanent Sub- committee on Investigations of the Committee on Government Operations, per- mission is hereby granted for the Chairman, or any member of the Subcommittee as designated by the Chairman, to conduct hearings in public session, without a quorum of two members of administration of oaths and taking of testimony in connection with the Hearing Aid Industry on Thursday, April 1, 1976. SAM NUNN, Acting Chairman. CHARLES H. PERCY, Ranking Minority Member. Senator PERCY. We wish to welcome all of you who are to participate in this first phase of hearings which will examine very important problems in the hearing aid delivery system in this country. More than 20 million Americans are believed to suffer some form of hear- ing impairment, from total deafness to mild loss. Many can be helped immeasurably by a hearing aid. Many cannot be helped at all. For the past year, this subcommittee has been looking into the manner in which hearing aids are marketed in the United States. At the present time, according to estimates, most persons with a hear- ing impairment first go to a hearing aid dealer for assistance. This places a tremendous responsibility on the dealer. He must be able to detect whether the hearing-impaired person is a candidate for a hearing aid on which the dealer makes a profit, or whether he should be referred to a physician, which may mean no business for the dealer. (1) PAGENO="0008" 2 Recently, the subcommittee asked three expert panels composed of audiologists and physicians to review the 20-lesson home study course provided dealers by the National Hearing Aid Society. The panels returned highly critical assessments of the curriculum. The first question that we shall ask is whether the American hear- ing aid dealer is truly qualified to be the entry point for hearing `health care in the United States. A regulation now being developed at the Food and Drug Administration addresses this critical issue. What with national health insurance on the horizon, if the FDA, by regulation, institutionalizes the present hearing aid delivery system, it will likely be folded into any health insurance program adopted by the Congress. Right now, the Food and Drug Administration is dragging its feet in failing, for over 2 years, to take decisive action to mandate a loophole-free medical clearance policy for hearing aids. Instead, disregarding the safety and health implication pointed out by its own experts, FDA permits hearing aids to be merchandised in the same manner as shoes and ships and sealing wax. We are also concerned that, while the Federal Trade Commission has proposed a rule to ban door-to-door sales and to require a 30- day trial period, the followup with a final order making that policy stick has not been forthcoming. Too often in the past, that Com- mission has gotten cold feet after proposing an action, only to let the proposal die through protracted delays. During these 2 days of hearings, we shall take testimony from physicians, audiologists, public prosecutors, persons victimized by hearing aid dealers, and representatives of the dealer commumty. It is no secret that there have been numerous complaints against hearing aid dealers. Some of these complaints have been fully in- vestigated by subcommittee staff and found to he without foundation. Many others have been thoroughly investigated and raise significant questions about the ethics, training and professionalism of the hear- ing aid dealers involved. We shall also examine the way in which dealers are regulated by State licensing boards, in the States where licensing laws are in effect, to determine whether present State regulations truly protect the interests of the hearing-impaired. Without prejudging the evidence to be `presented, it is fair to say that this subcommittee would not have corninitteed as much time and resources to this investigation as it has unless it felt that a great deal more could be done to better serve the hearing needs of many Americans. Hearing aids are a blessing to those who can benefit from them. I am one who is fortunately able to use and benefit from a hearing aid. But there are others who have invested hundreds, even thousands of hard-earned dollars on these devices in a desperate attempt to hear better, only to find that no aid can hell) them. It is for those who can use an aid as much a~s for those who cannot that these hearings are convened. Our objective is to examine the the problems in the hearing aid delivery system so as to afford the best possible assurance of quality health care to hearing-impaired Americans. I think the subcommittee is fortunate in having the ability to draw upon a great deal of expertise in this field. Probably the single PAGENO="0009" 3 most common disability that has occurred in any of our armed services is a hearing loss. The Veterans' Administration has had long, ex- tensive experience in helping the hard of hearing who have a service- connected disability. Certainly, this disability has impaired the ability of our young people to adequately serve in every capacity in the armed services. There is great interest that has been created in this field with the increasing number of television stations that are now presenting audiovisual assistance to the hard of hearing. There were captions on the 11 :30 news in Chicago last night. The entire half-hour was fully captioned for the hard of hearing. We can see every single morning in Washington one of our stations here providing sign language assistance. The other night, we were moved when the recipient of an Academy Award spoke to her deaf parents through sign language, expressing her appreciation to them for their contribution to her career. These are not isolated phenomena. There are about 20 million Americans with some hearing difficulty and it causes problems within families. I can't help but recall that I had a blind piano teacher when I was 12 and once in an unthinking manner, I said to her: "Isn't it just terrible being blind?" She said, "No~ it is really not. I would much rather be blind than deaf." I said~ "Why?" I was startled. She said, "I have been blind all my life and I have never seen anything but kindness and goodness in people. People are universally kind to a blind person, but I have friends that are deaf and they experience much annoyance; people are sharp with them; they can't understand why they can't hear." I have personally experienced the problems of someone who is hard of hearing. I can say that members of my own family have, on oc- casion, become upset with me because they apparently thought I wasn't listening. Or, people pass me by and say good morning and I don't hear them. They think I am being rude to them. These hearings are for the purpose of trying to find out what we can do to improve this situation. It had been my hope that the hearings would be really unnecessary. I have had extensive meetings with the industry, and they recognized that better standards needed to be promulgated. We were told they were promulgated. Some were developed. But there is no enforcement mechanism. Some hearing aid dealers belong to a society which has voluntarily initiated reforms. But it lacks the ability to get members to comply. The society does not even cover all of the dealers. Thus, only a per- centage of the dealers, even if they were adhering to the voluntary code, would be affected. Therefore, there seems to be a growing need for ftnding a basis for complete fairness in the industry by developing mandatory stand- ards not unsimil ar to many other industries that we have had to reg- ulate. My first preference is to see if the industry copes with the prob- 1cm itself. Government has enough to do without getting into this field. But when 20 million Americans are affected by this physical disabil- ity and when I cannot honestly report to the members of this subcom- mittee satisfactory progress by either the Government regulatory PAGENO="0010" 4 agencies responsible, or by the industry itself, we have no alternative other than to take the time of the Senate and the time of our witnesses, to have these hearings. We certainly approach them with an open mind, seeking the truth, not trying to recriminate. We want to build a body of evidence as to what is the best approach. I don't see how this country can go into a national health insurance program if we know as little about some of the problems in other fields as we know in just this one narrow field. But it is hardly a narrow field for any one of the 20 million Americans that are so affected. I wish to express deep appreciation to our witnesses who have offered their services and have come to testify at great personal inconvenience to themselves and to their own work. Dr. Darrell Rose, who I will call as our first witness, director, audiology section, Mayo Clinic, Rochester, Minn., is here because he feels these hearings are important. He has a very, very heavy work schedule of his own; but I think his contribu- tion to our general knowledge will be very great indeed. Dr. Rose, we are prepared to move right ahead. You can give yOur testimony. I think, as a matter of standard procedure, though it may not seem necessary in a hearing of this kind, we will swear you in. Do you promise to tell the truth, the whole truth, and nothing but the truth, so help you God? Dr. RosE. I do. TESTIMONY OP DR. DARRELL E. ROSE, DIRECTOR, AUDIOLOGY SECTION, MAYO CLINIC, ROCHESTER, MINN. Senator PERcY. Dr. Rose, you can go right ahead with your testimony. Dr. ROSE. Mr. Chairman, my name is Darrell Rose. I am the direc- tor of Audiology at the Mayo Clinic in Rochester, Minn. I hold a B.S. degree from Brigham Young University, an M.S. degree from Southern Illinois University and a Ph. D. degree from the University of Oklahoma Medical Center. I am a member of the American Speech and Hearing Association, American Association for the Advancement of Science, Accoustical Society of America, and the American Insti- tute of Physics. I formerly served on the Professional Services Board of the American Speech and Hearing Association. I am concerned about the present delivery system with regard to hearing aids. It has been my experience that many of the systems presently in use in this country do not maximally benefit the hearing impaired. In the past 51/2 years we have tested over 100,000 people in the section of audiology at Mayo Clinic. We have encountered people who have been fitted with hearing aids which have been of no benefit to them. Some of these people have subsequently been helped medically and have not had further need for hearing aids. Others have merely needed a change in the hearing aid or a modification of the hearing aid that they had. It is not entirely uncommon for us to see people who were sold two hearing aids when only one aid would have been sufficient. We also have a number of documented cases in which a hearing aid has been PAGENO="0011" 5 fitted to an ear in which there is no usable hearing. We have encoun~ tered people with normal hearing who have been sold hearing aids~ which were of no benefit to them. This problem is not peculiar to Minnesota. Our data is obtained on people from all 50 States as well as from some foreign countries. We are presently using a delivery system which we believe gives the pa- tient the maximum opportunity for determining the medical cause and treatment as well as the potential benefit of amplification when deemed necessary. We function under the assumption that any hearing loss is a medical problem and should be diagnosed by an otolaryngologist. At the Mayo Clinic, any patient with a hearing loss is given an au- diological as well as a complete otological examination. Only when the patient has had a complete examination in which medical and surgical possibilities are discussed do we discuss amplification. Our procedure is to recommend amplification on a trial basis whenever a patient has a hearing loss that causes a communication problem. Our procedure is to recommend a rental for 30 days prior to the purchase of an instrument. This allows the patient the opportunity to determine if the instrument is helping the patient sufficiently to warrant the purchase. It has been our policy in the past to refer patients only to dealers who will rent hearing aids. Even with our procedure, patients often obtain an aid and pay for it prior to the 30- day period. However, they are cautioned to do this only if they have a money-back guarantee at the end of 30 days. With local patients, that is patients in Minnesota as well as some other areas such as Chicago, we have no difficulty with the patients being able to obtain hearing aids on a rental basis. A number of dealers such as the Master Plan Service Co. have a procedure under which the patient can obtain an aid on a 30-day rental basis. He pays for the ear mold as well as 1 month's rental. The rental fee is usually $1 a day, although this does vary. At the end of the rental period, the patient can either return the aid and forfeit his rental fee or he can apply the rental fee to the purchase price of the aid. It should be pointed out that the purchase price of the instrument from a number of local dealers as well as the Master Plan Service Co. is considerably below the manufacturer's suggested re- tail price. Over the past few years, we have developed a fairly substantial list of dealers who follow this procedure. However, the list is primarily made up of dealers who have contacted us or from patients who have mentioned specific dealers to us. Not all dealers in the local area are willing to either rent or sell at prices which we think are competitive. The advantages in the rental system are that, one, it gives the pa- tient an opportunity to try an instrument without expending a great deal of private funds while insuring that he will try the instrument because he has some money invested. Second, it protects the dealer from a significant loss if the aid is returned. It also assures the patient that he will receive adequate services and instruction from the dealer in the first 30 days. In slightly over a year, we have documented more than 40 cases in which patients at the Mayo Clinic have either been fitted inappropri- ately or for medical reasons should not have been fitted with a hearing PAGENO="0012" 6 aid or hearing aids. The majority of these `patients do not live in Minnesota. This number is by no means the total number of people who have been through the Mayo Clinic that have had such problems. The information have has been voluntarilygiven to u's in the audiology section or in the otolaryngology section. The most tragic case that comes to mind, however, does involve a man in his sixties from' Minnesota, who is a cemetery custodian. , From 1969 to 1974, he is able to document the purchase of 11 hearing aids for a total of $3,996. He indicates that he has purchased other instru- ~rnents from which he was told he would be helped; however, he' does not have canceled checks or receipts for these additional aids. He also indicates that he once traded in his model A or model T Ford to obtain two hearing aids.' It is obvious that this gentleman is desperate for better hearing; however, with the type of hearing loss that he has, he cannot benefit from surgical or medical treatment and additional hearing aids will `be of no significant benefit to him. There are many instances in our files of individuals who have been sold hearing aids for an ear in which they have no ability to discrim- inate speech and where the other ear is essentially normal. We are seeing an increasing number of individuals who are sold all-in-the-ear hearing aids for which they will not receive the maxi- mum possible benefit. At the present time, it appears to me that people are purchasing all-in-the-ear hearing aids because of the cosmetic and not because of their acoustic characteristics. Ironically, even within the Mayo Clinic we have an individual who has been sold a hearing aid inappropriately~ This gentleman was em- ployed at the Mayo Clinic in a nonprofessional status. He had essen- tiallv normal hearing with a slight drop at 4~OOO Hz and normal speech discrimination and speech `reception threshold. He was sold a hearing aid. After wearing the aid for 2 weeks, he returned it to the dealer and complained that the hearing aid did not help. The dealer sent the aid back to the factory for repair. After receiv- ing the aid back, he still could not tolerate amplification. He took the aid back and tried to get his money back. The dealer would not give the money back because the purchase occurred more than 1 month earlier, despite the fact the aid had been to the factory for over 2 weeks. Subsequently, the man came to the Audiology Section of the Mayo Clinic and it was confirmed that he did in fact not need a hearing aid. Subsequently, in Small Claims Court, he was awarded a full refund. The previous two cases are individuals from Minnesota. To give some indication of the national scope of the problem, I would like to briefly discuss patients from three other States. First is a 61-year-old man from Kentucky who was sold an all-in- the-ear hearing aid for an ear that was essentially without hearing. Second is a case of a man from Montana with essentially normal hearing who was sold binaural hearing aids. When asked if the hearing aids were of any benefit, he replied, "They are of no damn good to me." Third, we have three cases from Michigan in which the individuals had essentially no usable hearing in one ear and relatively good heariI~g PAGENO="0013" 7 in the Other ear, but were sold hearing aids `for the poorer ear. They received no benefit from these aids. These are only a few of the cases that wehave documented. At the present time, in this country, we are faced with a number of basic pilôsophical and ethical questions regarding the various heai~ing aid delivery systems. My point of view is not consistent with that of the American Speech and Hearing Association or with that of a number of hearing aid manufacturers. . . I am of the opinion that a hearing aid loss is a medical disease and must be diagnosed by an otolaryngologist with the aid of the audio- logical tests. However, I do not believe it would be in the best interest of the patient for either an audiologist or an otolaryngologist to dis~ pens~ hearing aids, even under the guise of a nonprofit system. The present practices being conducted by a number of audiologists and otologists under the guidelines of the American Speech and Hear- ing Association's Code of Ethics allows the patient to be charged for "a hearing aid evaluation as well as followup rehabilitation." Prior to ASHA's Code of Ethics emphasis, it was not always corn- mon for the audiologists to conduct the hearing aid evaluation or the rehabilitation in the same manner that they presently charge for. Now, these additional charges bring the price of the complete package, in- cluding a hearing aid, up to nearly the same as the dealers' suggested retail price. I am aware that a number of audiologists suggest that only with this hearing aid evaluation and rehabilitation procedure can the p~- tient fully benefit from a hearing aid. It is my opinion that much of the hearing aid evaluation and rehabilitation conducted by audiologists dispensing hearing aids is of little value to the patient. Our procedure is to refer patients who have an audiological and otological examination to the dealer who will rent and sell for a reason- able price. The average price of a hearing aid sold by some dealers that we refer to is about $225. This does not include the otologist's or audiologist's charge. These prices were established by the dealers with- omit any suggestions from us. In view of the work done by the dealers and the cost of operating their facilities, these prices seem to be reason- able prices to me, although I do not profess to be a marketing expert. In Minnesota, the consumer protection law does not allow the audi- *olog~st to dispense hearing aids. Under this law, it is a1so~ umirdatory that anyone over the age of Go and under the age of 18 receive physician's or audiologist's recommendation before an aid caii be ~ ui- chased. People between the ages of 18 amid 60 can purchase an aid without a medical or audiologic recommendation if they sign a waiver. Although it has been stated to the contrary, we have no evidente that the number of people receiving quality medical care in the State of Minnesota has decreased. Even with the law, we have seen a few in- stances in which hearing aid dealers have sold hearing aids to people over the age of 60 without medical recommendation. We have also seen a number of cases in which individuals between 18 and 60 have purchased hearing aids which were of no benefit to them. However, it is my opinion that the law has been beneficial to some hearing-impaired individuals. The problem with the law is itis difficult to educate people amid to enforce. PAGENO="0014" 8 I also am concerned with the present attempts which allow hearing aid dealers to test as a diagnostic procedure. They are not trained for such procedures, nor can they carry out these procedures without a conthctof interest when fitting a hearing aid. One thing I am certain of is that the hearing-impaired individual is not being maximally helped by the continued bickering and the pub- licity that is brought about every time a State attempts to pass a law, whether it is for licensing dealers or audiologists or every time a new Senate investigation is started. We who are interested in the hearing- impaired must settle these issues to the benefit of the impaired and stop putting our so-called professional ideals or financial gains ahead of the individual who has a hearing impairment. This continued polarization, if allowed to continue, may seriously hamper the development of efficient and effective delivery systems. Senator PrnCY. Thank you very much indeed. I would like to mdi- cate that these hearings have been made possible as a result of very close cooperation between the majority and the minority counsels and ~staffs. Because many of the Senators on this subcommittee are involved in other hearings today, I am going to call upon, at the end of my own questioning of each witness and panel, the majority counsel and mi- nority counsel for any questions that they would like to ask. First, I would like to thank you again for being with us. Why do you feel it is that people-or do you feel that people with a hearing loss are generally reluctant to wear a hearing aid? What is the psycholog- ical difference between a hearing aid and a pair of glasses, when no one has the slightest hesitancy about wearing glasses? What is the dif- ference? You have worked in this field how many years? Dr. RosE. Since 1960. Senator PERCY. So you have got 16 years experience in the field. Dr. ROSE. I think we are seeing a lot of change in acceptance of a hearing aid in the last 10 years. There has been an almost complete turn about. When you would mention hearing aids to people who had a hear- ing impairment would immediately give you a negative reaction. How- ever, presently, I don't see this as much. Senator PERCY. As much? Dr. ROSE. Yes. Senator PERCY. Compared with eyeglasses? Dr. ROSE. There is no question that there isa greater stigma to wear- ing a hearing aid and the reason is I think because so many people wear glasses. Everybody you see wears them. So pretty quickly, it is, * I guess, the vogue to have glasses. Senator PERCY. Do you have any idea, out of the 20 million hearing impaired estimated, roughly what proportion could receive benefit from a hearing aid? Dr. ROSE. I am not, I think, in a position to answer that. I some- times get confused as to where the statistics come from. Let me say this, though, that people who have a communication problem because of their hearing, the majority of them can benefit from amplification. Senator PERCY. Let us say there are 20 million with hearing im- pairment. If 10 million people wore hearing aids today, do you think the reluctance of those not wearing them would be less? I can tell you why I was reluctant to wear one. But I want to hear you say it. You are the expert. PAGENO="0015" 9 Dr~ RosE. You can't see a hearing loss. It is hard for .a person with normal hearing to experience a hearing loss unless he plugs his ears or some such thing. When he does that, it is to benefit him, not to his detriment. But you can see a visual problem. It is not at all hard to develop a visual problem. In the dark, you don't see well. You understand' the problem. I think it is just a problem of education. I think people do not understand. Senator PEIioY. Let us take the average person who has a hearmg impairment and has never pursued it to see what could be done about it. Don't they begin to suspect the loss when everyone around them laughs at a line and they didn't hear what was so funny, and the television set has to be turned up a great deal more and other members of the family say, "Turn it down, it is too loud," even though the handicapped person needs it at that high volume? They will sit there with it turned down and won't catch the words at all but do nothing to help themselves. Yet when they can'tsee well, they immediately get glasses. 1-Tow long does it take them to really get around to feeling they need a hearing aid? Dr. RosE. We face another problem here which I think is quite dif- ferent from glasses; that is, if a person has a visual problem as do most of the people who wear glasses, I guess all of the people who wear glasses, their vision is considerably better. You put on a pair of glasses, my vision is 20-200 without them, 20-20 with them. I wouldn't be without them because I am helped a great deal. No one ever told me glasses wouldn't help me. My glasses are home in the top dresser drawer. For the person who has a hearing loss, many times amplification is not an immediate thing which is very helpful. With a person who has no problem with discrimination, they can put a hearing aid on and do quite nicely. But the person who has real pathology in the inner ear, puts amplification on, sound is not there, then all of a sudden it is there, bang, and it is not a comfortable thing. Many people don't adjust to it. If somebody says he has got a hear- ing loss and some one tells him, "Don't get a hearing aid. It isn't going to do you any good." That has to be a negative psychological effect.' As a matter of fact, in 1964, we did a survey of a number of people who had hearing aids. As I recall, out of 300 and some that had pur- chased hearing aids 2 years previously, half of them were not wearing the hearing aid because they said they didn't get any benefit from them. I think that is the type of advertisement that gets around very rapidly. Senator PERCY. Is it the cosmetic effect, or a psychological problem? Children do not seem to have a problem wearing glasses. But there are hard-of-hearing children that should wear a hearing aid, yet have a terrific reluctance to do so. Dr. RosE. There is no question about that. There is a great psycho- logical barrier. We see it with teenaged children, especially. Hearing impaired children who will wear a hearing aid very nicely up to 10 or 12 years of age, then they don't like the body aid they have. They want the ones that fit over the ear. We sometimes just don't have that for them. Many times they won't wear anything. PAGENO="0016" 10 Senator PERCY. You heard the old story about the Japanese hearing aid for $2, didn't you?' It is an ingenious device. I am surprised you `don't know about it. It is an 18-inch cord with hooks at either end. Y ou put one hook over the ear, drape it across the lapel, put the other here and when you put it on, you will be surprised how much louder people will speak to you. There is a lot of truth in that. I have always felt that, because people mumbled, I couldn't hear well. When I put my hearing aid on, I found people speak up. In fact, a rather intimate relationship develops with a lot of people. They `lean' over and speak right into your ear almost. But it helps me in-i- mensely to have them speak up a little bit more. If' is just like someone with a broken leg. You are going to help them. An aged woman, yOu are going to help her. A blind person, you are going to help him. This is no different. It is a physical disability like anything else, and you need help. Very iñtèlligeiit'people are extremely reluctant to get a hearing aid. There arO a lot of deaf people in the U.S. Senate, including Senators. I was the first Senator in my term here to ever wear a hearing aid and my hearing wasn't worse than some of my other colleagues. Once' I put it on~ `I had the' wives of two Senators come to me and say,' "Can't you get John to get a hearing aid? He needs one terribly. I am `encouraged that you have one." Six Senators, since then, have gotten hearing aids. They have had the courage to do it because someone else led the way. One of the hopes `I have from this hearing is that we are going to try to overcome that reluctance. But the interesting thing is when the Reader's Digest was preparing an article on this problem, they called and asked if I would `mind their printing that I had a hearing loss and wore a hearing aid. Somehow they felt it was a sensitive issue and asked if I would mind if they' published that: fact. I said of course not. I was happy to say `that I wear an aid. I broadcast it so people, when they see me, won't think that I am snubbing them when they say hello and I don't hear them. What accounts for the last 10 years of progress? Have manufactur- ers and dealers done a better job of promoting the idea that there is help that you can get and that you should come in and see whether or not an aid will help you? Dr. ROSE. I think the educational processes have advanced tremen- dously. I don't think they are where they should be yet, but I think they have advanced considerably. We still see people who have seen their physician who has told them don't get a hearing aid, it won't help you. But generally, I think the medical profession has led the way in rec- ommending amplification. The industry has done a tremendous job. I `think the majority of dealers have done a good job of advertising the fact'that hearing aids will help. I think another thing which we have found to be very beneficial to get people to wear amplification is the rental procedure. They will come in and say I don't want one of those things on. We' will say you can rent it for 30 days and find out how much it helps; see if it helps enough to warrant the purchase. Over 90 percent of them buy the aid after they have rented them. Some don't. PAGENO="0017" 11 Senator PERCY. My own impression is some manufacturers have done a very good job, and some have done a miserable job. Some hear- ing aid dealers have done an outstanding job, some have done a miser-. able job. My tendency always is to laud those who do a good job and remain silent about those who don't do a good job, or communicate privately to them. But I amgoing to start calling a spade a spade. I am going to start right on the floor of the Senate and in these hearings talking about those that I feel, from the evidence we have, have done an outstanding job, and those that have done a very bad job. I feel the witnesses can do tire same thing. When you have been stung and burned by someone, say so. But I want solid, concrete evidence, and everyone is under oath when they testify here. We have to reward those who have done air outstanding job, to avoid their being dragged down by the relatively few that are a discredit to the industry and a discredit to the profession. You are dealing with people's well-being and ability to contribute to society. I think it is an important matter. You mentioned the cost of $215? Dr. ROSE. $225 is our average number. Senator PERCY. That seems less than the cost figures at the retail level that I have seen before. Could you comment on whether in your judgment that is less and, if so, what the cost ranges are and why. in your own experience, these costs are considerably lower than those of which I am aware? Dr. ROSE. I think there is no question that the reason that the costs of hearing aids in our area are less is because some dealers felt that by the means of a direct referral-that is, they don't have people out selling door-to-door, they don't have the selling expenses. The majority of patients are referred from our clinic to local dealers-they have reduced the price. I think it is a healthy sign of competition when they do this. There is one organization in Minneapolis, the Master Plan Service Co., who followed the lead of the dealers in our area and reduced their prices tremendously. I think the reason that hearing aids cost as much as they do is the means of distributing them. I think door-to-door selling techniques require a pretty high payoff for the person who is doing the knocking on the doors. I am not sure that there is enough money available to get me to do that type of work because I don't function well that way. I think that is the main reason they are as high as they are. We have hearing aids that are sold as low as $179 and I believe some are as high as $269. I am not 100 percent sure of those numbers. But these are the ranges that some of the dealers in the local areas price their aids. Those are the ones that we refer to. Senator PERCY. Is it simply that possibly the manufacturers and dealers know there is a huge market of people who need aids, yet few come in, even though they happen to have the best hearing aid in the world? So they have got to beat a path to the individual and try to seek them out. Obviously, this is a very costly method of distribution. 79-9~4---76-------2 PAGENO="0018" 12 Wouldn't the distribution costs be less and, therefore, the cost to the consumer presumably less, if there was far more public information and awareness of the kind of assistance that may sometimes be gained from a hearing aid? Dr. ROSE. I think there is no question but that we need to educate the public with regard to hearing impairment, not only hearing aids but also the medical and surgical aspects of it. The education with regard to hearing impairment is almost non- existent. As you indicated, there are TV stations who are picking this up and about the only time that you really read a lot about hearing aids, is when the U.S. Senate has an investigation or the State legis- lature decides to license hearing aid dealers or audiologists. Then what we hear is just multitudes of bad material, how terrible they are, how vicious hearing aid dealers are. It brings to light the bad aspects. There are many people. We saw 1,230 people last year on whom we recommended hearing aids. There were only about 40 of the people-this was not all of the people-but about 40 of them who really had been burned. That certainly is not a large majority. I was not impressed with the number of the other fittings we had, but we certainly couldn't call them bad, you know, totally bad fits, I think a bad fit file is a terrible thing to have to keep. Every time I put a patient's name and number in the bad fit file, for some reason I don't feel good about it, because I don't think it helps the majority of people to know that there are people who are victimized. I think that there has to be a solution to that problem. We haven't been able to do it locally in our State, even though we have probably the best consumer protection law, as far as I know, in the United States. We still have people who are victimized. There is by no means a realistic system that allows people that have been victimized to get their money back. People who have written to the Attorney General and said, "I have been victimized, what do I do? Back comes a letter from our Attorney General which says, "Go to conciliation court." Immediately the elderly people say there is no way they are going to get me in court because there are attorney's fees and everything else which will amount up to more loss. What they don't know is for $5 they can go to Small Claims Court and have a judge hear the case and award them a proper decision. There is no enforcement at all. There are no teeth, as I see it, in the enforcement of an ethical delivery of hearing aids. We have people selling hearing aids who have by their own admission essentially no education. I don't think that we can continue to have that kind of a delivery system. I think we have to get people to the otologist, who is the medical doctor, to diagnose and treat ear disease. With the test that he gets, and audiologists generally do them, they can determine the diagnosis and assist in the proper recommendation. But I think for a person to go directly to a hearing aid dealer to get a hearing aid is not what we want. It certainly isn't what I want. Senator PERCY. I think you have put right into perspective and balance exactly what I hope to be the outcome of these hearings. We have several objectives. First, a public hearing does provide a PAGENO="0019" 13 format that, for good or evil, and in this room we have had it both ways, has an impact. It has access to media that is not available many, many times by an industry acting on its own. So there can be a great deal of dissemination of public information. I would hope that millions and millions of people would know that we are concerned about this problem and want to help them. Second, this could be a hearing that would discourage some people from going for help if we only dwell on the abuses, if we talked about the ripoffs. That would be exactly the opposite of what I hope would occur. But we want people to know that there are differences in the quality of service offered by different dealers, a difference in quality of product, service, and backup offered by manufacturers, and that there is a range of options from which they can choose. They ought to shop carefully in this field, as in all other fields. If they get stung, there ought to be some way that they can either have it rectified or prevented. The system of renting hearing aids followed by the Mayo Clinic sounds like a good way to make certain that the buyer and seller are equally committed to making the aids work. To your knowledge, do many dealers around the country follow this policy? Do you know if the National Hearing Aid Society endorses this particular system? Dr. BOSE. I am not sure of how many dealers follow such a policy. There are quite a number of dealers. I dare say it is less than a fourth of the dealers that rent prior to purchase, although that is a guess on my part. It is my understanding that the National Hearing Aid Society has included the rental system in one of their four recommendations, although to be perfectly honest, I have not seen it in writing, that they have approved this. I don't know what the procedure is they go through to approve such a system. The problem that bothers me about the National Hear- ing Aid Society's four point program is twofold. One, is that it really attempts to eliminate the need for a careful medical examination and audiological examination prior to the purchase. Their seven steps as I read them are not a valid reason to not go to a doctor. There are a number of fallacies, I think, in that which I won't take the time to mention now. But I think the thing that we have got to keep in perspective is that hearing loss is a medical problem and that a medical person has to first diagnose the problem before we put a hearing aid on the individual. Again, second, I am not sure that the National Hearing Aid Society and their four point program has been adopted, but if it has, it is my understanding that those who belong to the National Hearing Aid Society are a very small minority of the dealers. If they had an ironclad guarantee that a person could get his money back, we are still dealing with just a very minor portion of the people who are the entry point at the present time to the hearing impaired. I think that is not adequate. Senator PERCY. Recently, the American Speech and Hearing Associ- ation changed its policy to allow audiologists to sell hearing aids. PAGENO="0020" .14 Could you comment specifically on what your judgment is of this new- policy? Mr. CorrIN. Before you do that, .1 would enter as exhibit :No. 1 the Code of Ethics of the American Speech and Hearing Association. Senator PERCY. Without objection, it is so ordered. [The document referred to was marked "exhibit No. 1" for reference. and follows:] EXHIBIT No~ 1 CODE OF ETHICS OF THE AMERICAN SPEECH AND HEARING ASSOCIATION 1975 (Last revised January 1, 1971) PREAMBLE The preservation of the highest standards of integrity and ethical principles is.: vital to the successful discharge of the responsibilities of all Members. This Code of Ethics has been promulgated by the Association in an effort to highlight the fundamental rules considered essential to this basic purpose. The failure to specify any particular responsibility or practice in this Code of Ethics should not be construed as denial of the existence of other responsibilities or practices that are equally important. Any act that is in violation of the spirit and purpose of this Code of Ethics shall be unethical practice. It is the responsibility of each Member to advise the Ethical Practice Board of instances of violation of the. principles incorporated in this Code. Section A. The ethical responsibilities of the Member require that the welfare of the person he serves professionally be considered paramount. 1. The Member who engages in clinical work must possess appropriate quali- fications. Measures of such qualifications are provided by the Associations program for certification of the clinical competence of Members. (a) The Member must not provide services for which he has not been. properly traiiied; i.e., had the necessary course work and supervised practicum. (b) The Member who has not completed his professional preparation must not provide speech or hearing services except in a supervised clinical practicurn situation as a part of his training. A person holding a full-time clinical position and taking part-time graduate work is not, for the purpose of this section, re- garded as a student in training. (c) The Member must not accept remuneration for providing services until he has completed the necessary course work and clinical practicum to meet cer- tification requirements. The Member who is uncertified must not engage in private practice. 2. The Member must follow acceptable patterns of professional conduct in his relations with the persons he serves. (a) He must not guarantee the results of any speech or hearing consultative or therapeutic procedure. A guarantee of any sort, expressed or imnplie(l. oral ci \\utten is (onti'li% to piofcssiomi ml et mics ~ ium~on'tb'c s~ t mnunt of P ( a may be made, but successful results are dependent on many uncontrollable factors, hence, any warranty is deceptive and unethical. (b) He must not diagnose or treat individual speech or hearing disorders by correspondence. This does not preclude follow-up by correspondence of individuals previoushv seen, nor does it preclude providing the persons served professionally with general information of an educational nature. (c) He must not reveal to unauthorized persons any confidential information obtained from the individual he serves professionally without his permission. (d) He must not exploit persons he serves professionally: (1) by accepting them for treatment where benefit cannot reasonably be expected to accrue; (2) by continuing treatment unnecessarily; (3) by charging exorbitant fees. 3. The Member must use every resource available, including referral to other specialists as needed, to effect as great improvement as possible in the persons he serves. 4. The Member must take every precaution to avoid injury to the persons he serves professionally. PAGENO="0021" 15 Section B. The duties owed by the Member to' other professional wor~e'rs are ninny. 1. He should seek the freest professional discussion of all theoretical and practical issues but avoid personal invective directed toward professional coI~ leagues or members of allied professions. 2 He should establish harmonious relations with members of other profes- sbus. He should endeavor to inform others concerning the services that can be rendered by members of the speech and hearing profession and in turn' should seek information from members of related professions. He should strive to in- crease knowledge within the field of speech and hearing. 3. He must not accept fees, gifts, or other forms of gratuity for' serving as a sponsor of applicants for clinical certification by the American Speech and. Hearing Association. Section `0. The ASHA Member has other special responsibilities. 1. He must guard against conflicts of Professional interest. (a) He must not accept compensation in any form from a manufacturer or' a dealer in prosthetic or other devices for recommending any particular product. (b) The Member in private practice must not advertise. It is permissible `only to employ a business card or similar announcement, and to list on&s name, highest academic degree, type of services, and location in the classified section of the telephone directory in the manner customarily followed by physi- cians and attorneys. He may state that he holds the Certificate of Clinical Com- petence in the appropriate area (speech pathology and/or audiology) issued by the American `Speech and Hearing Association. (a) He must not engage in commercial `activities that conflict with his responsi- bilities to the persons he serves professionally or to his colleagues. He must not permit his professional titles or accomplishments to be used in the sale or promo- tion of any product related to his professional field. He must not perform clinical services or promotional activity for any profit-making organization that is engaged in the retail sales of equipment, publications, or other materials. He may be employed by a manufacturer or publisher, provided that his duties are consultative, scientific, or educational in nature. 2. He should help in the education of the public regarding speech and hearing problems and other matters lying within his professional competence. 3. He should seek to provide and expand services to persons with speech and hearing handicaps, and to assist in establishing high professional standards for such programs. 4. He must not discriminate on the basis of race, religion, age, or sex in his professional relationships w-ith his colleagues or clients. Dr. ROSE. The American Speech and Hearing Association, after considerable debate on the part of some of their members, have ap- pioveci a system in which an audiologist can dispense a hearing aid at cost. I think that there are a number of bad aspects to this. No. 1, I am not `sure what it does to the free enterprise system of our country if we have physicians and audiologists dispensing hearing aids at cost. I am not sure we will see the things that the free enterprise system has brought to us. That may be a minor timing. But I think it is some- thing we need to look at. The second thing is that I am afraid this brings into play a new type of hearing aid evaluation procedure. The audiologist now does a different procedure because lie can be paid for his services, but not the instrument. The new procedure that is used and the price that is paid for it is rather substantial. `The patient theii has a followup procedure which in theory is excellent, a rehabilitative aspect which is excellent, except that not many people need to go through this rehabilitative aspect. It is my impression that leoPle are going through this procedure whether needed or not. PAGENO="0022" 16 I shouldn't say not many, but especially those who have purchased a hearing aid and are now on the second hearing aid. They usually know as much about what the hearing aid and what they can expect from. it as does an audiologist. I am concerned about the at-cost delivery system because I think it is bringing into play some things which ar& not particularly beneficial to the hearing impaired. I think we are looking at the benefit to an audiologist. I don't believe that is the scope of this meeting. I don't know a lot of otologists and. audiologists that are suffering too much. I think it is the hearing impaired we need to be concerned about. Granted they can get an aid slightly cheaper; although not a great deal by going through this at-cost procedure, because the cost of a hearing aid evaluation and the followups pretty muc~h boost the price of the aid backup. If it is necessary an audiologist should be able to determine this,. then I think they should go through the steps whether the audiologist is dispensing the hearing aid or whether the hearing aid dealer dis- penses the hearing aid. Senator PEROT. Several audiologists have told subcommittee staff that various hearing aid manufacturers will invite audiologists to their factories to promote their products and pay for travel expenses.. Can you tell us what you know of this practice and comment on. whether it raises ethical questions now that audiologists can actually sell hearing aids? Dr. ROSE. I guess in the course of business activities it is not uncom- mon for people to take people to hunting lodges or foreign countries.. It is primarily for the purpose of inducing a sale, as I understand it.~ It is beyond my ability to rationalize trips, whether they be to Den- mark or to Phoenix; being from Minnesota, sometimes Phoenix seems a little more of a temptation than Denmark would be, but I don't un- derstand how professionals can go on these trips and then come back from the trip and be objective about the aid that he recommends. My position on this type of behavior has been expressed several times to the executive secretary and to the Ethical Practices Board of the American Speech and Hearing Association and it is my judgment that the association's policy has not changed and it appears to be ignoring the issue. I think it does bring up some rather serious professional, ethical questions. I guess I am not in a position or I guess I am a poor one to talk about how one goes about preventing this. The fact that invitations are extended say something to me about the ethical practices of the businesses. We know that it has happened. There have been audiologists that have traveled to foreign countries and also to places here in the United States to visit the factories and I think it does bring to the fore a very, very serious ethical problem. I would hope that if legislation is ever passed that includes Federal funding of hearing aids for the elderly, especially those individuals who participate in these business activities, both aucliolog~sts and man- ufacturers, should be excluded from the delivery system. I don't have the slightest doubt but that it will cut down on travel of some audiologists and the amo~mt of travel funds that are budgeted by manufacturers. I think it is a terrible example of professional ethics. PAGENO="0023" 17 I am very much opposed to it. I have had opportunities to go. I have been invited both to Phoenix and to Denmark. I have declined both invitations. It hasn't bothered me a bit to decline them. They seem to be able to fill the seat. Senator PERCY. What do you think the Federal Government's role should be with regard to the hearing aid delivery system? Dr. RosE. I think when we talk about the Federal Government's role, I think the first thing that we have to bring into play is the educational aspect. I think we have got to have some means, and it appears that it will have to be the Federal Government to educate the public with regard to hearing impairment, both medical and surgical as well as the amplifica. tion and rehabilitation methods. I think we need to assist, or need to have some more assistance, in the detailed study with regard to the specific value of the rehabilitative process that we are talking about. There are many who question the value of the rehabilitation proce- dure that I have mentioned. I am afraid that a number of these reha- bilitation programs, especially their merit, have to be clearly spelled out. I think this is especially true of the so-called successful VA and mil- itary programs. I appreciate the fact that in other testimony, the American Council of Otology have spoken of the high regard for the program of Walter Reed and they describe it as a 4- to 6-week pro- gram. It is my understanding that Dr. McCurdy is here today. He may well want to speak to this. But in trying to find out what that program is, so I could implement the good parts of it, I find I can't find a 4- to 6-week program. I have a hard time finding out what it would entail for a 4- to 6-week program. I think we also have to establish guidelines for people to follow when they are entering the system for the hearing impaired. As I stated previously, I think any alternative to the otologic and audiologic examination, by people who are incompetent to conduct these examinations, is unsatisfactory. I don't think hearing aid dealers are competent to do otologic and audiologic evaluations. By the same token, I strongly favor the position in which the otologists and audiologists stay out of the dispensing busi- ness. I think we have to institute some legislation that has adequate pen- alty for selling abuses. I am impressed with some aspects of the Federal Trade Commis- sion's guidelines. I think they will cut down on the number of the sell- ing problems that we have if they are implemented. Senator PERCY. Have you studied the revised proposed medical clearance procedure supported by the hearing aid task force of the Department of Health, Education, and Welf are, and, if so, what is your opinion of it? Mr. COTTIN. Again, before you respond, Dr. Rose, I would like to enter that report as exhibit No.2 in the record. Senator PERCY. The entire thing? Mr. COTTIN. Yes, sir. Senator PERCY. Without objection, it is so ordered. PAGENO="0024" 18 [The document referred to was marked "Exhibit No. 2" for reference and may be found in the files of the subcommittee.] Dr. ROSE. I am not sure I am clear on what aspect of that. I cer- tainly have not read that entire document. Senator PERCY. But you are generally familiar with it? Dr. ROSE. Yes. I have breezed through parts of it. Senator PERCY. This just pertains to the proposed medicai clearance procedure. iDr. ROSE. The role that I have seen outlined, and the letter that is implemented by Dr. G-lorig and Dr. McCurdy regarding the American Council's procedure, I think, is not adequate. It puts in the hands of the hearing aid dealer the right to make the decision whether or not further medical help is needed. I realize that they include, as I recall, three screening questions. "Has your ear drained since you were last seen by a doctor?" "Has your hearing suddenly got worse?" I believe the last one is, "Have you been dizzy?" What I really object to, and I think all three of them are weak be- cause I think when you take someone who has no medical training and you ask him to screen people with these three questions or the seven that are presented by the National Hearing Aid Society, you are ask- ing someone who doesn't have any basis of making a decision to make a medical decision or a medical diagnosis. I think if you will take the second one, that is, "Has your hearing gotten suddenly worse?", a person can have a mild loss on one side and a moderate loss on the other side, wear a hearing aid on the good side and lose all of his hearing in the other side and never be aware of it. When he goes in and the dealer asks him, have you had a sudden hearing loss? The answer is very legitimately, "No; I haven't had a sudden hearing loss," because lie doesn't know he has had it. I think this is especially true with people who wear a hearing aid on one side. They are rarely not aware of what is going on in the other ear because that is not the ear they use. I am not impressed with any procedure which will remove the physi- cian as the prime deliverer of hearing health care. In talking with Dr. Lindsay Pratt-I just talked to him day before yesterday-and Dr. McDonald of our staff, who is on the committee that theoretically went over there recently, they are opposed to this type of thing. I don't understand the mechanism that gets this type of thing into public record, but I know both of those people Dr. Pratt and Dr. Mac- Donald were indicating that they feel the physician is the prime per- son and should be the entry point for a person with a hearing im- pairment. Senator PERCY. Dr. Rose, with respect to the adequacy of delivery systems, what is the capacity of the medical profession and how many otolaiyngologists are there? You say you required a prescription from them for a hearing aid. What would be the ability of the profession to provide the kind of delivery that it might be called upon to offer? Dr. ROSE. I don't know how many otologists there are. But let me say this: I am relatively sure that we don't want them to prescribe a PAGENO="0025" 19 hearing aid. I think what we want the physician to do is to give a medical clearance for one. `I think there is a considerable difference there. I would expect that like most other problems that if we need a phy- sician's `approval, we can get one. I don't know the number of otolo- gists. It is my understanding, as I recall in the letter it indicated ap- proximately 5,000 in the United States. I haven't run onto anyone who said, "I can get to an otolaryngolo- gist." I was raised in the remotest areas of Idaho and even out there people can get to an otolaryngologist. There may be places in this country where a person can't get to one, `but I don't know where they are. I expect the otolaryngologist can handle the situation. Senator PERCY. Where could this subcommittee obtain a map to see where they are located? Dr. RosE. I am sure the American Council will be happy to supply you with one. I assume they have that information. Senator PERCY. Do you know Dr. George Shambaugh? Dr. ROSE. Yes. Senator PERCY. He is presently at the American Research Hearing Foundation. Can you tell the subcommittee what the objective and purpose of the foundation is? Dr. ROSE. I cannot. I am familiar with part of it. But I can't tell you the overall scope of the foundation. Senator PERCY. Dr. Shambaugh has had a theory that a certain amount of hearing loss comes from a loss of calcium in the bone. Would you care to professionally comment on that? Have you pre- scribed that or is it in general prescription, or is it a particular area of research that Dr. Shambaugh has specialized in and for which treat- ment is not now generally prescribed? Dr. RosE. I am not a medical doctor. As a result. I haven't pre- scribed anything. However, it is not uncommon at the Mayo Clinic for otologists to prescribe the sodium fluoride and calcium gluconate. It is my understanding that it is helping a number of people. There is still some controversy as to how, just how extensive the disease they are treating with this prescription is. Senator PERCY. For those for whom it is prescribed, is it a fairly simple procedure to follow to at least arrest hearing loss and possibly even bring improvement? Dr. Rosu. I think it would be safe in saying it arrests, but I have no personal evidence of people whose hearing has recovered from this. I think it is a process which may arrest the disease process. This is strictly subjective on my part because I am not an authority in sodium fluoride. Senator PERCY. I have had a number of sessions with Dr. Sham- baugh and have been interested in his foundation. Of course, I am anxious to further research in the field. I would like to turn to our chief counsel, Mr. Feldman, and express appreciation to him, to Keith Adkinson and David Vienna for the assistance and help that they provided in these hearings. Mr. FELDMAN. Thank you, Mr. Chairman. Senator Nunn has other duties today, as you know, because of the committee schedule. Therefore, we just have a couple of questions. PAGENO="0026" 20 Basically, I think you covered it in your last round of questions. I think this is critical because.I know the way we have operated before. We want to focus on conclusions or recommendations. The question that did strike me, Mr. Chairman, is the question of a prescription device and the number of qualified doctors who could carry out the types of examinations that you have been describing. I think this is critical since we can make all the recommendations in the world but if they can't be implemented it is not going to help much. My question again, for the record, do you favor having hearing :aids as prescription devices?. Is that your recommendation? Dr. ROSE. The reason is when I think of a prescription, I think of something which will cure something. I think of something which is precise. The fitting of a hearing aid is an art. It is not a science. Be- cause of that, I think it would be a mistake to make a prescription for *a given or a specific hearing aid. I think that is why I prefer the medical clearance. I couldn't pre- scribe a hearing aid, even if I were a medical doctor. I couldn't pre- scribe a given hearing aid. I could make some general recommenda- tions. But I couldn't prescribe an aid. Mr. FELDMAN. This follows up on the question that Senator Percy asked and perhaps it would be illustrative of a problem. I wear glasses, obviously. Many people wear glasses. Personally, I would not think of going to an optician without first going to an eye doctor to get my eyes checked to determine if there is any disease or defect. I think this is what Senator Percy is talking about in hearing aids. Do you see a difference in eyeglasses versus hearing aids? Why should you go through the procedure with hearing aids and not go through the same procedure with eyeglasses, where there might ~be diseases and defects also? Dr. RosE. You are right. I can't tell you much about the eye. The thing that. I am vitally concerned about is people will purchase hear- ing aids when in fact they have a serious medical problem which could be corrected. I think unless we educate people and move them in that direction, that we are doing less than the maximum for the hearing-impaired ~population. I know people who can buy glasses without going to get their doe- tor's OK. I guess I would probably be opposed to that because I think, again, you can run into the same problem. I think there is more con- trol with the distribution of eyeglasses than there is for the distribu- tion of hearing aids because there are essentially no controls on the distribution of hearing aids. Anyone can sell hearing aids, but I don't believe anyone can sell eyeglasses. I think there are some protective measures built in. Whether or not they are strong enough. I haven't the vaguest idea. Mr. FELDMAN. Finally, Mr. Chairman, if we could ask each of our qualified witnesses today to prepare a list by geographical distribution of qualified physicians who could make these evaluations. I think it would be of the utmost help. It will be important when we make our final recommendations if we can show that, yes, we do have qualified people, for instance, in, say, the rural areas of Idaho that an individual could go to. . PAGENO="0027" 21 What crossed my mind in reading your statement, Dr. Rose, is ~*here someone from rural Wisconsin, your neighboring State, would go. Dr. RosE. In jest I would suggest they just come over to the Mayo Chrnc. Mr. FELDMAN. Not if they are in upper Michigan. If that individual doesn't have access to a doctor, are we penalizing him if there is a qualified hearing aid dealer who might be able to assist him? Dr. ROSE. If he has a medical problem which will cause him death or serious illness and you allow him to buy a hearing aid to cover that ~up, yes, you are doing a tremendous disservice to that person. Mr. FELDMAN. I think that is what we are talking about. We are talking about medical problems. Correct? Dr. RoSE. Right. Mr. FELDMAN. Versus routine correction? Dr. ROSE. There can be no routine correction without a medical clearance as far as hearing is concerned, if I can use my definition of a hearing loss being a medical problem. That is maybe a coward's way of answering your question. But I; don't see any other solution to it. I don't know who is going to make the decision whether or not it is a medical problem unless you let a qualified medical doctor make it. Mr. FELDMAN. I think that is why we need to get the distribution. I think it would be most helpful in preparing our final recommenda- tion. Thank you. Senator PERCY. I wonder if you could, for the record, give us a pro- fessional analysis of the difference between prescribing eyeglasses and hearing aids, and prescribing treatment for some other disease. The doctor determines that a person has a particular ailment and there is a knOwn drug that he has prescribed before that helped it. He writes the prescription, sends it in, has it filled. But in the visual area, you really get down to a question of human judgment, don't you? You are looking at charts. You are asking a person which line he can see best. You put the drops in to assist, but you have to respond, depend, really, upon the responses of the individual to finally write out the prescription. But it is fairly precise. You can either see it or not see it. With a hearing problem, I spent so many hours in so many different booths of all kinds, trying to probe at this problem. You are trying so hard to help the person that is trying to help you. There is a lot of subjective decisionmaking you have to do to assist. Then you finally get down to the question, can you hear better with this aid or hear better with that aid? Could you professionally describe the problems a person goes through before finally, ultimately arriving at a decision? That really explains why you might say it is more difficult to prescribe a hearing aid. Dr. ROSE. I think you have touched on the problem that we have; that is, that we don't have an adequate procedure yet designed which will tell us exactly how well the individual hears. I think hearing aids at best are amplifiers and some individuals re- spond to amplification different than others, depending upon the type of hearing loss they have. PAGENO="0028" 22 When a person wears a hearing aid, he wears it because he benefits from it. We can get in the ballpark with regard to who can benefit and the type of amplification that might be best for him. But we are far from being exact. It is an art. That is why we have gone to the rental system. When we put a hearing aid on somebody, we ask them to let us know when the hearing aid isn't doing what you think it should do so we can help you get to the point that it gives you benefit. But the proof of a hearing aid is whether or not an individual will wear it. In 30 days he has got a pretty good idea and has been able to give us enough clues that we are able to get amplification on them so it benefits them. But the whole process is not a scientific one by any means. Senator PERCY. Thank you very much. I would like to comment that the hearings have had full supervision and oversight attention of our minority counsel, Mr. Stuart Statler. The lead minority staff member who has initiated these hearings and carried on the field investigation is Mr. Jonathan Cottin, who has, I think, done an outstanding job. I should like to also commend Stephanie Danko and Howard Marks of the minority staff for their cooperation with the majority and for their initiative and enterprise in helping. Mr. Statler? Mr. STATLER. I have just one question, Mr. Chairman. In the I-JEW task force report recommendations, they indicate a medical clearance procedure. It is a different one from the kind you were talking about. Basically it calls for seeing a doctor first. But there is a very major loophole in terms of a waiver provision that is open ended. Under the proposed draft, after you see the doctor, the doctor will not certify that an aid could be of benefit to the individual. Instead, ac- cording to the recommendation, the doctor would certify "that there are no medical reasons why a person should not be fitted with a heaiing aid." It is not that lie can benefit, but there are no medical reasons why lie cannot wear an aid. Could you discuss the differences between the actual benefit that an aid could be and what that would mean in terms of a regulation, and what this draft proposal would mean in terms of how a person could be helped or not helped by an aid? Dr. ROSE. The medical clearance regulation, a~s I understand what they would like, is that the physician or the otologist or otolaryngol- ogist makes a decision that there is nothing that can be done medically. So the person can be fit with amplification. There is a possibility that amplification will help. There is nothing to contradict amplification. I think that is a great first step. The second part of how one goes about regulating the distribution of the aid itself, I think is another issue. I think we have some subjec- tive problems that we have to be able to control. That is who makes the decision whether or not a hearing aid is helping the individual? My philosophy is that the hearing impaired individual has to make the decision, the person who is paying for the aid has the right to make PAGENO="0029" 23 the decision whether or not a hearing aid is helping him. If he isn't, he shouldn't be forced to pay for it or should be able to get his money back. [A letter dated April 6, 1976,. from the American Speech and Hear- ing Association regarding the testimony of Dr. Rose follows:] AMEJHCAN SPEECH AND HEARING ASSOCIATION, Washington, D.C., April 6, 1976. Senator CHARLES PERCY, Dirksen senate Office Building, Washington, D.C. DEAR SENATOR PERCY: The purpose of this letter is to clarify an apparent mis- understanding of the American Speech and Hearing Association's policy by one of our members who testified before the Senate Permanent Subcommittee on Investigation's Hearing Aid Industry Hearing on April 1, 1976. Dr. Darrell E. Rose testified that, "The present practices being conducted by a number of audiologists and otologists under the guidelines of the American Speech and Hearing Association's Code of Ethics allows the patient to be charged for `a hearing aid evaluation as well as follow-up rehabilitation.'" This Association's "Principles Governing the Dispensing of Products to Persons with Communicative Disorders" adopted in September 1974 state in Principle B.1: "Insuring objectivity in professional decisions concerning dispensing of products necessitates that: 1. Fees for professional services be independent of whether a product is dispensed," If aural rehabilitative services are being required of consumers who purchase hearing aids at cost from our members, then these members are in violation of the preceding stated Principle B.1. Other American Speech and Hearing Association members, besides Dr. Rose, have misinterpreted Association policy concerning members requiring aural rehabilitative services subsequent to dispensing hearing aids to consumers. Some of this misunderstanding appears to result from reading Principle A independ- ently from the rest of the Principles, particularly Principle B.1. Principle A states: "Products associated with the member's professional practice must be dispensed to the person served as a part of a program of comprehensive habilita- tive care." The intent of Principle A was to preclude members from engaging solely in the sale of products without assuming the responsibility of offering or providing for comprehensive audiologic habilitative services. It was not intended to require every consumer who purchases a hearing aid at cost from an Association member to receive subsequent habilitative services. During the months since a doption of these Principles, questions about the inter- pretation of several specific Principles, including Principle A, have been raised by a number of Association members. The Association's answers to those ques- tions will appear in the April 1976 issue of Asha. Concerning Principle A, the question posed to the Association's Ethical Practice Board is: "Can the person served be required to purchase or otherwise obtain audiological rehabilitation when purchasing a hearing aid from a Member?" The Ethical Practice Board's answer is: "Requiring au4iologic rehabilitation as a condition for purchasing a hearing aid from a Member (i.e., package plan) represents a conflict of interest and is considered in violation of the ASHA Code of Ethics. Following audiologic assessment and hearing aid selection services, the persons served must be free to obtain a hearing aid from the Member if needed irrespective of the person's decision to obtain subsequent rehabilitative services." We would appreciate your including this letter on the Hearing Record in order to preclude misinterpretation of American Speech and Hearing Association policy by persons reading Dr. Rose's statement. Thank you for your consideration of this request. Cordially, KENNETH 0. JOHNSON, Ph. D.. Ececutive Secretary. Senator PERCY. Dr. Rose, I wish to thank you, very much indeed, for your testimony. PAGENO="0030" 24 The Chair will call next a panel of three witnesses and we will hear* from them in this order: Mr. Ralph J. Bicksler, hearing aid purchaser,. Santa Clara, Calif.; Mr. Mohan Rao Malavey, audiologist, Ear Medi- cal Clmic, San Jose, Calif.; John C. Brennan, who purchased a hear-- ing aid, from Laurel, Md. The Chair would like to ask the staff, first of all, on whether wit- nesses who are individual purchasers are isolated cases or whether they were selected because of the fact that their kind of problem is a universal one characteristic of the kind of problems many purchasers face? Mr. CorrIN. Senator, first of all, we will introduce, after these wit- nesses have testified, a number of affidavits from people we have inter-* viewed around the country which tell of other examples of misevalua- tions and misfittings. In many cases, these persons are too old to come to Washington. The witnesses we have here today are representative of the problems that we have identified in the fieldwork over the l~st year throughout the country. Senator PERCY. Do you swear to tell the truth, the whole truth, audI nothing but the truth, so help you God? Mr. BICKSLER. I do. Mr. MALAVEY. I do. Mr. BRENNAN. I do. TESTIMONY OP RALPH I. BICXSLER, HEARING AID PURCHASER;. SANTA CLARA, CALIF.; MOHAN RAO MALAVEY, AUDIOLOGIST;~ EAR MEDICAL CLINIC, SAN JOSE, CALIF.; AND JOHN C. BRENNAN; HEARING AID PURCHASER, LAUREL, ND. Senator PERCY. Please be seated. The Chair would like to announce that during the course of these hearings, I feel quite cOnfident points will come up that people from industry, manufacturers, representatives of the associations and so forth, may wish to answer and submit further testimony about. Any such testimony that is submitted should be accompanied by an affidavit so that the subcommittee can have the same assurances it does when taking sworn testimony from a witness. To make this hearing record complete, it is the desire of the subcommittee to offer that opportunity to any responsible parties or persons who wish to submit subsequent testimony for these hearings. The hearing record will be kept open at the conclusion for a period of 30 days for that purpose. Mr. Bicksier, you have prepared testimony. Would you care to read. that, Mr. Bicksier? Mr. BICKSLER. Yes. Mr. Chairman, my name is Ralph J. Bicksler, and `I live at 3099 Agate Drive in Santa `Clara, `Calif. I am employed as an electronics technician by the Memorex Corp. of Santa Clara, Calif. Senator PERCY. Would you pull the mike up close? If anyone in the room has any problem on hearing, it is probably because the mikes are not close enough. If you will raise your hand, the Chair will ask that adequate amplification be provided. Of all hearings, this is one we all want to hear. Mr. BICKSLER. For several years, I have suffered from a hearing impairment that makes it very hard for me to distinguish certain PAGENO="0031" 25 sounds, including T's, D's, B's, and P's in the alphabet. About 5 years~ ago, my wife, who was inconvenienced by my hearing problem almost as much as I was myself, prevailed upon me to see an audiologist in. Sunnyvale, Calif. The audiologist tested me and told me I had a, nerve deafness. When I asked him if anything could be done for my problem, he said, hearing aids can sometimes assist persons with my kind of loss, but he did not recommend that I buy an aid. I was desperate to hear better,. I told him. He said if I insisted on purchasing an aid, I should do it on. a trial basis so that I could get my money back if the aid did not satisfy me. I was sent by him to a dealer in San Jose shortly thereafter. The dealer showed me an aid for about $300, on which he asked for a deposit amounting to half the selling price. Since I was short of cash, I never bought the aid. However, my hearing was no better and my' wife kept after me to do something to improve it. In the summer of 1974, feeling I must try and do something about my hearing, I responded to an advertisement in a magazine placed by- the Beltone Hearing Aid Co. Shortly thereafter, I received a tele-. phone call from William H. Gerrard of the Beltone Hearing Aid Serv- ice at 34 South First Street in San Jose, Calif., who set up an appoint- ment to test my hearing at my house. Mr. Gerrard said he worked for- the Beltone office and would test my hearing free of charge. Mr. Gerrard subsequently came Ito my home and tested my hearing with an audiometer. I did not tell `him of my previous visit to an audio-. logist. After he completed the audiograrn, he told me that I was suffer-. ing from a nerve loss in both ears. He said I might be helped with hearing aids in both ears. Before telling me this, he placed earphones over my ears, attached, a microphone to the audiometer which was connected to the earphones,. and walked into the other room. He spoke some words from the other room and then asked me if I heard them. I told him that I did, and he told me that hearing aids would be of use to me. He showed me a graph which, when compared to my audiogram test. results, showed that persons with my hearing level could hear better with aids. I believed him and expressed interest in buying two aids. He told me they would cost me $500 each. I said I did not have that kind. of money. He said I could put down $100 and pay him off at $25 a. month. I told him it was out of the question, and lie left. Two weeks later, Mr. Gerrard called me back and told me that he. had a good deal for me. He said he had a pair of barely used hearing aids, just like new, which had only been in operation for 30 days. He said I could have them for $250 each. I told him I still had a money' problem. He said he would try to arrange financing for me. He arranged a loan for `me with The Messingers of P.O. Box 1411, San Rafael, Calif. The loan, number 170 4845-7190, was for $524.70,. payable at 18-percent interest over 30 months, at $20 a month. I put. down $100 for the aids, Mr. Gerrard fit ear molds for the aids, and I began to use them, following his instructions of using them a few' hours a day at first, and later increasing the time for wearing them. However, when I put both aids on and turned them up, there was a. painful, loud noise in my ears. I experimented by wearing only one aid at a time, but the same pain continued. I kept trying to use the aids' PAGENO="0032" 26 for about 4 months, but they didn't help me distinguish sound any better and they were causing me a great deal of pain and. discomfort. My family was as unhappy as I was. I finally took the aids back to the Beltone de'der and told the recep tionist that I wanted to sell them back. She went iiito an office and Charles Ashlock, the manager of the office, came out. He told me, after examining the aids, that I had the wrong ear mold, and made another for me. With the new molds, the pain disappeared, but I could still not hear any better. I kept trying tO wear the aids, to get some use out of my investment, on which I continued to pay the $20 a month; but they were just useless. I went back to Mr. Ashlock and told him about my problem. He told me that I might need to try a new set of hearing aids. I told him I wanted to sell the aids back, but lie wouldn't hear of it. He said the only thing he could do was make an allowance for them, if I traded them in on a new set of aids. He told me new aids would cost me $1,000. I left, disgusted. and haven't tried the aids since. in March 1976, with my wife continuing to be frustrated at the difficulty we had in communicating, I took one of the aids to the Speech Development Laboratory at Wrest Valley College in Santa Clara, to see if something was wrong with the aid. Mohan Rao Malavey, an audiologist at the laboratory, tested my hearing in a soundproof room and also tested the aid on ~ne. After completing the tests, lie told me that my hearing loss was in a higher frequency range that cannot be served with present hearing aid technology. He told me that I had been taken by the dealer. He told me that the results of my hearing tests showed that I could hear as well with, as without the aids. I continue to pay for the aids that sit in my drawer, useless to me and my family. I feel that dealers should not be allowed to sell aids to persons who cannot use them. Senator PERCY. Thank you very much, indeed. I think before I ask any questions of you, we will have Mr. Malavey testify. Mr. Malavey? Mr. MALAVEY. Mr. Chairman. my name is Mohan Rao Malavey and I live at 2155 Main Street, Apartment 117, in Santa Clara, Calif. I am associate audiologist at the Ear Medical Clinic at 2120 Forrest Avenue in San Jose, Calif., and I also serve as an audiologist at the ST)eech Development Laboratory, West Valley College in Campbell, Calif. Senator PERCY. Could you supplement for the record where you re- cewed your education? Mr. MALAVEY. At the Temple University in Philadelphia. Pa. Senator PERCY. And what was the degree that you received? Mr. MALAvEY. Excuse me? Senator PERCY. What degree did you receive? Mr. MAL~\vEY. I received my master's degree in audiology. S~nator PERCY. Thank von. Mr. MALAVEY. On March 4, 1976. Ralph ~T. Bicksier came to the Speech Develonment Laboratory to find out why hearing aids that he had purchased some time before were not helnmg him. I conducted a series of audiological tests on him and the aid that he brought with I determined that the hearing aid was working properly. PAGENO="0033" 27 However, Mr. Bicksler, whose hearing loss is only in the higher frequency above 3,000 hertz, could not benefit from an aid, since hear- ing aids today are not designed to assist discrimination at that range exclusively. Hearing aids can be useful in the 500 to 2,000 hertz range. No aid can amplify exclusively above 3,000 as far as I know. I advised Mr. Bicksler that the aid that he brought in was and always would be useless for him because of his type of loss. When he told me that the dealer wanted to accept the aids as trade-in for a new set, I told him to forget about it; that new aids were not what lie needed. I was appalled that any dealer would try to sell this man a hearing aid. I determined, during testing of Mr. Bicksler, that whether he wore the aids or not, his hearing was the same. The money that he paid for those aids was a total waste, ~fl my pro- fessional opinion. I have worked with otolaryngologists and in a clinical setting since 1970. During that time, I have tested about 3,000 persons who have com- plained of hearing loss. I hold a certificate of clinical competence from the American Speech and Hearing Association and hold an MA degree in audiology from Temple University in Philadelphia. Rarely have I seen a worse case of misevaluation and misfitting of hearing aids than on Mr. Bicksler by the Beltone dealer in San Jose. I believe that no one should be able to sell a hearing aid until the person involved has been examined by a qualified physician, preferably a board-certified otolaryngologist, and an audiological workup has been done. This would have saved Mr. Bicksier the aggravation, as well as the money he wasted for his aids. Senator PERCY. Thank you very much, indeed. Of the 3,000 people that you have examined who have complained of hearing loss, would you be able to estimate roughly what proportion of those nothing could be done for, and what proportion of them would be assisted by a hearing aid? Mr. MALAVEY. M~ rough estimate would be 20, 25 percent. Senator PERCY. That nothing can be done for them? ~`rr. MALAVEY. Nothing could he done. Senator PERCY. My question was, What proportion of the 3,000 people that you have examined would be helped if they had obtained a ~ hearing aid? Mr. MALAVEY. I would say approximately 40 percent. Senator PERCY. Forty percent? Mr. MALAVEY. Yes. Senator PERCY. And 60 percent would not be helped at all? Mr. MALAVEY. Most of them have high frequency hearing losses which cannot be helped with a hearing aid. Senator PERCY. High frequency loss? Mr. MALAVEY. Yes; above 3,000 herz. Senator PERCY. Mr. Bicksler, as I understand it, you are still paying $20 a month for aids that are useless to you. It that correct? Mr. BICKSLER. That is correct, Mr. Chairman. Senator PERCY. I don't want to inquire into your personal affairs, but you have said several times that you couldn~t afford this. The total expenditure recommended at the outset was $1,000. Could you give the subcommittee some ideas as to what kind of a personal sacrifice that would he to you and your family? 79-954-76---3 PAGENO="0034" 28 Mr. BICKSLER. An expenditure of that size is something of no use te me. It is totally out of the question. If I had the $1,000 to spend, I would spend it on something for my wife, a coat, perhaps, or some- thing like that. At least it would be some enjoyment out of it. But to totally spend $1,000 in any way, shape, or form at the time I purchased the aids was tremendous because at that time we were recovering from a period of unemployment in which we had stacked up bills. I have just recently gone back to work. My wife had to go, too, so we could catch up. Senator PERCY. Can you tell the subcommittee however, if you had assurance that the investment of $1,000 would improve your hearing measureably, even though it would be a tremendous sacrifice to you, what would it mean in human terms to you and your family? Would it be worth $1,000 if in fact you would be helped? Mr. BICESLER. At that time, if I were assured and were actually helped by hearing aids, $1,000 would have been cheap. Senator PERCY. Can you describe in more definite terms what sort of frustrations you go through? You say your wife was after you. Mr. BICKSLER. That is correct. Senator PERCY. Tell us what she said. I want to compare it with what my wife says to me occasionally. Mr. BIOK5LER. You will probably understand what I say. You have to ask your wife to continually repeat what she says and it turns out * to be damned important, because it is extremely frustrating to her and to me. Senator PERCY. Does she get annoyed? Mr. BICKSLER. Yes. Senator PERCY. Understandably annoyed. Mr. BICKSLER. Repeating one of your own statements, when they think you are snubbing them or deliberately not listening, yes, they become annoyed, extremely. It is not easy. They tend to forget that you are not hearing so well. When they forget, and you don't, they become annoyed. When they become *annoyed, then all hell breaks loose. Senator PERCY. I don't know what kind of a person you are, an introvert or an extrovert, but because of your hearing loss, do you find that sometimes it is easier in a conversation to take the initiative, open up the subject, sometimes even tend to dominate it? Is it hard for you to respond to others when you don't hear everything? You and I have the same kind of a loss? We miss syllables. We, therefore, can't distinguish between words because the sound is the same for 6, 7, or 10 different words, since we miss the P's or the R's or whatever it may be. Mr. BICKSLER. That is right. I think basically I am an introvert. But when it comes down to my work, particularly, I have a fine interest in it. On the job it is noisy. In an area like that, when the boss tells me he wants something done, I want to be sure I get it correct the first time, not six times later. Quite often, it is difficult for me to understand what he has said he wanted done unless I have him repeat it sometimes two or three times, and hopefully I can take care of that problem with the hearing aids. Senator PERCY. Do you feel that improving your hearing would im- prove your job status and also improve your relationships with other people and the quality of life outside your working experience? PAGENO="0035" 29 Mr. BICKSLER. Most definitely. I am trying to advance in. the com- pany. To do that, you have to be able to communicate. WTell, communi- cation with me is extremely difficult because of my hearing problem. That makes the advancement a little slower and a little harder than it should be otherwise. That is on the job; in the home, most of the time, I am just. quiet because I don't get involved in conversations unless they are directly concerned with me and the family. I study a lot. That is the reason. Outsidç, in the social world, yes, I like to be able to go to places and enjoy hearing everything that is being said without having to lean over and interrupt my wife's attention and say, "What did they say?" If I could hear well again, the price would be~ almost immaterial. Senator PERCY. Because you have mentioned Beltone and not just because the èompany's a constituent of mine, I would like to be abso- lutely certain that the record is exact. According to records made available to the staff, the Beltone Hear- ing Aid Service had only one visit from you, when the ear molds were changed. Are you absolutely certain that you returned a second time and tried to sell the aids back? Mr. BICKSLER. Yes. I did. My wife can verify that. Mr. Ashlock, the manager, said, he had enough, an overabundance of the particular type of hearing aid I had and he had no use for them. But if I wanted to buy the hearing aid that fit into the ear totally, he would consider a trade. Senator PERCY. Overall, you spent about 6 months trying to get some use out of the aids, according to your testimony. Did you tell this to the dealer? Mr. BICKSLER. I didn't tell it to the dealer directly. He knows when I purchased the aids. I assumed that perhaps it was me having a hard time to adjust to the aids. I had two aids, two ears. I tried one, then the other. All of this takes time. That is why it took me so long to determine this isn't working. Senator PERCY. Was there anything further the dealer told you on your second visit that you have not mentioned? Mr. BICKSLER. I cannot think of anything. Senator PERCY. Based on your experience with this dealer, what would be your advice to persons with hearing impairment about to go to a dealer first for help? Mr. BICKSLER. I would suggest they first see a doctor and make sure that it isn't something that can be cured by the doctor, surgical or whatever, at least have an audiologist test. If he goes to the dealer, he knows what is wrong already, what he needs and whether or not it may ormay not help him. It puts him in a better bargaining position. Senator PERCY. How did you happen to go to the dealer first and not to the Speech Development Laboratory? And how did you happen to go to the Speech Laboratory? Mr. BICKsrnR. First of all, I didn't know about the Speech Develop- ment Laboratory at the time I went to the hearing aid company. Since then I have become a student at the college and I had found out about it being a student there, and decided one day. When you register at PAGENO="0036" 30 the college, there is a form you fill out where you indicate whether or not you have any medical problems, seeing, hearing, or any other kind of problem. The college evidently wants to aid people who need help in getting through school. Filling that form out, they sent me a letter advising me that they had a laboratory, if I wanted to, I could have them check my hearing a.nd so forth, to see if there was any help they could give me in obtaining my degree through them. I had not bOthered with the first letter I got. The second letter I got, I decided to go have them checked. Senator PERCY. Mr. Malavey, have you encountered other examples of hearing aids being sold to persons who cannot benefit from them? If so, how often does this occur in your experience? Mr. MALAVEY. Yes, sir. I have seen some of the people coming in with hearing aids and at the same time not being able to use the hear- ing aid effectively. I have seen several cases, and on the average I would say at least one or two every 3 or 4 months. Senator PERCY. As an experienced audiologist, would you tell the subcommittee if anything at all can be done for someone with Mr. Bicksler's handicap? What should he do now, if anything? Mr. MALAVEY. At this point, I don't think he can do anything about it. We are getting into another area right now. The problem is, we are able to do so much with different things, but the hearing aid industry doesn~t seem to come up with the types of hearing aids or the micro- phones or the amplification system that will effectively give or produce amplification, either exclusively, at low frequencies or exclusively in the high frequencies. That is the basic problem at this point. But as far as Mr. Bicksler is concerned, I don't think we can do anything at all at this point. Senator PERCY. Could you comment on what potential lipreading offers for an individual? / Mr. MALAVEY. Lipreading training would be effective if the person is hard of hearing and is not able to use a hearing aid. Also, if a per- son has a sensori-neurial type of hearing loss, say, moderate-to-severe hearing loss, the hearing aid is not going to clarify speech. It will amplify speech and if he has distortion, because of the sensori-neural problem, a hearing aid will amplify distortion also. So in that case, the discrimination is not going to improve and he needs some other help; that is, some kind of lipreading assistance. Senator PEIWY. Do you feel that a large proportion of people with hearing impairment go as a first step to a hearing aid dealer? Mr. MALAVEY. Most of them do. Senator PERCY. In your judgment, is that correct? Mr. MALAVEY. I don't think it is correct. Senator PERCY. Are you saying that just because you are a profes- sionally trained audiologist speaking on behalf of your profession? Mr. MALAVEY. No. I don't want to see them if they have a known medical problem. I would rather see them after they have been seen by the physician, whether he is a family doctor or a specialist. Senator PERCY. The suggestion has been made that hearing aid dealers be used simply as dispensers of* the instruments much like a pharmacist dispenses drugs at the direction of the physician. PAGENO="0037" 31 What is* your judgment on this suggestion? Mr. MALAVEY. My suggestion would be that they should see people with hearing problems when they come from the physician, or an audiologist, with some kind of recommendation. The hearing aid dealer is not going to lose anything. He is going to get the patient back if he needs an aid. The only thing is, they will get a medical clearance before they come for a hearing aid. I do strongly feel that the hearing aid dealer should not sell a hearing aid without any prescription, either from an otologist or from an audiologist, and, of course, audiologists should. always be guided by an otologist as far as the medical problems are concerned. Senator PERCY. I would like to ask you, Mr. Bicksler, if you have found during your experimentation period, when you wore a hearing aid, whether people did speak up to you a little bit louder? Does it help when people enunciate more clearly and speak louder? Mr. BICKSLER. As to when I wore the hearing aid, whether people spoke louder or not, I didn't notice it if they did. Loudness isn't what really makes the difference in my hearing. It is the background noise and how well enunciation is. Even sometimes with a quiet room like this is I have difficulty hearing because of enunciation and sometimes people when you ask them, please repeat it, I didn't quiet catch what you said, they will continue to repeat it the same way. They think they are saying it differently, but they are really not. Either that, or I am not hearing it any differently. Senator PERCY. Does your wife have a particularly high voice? Mr. BICRSLER. I think it is toward the high side. Yes. Senator PERCY. Is it a little easier to hear from a person who has a low voice? Is it easier for you to hear a man than a woman, for in- stance? They tend to have a lower voice level sometimes. Mr. BICKSLER. Generally,, yes. I have no problem hearing at alL Many of the people I work with, you hear voices at low levels, you have trouble with them. Senator PERCY. Does it help you when you just look right at the ierson ? ` Mr. BICKsLER. I have been practicing a small amount of lipreading fOr many, many years now. I have never taken courses, I just do it. Senator PERCY. In the process of education, and the education has to be both ways, I have found it helps me a great deal when I look right at ` the person and really concentrate. I find that paying close attention to someone helps me hear. Also, on the other side of it, it helps a great deal if someone who is talking to a person hard of hearing does articulate carefully; doesn't slur his words, doesn't speak as rapidly a.s Ronald Reagan did last night on his 30-minute telecast. I was listening intently and did hear everything he said, and I didn't like a lot of it. But I do feel that it is a two-way street and communication has to be both ways. `A person speaking wants to be understood. The sl?eaker should recognize that levels of hearing are quite different. Just as some people are short and some are tall; some fat and some skinny, some hear well and some don't. In speaking, there is a responsibility on the part of the speaker as well as the listener. PAGENO="0038" 32 Mr. BIOKSLER. That is right. Quite often my child will be running through the room talking to me. 1 will have to grab her a.nd say, "Wait a minute, stop, stand still and look at me so I can hear what you are saying." Senator PERCY. I would like to commend Memorex. I understand that you came out with no assurance you would be paid wages for the time that you are spending away from your j ob. You came because of your feeling you could help others even though there hasn't been pro- vided to you as much help as you would like. But I would like to commend Memorex Corp. for permitting you to come here. I think your contribution to others has been invaluable. I hope Memorex feels it would be worthwhile to have your wages con- tinued while you were here testifying. We have one last witness to be heard in this particular panel, Mr. John C. Brennan. Mr. Brennan, I have an urgent message from the `Foreign Relations Committee that my presence is needed there. We are unable to obtain another Senator. If it is convenient to our witnesses, we will recess for 15 or 20 minutes while I run over to the Foreign Relations Committee, which is just 3 or 4 minutes away. I will finish my work there `and then return here. IVould that inconvenience any of our witnesses? Thank you very much, indeed. The Chair then recesses the hearing for 15 or 20 minutes. [A letter dated April 26, 1976. on behalf of Beltone Hearing Aid Service regarding the testimony of Ralph J. Bicksier follows:] WOOL & RICHARDSON, ATTORNEYS AT LAW, ~an Jose, Calif., April 26, 1976. Re Ralph J. Bicksier, Public hearing date, April 1, 1970. Mr. STUART M. STATLER, Chief Couvsel to the ilfinority Se~i ate Pernia~ent gnbcomrnittee on Investigations Washington, D.C. DEAR MR. STATLER: Pursuant to your telegram to Mr. Gerrarci dated March 27, 1976, the following facts are offered for the hearing record regarding the above- named individual. This statement is presented on behalf of Beltone Hearing Aid Service, located at 34 South First Street, San Jose, California. The records of Beltone Hearing Aid Service show that Mr. Bicksler did not become dissatisfied with the hearing aids which be purchased on June 23, 1974 until February 3, 1975. This was a period of approximately seven months. As late as April 13, 1976, Mr. Bicksler has stated that if his hearing aids could be "fixed", he would be satisfied. Mr. Bicksier has trouble hearing, as is evident by his continued insist- ence that the hearing aids be adjusted. Mr. Bicksier admits to having trouble hearing. In addition, a question is raised as to the extent of Mr. Bicksier's dis- satisfaction by the fact that no complaint was made during the first seven months in which Mr. Bicksler had possession of the hearing aids. Despite the foregoing. Beltone Hearing Aid Service located at 34 South First Street, San Jose, California, has decided to refund to Mr. Bicksier the money spent by him in the purchase of those hearing aids which he insists do not improve his hearing problem. Mr. Bicksler was sold hearing aids to improve his hearing problem. This problem was apparent through the examination con- clucted in the office of Beltone Hearing Aid Service. Because the hearing diffi- culty has not been rectified to the satisfaction of Mr. Bicksler, Mr. Bicksler will be refunded his purchase money. Mr. Don Hocison is the new manager of the Beltone Hearing Aid Service located at 34 South First Street, San Jose, California, his position having been assumed on January 1, 1976. Mr. Hocison was riot the manager at the time Mr. Bicksier purchased his hearing aids. It is Mr. Hocison's intention to avoid PAGENO="0039" 33 all such controversies, as that which has arisen between his hearing aid service and Mr. Bicksler, from the outset. If any further information is desired of this Beltone Hearing Aid Service, Mr. Hodson will be happy to cooperate iii any manner desired. Thank you for the opportunity to submit this statement for the hearing record. ~Tery truly yours, WOOL & RICHARDSON, By WILLIAM E. GIrT. [A brief recess was taken with the following member present: Senator Percy.] Senator PERCY. Sometimes when we have to recess hearings you wonder what in heaven's name s so important. The matter at hand is very important. My colleagues in the Foreign Relations Committee thoughtfully held off any votes until I could return and speak on the issue. We just approved a $25 billion safety net in the event there is an oii embargo again to protect ourselves from the OPEC countries. That was worth leaving for. We have also just decided to defer discussion on the Intelligence Oversight Committee being established. I am grateful to my colleagues who recognize the importance of these hearings. They allowed me to carry on here right up to the point where they were ready to vote. But I am sorry for the interruption. Mr. John Brennan, Hearing Aid Purchaser, Laurel, Maryland. Mr. Brennan? Mr. BRENNAN. Mr. Chairman, my name is John C. Brennan. I reside at 513 Main Street, Laurel, Maryland. I retired in 1963, after 35 years of service at the National Headquarters of the Federal Reserve System in Washington, D.C., where I was General Assistant in the Office of the Secretary and Personnel Assistant. I am 68 years old. I first noticed a loss of hearing prior to the time I retired and I had sought the services of Dr. King \Tann, an ear, nose and throat doctor, with offices in Silver Spring, Maryland. Dr. Vann examined inc and found that I suffered from nerve deafness in my left ear. He advised that a hearing aid could not improve my hearing and that I should learn to live with my disability. However, despite the advice of Dr. Vann, I found it increasingly difficult to tolerate my hearing loss. I am quite active in my community and in late 1973, as a member of the Prince Georges County, Mary- land, Committee on Historical and Cultural Trust, I found that I was unable to hear some of my soft-spoken fellow committee members. I can hear individuals talking if there are no competing sounds, but if there is any background noise, I find that hearing becomes ex- tremely difficult. I found this impediment so great that I tendered my resignation to the committee, but it was rejected. One friend, who wears a hearing aid, apparently gave my name to a BeltOriè Hearing Aid dealer in Silver Spring, Maryland, as a p0- tential candidate for an aid. The dealer. Robert Cederloff, then located at 344 University Boule- vard, Silver Spring, Maryland, sent me a circular announcing that he would test the hearing-impaired at a motel in Laurel, Maryland, one day in November 1973. Even though Dr. I/ann had told me that a hearing aid could not help me, I wanted badly to fully participate in committee meetings. I PAGENO="0040" 34 felt that possibly I could be helped with the development of the transis- torized hearing aid~ and other technological advances made after the time I was examined by Dr. Vann. I decided to visit Mr. Cederloff and after I told him about my hear- ing loss, he proceeded to place headphones on my ears and tested my ability to hear a range of low- and high-frequency sounds. Mr. Cederloff made notations on a graph as I responded to the sounds. He placed the earphones over the left ear, then the right ear and then both. While on the machine, my hearing improved tremen- dously. I could hear a television clearly and then Mr. Cederoff's voice as he spoke to me from the corner of the. room where I was being tested. He warned that my hearing would deteriorate further. Senator PERCY. What did he mean when he warned that your hear- ing would deteriorate further? Mr. BRENNAN. I told him that I had no-- Senator PERCY. Had he made a medical analysis that would lead him to believe this? Mr. BRENNAN. That may have been an offhand remark, but it was stated. Senator PERCY. In other words, he was saying to you that whatever level of hearing you have now, it is going to get worse? Mr. BRENNAN. Yes, sir. Senator PERCY. Did he give you any reason for that? Mr. BRENNAN. He did not. Senator PERCY. But did this alarm you? Mr. BRENNAN. I accepted that as being reasonable with the acivanc- ing years. I accepted the prognostication. Senator PERCY. If you were experiencing difficulty then, the thought of getting worse as time went on was a cause of concern to you; is that right? Mr. BRENNAN. Not greatly, sir, because over the period of the past 10 years I would say I didn't notice any deterioration. So I took that with a grain of salt. But it was stated. The test results convinced me an aid would help. I ordered a hearing aid for my left ear that cost me $420. Mr. Cederloff implied that the aid would be manufactured and assembled for my own needs. But I thought it odd that he never took any notes and I said to myself that Mr. Cederloff must have a tremendous memory to remember my par- ticnlar needs. About 2 weeks later, I was fitted for the aid at Mr. Cederloff's Silver Spring, Md., office. My first experiences with the aid were novel and perplexing. I could hear far-away clocks ticking loudly and voices sounded like Mickey Mouse or Donald Duck cartoon characters. In committee meetings, when I futilely attempted to make the aid work, I turned it up so far that it would squeal and almost everyone would look at me. Some weeks after I was fitted with the aid, I returned to the dealer and complained about the aid's performance. Mr. Cederloff took out a miniature screwdriver and attempted some minor adjustments. Nothing helped. I went back to Mr. Ceclerloff for three adjustments in a matter of 2 months. No amount of screw turning helped improve the aid's efficiency. PAGENO="0041" 35 I finally told Mr. Cederloff that I wanted a refund. He was re- luctant to give me back my money and suggested several alternatives. One was wearing an eyeglass frame in which hearing aids for both ears would be installed in the bows. I rejected that proposal because only one ear was bad. I did not understand the need for two aids. Additionally, I only require corrective lenses for reading and I would not feel comfortable wearing glasses all the time. Another alternative Mr. Cederloff gave me was the use of an aid that would be attached to my left ear and then a tube would carry the amplified sound through my shirt collar and to my right ear. I rejected this proposal because I did not think my condition warranted being bound up in such an awkward arrangement. I finally insisted that Mr. Cederloff grant me a refund. He was very reluctant to take back the aid and told me that the Federal Trade Commission had ruled that all hearing aids that were used had to be considered as such and he could not sell my aid as if it was a new aid. I told Mr. Cederloff that I had hardly used the hearing aid and that I had not even finished with the first battery. He finally returned, under protest, only $225 of my $420 investment and I surrendered the aid. I felt put upon and went to an attorney who advised me that I could not proceed along legal channels to get an entire refund because there were no written or oral guarantees as to satisfactory performance. But I persisted and filed a complaint with the Montgomery County, Maryland, Consumer Affairs Department in the spring of 1974. Six months later, I received a check for $195, the balance owed me, from Mr. Cederloff. There was no accompanying note or explanation. It is true that I received a refund. But I am well educated, and know the proper channels through which to complain. I feel that many of the hearing-impaired are not as fortunate as I am and lack the wherewithal and knowledge of the system needed to fight for their rights as consumers. In my case, I felt that the hearing aid that I purchased would give me the same results I experienced when I was hooked up to Mr. Ceder- loff's testing machine during the demonstration. I believe that such demonstrations that give illusory hopes of corrected hearing are wrong. I additionally am convinced that no one should have to fight, as I did, for a full refund when a hearing aid proves unsatisfactory. Senator PERCY. Thank you very much, Mr. Brennan. You were told by Dr. Vann that a hearing aid really could not help you. Why then would someone of your intelligence actually go against your doctor's advice? Mr. BRENNAN. When I was examined by Dr. Vann, miniaturization and th.e transistor had not come into prominence. I wanted amplifi- cation. I thought that after a long lapse of years with those improve- ments I might get amplification. Senator PERCY. How did it come to your attention that miniaturiza- tion, advanced electronics and technology could offer help? Do you think your doctor was aware of that? Mr. BRENNAN. The transistor was not in existence when I was ex- amined by Dr. Vann, at least they were not in existence for hearing aid use to the best of my knowledge. PAGENO="0042" 36 Senator PERCY. Could you describe in detail the test that Mr. Ceder- hoff administered to you? Why were you convinced that a hearing aid would give you the same results as the testing machine? Mr. BRENNAN. He did not state that the hearing aid would give me the same results, but I thought it obvious that when he gave me the demonstration and when I bought the commodity that he was selling, I had no doubt in my mind that the results with the hearing aid would be the same as those on the demonstration machine which was the console device. Senator PERCY. What were the initial results with the hearing aid.? lVhat were some of the sounds that you heard when the aid was actually turned on? Mr. BRENNAN. As I indicated, I could hear crumpling newspapers a.nd clock ticking on the wall and the turning device on my automobile, but those weren't the things that I wanted. I wanted, and I told Mr. Cederloff that I wanted, to use the hearing aid perhaps once or twice a month at these committee meetings. I ha.d no need for it otherwise. I tried to make that very clear to him. Senator PERCY. In other words, your difficulty occurred primarily during committee meetings? Mr. BRENNAN. I wanted amplification of a few soft-voiced people that I could not hear. Senator PERCY. But did the dealer advise you that. more frequent use, conditioning yourself to it, would help you and that you were really not giving it a fa.ir chance? Mr. BRE~cNAN. He told me to wear it every day for 2 hours for a period of 2 months to accustom myself to it; to wear it in an off posi- tion; not on, hut off. Senator PERCY. Just wearing it while it was switched off? Mr. BRENNAN. Yes, sir. Senator PERCY. Just to get used to having it on? Mr. BRENNAN. I guess that was the idea. He was monosyllabic and he really didn't go into details. I got very few instructions. Senator PERCY. Does that really make sense? I hAve found my tendenc.y was not to put it on first of all. Then, to put it on just as infrequently as I could. I wa.s like you. I could have kidded myself, you know. Except that we didn't have an audio system in the Senate floor. That is the only reason I need it. I just can't hear noise from a distance. But I fought to get an audio system over there because I was convinced a lot of other Senators didn't hear everything. Some of the things you hear, you later decide you would be better off if you hadn't heard. But you ought to be able to hear. So. we did put an audio system. in. That helped. But I found that I had to wear the aid all the time in all circumstances in orde.r to get the most benefit out of if. I really want. it on, on the Senate floor, and during hearings. You say you didn't get good instruction. Why not? Mr. BRENNAN. I wonder t.oo. Senator PERCY. I am not trying t.o prescribe, for you. I want to help von if I possibly can in inst relating my circumstance. But I am in- terested in the relationship you established with the dealer. Mr. BRENNAN. I think maybe. my case was a little different because I only wanted to wear a hearing aid once or twice a month at these PAGENO="0043" 37 meetings. I didn't have the need for it, to wear it every day or to wear it for 2 hours every day. I told him that. So he said don't cut it on, lust wear it for 2 hours every day for a period of 2 months, I am pretty sure that is what he prescribed. Senator PERCY. What did Mr. Cederloff do when you brought the aid in for adjustments? Mr. BRENNAN. He said very little, hut, as I said, he took the miniature screwdriver out, took the screwdriver and made an adjustment. Those were during the days of the gasoline shortage. I wasn't happy about the trips I made from Laurel to Silver Spring. Senator PERCY. But the inference was that the problem could be taken~ care of by a minor adjustment with a little screwdriver and that was it. Mr. BRENNAN. He didn't say that. Senator PERCY. The inference? Mr. BRENNAN. I operated on inferences throughout. Senator PERCY. He didn't probe more deeply into the nature of the problem? Mr. BRENNAN. No. Senator PERCY. He just gave it back to you? Mr. BRENNAN. He may have said it may be better or see if that is better, but I don't recall. Senator PERCY. What were your feelings when Mr. Cederloff only gave you a partial refund and kept $195 of the $420 that you paid for the instrument? Mr. BRENNAN. I thought I should cut my loss. I thought it was better to get a partial amount than to have to go to court and fight for the wholo amount. Senator PERCY. Did you write the National Hearing Aid Society about the problem? Mr. BRENNAN. I did. Senator PERCY. What sort of reply did you get? Mr. BRENNAN. Very bland, unspecific reply because I set forth my problem in detail. I think it was a two-page, single-space letter. I did receive back a reply saying in essence if you had stuck with the dealer, your problem over a period would probably have been helped or cor- rected; something to that effect. Senator PERcY. We have a copy of that letter from the executive di- rector, Mr. Anthony DiRocco, dated March 14, 1974. Without objection it will be inserted in the record at this point. [The document referred to was marked "Exhibit No. 3" for reference and, follows:] EXHIBIT No. 3 NATIONAL HEARING AID SocIETY, Detroit, Mich., March 14, 1974. Mr. JOHN C. BRENNAN, Laurrl, Md. DEAR MR. BRENNAN: We have completed our investigation of the hearing aid transaction between yourself and Robert Cederloff of Silver Spring, Maryland. Mr. Cederloff has informed us that the fitting of the aid was made with no promise of results, verbal or written, and it is his feeling that with more use and counseling with the aid, the problems would have eventually been overcome, or if he had been allowed to make the conversion to a CROS fitting, the results would PAGENO="0044" 38 have been excellent. (This is the "double" hearing aid that you referred to in your letter of February 25th). Then, Mr. Cederloff explained that the hearing aid could not be re-sold as "new" and, as you reported, you arrived at a compromise figure of $225.00 refund on the aid. I am sorry that you did not give yourself an opportunity to adjust to the hear- ing aid as recommended by Mr. Cederloff. In view of all of the above information, we do not find that Mr. Cederloff is guilty of any violation of the Code of Ethics. Sincerely, ANTHONY DiRocco, Executive ~Secretary. Senator PERCY. In that letter the society said that it agreed with Mr. Cederloff that, with more use and counseling, the problem with the aid could have been overcome. How did you react to that? Mr. BRENNAN. I guess I was disappointed in the letter that I re- ~eived. But I can't recall any specific reaction. It wasn't helpful. Senator PERCY. How much counseling did you actually get? Mr. BRENNAN. Very, very little. Senator PERCY. They say that they agreed with Mr. Cederloff and that more counseling would help you. Did Mr. Cederloff see a copy of that letter? Mr. BRENNAN. I think the letter stated that Mr. Cederlo'ff had been in touch with the association. Senator PEROY. When the `society said more counseling would help you, did he give you more counseling? Mr. BRENNAN. At that time I had discontinued the relationship. I wasn't going back to him. Senator PERCY. When you demanded your money back, did he call and offer to provide more counseling? Mr. BRENNAN. No. Senator PERCY. It was just a question of whether you were going to get the money back. When you filed a complaint, you just got the check withont explanation? Mr. BRENNAN. That is right. Senator PERCY. No followup? Mr. BRENNAN. No, sir. Senator PERCY. Is it your feeling that very few people, relatively speaking, would bother to do as much as you have done? Mr. BRENNAN. I am sure that is true. I am `sure the `ordinary person wouldn't have written the number of letters to the various organiza- tions and associations that I did. Senator PERCY. Mr. DiRicco also suggested that you should have considered a hearing aid running from your bad ear to your good ear. What do you think about this suggestion? Mr. BRENNAN. For a person who went to a dealer to get an appliance that would be used twice a month, I couldn't see why I should go around with that arrangement running down my collar, up the collar, into the other ear. I just thought that was ridiculous. Senator PERCY. Did you ever try it, though? Mr. BRENNAN. No, sir, I did not. Senator PERCY. You don't feel that that approach would, for your particular difficulty, offer any assistance? PAGENO="0045" 39 Mr. BRENNAN. No. I don't have difficulty except inT meetings, iii o~roups. Face-to-face conversation I have no trouble at all. ~ Senator Pi~aic~. Based on your experience, what advice would you offer to the hearing-impaired people about following their doctor's advice? Mr. BRENNAN. That is the optimum solution, follow your doctor's advice. I didn't do that. Senator PERCY. In other words, do you feel the doctor has an objec- tivity and a professional background that would cause him to want to prescribe fOr you exactly what would help and not over prescribe or mislead you? A hearing aid dealer is in the business of selling hearing aids. You have that conflict in the profit system, the system in which I grew up. We are trying to preserve the integrity of the system and get rid of abuses. It is those who abuse the system that many times cause the greatest damage to the system from which they benefit. Do you feel it really is a problem to get a forthright analysis from a hearing aid dealer who is in business to sell and whose social motiva- tions and objectivity is subject to considerable economic pressures? Possibly that is not the best way to get advice for the first fitting at least. Do you believe a doctor's advice, in your judgment and personal experience, is the best judgment? Mr. BRENNAN. Right, sir. IA letter and affidavit from Robert M. Cederloff re ,Jolrn Brennan follows:] BELTONE HEARING Am SERVICE. Silver Spring, Mci., March 31, 1976. Re: John Brennan, Hearing Aid Committee hearing, April 1 and 2. CHARLES H. PERCY, U.S. Senator, 4321 Dirksen Office Building, Washington, D.C. DEAR SENATOR PERCY: I have been advised by the Senate Permanent Investigat- ing Committee that there will be a hearing regarding the hearing aid industry April 1st and 2nd. I have also been informed that a Mr. John Brennan will be present to testify with respect to his purchase of a hearing aid from me in November, 1973. A Mr. Howard Marks from your committee appeared in my office and interviewed me in respect to that transaction on March 25, 1976. On Monday, March 29, I was notified by Western Union from Mr. Stuart Statler of the Per- manent Sub-Committee that I may appear to testify in respect to the allegations. on April .1st. Because of my business commitments I will be unable to testify in person on the date you have requested, however, I am more than willing to testify to the Senate Committee or other interested parties at any time that adequate advance notice could be given. Because of the exceedingly unfair notice of the Committee, allowing me in- sufficient time to properly prepare my statement, I expect my following notorized. statement to be read into the record immediately following that of Mr. Brennan's, containing his allegations in respect to me. I find it hard to believe that elected representatives in a democratic society would knowingly engage in such unfair procedures as those having been cast upon me. My sworn statement is as follows: On November 17, 1973, Mr. Brennan visited one of our service centers upon the recommendation of one of his close friends to investigate the possibilities of getting hearing help for his left side. After an audiometeric test consisting of air conduction and bone conduction with masking, the master selectometer was used OR his left side, with masking on the right side to determine his ability to dis- criminate. This test proved that his discrimination could be improved and an 8 transistor behind the ear bearing aid was recommended for him. At this time PAGENO="0046" 40 a deposit was made and the ear impression was taken. A copy of this audio- gram is attached showing a season-neural, high frequency hearing loss of mild degree on the right side and a moderate-severage hearing loss on the left. These readings will closely compare with any hearing test conducted on an ASA calibrated audiometer. On November 23, the hearing aid was picked up, and because Mr. Brennan did not have his check book, he agreed to mail the balance in a few days. The check was received on December 1, 1973, with an accompanying letter stating: "The only problem I have had with the instrument so far is that, after wearing it for several hours, it begins to tickle or itch. I imagine that there is still some chemi- cal coating on the ear insert that will disappear with time--as happens on the flippers of brand new eyeglasses. Very truly yours, (signed John C. Brennan) ." On December 7, 1973, Mr. John Brennan returned and complained of a tiny sound in the instrument. This particular hearing aid has a tone control, so a tone adjustment was made. On February 1, 1974, Mr. Brennan return and complained that he could not hear satisfactorily at the meetings he had attended. In questioning him I found out that he would only wear the aid when attending the meetings and I instructed him to wear the aid daily so that he would become more accustomed to hearing with it. I also suggested that we could convert the aid to a CR08 type fitting at no cost to him, (a hearing aid specially designed to pick up the sound from the side with poor discrimination and transfer the sound to the side with good or normal hearing) but because of the cosmetic effect he would not take my recom- mendation. In most circumstances if a client will not follow the procedures rec- ommended to him it is unlikely that success will be achieved. On approximately February 18, 1974, he returned again and said that he would like to return the aid and get a refund. I explained that due to the fact that the aid had been registered to him by the factory and the guarantee sent to and re- ceived by him that it could not be resold as new, the earmold and accessories had no resale value, and a full refund could not be made. The original selling price of the aid was $420.00 (complete) and I offered him a refund of $200.00. Mr. Bren- nan felt that $250.00 would be fair so at that time we reached a compromise figure of $225.00 and all seemed to be satisfactory, with the aid being returned to me and the earmold given back to him. On February 22, 1974, my check #2654 for $225.00 was mailed to him and the matter seemed to be closed. The fitting of this aid was made with no promise of results, verbal or written, and it is my feeling that with more use and counseling with the aid the problems PAGENO="0047" 41 could have been overcome, or if I had been allowed to make the conversion to a CROS fitting the results would have been excellent. In the last ten years, I've fit a great many bearing loses similar to Mr. Bren- nan's and to lily knowledge, everyone has been very much satisfied. In the period of time that I have been Hearing Aid Specialist, I have personally fit in excess of 1,000 hearing aids, and under my direction, my office has fit more than 3,000 hearing aids. My personal records indicate that the overall complaint is ap- proximately 3 out of 1,000. Also in the last ten years I have attended advanced and specialized courses conducted by Dr. Doudna, University of Maryland, Dr. Resnick, Washington Hospital Center, and numerous local specialized classes conducted by my manufacturer. I have this date requested that the Subcommittee supply to me the complete scope of this complaint so that I may properly defend myself. However, general allegations were the only information I could receive. I also requested that the information from Mr. Marks' memo from the interview of March 25, 1076 be sup- plied to me, and again, specifics were denied. I feel that with the training and experience I've had in this field, my capabili- ties and expertise in fitting hearing aids to be equal to or to surpass that of anyone in the hearing aid field. I am also sure that when it comes to dealing w-ith the public, anyone can realize it's impossible to please everyone. Yours truly, ROBERT M. CEDERLOFF. See attached notarized affidavit. State of Maryland, County of Montgomery. On this 31st day of March, 1076, before me personally appeared Robert Ceder- loff, to me known to be the person described in and who executed the foregoing instrument, and acknowledged that he executed the same as his free act and deed. ROSA A. BOND, Notary Public. My commission expires July 1, 1078. Senator PERCY. I want to thank our witnesses very much and turn to majority counsel for questions. Mr. FELDMAN. I have just one question following up on your ques- tion, Senator. Mr. Bicksier, did you ever go to a physician, a qualified physician who had expertise in hearing aid impairments, diseases, and defects? Mr. BICKSLER. I don't know what expertise the physician had, but I had been to an ear, eye, nose, and throat doctor for my ears. Mr. FELDMAN. What stage? Before you saw Mr.- Mr. BIOKSLER. At the stage my wife insisted I go to see an audiol- ogist in Sunnyvale. I went to the Sunnyvale Clinic to see the ear, eye, nose, and throat doctor. Upon his examination, it was something that couldn't be helped by medicine or surgery and from his examination, I went to the audiolo- gist at that same clinic. This was the first audiologist I had ever been to. This is the one I did not tell the Beltone Hearing Aid about. Mr. FELDMAN. Then subsequent to that you tested hearing aids? You tried hearing aids? Mr. BICKSLER. No. I did not because I could not afford the hearing aid. I didn't even try one. Mr. FELDMAN. But you went through your different attempts to correct your hearing? Mr. BICKSLER. No. This was the first audiologist I had. He was the one that recommended I try them on a trial basis and I could not af- ford it. From that time until the time I applied or reapplied to the ad for Beltone, I had not tried anything except living with it. Mr. FELDMAN. Mr. Malavey, do you tell your patients or individuals who come to you to seek qualified advice from physicians prior to ob- taining hearing aids? PAGENO="0048" 42 Mr. MALAVEY. Yes. Mr. FELDMAN. That is your standard operating procedure? Mr. MALAVEY. Yes. Mr. FELDMAN. That is the procedure you feel should be followed by all audiologists? Mr. MALAVEY. Yes. Mr. FELDMAN. Thank you. Mr. COTTIN. Mr. Chairman, I ask your permission to introduce into the record at this time the memorandum of an interview between the staff and William H. Gerrard, the hearing aid dealer who sold Mr. Bicksler his hearing aid. Mr. Gerrard said that it was his belief that the hearing aids he sold him were effective in helping Mr. Bicksier hear better. I also wish to enter in the record at this time the memorandum of an interview between the staff and Robert M. Oederloff who sold Mr. Brennan his hearing aid. In the interview, Mr. Cederloff said that he regretted now that he had given Mr. Brennan a refund and feels that if Mr. Brennan had continued to use the aid, he would have benefited from it. I also ask leave to introduce copies of telegrams from the subcom- mittee to Mr. Gerrard, Mr. Cederloff, and Mr. Ashlock inviting them to testify today or, in the alternative, to submit a statement for the record. Mr. Chairman, with your permission, I now would like to introduce affidavits concerning alleged hearing aid misfittings in several States which the staff has investigated. First, is an affidavit from Dr. Robert Kramer of Joliet, IlL, who describes his treatment of patients who were sold hearing aids although they were either clinically deaf or were not advised by hearing aid dealers that surgical procedures could restore their hearing and were instead sold hearing aids. An affidavit from Stephen D. Gannaway, an audiologist associated with Dr. Kramer, gives additional information on these alleged hear- ing aid misfittings. Another affidavit from Linda Morrison of Daytona Beach, Flit., describes how she was talked into purchasing a hearing aid by a dealer who failed to advise her that her hearing condition was correctible by surgery. Accompanying this is an affidavit from Dr. Robert A. Merreli, Jr., of Daytona Beach, Fla., who examined Ms. Morrison and made the medical determination that she was suffering from otoscierosis, a disease that can be corrected by surgery. Wynn Walters of Daytona Beach, the hearing aid dealer who sold Ms. Morrison the aid, was interviewed by the staff and referred the staff to his lawyer, who said that he had directed his client not to answer any questions. I ask that a memorandum of that interview be included at thi~ point. I also ask permission to place in the record a complaint flied by the State of Florida against Wynn Walters as well as depositions taken by the Florida Department of Health and Rehabilitation from Linda Morrison and Dr. Merrell. Next, Mr. Chairman, I ask leave to place in the record an affidavit from Elda Mae Sewell of Santa Clara, Calif., who claims that she was sold a hearing aid when she had, in fact, normal hearing. PAGENO="0049" 43 A supporting affidavit from Dr. Arthur Spar of Santa Clara, Calif., indicates that he examined Mrs. Sewell and found her to have normal hearing. I also ask permission to enter the memorandum of an inter- view with H. Paul Schwadel, the executive director of the Bay Area Union Professional Center, who said that Mrs. Sewell should not have been sold the hearing aid, which his firm sold her. Mr. Chairman, I ask permission to introduce three affidavits from Susan A. Toaz, Rena McKenzie, and Anne Dow, all Florida residents who claim that they were sold hearing aids by Victor Claprood, who confirmed that he failed to deliver hearing aids to Mrs. Toaz, Mrs. McKenzie, and Mrs. Dow. I also submit the record of indictment and conviction of Claprood on two other, but similar cases in Sarasota County. I further ask your permission to enter in the record an affidavit from Thaddeus Macy Crumpler of Pharr, Tex., who describes his purchase of a hearing aid from Louis Thibault in McAllen, Tex., and his efforts to get satisfaction from his dealer when the aid did not serve him. I also ask permission to enter in the record an affidavit from Dr. Francis I. Catlin of Houston, who examined Mr. Crumpler and found him to be deaf in the ear for which a hearing aid was fitted by Mr. Thibault. I also ask permission to enter in the record the memorandum of an interview with Mr. Thibault in which he declined to cooperate with the subcommittee. Subsequent to that interview, the records of the transaction with Mr. Crumpler and Mr. Thibault were subpenaed by the subcommittee. Finally, Mr. Chairman, all of the dealers mentioned in these affi- davits were advised by telegram of these hearings and invited to sub- mit statements regarding these allegations. To date, we have heard from none of them. I ask permission to place copies of these telegrams in the record and for the record to remain open for 30 days to allow time for these named dealers to submit statements relating to the mat- ters just discussed. Senator PERCY. Without objection, the exhibits will be entered with this condition precedent, that the staff will advise those people whose telegrams have been submitted to the hearing record that they have been inserted in the record and, once again, indicate that the subcom- mittee would like to have answers to the questions. This would be pre- ferable to no response, which gives the impression that they are with- holding information from the committee. It is so ordered. [The documents referred to were marked "exhibit Nos. 4 through 24" for reference and follow with the exception of exhibits 11 and 12 which may be found in the flies of the subcommittee.] EXHIBIT No. 4 MEMORANDUM To: Hearing aid case file. From: Jonathan Cottin. Subject: Beltone Hearing Aid Service, San Jose, Calif. Date: March 18, 1976. On this date I interviewed William H. Gerrard, a "consultant" to the Beltone Hearing Aid Service at 34 S. First Street in San Jose, California, and Donald 1-lodson, the operator of the Beltone Hearing Aid Service there. 79-9~i4-7G-----4 PAGENO="0050" 44 They were apprised that statements had been obtained from Ralph J. Bicksier, who had purchased two hearing aids from Beltone in San Jose, and an audiol- ogist, Mohan Rao Malavey, both of whom contended that the hearing aids sold Bicksler were of no use to him. Hodson, who bought the Beltone office in January 1976, was not involved in any way in the sale of the hearing aids to Bicksler. Gerrard said he has been a licensed dealer in the state of California since 1972. He said he had taken three short courses lasting from three days to a week offered by the Beltone Corporation. At least one of these courses was taken immediately before he took a dealer licensing exam. He said he had taken the licensing exam twice, failing it once on a "computer error" that was the fault of the state and not his own. ~Records which were provided the Subcommittee by Hodson show that Bicksier was sold the two aids on June 8, 1974. The used Beltone Andante hearing aids with registration numbers 1/0 4845 and 1/0 7190, were delivered on July 16, 1974. Mr. Gerrard could not recall the sale to Bicksler, except by referring to the records. He said that an audiogram showed that Bicksier had. "fair hearing, not too severe in the low frequencies." He said that in the higher frequencies beginning at around 2,000 hers, his hearing ability dropped off. He said that hearing aids were "good" for Bicksier's type of hearing impairment. He said that records show he gave Bicksier a "selectometer test," in which a master hearing aid with the capability to make amplifications at many levels, was used. He said with this test, he would apply the earphones to the customer's ears, walk into the next room and speak words which, if the customer heard them, would indicate that he could benefit from a hearing aid. Mr. Gerrard said that "I wouldn't even have sold him a hearing aid unless he said (after trying the selectometer), "that's the way I'd like to hear.'" Mr. Gerrard said he had "no doubt at all" that the hearing aids would help Bicksier. In reviewing the records, Mr. Gerrard said there was an entry by Mr. Ash- lock, the previous owner of the San Jose office, indicating that Mr. Bicksier returned on February 3, 1975 and that new ear molds were provided. Asked what he would infer from the February 3 visit, Mr. Gerrard said: "I would assume he was dissatisfied." But he said he was never apprised of this situation. He said that after the molds were changed, Mr. Ashlock in- dicated that Mr. Bicksler said that he heard better. There was no notation after that date of any subsequent visit from Mr. Bicksier. Mr. Gerrard said he never heard a word about the Bicksler matter after he had made the original sale. "I can't understand Ashlock not telling me (about Bicksier's unhappiness) ," said Mr. Gerrard. Both Mr. Hocison and Mr. Gerrard said they would like Bicksier to be satisfied. Hodson said he was going to get in touch with Bicksler to "get this man off my back." Exrnnir No. 4A MEMORANDUM To: Hearing aid case file. From: Howard S. Marks. Subject: John C. Brennan. Date: March 25, 1976. On this date, I visited the offices of Robert M. Ceclerloff, the Director of the Beltone Hearing Aid Service at 344 University Boulevard West, in Silver Spring, Maryland. I advised him that Mr. Brennan would testify at a Sub- committee heariing on April 1, 1976, regarding business dealings with Mr. Cederloff. 1\ir. Cederloff indicated that he wanted to cooperate with the Subcommittee and said that Mr. Brennan purchased an aid on November 18, 1973 after tests showed a 46 decibel loss on the left said and a 17 decibel loss on the right side. Mr. Cederloff then utilized a Master Hearing Aid instrument which Mr. Brennan said improved his hearing. Mr. Cederloff denied that there was any difference between the amplification Mr. Brennan experienced on the machine PAGENO="0051" 45 and the amplification of the hearini~' aid he purchased. He also denied telling Mr. Brennan that his hearing would deteriorate. He said Mr. Brennan's hearing aid was custom designed because Mr. Brennan needed a special power setting which he ordered. Additionally, he personally made the ear mold for Mr. Brennan, he said. Mr. Cederloff was asked about Mr. Brennan's initial dissatisfaction. with the aid and he replied that his difficulties were caused by Mr. Brennan's unwilling- ness .to take enough time to get used to the aid. He also stated that shortly after Mr. Brennan purchased the aid he sent in the balance owed. "If Brennan was so dissatisfied, why did he send in a check?" I Mr. Cederloff was asked whether minor adjustments were performed on the aid and he replied that because Mr. Brennan was complaining about high frequency sounds, he adjusted the aid to receive more low frequency. sounds. When that failed, he readjusted the aid to receive high frequency sounds because "sometimes you have to virtually do the opposite. Some hard of hear- ing people have heard wrong for so long they don't know how to hear right." Mr. Cederloff was asked whether he suggested Mr. Brennan buy an aid for Mr. Brennan's good ear. He denied the assertion. Instead, he said he proposed the use of a Contralateral Routing of Sound Aid (CROS) that would simply aniplify sounds through a microphone attached to an eyeglass bow or wire near the left ear and route them to the right ear. Cederloff conceded the device he suggested resembled a hearing aid. He was asked why he withheld $195 from Mr. Brennan and he replied that "used" aids were sold at one-third off the new price and he bad to pass this loss along to Mr. Brennan. Mr. Cederloff was asked why he finally agreed to a full refund and he replied that "my time was worth more than the aggravation that he was giving me. I never felt that I was wrong. He was not entitled to a full refund." EXIIIBIT No. 5 AFFIDAVIT OF ROBERT J. KRAMER, M.D. I, Robert J. Kramer, M.D., freely and voluntarily make the followring state- ment to Jonathan Cottin, who has identified himself to me as a member of the LTnited States Senate Permanent Subcommittee on Investigations of the Com- mittee on Government Operations. No threats, force, duress, promises or repre- sentations have been used to induce me to make this statement. I ani a citizen of the United States and live at 700 Prestige Drive in Joliet, Illinois. I am a board-certified otolaryngologist and practice medicine at 3077 West Jefferson Street in Joliet, Illinois at ENT Surgical Associates, Ltd. I have a bachelor's degree from Farleigh Dickinson University, an M.D. from Northwestern University, served an internship at `Chicago Wesley Memo- rial Hospital, did my residency in otolaryngology and maxillofacial surgery at Northwestern University Medical Center and completed a fellowship in head surgery at Southwestern University Medical Center. I am licensed for the prac- tice of medicine in Illinois and California. I have been clinical instructor at Northwestern University and the Cook County School of Nursing, was assistant chief of otolaryngology at the Naval Hospital in San Diego and am presently associated with St. Foseph and Silver Cross Hospitals in Joliet. I have courtesy staff privileges at five other hospitals in the surrounding area. I have published papers or presented them before the Triologic Society and in U.S. Naval Medicine. I have attended numerous special courses in otolaryngology. I am a fellow of the American and Inter- national Colleges of Surgeons and the American College of Otolaryngologists and am a diplomate of the American Board of Otolaryngology and a member of numerous other professional organizations. Since going into private practice with ENT Surgical Associates in 1971. 1 have treated numerous patients for ear disorders who were w-earing hearing aids and totally unaware that medical or surgical procedures could help them. They lacked that knowledge because their hearing aid dealers never told them. In many of these instances, it was apparent that either dealers did not recognize medical pathologies in their customers, never tested them properly, or kept the informa- PAGENO="0052" 46 tion of possible medical correction from their customers. I have found that most dealers do not refer their customers to otolaryngologists. Most of those who appear at my office come on their own, after experiencing continual deterioration of their hearing. I have found that dealers often overlook blatant ear pathologies, including perforated ear drums, draining ears, active infections, all of which are normally treatable by surgical or other medical procedures. One woman ~with otoscierosis in both ears had been buying hearing aids for 15 years when she came to me. The dealer never referred her to a medical pro- fessional, although the air bone gap that would have shown up on an audiometric' exam should have signalled the dealer that medical action was indicated. She came in on her own. It is very rare that a dealer sends a customer to a `doctor. Three of my patients have given permission to use their names and their cases to assist the Permanent Subcommittee on Investigations. One, Mrs. Jacqueline Rae Bati of Joliet, came to me in May 1973 with progres- sive hearing loss in both ears. Examination and audiometric testing showed that she bad otosclerosis, a calcification of bone in both ears, with the situation worse In her right than in her left ear. I recommended a stapedectomy, a surgical pro- cedure to remove the stapes. She had been wearing a hearing aid for some time on her right ear, but had shifted it to her left because it was no longer helping' her right eav. Subsequently, operations were performed on both her ears and the bone growth was removed. She regained normal hearing and is now completely rehabilitated. My concern is with the hearing aid dealer who sold her an aid when a medical problem was present. He must be totally interested in the sale of a hearing aid' for a profit. There was no question that proper audiological testing would have indicated a medical pathology. Either he didn't test her or he refused to tell her that she had a medically treatable problem. Surgery on otosclerosis in America has been successfully carried out in America on a regular basis for more than 15 years. In the case of Mrs. Julia Smego of Joliet, who first came to me in 1972, with severe pain in her right ear, testing and examination showed her to have a cholesteotoma, a skin cyst in the ear, and a perforated eardrum. She was wearing a hearing aid in her right ear, although our testing showed that her left ear was better. When .1 asked her why she was wearing an aid in her right ear, which was the weaker, she told me that her hearing aid dealer had recommended that. I advised her to switch the aid to her stronger ear, which she did with positive results. Some time later, I removed the cholesteotoma which resulted in slight improve- ment in her right ear. However, adequate testing by a dealer should have identified the medical pathology long before this patient visited me with a disease-cholesteotoma- that is sometimes life-threatening. The dealer's failure to make a medical referral could have cost Mrs. Smego her life. Mrs. Ella Boden of Joliet came to me in the Spring of 1975 with drainage in. her right ear. At the time, she was wearing eyeglasses equipped with `binaural hearing aids. But the right aid was not attached to her ear because, she said, it was doing her no good. Examination and testing revealed that she had a per- forated right eardrum and that she was clinically deaf in her right ear. She had only recently purchased the aids,' she said. It was apparent that her dealer had sold her an aid for a deaf ear. These are just a handful of examples of how dealers, who are businessmen essentially, fail to treat medical problems in a responsible way. While I believe in the usefulness of hearing aids, I seriously question the professionalism of many of the dealers who sell them. Hearing loss is a medical disease. The only way to assure persons with hearing impairment of proper treatment is for there to be proper equipment, operated by skilled personnel and with the data analyzed by professionals. It is not enough for a dealer to have a high school education and a 20-lesson home study course offered by the National Hearing Aid Society. In the interest of the medical wellbeing of the hearing impaired in this country, I believe the government must team up with the medical and audiological professions as well as the hearing aid industry to upgrade dealer training. Perhaps with some financial assistance from the Department of Health, Educa- tion and Welfare, colleges could offer university-level programs for dealers in PAGENO="0053" 47 acoustics, basic audiology and otology, as well as rehabilitation, including lip- reading. An HEW grant to start such a program, which must involve state medical societies, ear nose and throat health committees and others, would be money well spent and might help bring all these groups who are part of the hearing health delivery system together for the first time. I have read, reviewed and initialed each page of this statement and I swear, to the best of my knowledge and belief, that the statement contained herein is true and correct. ROBERT J. KRAMER, M.D. Sworn to and subscribed before me this s/21 day of August, 1975. S/MAY J~ GIVENS, Notary Public. EXHIBIT No. 6 AFFIDAVIT OF STEPHEN D. GANNAWAY I, Stephen D. Gannaway, freely and voluntarily make the following statement to Jonathan Cottin, who has identified himself to me as a member of the United States Senate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am citizen of the United States. I live at 1101 Taylor Street in Joliet, Illinois. I am president and board chairman of Joliet Audio Vestibular Laboratories, Inc., at 3077 West Jefferson Street in Joliet. I am an audiologist. I hold a bachelor's degree in speech pathology from Eastern Illinois University and a master's degree in audiology from the University of Illinois. I am an instructor in audiology at the College of St. Francis in Joliet. I am a member of the American Speech and Hearing Association, the Illinois Speech and Hearing Association, the Society ef Medical Audiology and the American Audiological Society. Before joining Joliet Audio Vestibular Laboratories in 1973, I was an audiologist in the Joliet and Decatur, Illinois, school systems for two years. My duties at my present jol) include the examination and testing of persons referred to the Laboratories by ENT Surgical Associates, Ltd., which shares offices with Joliet Audio, when there is a medical judgment that a hearing loss ~ present in a patient. I am responsible for verifying medical pathology identified by the otolaryngologists practicing at ENT Associates. I conduct pre- and post- operative audiological testing on these patients so as to keep track of any change in hearing that occurs due to any surgical or medical procedure performed by the doctors of ENT Associates. In the course of my work, I have encountered a number of patients who wear or were wearing hearing aids who were not properly cared for by their hearing aid dealers. In almost every such case, the patient has come to ENT Associates on his own. Seldom does a dealer make a referral of a patient to a doctor, in my experience. This reluctance to make medical referrals continues to this day, even though the National Hearing Aid Society has established a policy that all dealers should have their customers examined by a physician. I have seen numerous cases where dealers have made poor hearing aid fittings, selling a customer an aid that was too powerful or not powerful enough. Patients have come to our offices wearing hearing aids that. it turned out after examina- tion, were not medically indicated. Many other patients I have seen wear poorly fitting aids with loose ear molds, or with mold canals into the ear that are too long, causing too much distortion, or with molds that had rough edges, causing irritation and pain. While I believe that hearing aids are extremely useful in a large number of cases, and can really help many hearing-handicapped persons, there is an uneven level of competence among dealers. This question of competence places the hearing impaired person at risk if he goes to a dealer before consulting profes- sional medical personnel. Unfortunately, this happens a great deal. In one case in our files, a dealer fitted an aid on a woman whose audiometric test results clearly demonstrated that she had a medically treatable problem. The patient, Mrs. Jacqueline Rae Bath, of Joliet, first came to ENT Associates on May 23, 1973, complaining of a hearing loss. Andiometric testing showed that she had an air bone gap and medical examination found that she had otoscierosis PAGENO="0054" 48 o. both ears. Stapedectomies on each ear were performed and Mrs. Bati presently has normal hearing. If her dealer had conducted normal air and bone conduction audiometric tests, he should have been able to identify an air bone gap. In the case of Mrs. Ella Boden, an elderly Joliet patient, she came to ENT Associates in June 1975 complaining of drainage from her right ear. She was wearing glasses fitted for binaural hearing aids, but did not have the right aid connected, saying it was not helping her. Examination showed that she had a perforated tympanic membrane in her right ear. Further audiometric testing found that she was clinically deaf in her right ear. This meant that she should not have been sold an aid for her right ear. This aid for her right ear was totally and completely unjustified medically. Mrs. Boden told our staff that the binaural aids, recently purchased, replaced a set which she had previously used for a number of years. While it is possible that the first set was helpful to both ears, more recent audiometric testing by the dealer before the sale of the second binaural set should have revealed deafness in her right ear, and no aid for the right ear should have been sold her. Mrs. Julia Smego, another ENT Associates patient, first visited tl1e office in March 1972, with pain behind her right ear. She was found to have substantial hearing loss in both ears, but Dr. Robert J. Kramer of ENT Associates diagnosed an inactive cholesteatoma in her right ear, which also had a significant air bone gap, indicating other medical problems. She was wearing a hearing aid in her right ear, which she said she had only recently purchased. In June 1973, Mrs. Smego underwent a tympanomastoidectomy to remove the cholesteatoma which had become active, which is potentially a life-threatening illness. In her case, the dealer. who sold Mrs. Smego the aid for her right ear, without referring her to a medical doctor, either missed the pathology or failed to test the right ear properly. While a hearing aid for the right ear was indicated, medical examina- tion to protect this woman's life was also needed. This the dealer did not so recommend. The cases I have cited are just some of the examples of inadequate profes- sionalism on the part of some hearing aid dealers. I believe there is a need for hearing aid dealers, but their training must be substantially upgraded and made uniform if they are to properly serve the hearing impaired of the United States and protect their lives. I have read, reviewed and initaled each page of this statement and I swear, to the best of my knowledge and belief, that the statements contained therein are true and correct. S/STEPHEN D. GANNAWAY. Sworn to and subscribed before me this s/ 20th day of August, 1975. 5/ JAMES E. SCHRAM, Notary Public. /Expirati.on March 17, 1979 ExHIBIT No. 7 AFFIDAVIT OF LINDA L. MORRISON I, Linda L. Morrison, freely and voluntarily make the following statement to Jonathan Cottin and Howard S. Marks, who have identified themselves to me as members of the United States Senate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am a United States citizen. I live at 516 Phoenix Avenue in Daytona Beach, Florida. I am a keypunch operator at the General Electric plant in Daytona Beach, Florida, where I have been employed for the last eleven years. I success- fully completed a course in I.B.M. keypunch operations at the American Institute in Washington, D.C. I first noticed a loss of hearing four or five years ago. Listening had b'~come progressively more difficult. I would miss one or two words in a phrase. I was lost in a conversation. I was embarrassed because I kept asking people to repeat words. Working among noisy computers and keypunch machines did not help. This steady hearing loss really started to bug me early in 1975. I said to myself, if I got my hearing tested, maybe something will be done. In early April 1975, 1 saw an advertisement in a local newspaper placed by Wynn E. Walters and Associates, 133 Magnolia Avenue, Daytona Beach. Florida. PAGENO="0055" 49 The advertisement appealed to me because it featured a new "Miracle Ear," model hearing aid that could be concealed from view. Therefore, not only could my hearing be improved, but I would not be embarrassed by a large, unattractive hearing aid. On April 11, 1975, I visited the firm featured in the advertisement. Before reading the advertisement, I had never heard of this firm or its owner, Mr. Wynn B. Walters. I believed the firm to be a reputable one. Mr. Walters waited on me. I told him that I had seen his newspaper ad and that I was interested in an all-in-the ear hearing aid that would help me hear well again. I told him about my impairment. He never asked me whether I had ever seen a physician, audiologist or any other health care professional or hearing aid dealer about my hearing loss. He then gave me a test in which he sat in front of me and had me turn my head to the left and cover my right ear. He then read a series of words, which I was asked to repeat. He repeated the procedure with my head turned to the right. He informed me that I had missed several words he said. He then gave me a second test, by placing earphones over my ears and sending sounds through them with varying degrees of loudness. These were the only two tests he administered. Both of them took a total of about 10 minutes. Mr.. Walters then told me that my impairment could be helped by an Electrone B-SO hearing aid, the type that I was first interested in. He took one of these instruments from stock and inserted it in my left ear. It helped me to distinguish sounds that I had not heard for some time. I was pleased with the aid at first and told him so. He told me that it cost $250. I gladly agreed to purchase it and paid him the sum with my BankAmèricard. The entire transaction lasted 30 minutes. A few days after purchasing the aid, I began suffering headaches that I be- lieved were caused by the additional background noise that I was picking up from my new hearing aid. Also, the aid was irritating my left ear, causing soreness and discomfort. It did not properly fit my ear, because it fit too loosely, and nearly fell out of my ear as I walked on several different occasions. I became more and more dissatisfied with the aid and told some of my office colleagñes about my problem. Some advised me to see Dr. Robert A. Merrell, Jr., an ear specialist. Since I bad begun to realize that my hearing impairment was not beyond correction, I decided to see Dr. Merrell and in April 29, I went to his office for an examination. He and his staff administered a number of tests, lasting about 45 minutes. In addition to the tests performed by Mr. Walters, I was also given another test in which a device was placed behind each ear and my reaction to sounds was measured. I was told that this was a bone conduction test. Its purpose was to determine whether my hearing ability was better if sound was allowed to bypass my ear canal and the bones outside my middle ear. Dr. Merrell then examined me and advised me that my impairment was prob- ably caused by an abnormal bone growth. I told him that I had recently pur- chased a hearing aid that was helping me to hear somewhat better but was quite irritating to my ear and fit improperly. I showed him the aid. He told me that there was nothing wrong with my wearing an aid, if it helped, but that the aid I showed him was the wrong type of instrument for the hearing problem that I suffered. He told me I had tw-o options if I wanted to improve my hearing. One was to purchase a behind-the-ear hearing aid, which would bypass the bone blockage in transmitting sound. The other was to have surgery for removal of the bone growth. At no time did he urge me to have surgery or purchase another aid. He simply advised me of my choices. I was chagrined to learn that Mr. Walters had sold me the wrong type of aid, and equally disturbed to know that he didn't even bother to test me for sound behind the ear. On May 19, 1975, I returned to Dr. Merrell for a second examination and con- sultation. The result of the second test series was the same as the first. I have still not decided what I shall do about my hearing problem. Mr. Walters says he w-ill not refund my $250, and his aid sets unused in a drawer in my home. I want very much to hear again, because it is so frustrating and embarrassing to miss so much. But I am not wealthy and cannot afford to waste any more money on hearing aids that are more trouble than they are worth. I do not want to be made a fool of again by a `hearing aid dealer. PAGENO="0056" 50 I have read, reviewed and initialed each page of this statement, and I swear, to the best of my knowledge and belief, that the statements contained therein are true and correct. s/LINDA L. MORRISON. Sworn to and subscribed before me this s/llth day of February 1976. S/MARGUERITE JOHNSTON, Notary Public. EXHIBIT No. 8 AFFIDAVIT OF ROBERT A. MERRELL, JR. I, Robert A. Merrell, Jr., freely and voluntarily make the following statement to Jonathan Cottin and Howard S. Marks, who have identified themselves to me as members of the staff of the United States Senate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am a citizen of the United States and am in the professional practice of Otolaryngology at 1435 Dunn Avenue, Daytona Beach, Florida. I hold a B.S. from The Citadel, graduated from Duke University School of Medicine, took two years of General Surgery training at Yale University Medical Center and three years of Otolaryngology training at the same institution. On the completion of my training I became board eligible in 1985. I am on the executive committee of Halifax Hospital Medical Center and the Volusia County Medical Society. I am chief of the Department of Otolaryngology at Halifax Hospital Medical Center, and a member of The American Medical Association, Florida Medical Association, Florida Society of Otolaryngology, The Council on Otolaryngology. On April 29, 1975, Linda L. Morrison, a resident of Daytona Beach, came to my office for an examination. According to my medical records, Miss Morrison stated at the time of her initial examination "I think I have nerve deafness". She also stated that she had purchased a hearing aid three weeks ago and felt that it had given her some help. She stated that she wanted to have her hearing tested. She also complained of some ringing in her ears and occasional dizziness. She felt that her right ear was her best hearing ear. Audiograms performed in my office and confirmed by an audiologist at the Easter Seal Center indicated that the patient had nearly normal hearing in both ears by bone conduction. This test applies calibrated sound to the bone behind the ear, bypassing the conductive mechanisms which include the ear canal, the eardrum and the three ossicles, thereby measuring the hearing capacity of the inner ear. The second portion of the hearing testing consisted of the air conduction test, in which sound `is applied to the outside of the ear to determine how the patient actually experiences sound. This showed poor hearing in Miss Morrison's ears with a range of 55 decibels in the lower frequencies rising to about 45 decibels in the higher frequencies. At the time of this original examination I told Miss Morrison that I thought she had a condition called otoscierosis which is due to an abnormal growth of hone in the inner ear that was blocking sound from entering her inner ear. I told her that if she wanted to have her condition treated, she either undergo surgery in which the bony growth would be removed, should this prove to be otosclerosis, or she could continue to use a hearing aid. She expressed an interest in the surgical procedure and at that time a reappointment was scheduled for reconfirmation of her hearing loss, further testing, and a conference for discus- sion of the surgical procedure. On May 19, 19~5 she returned for the second series of test and consultation. The second test reconfirmed the earlier findings and we again discussed her options. She decided to give the matter more thought. She appeared very disturbed that her hearing aid dealer had not advised her that she had a bone conduction problem and that it was possible for surgery to PAGENO="0057" 51 be performed on her ear in order to improve her hearing. Under those circum- stances, if the operation was successful she would, of course, not need to use a hearing aid. From what she told me I deduced that her hearing aid dealer never performed a bone conduction test, and this was later borne out in testimony by Wynn Walters, the hearing aid dealer. Miss Morrison came to me on her own and not by referral from her dealer. I regard this failure to advise her that she had a conductive hearing loss as professional negligence on the part of the hearing aid dealer. Patients with conductive hearing losses can have potentially life-threatening conditions such as malignant tumor, cholesteatomaS (which can progress with destruction of the inner ear to the point that the patient has permanent dizziness, facial paralysis, or even brain abscess.) There are many other middle ear conditions which can be initially discovered by finding out that a patient has a conductive hearing loss and having been examined by a competent physician. The dealer, by not per- forming a bone conduction test, was remiss. I have read, reviewed and initialed each page of this statement and, I swear, to the best of my knowledge and belief, that the statements contained herein are true and correct. ROBERT A. MERRELL, 1r., M.D. Sworn to and subscribed before me this 11th day of February, 1976. DORIS A. MALONE, Notary Public. EXHIBIT No. 9 MEMORANDUM To: Hearing aid case file. From: Jonathan Cottin. Subject: Wynn E. Walters, Florida hearing aid dealer. Date: February 11, 1976. On this date, Subcommittee staff member, Howard S. Marks and. I visited the hearing aid office of Wynn E. Walters at 133 Magnolia Street, Daytona Beach, Florida. I advised Walters that we had obtained affidavits from persons involved in the purchase of a hearing aid from him on April 11, 1975. I said that I was visiting him to obtain his response to charges that he sold Linda L. Morrison of 716 Phoenix Street in Daytona Beach a hearing aid although she bad a bone conduction problem that would have indicated referral to a physician. As Iwas explaining this, two customers came into the store and Walters ex- cused himself to talk to them in his inner office. During, the course of his conversation with the two customers, a discussion which we readily overheard, one of the customers asked if she needed to .see a doctor, before purchase of a hearing aid. "You don't have to see a doctor," said Walters. "~I'm an ear specialist." After the customers left, Walters invited us into his inner office. I asked him if he had conducted .a test for bone conduction on Miss Morrison. He said that he had. I asked him if he would let me see the audiogram that would prove it. He said it was In the hands of his lawyer. I asked if his lawyer would make it available. He called his attorney, who wasn't in. A few moments later his attorney, Richard Kane of Daytona Beach, telephoned him back. In our presence, Walters advised him of our visit. Walters then told us he could say no more to us and directed us to visit his attorney. We called on Kane and advised him of the purpose of the investigation and the reason for visiting his client, Wynn E. Walters. He said that Walters was presently the target of three state and local investi- gations. He said that he did not think, in view of this, that Walters should answer our questions. He said, however, that we were entitled to review everything in the public record regarding all of these actions: state and local, against his client. I asked him if be would make available to the Subcommittee the aucliogram of the bone conduction test that Walters said he performed on Miss Morrison. He replied that he would take it under advisement, and if he felt be could would forward that to the Subcommittee. PAGENO="0058" 52 EXHIBIT No. 10 State of Florida, The State Attorney, for the Seventh Judicial Circuit Docket No.: SAC-76--102 In the matter of: WyNN E. WALTERS, d/b/a WYNN WALTERS & ASSOCIATES, d/b/a DAYTONA HEARING AID SERVICE COMPLAINT Pursuant to the provisions of Chapter 501, Florida Statutes, Part II, and by virtue of the authority vested in it by said Statutes, the State of Florida, having reason to believe that WYNN E. WALTERS, d/b/a WYNN WALTERS & ASSO- CIATES, d/b/a DAYTONA HEARING AID SERVICE, hereinafter referred to as "Respondents" has violated the provisions of Chapter 501, Florida Statutes, Part II, and it appearing to the State that a proceeding by it in respect thereof would be in the public interest hereby issues its Complaint in that respect as follows: 1. Respondents operate a business enterprise located at 133 Magnolia, Daytona Beach, Florida. 2. Respondent is operating a concern that offers sales and services to the public "supplying" hearing aid devices, accessories and servicing. 3. That from October 3, 1073 to March I, 1076, the Respondent has engaged in unethical, unfair, deceptive and fraudulent trade practice in violation of Chapter 501, Florida Statutes, Part II. 4. Respondent has violated the Rules of the Department of Legal Affairs, Chapter 2-9, Advertising Sales duly created pursuant to Chapter 501, Florida Statutes, Part II and approved by the Cabinet thereafter in that the Respondent has: (a) misrepresented the ownership, manufacturer, source and origin of. hearing aid devices sold; (b) misrepresented the age, model, grade, style and standard of hearing aid devices sold. (c) has misrepresented the sponsorship, endorsement and approval of goods and services; (d) has misrepresented the affiliation, connection or association of hearing aid devices, accessories and services offered by the Respondent; (e) misrepresent the nature, characteristic standards, ingredients, uses, bene- fits, qualities and quantities of hearing aid devices, accessories and services offered; (f) misrepresented that hearing aid devices are new or original when they are used, altered, deteriorated or repossessed; (g) advertised goods and services with the intent not to sell them as adver- tised. 5. The Respondent has maintained a consistent program of advertising which advertises hearing aid devices and accessories at a discount or reduced sale price but which in fact are no lower than that same product or service offered to the public by the Respondent or by other suppliers of the same hearing aid devices and accessories in the Daytona Beach area in violation of Rule 2-9.03, Rules of Department of Legal Affairs. 6. The Respondent has engaged in bait and switch operation by advertising hearing aid devices, accessories and services which are not a bona fide offer to sell the product by refusing to show, demonstrate or sell the product or service offered in accordance with the terms of the offer as found in the advertisement, the disparagement by actual words of the advertised product or service or the dis- paragement of the guarantee, availability of services, repairs or parts; and failed to have available at the place of business listed in the advertisement a sufficient quantity of the advertised product to meet reasonable anticipated demands, all in violation of Rule 2-9.04, Rules of Department of Legal Affairs. 7. That Respondent does prey upon and engage in high pressure sales tactics upon the elderly and infirm who seek his professional assistance. 8. Respondent has engaged in numerous acts of unethical conduct as defined in Fia. stat. 468.130 and more specifically .at sub paragraphs (1, 3, 4, 5, 7, 9, 10, 11, 12,13). PAGENO="0059" 53 9. Respondent represents that by advertising and sales pitch that the use of the hearing devices will improve and preserve hearing or that such. bearing device will cure the cause of a bearing impairment. 10. Respondent has failed and refused to cooperate with any State Agency to correct the unfair and deceptive nature of his advertisements and sales pattern. 11. The Respondent, by these deceptive, unfair and fraudulent trade prac- tices is a danger to all those who seek his services. Therefore, the State, after proper bearing, and findings of fact, the State will contemplate the issuance of an Order. (a) Requiring the Respondent to cease and desist the established deceptive and unfair trade practices. (b) Requiring restitution to those members of the public deemed injured by the acts of the Respondent and requiring a deposit of funds by the Respond- ent thereon. Executed this day of , 1976, in Daytona Beach, Volusia County, Florida. STEPIIEN L. BOYLES, State Attorney of the Seventh Judicial Circuit. ExHIBIT No. 13 AFFIDAvIT OF ELDA MAE SEWELL I, Elda Mae Sewell, freely and voluntarily make the following statement to Jonathan Cottin, who has identified himself to me as a member ~f the staff of the United States Senate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am a citizen of the United States and live at 415 Bernardo in Santa Clara, California. I am a licensed vocational nurse and employed as a general duty nurse at Agiiew State Hospital in San Jose, California. About two years ago, I was fitted for new eye glasses at the Bay Area Union Professional Clinic at 4483 Stevens Creek Boulevard in Santa Clara, California. The man who sold me the glasses suggested that I have my bearing tested, at no cost to me, at the Bay Area Union Professional Clinic. I agreed to and set up an appointment to return to the office, which is also engaged in the sale and fitting of hearing aids, for my free hearing test. The woman who tested me told me, after completing an audiogram on me, that I was going to lose my bearing in a very short period of time. She was very insistent that I needed a bearing aid right away. I told the woman that I felt I had normal hearing. She told me that she was a licensed hearing aid sales- person and that I did not know what I was talking about. I was afraid that she was right, and agreed to make a down payment on a hearing aid. She gave me a hearing aid and told me to take it home and examine it. After a few days, I realized that I should never have purchased the aid without having first gone to a physician. I w-ent back to the woman who sold me the aid and told her that I did not want the aid and that I was going to a doctor for an examination of my hearing. The woman who originally sold me the aid told me that I was obligated to pay her the balance and that she would not take the aid back. Under extreme pressure, I paid her the balance owed for the aid. Then I went to a lawyer and told him what had happened. He wrote a letter to the dealer asking for repayment for the cost of the aid. I arranged for an examination of my ears by Dr. Arthur Spar of the Kaiser Permanente Ear, Nose and Throat Clinic in Santa Clara. California. An audio- gram was performed and Dr. Spar examined my ears. Following the exmination, he told me that I had normal hearing in both ears and that I did not need a hearing aid. After learning this, I went back to the dealer and told her what the physician said. She was extremely hostile to me. She refused to refund my money. I walked out. Some time later, my attorney was able to obtain a partial refund for the hearing aid I purchased but did not need. PAGENO="0060" 54 I have read, reviewed and initialed each page of this statement and I swear, to the best of my knowledge and belief, that the statements contained herein are true and correct. ELDA MAE SEWELL. Sworn to and subscribed before me this 17th day of March, 1976. MARY S. MISFELDT, Notary Public. ExHiBIT No. 14 AFFIDAVIT OF ARTHUR SPAR, M.D. I, Arthur Spar, M.D., freely and voluntarily make the following statement to Jonathan Cottin, who has identified himself to me as a member of the staff ot the United States Senate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am a citizen of the United States and am in the practice of otolaryngology at the Kaiser Permanente Medical Center in Santa Clara, California. I am a partner in the Kaiser Permanente Medical Group. I am a board-certified oto- laryngologist. I hold an M.D. from the University of Nebraska College of Medi- cine, an M.S. from the University of Minnesota and a master's degree in public health from the University of California, Berkeley. I have practiced otolaryngology at Kaiser Permanente in Santa Clara since 1970. On October 14, 1974, I examined Mrs. Elda Mae Sewell of 415 Bernardo in Santa Clara, California. She had come in to see if the hearing loss diagnosed by the Bay Area Union Professional Center of 4483 Stevens Creek Boulevard in Santa Clara was verifiable. An audiogram taken by Mark Toscher, an audiologist for the Kaiser Perma- bate Ear, Nose and Throat Clinic indicated that Mrs. Sewell had virtually nor- mal hearing in both ears. My examination of Mrs. Sewell confirmed this. No hearing aid was indicated for her on the basis of the audiogram taken by. Mr. Toscher. I concluded that Mrs. Sewell was inappropriately sold a hearing aid by the dealer. I also noted, in examining the audiogram taken by the dealer, that it showed a flat loss of almost the same level in each ear-40 per cent. The dealer's audiogram shows that no bone conduction test was administered to Mrs. Sewell, which I regard as unprofessional. It is normal, in the testing of persons for hearing impairment, to check bone conduction as well as air con- duction so that a'.determination can accurately be made about the nature of the hearing loss, if one exists. I can only conclude, on the basis, of examining the two audiograms, that the one conducted by the dealer might have been inaccurate. In any, event, the dealer should have done a bone conduction test to deter- mine if the hearing loss indicated in the air conduëtion test might~ have' been from nerve deafness. I have, read, reviewed and initialed each page of this statement and I swear, to the' best of my knowledge and belief, that the statements contained herein are true and correct. ARTHUR SPAR, M.D. Sworn.to and subscribed before me this 17th day of March, 1976. DOROTHY L. WASHAM, Notary Public. EXHIBIT No. 15 ME~1ORANDUM To: Hearing aid case file. From: JOnathan Cottin. Subject: Elda Mae Sewell. Date: March 18. 1976. On this date, I interviewed H. Paul Schwadel, Executive Director of the Bay Area Union Professional Center, which dispenses eyeglasses and hearing aids from locations in San Francisco, Santa Clara and Carmichael, California. PAGENO="0061" 55 Asked to reconcile the dramatic differences in the audiogram results between that taken by Hazel 1\f. Shultz, an employee of the Bay Area Union Professional Center in Santa Clara, and that taken at the Kaiser Permanente Hospital in Santa Clara, Schwadel replied: "I have reason to believe that Mrs. Shultz was at fault." Records made available to the Subcommittee show that Mrs. Sewell,. who paid $274.53 for the Fidelity P173 hearing aid serial #14819 to the Bay Area ijnion Professional Center on or about May 14, 1974, the date that Mrs. Shultz performed the audiogram. That audiogram showed an approximate 50 decibel loss in both ears for Mrs. Sewell. On October 14, 1974, tested at the Kaiser Per- manente Hospital, Mrs. Sewell's hearing was shown to be virtually normal in both ears. After Mrs. Sewell'~ lawyer, Robert 11 Christensen of San Jose, filed a complaint against the dealer for the apparent misfitting, Bay Area Union Professional Center refunded $224.53 to Mrs. Sewëll, representing her payment for the hear- ing aid minus rental charges and the cost of an ear mold. Schwadel said that Mrs. Shultz was dismissed from Bay Area Union Pro- fessional Center on June 4, 1975. The payment to Mrs. Sewehl by Bay Area Union Professional Center was on January 10, 1975.. _______ EXHIBIT No. 16 AFFIDAVIT OF SUSAN A. TOAZ I, Susan A. Toaz, freely and voluntarily make the following statement to Howard S. Marks, who has identified himself to me as a member of the United States Senate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am a citizen of the United States. I reside at 2511 Flamingo Boulevard, Apart- ment L6, Bradenton, Florida. I moved to Bradenton in 1960 with my now deceased husband in 1960 from Lansing, Michigan. I am 76 years old. I am a retired secretary and a graduate of the Metropolitan Business College in Elgiin, Illinois. I first noticed a loss of hearing two years ago. I had to increase the volume on my television set and had to sit closer to the pulpit in church in order to hear the pastor. In September, 1975, I answered an advertisement placed in a local newspaper by Tn-County Hearing Aid Service, 608 13th Street West, Bradenton, Florida. Mr. Victor Olaprood, who told me he owned the company, gave me a hearing aid test which he told me be would not charge me for. He placed plugs in my ear that were connected to a little machine. He played various sounds on the machine. Mr. Claprood also read off a list of words and I could not hear some of the words. Following the tests, 1~Ir. Claprood said that I had 43 percent hearing in my right ear. I then purchased a Dahlberg hearing aid with the aid hiddcn in the bow of a pair of eyeglases. It cost me $385. Although my hearing improved, this aid was unsatisfactory because its relatively heavy weight forced my glasses to continu- ously slide down my nose. On July 17, 1975, Mr. Claprood visited my apartment uninvited. He wanted to know if I had received notification from the Dahlberg hearing aid company about its new all-in-the-ear model. He seemed to be surprised that the hearing aid company had not mailed me this notice, and proceeded to explain this new model to me. He told me that it would not be attached to my eyeglasses which would solve the slippage problem. The new aid would also be less noticeable. Mr. Claprood said that I should try it out. The total price would be $395, but I would receive a $214 credit for the hearing aid I was wearing at the time. But Mr. Claprood said that he could not grant me the credit until I had liked the new hearing aid after wearing it. I then wrote out a personal check for $395 payable to Tn-County Hearing Aid Service. Even though Mr. Claprood promised the new hearing aid as quickly as possible I did not receive it. A month later, I finally confronted Mr. Claprood in person about the delay in receiving the new aid. He told me that he was so busy because of heavy volume of orders for the new aid that he was not able to get around to my order, but that I would be receiving it shortly. PAGENO="0062" 56 Since then, I have not seen or heard from Claprood. I continue to wear my 01(1 hearing aid which is unsatisfactory. I am not a wealthy woman and live off my Social Security. I can ill-afford to lose $395. I hope that something can be done to prevent disreputable hearing aid dealers like. Mr. Claprood from preying on the elderly. I have read, reviewed and initialed each page of this statement and I swear, to the best of my knowledge and belief, that the statements contained therein are true and correct. S/SUSAN A. ToAz. S/RICKARD B. CUMMINGS. Sworn to and subscribed before me this s/14 day of s/Feb., 1976. EXHITIT No. 17 AFFIDAVIT OF RENA M'KENZIE I, Rena McKenzie, freely and voluntarily make the following statement to Howard S. Marks, who has identified himself to me as a member of the United States Senate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am a citizen of the United States. During the winter, I reside with my hus- band at 1506 26th Avenue West, Bradenton, Florida. My permanent addre~s is 4469 Carolyn Road, Piegeon, Michigan, where I reside from May 1st to October 1st. I am a retired registered nurse having successfully graduated from Saginaw Womans Hospital. Even though I am retired, I continue to renew my certification each years with the State of Michigan. I am 73 years old. Three years ago I began to notice a hearing loss. The loss became more severe and I began to miss words and I had to ask people to repeat phrases that I failed to hear. In 1974, I heard a radio advertisement promoting the sale of hearing aids, sponsored by the Tn-County Hearing Aid Service, 608 13th Street, West, Braden- ton, Florida. I telephoned Tn-County Hearing Air Service and told a salesman about my hearing loss. A salesman employed by Mr. Victor Claprood, owner of Tn-County Hearing Aid Service, came to my home and performed several tests. One machine he brought gave out tones that I heard through earplugs. The salesman played various sounds on this machine. He also read off thirty words in front of each ear, which be asked me to repeat. The salesman told me that I had missed half the words. He then advised me that I needed a hearing aid for my left ear because it would help me hear complete sentences. I ordered a $395 hearing aid that I found to be bene- ficial. It fit into a pair of eyeglasses. A year later, however, I began to experience difficulties with the aid. It went dead and I brought it in for repairs to a hearing aid dealer in Connecticut. It cost me $55 to get the aid working again, but only a month passed and once again it was not functioning. Shortly after arriving in Bradenton, Florida, for the winter, I called Tn- County Hearing Aid Service, to arrange for an appointment to get the hearing aid repaired. On October 9, 1975, Mr. Victor Claprood visited my home and advised me that it would cost $44 to repair the aid. Mr. Claprood then told me about a new all-in-the-ear-model aid that would not have to be connected to an eyeglass frame. He said that the total price for the new hearing aid would be $218.55, which included a $150 credit for the aid that I was wearing. Mr. Claprood said that he would give me a two-year guarantee against any problems that would include free service and repairs. I told Mr. Claprood that I would purchase the new hearing aid because I liked its appearance. I gave him a personal check for $218.55. He then took a mold im- pression of my left ear, so I could be fitted properly with the new aid. Mr. Clap- rood also promised me the use of a "loaner" hearing aid, because he wanted my traded-in hearing aid that day. Because he did not have the "loaner" hearing aid with him, Mr. Claprood promised to deliver it as soon as possible. I never heard from or saw Mr.. Claprood again. My husband and I phoned his office repeatedly and was told that he was "out." When we visited his office. u-c were told that he was not there, but that he would call me when he returned. PAGENO="0063" 57 Three months passed and I finally gave up hope of receiving the new hearing aid from. Mr. Claprood. I finally went out and purchased a new $350 Zenith hear- ing aid for my left ear. During that three-month period, I was without a hearing aid and I found that I missed portions of many conversations and some of my favorite, television programs. I am very angry over the fast-talking treatment I received from Mr. Victor Claprood and his Tn-County Hearing Aid Service. I have read, reviewed, and initialed each page of this statement and I swear, to the best of my knowledge and belief, that the statements contained therein are true and correct. S/RENA MCKENZIE. S/RICHARD B. CUMMINGS. Sworn to and subscribed before me this s/l4th day of s/February 1976. EXHIBIT No. 18 AFFIDAVIT OF ANNE DOW I, Anne Dow, freely and voluntarily make the following statement to Howard S. Marks, who has identified himself to me as a member of the United States Sen- ate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am a citizen of the United States. `I reside at 7102 11th Avenue West, Braden- tori, Florida. I moved to Bradenton in 1971 from Detroit, Michigan, after I retired as a buyer for the J. L. Hudson department store. I am 71 years old. I have worn a hearing aid since early 1972. I needed the hearing aid because over a number of years, I had failed to hear the ringing of telephones, conversa- tions and television programs. I purchased my first hearing aid from Mr. Frank A. Zirpoli, Sr., whom I understood, owned the Professional Hearing Aid Service, Inc., 30 Kings Court, Sarasota, Florida. Mr. Zirpoli sold me a $349 Coticon aid for my left ear. I was very satisfied with this aid, because my hearing improved when I wore it. Because I was satisfied with the aid and because of the excellent service I received from Mr. Zirpoli, I trusted him. Over three years passed, and on Feb. 2, 1975, Mr. Victor Claprood visited my home unsolicited. He said that he was from the Professional Hearing Aid Service. I assumed that Mr. Claprood was employed by Mr. Zirpoli. Because I trusted Mr. Zirpoldi, I let Mr. Claprood into my home. I was very favorably impressed by Mr. Claprood. He seemed to be in his late thirties or early forties. He was nice looking, tall, slim, and an excellent dresser. I felt at ease with Mr. Claprood because he was very quiet and he never hurried me. He seemed genuinely friendly. He was a Bradenton neighbor of mine, in fact, he only lived a short distance away. He talked a good deal about his family. He mentioned his wife and showed me snapshots of what he said were his two young sons. He also told me about his dog and about some difficulties the dog was encountering with a neighborhood snake. After he told me about his family life, I said to myself, "you can trust someone like that". I invited Mr. Claprood into a room in my house, w-hich I call the Florida room, and we began to chat. He talked in a normal voice, but then it become louder and he informed me that I was missing some words and that I should be tested. He placed a pair of ear plugs in my ears to test sounds that came from a portable machine that he carried around. Following the test, Mr. Claprood told me that I needed a hearing aid for both ears, instead of just for the left ear, and he recommended that I purchase two new Dahlberg hearing aids that would fit into the bows of an eyeglass frame. Mr. Claprood said that the total price was $650, which would cover both aids and the new temples for my glasses. I would have to supply the front of the eye- glass frame. I gave Mr. Claprood a check for $150 as a deposit. On March 10, 1975, I gave him a check for the balance. Mr. Claprooci delivered the new aids and tested them on my ears. I initially told him that the new aids worked satisfactorily. But because of the weight of the frames caused by the aids, the glasses kept sliding down my nose which resulted in time aids popping out of my ears. I even placed adhesive tape on the frames to prevent the slipping, but nothing helped. I knew that I could not PAGENO="0064" 58 wear this type of hearing aid. Because of this slippage problem, when I did wear the aids, they whistled. I attempted to reach Mr. Claprood regarding this problem, but he never seemed to be in his office. A man that answered the phone said Mr. Claprood was very busy making house calls and he would return my phone call as soon as he bad a chance. The man that answered said that Mr. Olaprood was a nice guy and an honest man that he was simply trying to do everything himself. When I contacted the Sarasota office of the firm I was told that Mr. Zirpoh who had sold me my first aid in early 1972, was no longer associated with the firm. At no time did Mr. Claprood inform me that he owned the firm. Much to my surprise, on August 28, 1975, Mr. Claprood visited my home. He told me that he was aware that I bad problems with the aid that be originally sold but that a new aid had been developed which might be better suited for me that would fit entirely in the ear and was inconspicuous. I never directly faulted Mr. Claprood for my problems with the hearing aid that I bought in February that was unsatisfactory. I felt that it was not suited for me, as other people were happy with this eye frame type hearing aid. Still, I was less trusting of him than before, because I discovered that he was not working for Mr. Zirpoli and because he did not return my phone calls. However, Mr. Chtprood immediately mentioned that he had a new type hearing aidthat would clear up my problem with hearing background noise. Background noise that I picked up in my hearing aid had become a major nuisance. I had difficulty playing Bridge because I kept hearing the chatter of other players and could not hear my partner bidding. I could not attend plays or movies because I kept hearing background noises. I became an eager listener to Mr. Claprood because I was so desperate to rid myself of the background noise problem that had made my social life so difficult. He allowed me to use a sample model and I found that I could hear clearly again. I was excited by this development. I was so eager to clear up this problem that once again I trusted Mr. Claprood. I just do not have a suspicious mind. I have no reason to mistrust anyone. I even gave Mr. Claprood the names of five of my friends, who I.thought could use this type of hearing aid. They all reported back later how much they liked Mr. Claprood. Mr. Claprood said that the new aids would be seven dollars less than the aids I was wearing. He said, however, that he needed a $400 "security deposit" from me until he received a refund from the manufacturer of the hearing aid that I was giving back to him. I was very hesitant to give him the $400, but he said that he could not afford to advance this kind of money out of his own pocket. I said to myself that Mr. Claproodwas a hard-working businessman and I liked that. He was trying to make a go of the business, but he did not have enough money. Because I was so desperate to get these aids and because he seemed like a hard working businessman, I gave him a $400 check to cover this "security deposit." Mr. Claprood did give me a written assurance of his good faith. He wrote a statement that the new all-in-the-ear aids would be given to me on a GO (lay trial basis. If I was not satisfied, I could receive a complete refund, Mr. Claprood wrote. Mr. Claprood then made a mold impression of my ears. Several weeks later, Mr. ClaproQd returned to my home, but only with the hearing aid for my left ear. He explained that the aid for my right ear had arrived in a defective condi- tion and that he had sent it back to the manufacturer. I immediately told him that the left hearing aid did not work, but he said that it would he unfair to test one of the aids without the other. He also said that when the right hearing aid was delivered that I would receive a refund check for $407, which would cover the refund on my "security deposit and the fact that the two new aids were seven dollars less than my traded-in aids. I never saw or heard from Mr. Claprood after that meeting in my home in September, 1975. I made repeated phone calls to his office, but Mr. Claprood never returned my calls. Recently, I returned to Mr. Zirpoli, who says that he now has bought out the Professional Hearing Aid Service from Mr. Claprood, who has had his dealers license revoked by the State of Florida. Mr. Zirpoll told me that the new all-in- the-ear model that Mr. Claprood delivered was unsatisfactory because it did not fit my ear. Mr. Zirpoli took a new mold of my right ear that cost me $69, bringing the entire cost of this 12 month ordeal to over $1,050. I am currently using the aid I bought in 1971. PAGENO="0065" 59 I have read, reviewed and initialed each page of this statement and I swear, to the best of my knowledge and belief, that the statements contained therein are true and correct. S/ANNE Dow. S/JAMES C. Foy. Sworn to and subscribed before me this s/l6th day of s/February 1976. EXHIBIT No. 19 MEMORANDUM To: Hearing aid case file. From: Howard S. Marks. Subject: Victor H. Claprood. Date: March 26, 1976. On this date, I telephoned Mr. Claprood, 9009 N.W. 9th Avenue, Bradenton, Florida aiid told him that three former customers bad signed affidavits alleging that be had failed to deliver hearing aids that they had purchased. I told him that the affidavits would be entered into the public record on April 1, 1976, when the Subcommittee would commence hearings. He agreed, somewhat reluc- tantly, to cooperate. He confirmed that he failed to deliver hearing aids to Mrs. Susan Toaz, Mrs. Rena McKenzie and Mrs. Anne Dow. "We just went financially bankrupt and we were forced out of business. We were doing the best to deliver. However, with the economy dropping, the money flow stopped and that stopped everything. "Restitution is being made so people are not losing anything," he said. He declined further comment. I also telephoned Randall Concello, a Sarasota, Florida, attorney, representing Mr. Claprood. Mr. Concello said that Mr. Claprood over the past year had fitted 150 to 200 persons for aids. After June or July 1975, he was unable to deliver aids to 28 customers because his hearing aid suppliers and the U.S. Postal Service denied him credit. They placed him on a cash-only basis. "He would take the money of Mrs. X to pay for Mrs. Y's hearing aid. In the end there were 28 people whose money he had used for other people's hearing aids," said Mr. Concello. When the time came, Mr. Claprood did not have the cash to purchase aids for those 28 peo- ple from his supplier, his lawyer said. ExHIBIT No. 20 In the Circuit Court in and for Sarasota County, Florida, in the Year of our Lord One Thousand Nine Hundred and Seventy-five STATE OF FLORIDA V. VICTOR P. CLAPROOD Count I. Grand Larceny Count II. Grand Larceny. State: FS 812.021, FS 812.021 In the Name and by Authority of the State of Florida: JOHN J. BLAIR, State Attorney of the Twelfth Judicial Circuit of the State of Florida, prosecuting for the State of Florida in the Circuit Court in and for the County of Sarsota, Florida, under oath information makes that VICTOR P. CLAPROOD, late of the County and State aforesaid, on the 7th day of April in the year of our Lord One Thousand Nine Hundred and Seventy-Five, in the county and state aforesaid did unlawfully and feloniously steal from the pos- session and lawful custody of F. GLENN SHOEMAKER, Money, value of one hundred dollars ($100.00) or more, lawful currency of the United States of America, with the intent to permanently deprive or defraud the true owner of his property or the use and benefit thereof, or to appropriate the same to the use of the taker or person other than the true owner, in violation of Section 812.021. 7~-954-76--5 PAGENO="0066" 60 (1) (a) Florida Statutes contrary to the statute in such case made and provided and against the peace and dignity of the State of Florida; COUNT II. JOHN J. BLAIR, State Attorney of the Twelfth Judicial Circuit of the State of Florida, prosecuting for the State of Florida in the Circuit Court in and for the County of Sarasota, Florida, under oath information makes that VICTOR P. CLAPROOD late of the County and State aforesaid, on the 2nd day of September in the year of our Lord One Thousand Nine Hundred and Seventy- five, in the county and state aforesaid did unlawfully and feloniously steal from the possession and lawful custody of VIOLA GOODACRE, Money, value of one hundred dollars ($100.00) or more, lawful currency of the United States of America, with the intent to permanently deprive or defraud the true owner of his property or the use and benefit thereof, or to appropriate the same to the use of the taker or person other than the true owner, in violation of Section 812.021(1) (a), Florida Statutes, State of Florida, County of Sarasota: I hereby certify that the foregoing is a true and correct copy of the original filed in this office. Witness my hand and seal this March 26, 1976. R. H. HACKNEY, Jr., Clerk of Circuit Court. by: H. HORN, Deputy Clerk. Contrary to the statute in such case made and provided and against the peace and dignity of the State of Florida Not Arrested. JOHN J. BLAIR, State Attorney, Twelfth Judicial Circuit, State of Florida. ORDER FOR PRESENTENCE INVESTIGATION Date: March 15, 1976. STATE OF FLORIDA v. VICTOR P. CLAPROOD Case No: 75-813-CF-A-OY Charge: 2 Cts. Grand Larceny. Plea: Guilty Adj: Guilty Negotiated plea: Yes: No: Nob contendere Withheld To Florida Parole & Piobation Commission Suite 30 2074 Ringhng Blvd Sarasota, Florida 33577. Under the provisions of F.S.A. 498.01 you are hereby directed to conduct a Presentence Investigation on the Defendant and return your written report to the Court by 4-12-76 at 10:30 a.m. Other: Rest.-fine up to Court. Prob. time up to Court ($1,000 Ecrow). State of Florida, County of Sarasota. I hereby certify that the foregoing is a true and correct copy of the original filed in this office. Witness my hand and seal this March 26, 1976. R. H. HACKNEY, Jr., Clerk of Circuit Court DAKAN, Presiding Judge Circuit Court. by: H. HORN, Deputy Clerk. EXHIBIT No. 21 AFFIDAVIT OF THADDEUS MACY CRUMPLER I, Thaddeus Macy Crumpler, freely and voluntarily make the following state- ment to Jonathan Cottin, who has identified himself to me as a member of the United States Senate Permanent Subcommittee on Investigations of the Corn- PAGENO="0067" 61 mittee on Government Operations. No threats, force, duress, promises or repre- sentations have been used to induce me to make this statement. I am a citizen of the United States and live at 1212 Azalea in Pharr, Texas. I am co-owner, with my son, of the K.M. Crumpler Company, a transportation firm in Pharr, Texas. I am 69 years old. In recent years, I have suffered a number of serious illnesses and undergone major operations to correct them. My lower right arm has been amputated and several years ago I suffered a stroke which partially paralyzed my left side. At about the same time that I suffered the stroke, my hearing began to deteriorate in my left ear. In the summer of 1975, I decided to see a hearing aid dealer in the hope that I could be helped with `an amplifying device. I was desperate to have better hearing. My wife, family and friends all had trouble being heard because of my worsening hearing. My wife, in particular, was very anxious that I try out a hearing aid. I discussed the idea with a physician, who gave me the name of several hearing aid dealers in McAllen, Texas. The physician told me he was not optimistic that a hearing aid would help me. He did not recommend that I see a dealer. But I went to the Beltone hearing aid dealer in McAllen, because I did not feel I had anything to lose. My hearing was getting worse and there was nothing the physician could `do for me. The physician told me that if I insisted on trying a hearing aid, I should only do it on a trial basis, so that I could give it back if it did not help me. *WhenI went to the hearing aid dealer, he `tested my hearing and suggested I try on a hearing aid. He fitted a Beltone Aria to my left ear, and adjusted it. I noticed that the aid made sounds louder to me, but I wasn't certain that I could actually understand any better. The salesman urged me to try the aid out for awhile. I made a down payment on the aid `and took it with me. I wore the aid for long periods of time each day after I obtained it, trying to get used to it. I was determined to make it work for me. But, unfortunately, while it made sounds louder, I could not tell what they were any better `than before I wore it. I repeatedly returned to the Beltone dealer, whose name~ I can- not remember, and asked for the aid to be readjusted. But nothing seemed to help. Sometimes, when I was wearing the aid when a lot of people were talking, the aid amplified the sounds so loud that I could make nothing out and I felt totally confused. My wife insisted that I continue to wear the `aid because she wanted me to hear her better. Often, I could not make out what she `was saying and would ask her to repeat things many times. But the aid. did not help. Eventually, after about three months, I gave up trying to use the aid. It was useless to me. In all, I paid $489 for that hearing aid. A few months after I bought the' aid, I was examined by Dr. Francis I. Catlin, Chief of Service at the Department of Otolaryngology at St. Lukes' Episcopal and Texas Children's Hospitals in Houston, Texas. I was `tested for more than an hour by an audiologist prior to my examination by Dr. Catlin. After the examination, Dr. Catlin told me that my hearing im- pairment could not be helped by a hearing aid. In effect, he confirmed what I had discovered through a continuing attempt to have the aid work for me. I had wasted $489. He told me that I was practically deaf in my left ear. Since the trial period on the aid has expired, I never bothered to ask for my money back from the dealer. Anyone who would sell me an aid I did not need in the first place, I figured, would not be anxious to return the money I paid. Fortunately for me, I have some income from the transportation firm and while I don't like to waste money, I can at least afford it. Unfortunately, there are a lot of people who are very poor who have poor hearing. I hope something can be done to protect such persons from hearing aid dealers who are more interested in profit than the health of the people they serve. I have read, reviewed and initialed each page of this statement and I swear, to the best of my knowledge and belief, that the statements contained therein are true and correct. S/THADDEUS MACY CRIJMPLEB, S/By MARIE GARZA, Nurse. S/Patient unable to sign affidavit. His private nurse signed for him. Sworn to and subscribed before me this s/llth day of March 1976. S/NELLIE P. Lua, S/Harris County. PAGENO="0068" 62 ST. LUKE'S EPISCOPAL/TEXAS CHILDREN'S HOSPITALS, DEPARTMENT OF OTOLARYNGOLOGY, FRANCIS I. CATLIN, M.D. Patient's Name: CRUMPLER, THADDEUS M. Date: March 4, 1976. CONSULTATION REPORT: T.I.R.R. #27-864 This 69 year old gentleman comes in with a history of hearing loss in the left ear since he had a stroke in July, 1974. The patient states that he hears well in the right ear except when the listening situation is difficult. He has had no drainage from either ear, but has noted a little tinnitus on the left side. He has recently purchased a hearing aid and says that this does not help him because too much noise comes into the ear and he has found that he gets along just as well without the aid as with the hearing aid. Past history reveals a right below the elbow amputation in September, 1.953, a right carotid endarterectomy in 1974 and a left carotid endarterectomy in the same year. At the time of the second procedure, he had an artereo-femoral bypass stenotic lesions and postoperatively was noted to develop a left hemiparesis. In 1973 he had a partial gastrectomy and in 1975, his gall bladder was removed. He has no allergies, but avoids sweet foods since his operation. PhysicaZ e~ramination Neck: Cervical glands are not enlarged. Trachea is in the micilino tug. Thy- roid gland is not enlarged. Ears: There is a little keratin plaque on the antihelix of the right auricle. External canals appear normal. Both tympanic membranes show slight sclerosis but are intact and in normal position. Nose and mouth: Airway appears adeqaute bilaterally. The septum is intact. No discharge or polyps are seen. Nasopharynx reveals minimal lymphoid tissue. No discharge or polyps are seen. Pharynx appears benign. Palate elevates in the midline. Tonsils are atrophic. Patient has complete edentia with upper and lower dentures. Throat: Larynx, epiglottis and pyriform sinuses appear normal. Vocal cords appear normal and have good mobility. Sinuses: Frontals and antra are clear to transillumination, no sinus tender- ness is noted.. Hearing: Audiological testing on 3-4-76 reveals a normal sensitivity through 1000 Hz, moderate sensorineural loss through 2000 Hz with a severe loss abov.e 2000 on the right. The left ear reveals a severe sensorineural loss. Impedance audiometry is consistent with normal middle ear function bilateral. Patient's speech reception threshold is at the 15 dB level with a 92 percent PB Max score in the right ear and at the 65 dB level in the left ear with a 0 percent discrimination score. Impressions: Sensorineural hearing impairment-bilateral: severe on the left, moderate on the right. Because of the distorting nature of the audiogram in the right ear, this patient is not a good candidate for hearing aid use. Amplification is not recommended in either ear. I would recommend retest of his hearing in one to two years or if any change occurs in auditory function. ExHIBIT No. 22 AFFIDAVIT OF FRANCIS I. CATLIN, M.D. I, Francis I. Catlin, M.D., freely and voluntarily make the following statement to Jonathan Cottin, who has identified himself to me as a member of the United States `Senate Permanent Subcommittee on Investigations of the Committee on Government Operations. No threats, force, duress, promises or representations have been used to induce me to make this statement. I am a citizen of the United States and Chief-of-Service, Department of Oto- laryngology, St. Luke's Episcopal and Texas Children's Hospitals in Flouston, Texas. I am also a Professor of the Department of Otorhinolaryngology and Communicative `Sciences, Baylor College of Medicine, Houston, Texas. I am a board-certified otolaryngologist. I have served as chairman, from 1967 to 1971, of the Communicative Disorders Research Training Committee, National Institutes of Neurological Diseases and Stroke, was a member of `the `editorial board of PAGENO="0069" 63 Archives of Otolaryngology trom 1964 to 1974, am a member of the Hearing Coin- mittee of the American Council of Otolaryngology and served on the Faculty, Continuing Education Courses, American Academy of Ophthalomology and Oto- laryngology from 1962 to 1974. I am also a member of the Committee on Hearing and Equilibrium of the American Academy of Ophthalmology and Otolaryn- gology and am chairman of the Subcommittee on Conservation of Hearing of that parent committee. I examined Thaddeus Macy Cruinpier of Pharr, Texas in the Department of Otolaryngology, St. Luke's Episcopal/Texas Children's Hospitals on 3-4-76. An examination of the ears, nose and throat, in addition to a review of the audiological work-up performed at these hospitals on the same day, indicated that the patient had a pure sensorineural hearing loss in both ears with a severe loss in the left ear. I advised Mr. Crumpler that he could not be helped by surgery. I also told him that the audiological assessment of his hearing indicated that he would not be a good candidate for hearing aid in the right ear because his hearing was within normal range through 1000 Herz in that ear and that the distorting nature of the high frequency hearing loss in the ear would also contraindicate the use of a hearing aid. I advised him that he would not be a candidate for a hearing aid in the left ear because his hearing was too poor to benefit from amplification. This recommendation was made on the basis of his pure tone, as well as his speech tests. Mr. Crumpler indicated to me that he had purchased a hearing aid for the left ear and that he had found that it was of no use to him. I advised him that I would expect this to be the case after examining him and reviewing his audiologic test findings. In my professional opinion, it was an improper and inappropriate action for any hearing aid dealer to sell Mr. Crumpler a hearing aid considering his type of hearing impairment. I also believe that the dealer should have advised Mr. Crumpler that there was little likelihood that an aid would help him to hear things any more clearly, particularly since Mr. Crumpler's hearing in the right e~ir is within normal limits in the lower and mid-portion of the frequency range for the hearing of speech. Mr. Crumpler's case is one of several I have reviewed over my years of ex- perience and practice of otolaryngology. It is my opinion that most hearing aid dealers lack the proper training to diagnose hearing loss causes. Too often, as in the ease of Mr. Cruinpier, the patient comes to the physician on his own and is seldom referred by a dealer for medical assessment. I have read, reviewed and initialed each page of this statement, and I swear, to the best of my knowledge and belief, that the statement.s contained therein are true and correct. FRANCIS I. CATLIN, M.D. Sworn to and subscribed before me this 18th day of March, 1976. OLIvE V. HAR.RISS, Notary Public. Notary Public in and for Harris County, Texas. My Commission Expires July 14, 1977. _______ ExHIBIT No. 23 MEMORANDUM To: Hearing aid case file. From: Jonathan Cottin. Subject: Thaddeus Macy Orumpler. Date: March 12, 1976. On this date. I visited the offices of Louis R. Thibault, the Director of the Beltone Hearing Aid Service, at 910 N. Main Street. in McAllen, Texas. I advised him that the Subcommittee had affidavits from Crumpier and Dr. Francis I. Catlin which suggested that a hearing aid for Crumpler was medically inadvisable. Mr. Thihault replied that he wanted to cooperate with the Subcommittee and indicated that a hearing aid was rented to Mr. Crumpler on April 30, 1975. He said that Mr. Crumpler was tested on that date, that an aid was provided him about "four or five" days later and that Mr. Crumpler sent a check for $35 to cover the one-month rental on the aid. Mr. Thibault said that "in many in- PAGENO="0070" 64 ~stances," his hearing aid office uses a 30-day rental program. He also said that a 30-day money-back guarantee is provided for other hering aid purchasers. He said that the 30-day rental program is for those hearing aid purchasers who are "more questionable." When he was asked what "more questionable" meant, he replied that it was a question of "how well motivated" a hearing-impaired per- son is. He said that the first hearing aid rented to Mr. Crumpler was a Beltone Etude but that this was later exchanged for another aid-a Beltone Aria. He was asked why the change in aids was made and lie replied: "In an effort to try to help and satisfy him, a change was made." He said that Mr. Crumpler "complained about some wind noise." Mr. Thibault was asked on three different occasions if he would relate to this. investigator the results of the audiogram which was conducted on Mr. Crumpler on April 30, 1075. However, he refused to do so without advice of counsel. He expressed more and more reservations about commenting further on the Orumpler matter. However, before he assumed this attitude, he said that Crumpler bad come to the office "three or four times" to complain about his hearing `aid. Thibault also said that, in addition to the rental fee of $35, Crumpler also paid $454 for the Aria hearing aid that he (Grumpier) now owns. Mr. Thibault also said that he didn't need to make "eight or ten sales" which would later cause him trouble, since he lives in a small town where word would quickly get around. Following this comment, he said he would "prefer not to answer further ques- tions" without consulting counsel. ExHIBIT No.24 [Mallgram] WASHINGTON, D.C., March 30, 1976. This mailgram is a confirmation copy of the following message: ~TANFORD D. GERTZ, Dlr., 4160 Laurel Grove Ave., StudiO City, Calif. This is to advise you that testimony will be heard regarding your activities as proprietor of a hearing aid business in Los Angeles during 1974 at a public hearing April 2 before the U.S. Senate Permanent Subcommittee on Investiga- tions in Room 3302 Dirksen Building, Washington, D.C., If you wish to appear at this hearing to make a statement regarding this matter, notify me by calling 202- 224-9157, you may instead submit a written statement to the subcommittee on or before May 2, 1976 that will be included in the hearing record, should you choose neither course of action, this will notify you that the record of your indictment and conviction in connection with this matter will be placed in the hearing transcript during the hearing. STUART M. STATLER, Chief Counsel to Minority. [Mallgram] WAsHINGToN, D.C., March 30, 1976. This maligram is a confirmation copy of the following message: CHARLES A5HLOOK, Dir., Beltone Hearing Aid Service, 34 South 1 St., San Jose, Calif. This is to advise you that testimony will be heard April 1, 1976, alleging map.. propriate fitting of the hearing aid for your client, Ralph 1. Bicksler at a public hearing before the U.S. Senate Permanent Subcommittee on Investigations in Room 3302 Dirksen Office Building, Washington, D.C. If you wish to appear at this hearing to make a statement regarding this matter, notify me by calling 202-224-9157, you may instead `submit a written statement to the subcommittee on or before May 2, 1976 that will be included in the hearing record, should you choose neither course of action, this will advise you that a memorandum of an interview held with William Gerrard by subcommittee staff regarding this matter will be placed in the record during the hearing. STUART M. STATLER, Chief CounseZ to Minority. PAGENO="0071" 65 (Maligram] WASHINGTON, D.C., March 30, 1976. This mailgram is a confirmation copy of the following message: EMILI0 H. MARQTJEZ, M.D., Dir., 4055 Whittier Blvd., Los Angeles, Calif. This is to advise you that testimony will be heard regarding your activities prescribing hearing aids for clients of Sanford D. Gertz, during 1974 at a public hearing April 2 before the U.S. Senate, Permanent Subeommitee on Investiga- tions in Room 3302 Dirksen Building, Washington, D.C. If you wish to appear at this hearing tO make a statement regarding this matter, notify me by calling 202-224-9157, you may instead submit a written statement to the subcommittee on or before May 2, 1976 that will be included in the hearing record. Should you choose neither course of action, this will notify you that the record of your indictment and conviction in connection with this matter will be placed in the hearing transcript during the hearing. STUART M. STATLER, Chief Counsel to Minority. [Maligram] WASHINGTON, D.C., March 27, 1976. This mailgram is a confirmation copy of the following message: VICTOR M. CLAPROOD, DLR, 9009 Northwest 9 Ave., Bradenton, Fla. This is to advise you that affivadits will be submitted for the record during public hearings April 1, 1976 before the U.S. Senate permanent sub-committee on investigations regarding charges of inappropriate fitting of a hearing aid by your firm on Anne Dow, Susan A. Toaz, Rene McKenzie. A memorandum of interview between sub-committee staff, your lawyer and yourself will be included in the hearing record. Should you desire, you may submit a written statement to the sub-committee regarding this matter which will be included in the hearing record if received on or before May 2, 1976. STUART M. STATLER, Chief Council to the Minority [Maligram] WASHINGTON, D.C., March 27, 1976. This mailgram is a confirmation copy of the following message: Louis R. THIBAULT, Care Beltone Hearing Aid Service, ~.910 North Main St., McAllen, Tew. This is to advise you that affidavits will be submitted for the record during public hearings April 1, 1976 before the U.S. Senate permanent sub-committee on investigations regarding charges of inappropriate fitting of a hearing aid by your firm on Thaddeus Macy Crumpler. A memorandum of interest be- tween sub-committee staff and yourself will be included in the hearing record. Should you desire, you may submit a written statement to the sub-committee regarding this matter which will be included in the hearing record if received on or before May 2, 1976. STUART M. STATLER, Chief Counsel to the Minority. TRIBAULT'S BELTONE HEARING Am SERVICE, MoAllen, Tea'., April 6, 1976. Be hearing aid fitting for Thaddeus Macy Crumpler, P.O. Box 418, Pharr, Tex. Mr. STUART M. STATLER, Chief Counsel to the Minority, Permanent Subcommittee on Investigations of the Committee on Government Operations, Russell Long Senate Office Build- ing, Washington, D.C. DEAR Ma. STATLER: The following are the facts as I know them to exist in the case of Thaddeus M. Crumpler of Pharr, Texas. PAGENO="0072" 66 On April 30, 1975 Mr. Crumpler came into our office for a hearing test. At the conclusion of the test Mr. Crumpler was advised that the assistance which he could receive from a hearing aid on the left ear was questionable as noted on the aucliogram. He seemed to be desirous of some assistance for the impairment on his left ear. The rental of a hearing aid was arranged, for the benefit of Mr. Crumpler and his family to subjectively evaluate any benefits which a hearing `aid may provide. After a suitable period of time, Mr. Crumpler and his family determined that the hearing aid was of some benefit to him, and he decided to purchase the hearing instrument. This purchase was made at the discretion of the buyer, and his free choice alone. To this date, Mr. Crumpler has not complained to this office, and continues to purchase batteries for his hearing aid. Sincerely, Louis R. THInAuI~T. [Maligram] WASHINGTON, D.C., March 27, 1976. This mailgram is a confirmation copy of the following message: PAUL SCHWADEL, Ea,ecutive Director, Bay Area Union Professional Center, 715 Bryant St., San Francisco, Calif. This is to advise you that affidavits will be submitted for the record during public hearings April 1, 1976 before the U.S. Senate permanent sub-committee on investigations regarding' charges of inappropriate fitting of a hearing aid by your firm on Elda Mae Sewell. A memorandum of interview between sub-com- mittee staff and yourself will be included in the hearing record. Should you desire, you may submit a written statement to the sub-committee regarding this matter which will be included in the hearing record if received on or before May 2, 1976. STUART M. STATLER, Chief Counsel to the Minority. [Maligram] WASHINGTON, D.C., March 27, 1976. This mailgram is a confirmation copy of the following message: WILLL&M H. GERRARD, Care Beltone Hearing Aid Service, 34 South First St., San Jose, Calif. This is to advise you that testimony will be taken April 1, 1976 alleging inappro- priate fitting of a hearing aid on your client, Ralph J. Bicksier at a public hearing before the U.S. Senate Permanent Subcommittee on Investigations in room 3302, Dirksen Office Building, Washington, D.C. If you wish to appear at this hearing to make a statement on this matter, notify me at 202-224-9157. You may instead submit a statement on or before May 2, 1976 that will be included in the hearing record. Should you choose neither course of action this is to advise you that a memorandum of an interview held with you by sub-committee staff about this matter will be placed in the hearing record. STUART M. STATLER, Chief Counsel to the Minority. [Mailgram] WASHINGTON, D.C., March 27, 1976. This mailgram is a confirmation copy of the following message: WYNN WALTERS, Care Daytona Hearing Aid Service, 133 Magnolia, Daytona Beach, Fla. This is to advise you that affidavits will be submitted for the record during public hearings April 1, 1976 before the U.S. Senate Permanent Subcommittee on Investigations regarding charges of inappropriate fitting of a hearin~ aid by your firm on Linda Morrison. A memorandum of interview between sub-committee staff and yourself and your attorney will be included in the hearing record. PAGENO="0073" 67 Should you desire, you may submit a written statement to the sub-committee regarding this matter which will be included in the hearing record if received on or before May 2, 1976. STUART M. STATLER, Chief COunsel to the Minority. [Mailgram} WASHINGTON, D.C., March 27, 1976. This mailgram is a confirmation copy of the following message: ROBERT M. CEDERLOFF, Care Beltone Hearing Aid $ervice, 344 University Blvd. West, Silver spring, Md. This is to advise you that testimony will be taken April 1, 1976 alleging in- appropriate fitting of a hearing aid on your client, John C. Brennan at a public hearing before the U.S. Senate Permanent Subcommittee on Investigations in room 3302, Dirksen Office Building, Washington, D.C. If you wish to appear at this hearing to make a statement on this matter, notify me at 202-224-9157. You may instead submit a statement on or before May 2, 1976 that will be included in the hearing record. Should you choose neither course of action this is to advise you that a memorandum of an interview held with you by sub-committee staff about this matter will be placed in the hearing record. STUART M. STATLER, Chief Counsel to the Minority. Senator PERCY. Any further questions? I want to thank our wit- nesses very much, indeed, for the appearance today. I think your testi- mony has been very helpful. The Chair calls next Dr. Rufus M. Holloway, Otolaryngologist, Or- lando, Fla. Doctor, will you come up and help me once and for all pro- nounce your profession? Dr. HOLLOWAY. Ear, nose, and throat. [Laughter.] Otolaryngology. Senator PERCY. Thank you very much. Do you swear to tell the truth, the whole truth, and nothing but the truth, so help you God? Dr. HOLLOWAY. I do. TESTIMONY OF DR. RUFUS M. HOLLOWAY, OTOLARYNGOLOGIST, ORLANDO, FLA. Senator PERCY. Please be seated. If you would proceed with your own testimony in any way you see fit. * Dr. HOLLOWAY. Thank you very much, Senator Percy. My name is Rufus Holloway. I am in the practice of otolaryngology *in Orlando, Fla. I am board certified in otolaryngology and have been in practice Since 1967. I am a graduate of Duke TJniversity Medical School and took my training in residency of otolaryngology at the University of Florida in Gainesville, Fla. I am associated with three other men in my field. In 1972, my colleagues and I beèame very concerned about the pro- fessional competence and ethics of some hearing aid dealers in the Orlando area. Numerous patients were coming to us, who had pur- chased hearing aids in the area, and were complaining of continued dif- ficulties with their hearing. In almost every instance, the patient came on his own and was riot referred by a dealer. On examination, in many cases, it was discovered that these patients either had been fitted with the wrong type of hear- PAGENO="0074" 68 ing aid for their type of hearing loss, or that surgery. and not a hearing aid could help them. I was particularly appalled that some dealers apparently lacked the training to determine when a medical pathology existed. I had to con- clude that either they did not have the education to make the judgment that medical intervention was required, or they ignored the evidence of pathology in order to make a sale. When I examined patients, who had been sold aids, who were either suffering from an ear disease or, in our opinion, didn't need an aid, I often telephoned the hearing aid dealers involved and strongly recom- mended refunding the purchase price of the aid to the patients. In effect, I got sick and tired of diagnosing patients with ear path- ologies who told me that they had four or five unused hearing aids in their drawers at home. They had bought these aids from dealers who had missed these medical problems. The aids were of very limited use to these patients. My partners and I therefore decided to set up a hearing aid sales office in our place of business. It was only in this way that we felt we could control the dispensing of hearing aids, which we knew were in- dicated in oniy about 1 of every 10 cases. We hired a hearing aid administrator who had trained for several years in New York. We discussed our project with a number of our colleagues, because we were concerned that our entry into the hearing aid business might be construed as unethical. We decided, however, that there was little risk of abuse, since we intended the hearing aid sales operation as a control against unnecessary hearing aid purchases and as a method of render- ing more professional hearing aid service. The unprofessional and un- ethical conduct of some dealers in the Orlando area drove us into the business-not the need for more income. In fact, our hearing aid sales business lost $2,500 last year. The prin- cipal reason for this is that, of every 100 patients with hearing prob- lems whom we see, only about 10 can benefit from the use of a hearing aid. We sell about 10 aids per month. This represents the patients from four otolaryngologists serving a population of about 150,000 people. Since we know from our experience that most persons with hearing impairment see a dealer first, and since so many dealers miss, by inten- tion or lack of training, medical pathologies, I believe that our original goal of controlling the dispensing of hearing aids for our patients was~ a sound one. I believe we have protected hundreds from paying out money need- lessly for hearing aids that they would find of no use to them. Our hearing aid salesperson is paid a straight salary, with no com- mission. This guards against any possible abuse on his part. Since his wage is not dependent on sales, and since my colleagues and I closely monitor his operation, he has no financial stake in selling hearing aids to anyone. If we need the assistance of an audiologist in treating a patient or~ analyzing a problem-we have had one in our office until recently-we~ can call and have called on a number of competent audiologists prac- ticing in the Orlando area. PAGENO="0075" 69 We know that our patients are under no pressure to buy a hearing aid, and now feel comfortable that they are being treated, from ithtial~ interview to* final disposition of their cases, in a most professional. manner. . One major improvement in the hearing aid delivery system that is~ made possible because of the arrangement in my office is that hearing: aid purchasers have a virtually risk-free period in which to becom& accustomed to an aid. We have instituted a 1- to 2-week trial policy on each hearing aid sold in our office. Payment is made only after the patient is satisfied that he or she received enough benefit to warrant the purchase. I believe it is impossible for a patient to get a true measure of a new aid without such a trial period. I believe such a policy should be required of all hearing aid dealers, because it would eliminate a lot of unnecessary sales. We did not set up the hearing aid sales operation to lose money and hope one day that it will at least break even. But to my mind, the financial loss is, while not insignificant, a relatively small price to pay for protecting our patients and professionalizing the hearing aid delivery system. Senator PERCY. When you say, Dr. Holloway, that prior to 1972 pa- tients were coming to you wearing the wrong type of aid for this type of loss, would you give sOme examples of this? Dr. HOLLOWAY. I think we have already touched on some examples of people who do not need hearing aids. Basically, I think the majority of those fall into the group with the high frequency, nerve type hear- ing loss, with poor understandability or discrimination scores. In those individuals, and you have alluded to the fact that you per- haps are one, no matter how high you turn the volume, you do not pro- vide any increase in understandability. So I would say that the ma- jority of the patients that have been fitted incorrectly fall into that category. There are some medically correctible lesions that we see that have hearing aids on them when we see them. But at the same time that I criticize certain hearing aid dealers, I would like very much to com- mend those who do pick up these type of hearing losses and who have referred those patients to our office. There are those types, that caliber of people, in the hearing aid business. They are in my experience not the majority, but they do exist. Senator PERCY. When you say only about 1 of 10 of your patients can be helped by a hearing aid, are your patients typical of the cross section of the American public, all age levels, all income levels? Or, because of your location, would they be less typical of a national pattern? For instance, in Orlando, would you have a higher proportion of older people than might be found elsewhere? Dr. HOLLOWAY. I think there is very little doubt that the latter state- ment certainly is correct, that we are in an area where retirement is prevalent, where people are in a higher age group. PAGENO="0076" 70 I am not totally aware of all of the ramifications throughout the country, different type practices, et cetera, because I have only prac- ticed in Orlando. 1 am a native Floridian. but do believe that we see the broad spectrum of medical and audiometric problems. We are particularly concerned, though, about the elderly patient who has been fitted with a hearing aid, that in our opinion did not need one, and how difficult it is at certain times to obtain a just settlement for this particular patient. It .is getting better, but it still exists. Senator PERCY. We have had some testimony today that indicated that on the other side of the country an expert determined that about 40 percent of the patients would be helped by a hearing aid. In your area, you say aids will benefit only 10 percent. Do you have any basis for knowing what proportion of the 20 million hearing- impaired people in this country would be helped by a hearing aid? Dr. HOLLOWAY. I really do not have any concrete evidence to support my 1 in 10. even. I would say that in our area, though, 4 in 10 who have a hearing problem and who come to the physician for a hearing Problem being helped is high. I don't believe it is that high in Florida, inmy area. Senator PERCY. If any of our guests in the hearing room today would be. able to provide the subcommittee with information as to what the best estimate is for that proportion of the population that ha.s a hearing deficiency that could be helped in a measurable way `by a hearing aid, the record will be kept open for that data. You say that some dealers lack sufficient training to ferret out pathologies that may be present in the ear. `Can you tell the subcom- mittee how you actually know that to be afact? Dr. HOLLOWAY. Yes. We have seen patients who have fluid in their middle ear and who have been fitted with a hearing aid. That is a `diagnostic procedure which can he, easily accomplished in any otolo- g1~t's or otolarvngoloo~ist's or ear nose and throat mqn's office We can usually tell fairly accurately `whether fluid is uresent. An- other problem is a subtle perforation in the eardrum which has been overlooked by a casual glance. Perhaps another good example would be t.he otoselerosis that was mentioned earlier that presents with a hearing loss, but it is a concluc- tive-tvpe loss rather than a nerve-type loss. That is one that we have seen from time to time that has been missed. Am I answering the `question? Senator PERCY. Specifically, do some dealers in your judgment ignore, the presence of a disease simply `because they want to ring up a sale? if so, can you elaborate? Dr. HOLLOWAY. I would hate to accuse anyone. It would from time to time seem there is some evjuiepce for that belief. But I do not know that for sure. All I can really tell you is that we see natients that have bean fitted with a hearing aid: maybe sometimes they wanted them. Maybe sometimes the dealer pressed them. Both have occurred. They `don't need them. But the exact motivation is a bit hard to pin dowrn I think. PAGENO="0077" 71 Senator PERCY. When you telephoned dealei~ and said, `in your judgment, that the hearing aid really was not needed and asked for a refund for the patient, what kind of a response did you get? Dr~ HOLLOWAY. When we first started doing this, there was some question of a conflict of interest in my own practice and in our practice about selling hearing aids in our office. So dealers were very much alarmed about this. We met with some resistance from time to time. But basically, when we asked a dealer to refund the money, we have had good luck in maybe 75 percent of those. The pitiful problem, I think, is that the people who are misfitted really want to know. They are very anxious to have information about their hearing. They are desperate in many instances. They are willing to try almost anything. They are easily misled and they are uninformed. I feel that that is a very important aspect of our investigation here. The information element is missing. I wonder if that isn't the focal point of the entire hearingS as you stated earlier? Senator PERCY. You indicated that you sold only 10 aids *a month. Could you tell the subcommittee why it is that you only sold 1 out of 10 patients a hearing aid? What are the other problems that the 90 per- cent suffer from that would indicate a hearing aid would not assist? Dr. HOLLOWAY. I guess the most classic example is the man 73 years old who says, "I don't any longer hear my wife well and I am confused when I am in a noisy environment," and comes in wanting help. He does indeed have a nerve loss. It is a modest one. His discrimination or understandability scores are probably 60 percent. He is a good examnie of a patient who is prob- ably not going to `benefit from a hearing aid. But to be specific about the figures, some particular people with the exact identical audiogram will wear a hearing aid successfully and the next one will not. I think that is the majority~ though, of the patients that come in and do not need the hearing aid think that they do. Then you have a percentage, as I indicated, I believe, of those that have a conductive-type hearing loss. A lot of people have wax in their ears; a very simple thing. Senator PERcY. As a matter of fact, you can accumulate wax in the hearing aid. That is a very simple thing to get out, with a little soap and water. But it is very annoying until you discover what is wrong. All of a sudden, you think your hearing is getting worse. Dr. HoLLowAY. I am reminded of a man 80 years old who came in his office with his son and daughter, both in their late fifties or sixties and they were very, very concerned that the old man was getting deaf. In- deed, he was. I examined him and told him that I really didn't have anything to offer him except to tell him that perhaps a hearing aid might help him. He said, "Yes, sonny, I just went downtown and they wanted $600 for a pair of those hearing aids. Frankly, there is nothing I would pay ~600 to hear." So that is one group of people, too. Senator PERCY. Just two other questions. Why did you feel a trial period is necessary? Can't you just tell by examining the patient whether the aid is beneficial? PAGENO="0078" 72 Dr. HOLLOWAY. I can in no way do that. I am convinced that of the information that I am aware of that the only really successful way of wearing a hearing aid is to try it, and the time period is variable, cer- tainly some people know right away and others don't know for a month. I believe no pressure should ever be applied to anyone who has taken a hearing aid. Of course, certain time limits I guess have to be in- stituted. I don't even like the rental plan because I feel that is a little more pressure than I personally would like to see applied. Senator Pm~oy. Do you prefer a money back guarantee? Dr. HOLLOWAY. I just prefer not making a decision about the aid. They pay $10 or $15 to make a mold, which is something that is a cost item and has to be absorbed, and then take the aid home, wear it, see how they like it. If they like it, come back and tell us about it. If they don't, come back and drop it off, or ask for-maybe they want to try another kind. ~There is always that gray zone. Senator PERCY. But on the caveat emptor theory, dealing all day ~ts you do with patients who have hearing difficulties, would you advise any purcthaser to assure themselves ahead of time that if the aid doesn't work, they are not going to be stung? Do you feel they should pay out-of-pocket costs only appropriate for an ear mold, but have a money-back guarantee for a reasonable period of time? Dr. HOLLOWAY. I sure do. I inform everybody that I even talk to about an aid that that is the most pertinent point I can make. Senator Pi~Rc~. The last question is on sales price. What price did you sell th~ hearing aids at? Did you sell them at the suggested retail price? Dr. HOLLOWAY. We do. Senator PERCY. Put out by the manufacturer? Dr. HoLLowAY. We do. As I say, we don't break even on it. I think in volume perhaps it could be brought down. I am in a situation right now that I would like not to be in, frankly. I wish that the public had enough information, really, that we didn't need to become involved in hearing aids at all. I think that will happen if we can submit more in- formation to the people. Senator PERCY. Does the majority Or minority counsel have any ques- tions? Thank you, Dr. Holloway, very much, indeed. Our final panel, the Chair calls now: Dr. F. Blair Simmons, chair- man, Division of Otolaryngology, Stanford School of Medicine, Stanford, Calif.; Dr. Robert J. Ruben, chairman and professor, Al- bert Einstein College of Medicine, Yeshiva University, New York; Dr. Michael G-lasscock, assistant clinical professor of Otolaryngology, Vanderbilt University, Nashville, Tenn. We appreciate very much your appearance today. Do you solemnly swear to tell the truth, the whole truth and nothing but the truth, so helpyou God? Dr. SIM~roNs. I do. Dr. RuBEN.Ido. Dr. GLASSCOCK. I do. PAGENO="0079" 73 TESTIMONY OP F. BLAIR SIMMONS, M.D., CHAIRMAN, DIVISION OP OTOLARYNGOLO'GY, STANFORD SCHOOL OP MEDICINE, STAN- FORD, CALIF.; ROBERT 1. RUBEN, M.D., CHAIRMAN AND PRO- FESSOR, DEPARTMENT OP OTORHINOLARYNGOLOGY, ALBERT EINSTEIN COLLEGE OP MEDICINE, YESHIVA UNIVERSITY, I~EW YORK, N.Y.; MICHAEL GLASSCOCK, M.D., ASSISTANT CLINI- CAL PROFESSOR OP OTOLARYNGOLOGY, VANDERBILT UNIVER- SITY, NASHVILLE, TENN. Senator PERCY. Dr. Simmons, why don't we start with you. Dr. SIMMoNs. Mr. `Chairman, my name is F. Blair Simmons. I am professor and head of the Division of Otolaryngology at the Stanford University Medical Center in Stanford, C'alif. I am a board-certified otolaryngologist and hold membership in such organizations as the American Academy of Opthamology and Otolaryngology, the National Association of Hearing and Speech Agencies, the Society of University Otolaryngologists and the American Otological Society. Since 1966, I have served as a member of the Committee on Hear- ing, Bio-Acoustics and Bio-Mechanics of the National Academy of Sciences National Research Council. I am associate editor of the Annals of Otology, Rhinology and Laryngology and have `been an editor and chairman of an American Academy of Opthamology and Otolaryngology Study Section on Hear- ing Aids. I `also have, since 1973, served on that Academy's `Committee on Hearing and Equilibrium. In assessing the problems of the hearing aid delivery system as it exists today, it is my opinion that no single method or professional group has all the answers. The successful fitting of an aid is really a combination of talents and past experiences. My own practice is located in a highly sophisticated and affluent community where dealers, audiologists and otolaryngolo- gists all do a reasonably good job. I see very few patien'ts previously fitted with an aid that could have been helped `medically instead. I do not know how many are inappropriately fitted, by actual measurement in my own community. However, I do feel very uncomfortabl'e on those occasions when I must suggest that a patient purchase an aid from an unknown dealer several hundred miles away. I also find it interesting that when I have made such referrals, sent a personal note, copies of hearing tests and so on, I have not once in over 15 years received any feedback from a dealer. The fitting of hearing aids is largely a matter of trial and error, in which the hearing test (audiogram) is used to estimate the possible aids for an individual's hearing loss. Within that range of aids, it is then customary to then try several, hoping that one will stand out among the others in the customer's or patient's opinion. Sometimes this "opinion" is tested by more hearing evaluations while that person is wearing the aid, sometimes not, and rarely is' the potential purchaser tested in an environment which approximates his typical hearing circumstances. ` ` ,`: PAGENO="0080" 74 Ideally, if an "acceptable" aid is uncovered in this manner, he or she wears it for a few weeks-a hearing aid trial-before deciding on a purchase. In some ways, these procedures may be compared to the purchase of a pair of glasses, as directed by the store owner (hearing aid dealer), by a comparative shopper (audiologist) or by a management consultant (otolaryngologist). Having once been directed to the proper bin, eyeglasses, the cus- tomer makes the final selection himself by trial and error, possibly with the help of an eye chart if he happens to bring one along. One of the issues relevant to the difficulty in properly fitting a hear- ing aid is that there is a high degree of variability in the performance of individual aids. I have discovered that there is poor quality con- trol in the industry. Often, two aids of identical make and model have different acoustic characteristics. In practice, it is not possible to use the manufacturers' specification sheets to make a final selection of a hearing aid. Too much variabilityexists. And finally, one to see whether it is beneficial as compared to another. Some forward-thinking manufacturers acknowledge this problem and measure the acoustic characteristics of each aid, forwarding these measurements with the aid to the dealer or customer. Others do not. While such measurements do not solve the problem, they do allow for comparing one aid with another. At the delivery point, the equipment to check the quality of each hearing aid is expensive-even pro- hibitively so-and is not available in most dealers' sales outlets, speech and hearing centers or physicians' offices. Another problem concerns the life of the average hearing aid. There is no assurance that even the ideal aid will not be damaged in transit, dropped and replaced on the shelf, or damaged by the wearer unknowingly, thus changing the acoustic characteristic slightly or severely. Yet, maintenance of aids is based solely on wearer complaints, and when such complaints occur, we frequently cannot be sure if it is actually the hearing aid or the person's hearing which has changed. We can measure the hearing but rarely can we measure the aid accurately unless something obviously major is wrong with it. This is a terribly important problem with small children who rarely complain or do not notice changes in sound quality. The better hearing- handicapped nursery schools are aware of this and find it necessary to check each child's aid every day. Such checks are the only hard data I am aware of on sustained hearing aid performance. On an average somewhere between 20 and 40 percent of these aids are found to be malfunctioning on a daily to monthly basis. While weak batteries or broken cords are common and easily detectable and repaired, internal hearing aid defects are much more difficult to deal with. Management and prevention of defective aids-except for the care- lessness of the user-is basically a systems problem. Better electronics and more modern approaches to detection monitoring are clearly indicated. I believe I am objective about this question and looking at the in- dustry from the outside, there appear to me to be honest conflicts PAGENO="0081" 75 between the rising costs for research and development, profit margins and repair versus replacement costs. Quality control is a tremendous problem in the manufacture of hear- ing aids. For example, the frequency response of a hearing aid is usually adjusted by changing one resistor and one capacitor connected to a basic integrated circuit chip. The cost of these two parts is a few cents apiece. Yet, as these parts arrive from the supplier, each must be indi- vidually measured because a high percentage will not meet tolerance requirements. In effect, the cost of the components is less than the cost of quality control. There is room for much improvement in the areas of engineering design which could improve quality control, repair problems and post- sale defects and cost. However, the realities of the marketplace and the nature of the industry itself, with many small companies appealing to a limited market, interfere with ideal engineering design. It costs a great deal of money to develop an integrated circuit chip, but such chips are the heart of today's aids. Nevertheless, once a chip has become available in large production lots, they are cheap. Pocket electronic calculators, for instance, can be purchased whole- sale for about $10 and the most expensive components are probably the push buttons, not the integrated circuit chip within. In a hearing aid, the manufacturer adds, instead of push buttons, a microphone, miniature loudspeaker or receiver, a volume control, a few resistors and capacitors, a battery holder and a case. Very few chips are available for hearing aid use, and if my guess is correct, all manufacturers use the same chips. As an aside, the last time I heard a couple of years ago there were about three chips available and applicable throughout the entire indus- try for all ranges of hearing aids. Considerable long-term savings in labor and repairs could be had by simply producing a wider range of chips. Development costs un- doubtedly would be high, but production and labor costs would be low. However, it is clear that the industry, composed of relatively `low- volume manufacturers, cannot afford these developmental costs in today's marketplace. The ideal hearing aid has yet to be built which satisfies everybody. I think we can do better and I think most of my colleagues in both medicine and the hearing aid industry would agree. Senator PERCY. When you have a production line, and you have hearing aids coming off that line, you tend to think they would all be alike. I used to think the same thing about cameras when I was an industralist. I wondered why we had to go to the extraordinary ex- pense with movie cameras of having every single one of them indi- vidually calibrated for eight frames a second. You have 150 parts, they can be put together in an infinite number of combinations. It can only be checked and calibrated one by one. It is expensive. But the camera would be worthless without the tests. I suppose the same thing is true right `here. We are going to get into the mechanical nature of manufacturing. The field work is being done on that now. Certainly, manufacturers will be given an opportunity to testify on those problems, which obviously contribute to costs. 79-954------76---6 PAGENO="0082" 76 But you have raised a number of issues that would be inappropriate for me to inquire into now, until we have `had an adequate opportunity for the manufacturers to also prepare testimony. Our next witness, and I think it would be better to question you at one time, is Dr. Robert Ruben. Dr. RUBEN. `Senator Percy, members of the committee, ladies, and gentlemen. I would like to thank you for the opportunity to present some of my ideas concerning the problem of the hearing impaired and in particular the utilization of hearing aids by the hearing4mpaired citizens of the United States. For close to two decades, I have been professionally involved with research, medical, social, and economic aspects of the hearing impaired. This work has resulted in several appointments, including that of research associate at the National Institute of I-Iealth; professor and chairman of otorhinolaryngology at Albert Einstein College of Medi- cine of Yeshiva University; chief medical consultant at the New York League for the Hard of Hearing and other similar positions. It should be noted that most of the patients I see are those afflicted with hearing disability, and that I have been privileged to study and care fOr individuals with hearing impairment. I have also had experience in examining and designing health care delivery systems for the hearing impaired both in the United States and abroad. The present health care delivery system for the hearing impaired in the United States appears not to be meeting the needs of patients for several reasons. The hearing-impaired individual is one who usu- ally has a hearing loss as the most obvious symptom of his or her disease. Some of these patients can be helped to regain the hearing loss, or at least further loss can be prevented, by medical and/or surgical treat- ment. In others, hearing loss is the first sign of another disease which may be both life threatening and treatable. In the largest group of patients the hearing loss is not treatable and is not a sign of another disease, but is frequently of genetic origin. Hearing aids can improve the quality of life of many of these pa- tients. In many instances these patients will also require aural habili- tation. All of these patients need periodic otologic and audiologic re- assessment. The present delivery system for the hearing impaired citizens of the United States fails to meet these standards. A hearing impaired patient can obtain a hearing aid by simply going into a store and purchasing the device, without any medical or audiologic assessment. The typical seller of hearing aids does not have the medical train- ing necessary to obtain a medical history, nor to interpret amedical his- tory; nor does the typical seller have the diagnostic skills necessary to examine the ear, `let alone the other portions of the mouth, nasophar- ynx, head, neck, and nervous system, which are essential in enabling a correct diagnosis to be made. Furthermore, testing of the patient's hearing may or may not be carried out in a soundproof room, with special calibrated equipment and the use of techniques, in a manner which will meet minimal stand- PAGENO="0083" 77 ards. These standards have been established for these tests by various professional groups. The ability to obtain a hearing aid without medical and audiological advice clearly delineates an inadequate delivery system. There are two other aspects of the present delivery system which are unacceptable and economically wasteful. The first of these is that the hearing aid dealer, by and large, does not have the medical and audiological training to diagnose and treat hear- ing disorders. Furthermore, the dealer is in the position of conducting a business from which he must make a profit on his investments of cap- ital and time. One aspect of the economics of retailing hearing aids is that they are usually sold by low-volume retailers and thus the profit per unit must be greater than that of high-volume retailers. In some instances, hearing aids are sold not on the basis of the pa- tient's needs but on the basis of what the traffic will bear irregardless of the efficacy of the device in improving the patient's ability to com- municate. The second problem is the well-known need for aural habilitation. Aural habilitation is a training program not only in the mechan- ics of how to use the hearing aid but also in learning how to interpret the sounds which are heard. Serious cases require special training in how to combine the limited auditory input the hearing aid gives with the use of visual cues. A hearing aid, for many patients, is not the same as a pair of eye- glasses. The hearing is seldom brought back to normal, there is usually still a hearing loss and, most importantly, there is a significant amount of distortion in that which is perceived as sound. The hearing aid dealer, for the most part, has no training in these skills, nor do these aspects of the care of hearing impaired increase the dealer's profit. An acceptable and efficacious delivery system for the hearing-im- paired citizen of the United States must include the following: 1. The hearing-impaired patient should be first seen by an otolo- gist for a complete medical assessment. 2. The hearing should be tested by a qualified person, using acceptable sound-treated rooms, instruments and techniques. 3. The hearing aid, if needed, should be purchased after proper medical and audiological evaluation. 4. The hearing-impaired patient should, when needed, have aural habilitation. 5. There should be periodic otologic and audiological reassess- ment. This briefly outlined delivery system differs from that proposed by the interdepartmental task force assembled by the Assistant Secretary for Health of the Department of Health, Education, and Welfare to study the hearing aid health care issue, which 1 feel is lacking in fun- damental provisions for an efficient and efficacious delivery system for' citizens of the United States. Senator PERCY. Thank you very much. Dr. Glasscock, I would leave it to your judgment. It seems to me that you might be able, because of the lateness of the hour, to summarize your statement. The entire statement, of course, will be placed in the record. But the Chair will proceed as you wish. PAGENO="0084" 78 [Statement referred to follows:] STATEMENT OF MICHAEL GLASSCOCK, M.D. Mr. Chairman, I am Michael Glasscock, M.D. I am a board-certified otolaryn- gologist practicing at 1811 State Street in Nashville, Tennessee. In addition, I am an Assistant Clinical Professor of Otolaryngology at Vanderbilt University in Nashville. I am a member of the American Otologic and American Triologic Soci- eties, as well as the American Council of Otolaryngology. I have produced a num- ber of training films in the otology field and have published more than 60 articles on my field in numerous medical journals. The health care delivery system of hearing aids as it exists today does not function in the best interest of the almost 20 million Americans who are unfor- tunate enough to have a hearing impairment. The purpose of this communica- tion is to examine this system critically, to evaluate some of the new proposals for its revision and to offer a new approach to the dispensing of hearing aids to the hard-of-hearing individual. THE PRESENT SYSTEM At the present time, hearing aids are available to the general public by a num- ber of routes. I. Solicitation: (a) A hearing aid dealer places an advertisement in the local newspaper stating the fact that he has hearing aids available to hard-of-hearing indi- viduals. (b) The hearing aid dealer goes from door-to-door in a neighborhood seeking out hard-of-bearing individuals. (c) The bearing aid dealer works through client referral to find other individuals with bearing loss. The hearing aid dealer may or may not seek medical clearance. II. The patient seeks help: (a) A hard-of-bearing individual seeks out the hearing aid dealer and asks for a hearing aid. (b) A hard-of-hearing individual seeks out a physician, who in turn may or may not recommend a hearing aid, depending upon his knowledge of the subject. The doctor then sends the patient to a clinical audiologist or directly to a hearing aid dealer. (c) The patient goes directly to a speech and hearing center and has a hear- ing test by a clinical audiologist, who may or may not seek medical clear- ance. The clinical audiologist prescribes a hearing aid and sends the patient to a hearing aid dealer. GUIDELINES SET FORTH BY TASK FORCE ON HEARING AID DELIVERY SYSTEM FOR DHEW In 1974, a DHEW Task Force was organized to study the problem of hearing aid dispensing in this country. The Task Force is to be commended on the thor- oughness with which they approached this problem. Many of the conclusions they reached were valid and meaningful. Their overall grasp of the situation was good. There are some glaring discrepancies in this report, however, and some guidelines have been set forth that are not realistic and are not in the best interest of the hearing-impaired individual. Their statement on false advertising and misrepresentation by the hearing aid industry is well taken, as is the call for standardization of the industry's products. The proposal for a mass educational campaign is excellent and long overdue. The high cost of hearing aids themselves was well-covered and brings to light a whole area for special investigation. The Task Force expressed the need for further research in hearing aid production and application. While these and other aspects of the report are to be commended, I feel the following guidelines are ill-conceived: The report states that an individual under 8 years of age must have a medical clearance by a physician specializing in diseases of the ear (or from a duly li- censed physician if no such ear specialist is in the community). An individual 18 years or older could sign a waiver from this requirement. PAGENO="0085" 79 In addition, there are proposed seven conditions under which an aid could not be sold without a medical clearance. These are: 1. Visible congenital or traumatic deformity of the ear. 2. History of active drainage front the ear within the previous 90 days. 3. History of sudden or rapidly progressive hea.ring loss within the previous 90 days. 4. Acute or chronic dizziness. 90 days. 5. Unilateral hearing loss of sudden or recent onset within the pre- vious 90 days.. 6. Audiometric air-bone gap equal to or greater than 15dB (ANSI) at 500 Hz and 2,000 Hz. 7. Visible evidence of cerumen accumulation or foreign body in the ear canal. Let's examine these guidelines carefully and critically. First, if a medical clearance is required for those under 18, then why not everyone? How can the average lay person, regardless of age, be in a position to waive his right to a medical examination? Assume for the sake of argument that the individual is dealing with a dishonest dealer and that he really does not need a hearing aid. By signing the waiver he has given up his right to a second opinion and has placed himself in a position of diagnosing his own hearing impairment. If a medi- cal clearance is essential for those under 18, it must surely be so for those over 18 as well. The medical clearance itself must be given by an otolargyngologist. A duly li- censed physician unfortunately is not a satisfactory substitute. As medical schools are structured today, it is possible for many physicians to graduate With absolutely no training in diseases of the ear. In many schools, otolaryngology is an elective subject and a medical student may decide upon another course. An example in point is Vanderbilt University's Medical School. It has no Department of Otorhinolaryngology and the students receive absolutely no training in the diagnosis or treatment of diseases of the ear. Consequently, physicians with such a background are not capable of rendering a diagnosis in an individual with a hearing impairment. There are those individuals who say it is not practical to have all hearing aid candidates seen by an otolaryngologist because each community does not have one available to them. This argument is not a valid one. The system of trans- portation in the country is excellent. There are very few hearing-handicapPed individuals who are not within an hour's drive of a community in which there is at least on otolaryngologist. Now let's examine the seven conditions under which no hearing aid could be sold without a medical clearance. First, this statement of conditions assumes that the hearing aid dealer is going to take a careful medical history and that he is going to complete a thorough physical examination of the individual's external ear, external auditory canal, and ear drum. To expect a lay person (hearing aid dealer) to assume these medical duties is unreasonable and unwise. Therefore, assuming that the seven conditions themselves are valid, it is not within the capability of a hearing aid dealer to make these medical decisions. It must be remembered that a hearing loss is merely a symptom of a medical problem involving the ear and/or central pathways and not a disease in and of itself. To assume that one can confine the total ramification of auditory systems dysfunction to seven danger signals is not reasonable. Unfortunately, auditory symptoms are at times the only symptoms of serious central nervous system disease. An example is an acoustic neuroma, which is a tumor arising on the hearing and balance nerve and is considered a brain tumor. These central nervous system lesions occur in the cerebellopontine angle and produce a unilateral sensorineural hearing loss. The loss is progressive and very insidious in onset. The unilateral provision in these seven conditions states that the loss must be of recent onset or within the previous 90 days. Using this guide- lines, an aid might be placed on an individual with such a tumor. The lack of a defimtive diagnosis in this type of case would endanger the patient's life. An early diagnosis is of extreme importance. Let's examine the case of drainage from the ear. Again, the 90-day provision is of no value because many ears with chronic disease will only drain periodically arid may go as long as six months to a year between infections. An ear that has a perforation and is dry will almost always start to drain when the ear canal PAGENO="0086" 80 is closed by a hearing aid mold. Is the hearing aid dealer expected to diagnose a perforation of the ear drum? Is the general physician expected to diagnose the same condition when he has never been taught how to examine a normal ear drum? There are certain forms of sensorineural hearing loss that are now amen- able to medical or surgical correction. Three instances of this are cochlear otoscierosis, cochlear hydrops and lvetic hearing loss. These are medical diagnoses requiring sophisticated X-ray and blood studies. The seven conditions set forth by the Task Force could in no way establish the presence of any of these conditions. Each and every one of these seven conditions can be discredited and shown to be an invalid method of determining the need for a medical clearance. It is sheer folly to put a lay person in the position of making critical medica1~ judgments. HEARING AID DEALERS According to the DHEW Task Force report, there are an estimated 15,000' hearing aid dealers in this country. Of this number, only about 2,200 have re- ceived certification by their association, the National Hearing Aid Society. Their training is inconsistent and varies from state to state, depending upon current licensing laws. They are in no way prepared to make medical decisions. It is apparent that a small nucleus of dealers have received a minimum of' training and supervision. To completely ignore the competent hearing aid dealer would be a gross injustice. Many of these individuals have been fitting aids sue- cessfully for years and have amassed a tremendous amount of practicing knowl- edge. There is convincing evidence that the NHAS is attempting to upgrade the general knowledge and professionalism of their members. These individuals must not be ignored in any scheme to deliver hearing aids to the general public. TIlE CLINICAL AUDIOLOGIST The Task Force has established that: the American Speech and Hearing Association (ASHA) has estab- lished minimum professional standards for audiologists which include: (a) earning a Master's degree, or its equivalent, in audiology including 300 hours~ of supervised clinical experience and (E0 hours of related course work; (b) completing an additional year of full-time supervised clinical internship in~ audiology; (c) passing a national examination in audiology which is ad-- ministered by the Education Testing Service, Princeton, New Jersey. Both the academic and clinical experience required for the recommendation, selec- tion and use of hearing aids are integral parts of the audiology training program. Clearly, the professional standards for audiologists exceed those- required for hearing aid dealers. Certainly, one could not argue with the statement that the clinical audiologist is better equipped to measure the amount and character of a given hearing loss than is the average hearing aid dealer. The clinical audiologist~ ho~cvever, is in no better position to make medical judgments than is the hearing aid dealer. There is some question in the minds of many professionals as to the validity' of the current method of hearing aid selection as practiced by the clinical audio- logists. To assume that there is only one method of selecting an aid would be presumptions. There is no convincing evidence that just because an individual holds a degree in audiology he is an expert in the fitting of hearing aids. THE OTOLARYNGOLOGIST The specialty of otolaryngology is a broad one, encompassing the entire head' and neck region. The otolaryngologist has five years of training after leaving medical school. One aspect of this specialty is the study of the diseases of the- ear. While any otolaryngologis-t is capable of making decisions in regard to medi- cal clearance for a hearing aid, he may not be capable of determining who is best suited for an aid or which particular aid is best to use. The reason for this is that there is no uniform training available to the resident in otolaryngology on the subject of hearings aids. Therefore, the decision of what type of aid should be used in a given situation should not be in the hands of the otolaryngologist. A PLAN FOR THE FUTURE I believe that the federal government should sponsor a program to certify" otolaryngologists, audiologists, and hearing aid dealers. This program wouid PAGENO="0087" 81 be administered with the cooperation of the American Council of Otolaryngology, the NHAS and the ASHA. The purpose of the program would be to standardize the method of hearing aid selection, taking into account the knowledge of. the NHAS and ASHA members. The method of hearing aid selection would have to be worked out by a board consisting of NHAS and AS'HA members. The method or methods would be en- dorsed by both groups and would become the standard manner in which aids are to be selected. Otolaryngologists would become more familiar with hearing aids and their use. The graduates of this program would have a number certifying that they had met the requirements necessary to become a part of the Hearing Aid Delivery Team. This number would he similar to a narcotics number assigned to physicians who dispense certain controlled dn.igs. The logical place to start with this team approach would be with MediGare patients, `branching out to all individuals with a hearing impairment `with the initiation of national health insurance.. The otolaryngologist would be the entry point for all hearing-impaired inclivid- uals. Working with the audiologist, the otolaryngologist would determine the type and extent of hearing loss. `He would establish a medical diagnosis based upon `the hearing tests, his physical examination and any laboratory studies that might be necessary. Once the diagnosis was made the otolaryngologist would de- dde whether the individual had a medically or surgically correctable hearing loss. If not, he would refer the individual to an audiologist who would counsel the patient concerning his hearing loss and whether it was amenable to amplifica- tion. The audiologist would supply the dealer with a complete aucliometric study and recommendations for a specific aid. The dealer would be responsible for sup- plying that aid hut would have the privilege of changing the aid with the coop- eration of the audiologist if the aid were not satisfactory for the patient. In this manner, the hearing aid dealer and the audiologist can work together to select the best aid and adjustment for the hard~of~hearing individual. The dealer would be responsible for servicing the `aid and for repairs that might become necessary. The audiologist would work with the patient to supervise his rehabilitation. A hearing aid would not he considered sold until the patient had been able to accept the aid and wear it with success. A trial period of 30 &tys should be sufficient for this purpose.' SUMMAB~ A hearing aid is a medical prosthesis and can be of great value to some mdi- viduals with a hearing handicap. Neither the hearing aid dealer nor the audiolo- gist should be the entry point for the hard-of-hearing individual into the hearing aid delivery system. An aid should never be placed on an individual without a prior medical diagnosis established by an otolaryngologist. The audiologist and hearing aid dealer should work together for the benefit of the hearing aid user. Only those otolaryngologists, audiologists and hearing aid dealers who have been certified as to competency in the knowledge of hearing aids should be allowed to become a part of this Hearing Aid Delivery Team. From a practical standpoint, the logical place to start is with MediCare patients. As the system grows and becomes practical, it could be easily integrated into a national health system. Dr. GLASS000K. Thank you, Mr. Chairman. I will try to summarize this rather lengthy statement for you. I am a board-certified otolaryngologist practicing at 1811 State Street in Nashville, Tenn. In addi'tion, I am an assistant clinical professor of otolaryngology at Vanderbilt University in Nashville. I am a member of the American Council of Otolaryngology. I have produced a number `of training films in the otology field and have published more than 60 articles on my field lfl numerous medical journals. I personally feel that the health care delivery system of hearing aids as it exists in the country today does not function in the best interest of the hearing-impaired individual. The purpOse of my statement, therefore, is to critically examine this system, to evaluate the Department of Health, Education, and Welfare PAGENO="0088" 82 task force proposals and to propose to you what I consider to be a new approach in dispensing hearing aids. At the present time, hearing aids are available to the public through solicitation by the hearing aid dealers. The patients themselves will go either to the doctor, otologist, or the hearing aid dealer or the patient may go directly to a hearing and speech center. In 1974, the DREW task force studied the dispensing of hearing aids in this countr and came up with some recommendations and con- clusions. Many of these, I think, are well taken and are extremely good. There are some aspects of this report that I disagree with very much. I would like to bring those to your attention. Basically, one of these is that the report states that an individual under 18 years of age must have medical clearance by a physician specializing in diseases of the ear or a dul.y licensed physician if no such ear specialist is in the com- mimity. An individual over 18 years of age could sign a waiver. In addition, there were seven conditions that were put forth in which an aid could not be sold without a medical clearance if these were present. Briefly, these have to do with whether there is congenital deformity of the ear, history of drainage, and unilateral loss and things of this nature. I think when you look at these particular guidelines carefully you will see that there are some inaccuracies here in my own opinion and they do not hold un well under close scrutiny. I see no reason why someone over 18 years of age should sign a waiver giving away his right to second opinion or placing himself in a position of diagnosing'his own medical problem. Medical clearance, as far as I am concerned, should he done only by an otolaryngologist. The genera] physican duly licensed is not in the position necessarily to make medical judgments concerning the ear. The reasou for this is that in many medical schools todayS otolaryn- gologv is an elective and an individual can go through medical school and never been properly trained in the method of examining the ear. At my own university. unfortunately we do not have a department of otolaryngologv that is active au d medical students receive very little if any training in problems of the ear. If you look at the seven conditions for medical clearance, I feel these `are totally inadequate. You cannot take any of those seven conditions and use them, in my opinion, in a way to make sure that that individual does not have a life-threatening problem. In my statement I mention the fact that unilateral nerve loss may in- dicate the presence of central nervous system disease. I do not feel that anyone other than an otolaryngologist is in the position to carefully diagnose and rule out central nervous system dis- ease, and I think it is pure folly to expect a lay person to do this. I think you can take all of the conditions that have been set forth and systematically tear them down. So I feel that they are not, certainly not, they don't stand up to critical analysis. I would like to briefly summarize the three different groups of people that we have been talking about here this morning. One `is the hearing aid dealers. According to the task force there are estimated Th,000 dealers in the United States. Of this number only about 2,200 are certified or belong to the National Hearing Aid Society. PAGENO="0089" 83 So the society has very little control over the vast majority of the hearing aid dealers in the country. The training of the hearing aid dealers would seem to be incon- sistent and would vary from State to State depending on their licens- ing laws. I see nothing in their training that would tell me that they are pre- pared to make any type of medical decision. I do feel that there is a small nucleus of dealers who belong to the National Hearing Aid So- ciety who are honestly trying to improve the members and to improve their hearing aid dealers across the country. I feel that they have amassed over the years a vast knowledge of hearing aids and that this knowledge should be given to the people of the country. The clinical audiologist, certainly again, according to the task force, has a very good background and training. They must have an M.S. degree in order to be called an audiologist. They are extensively trained in dete~ting hearing loss. As Dr. Rose mentioned this morning, I think that there is some ques- tion as to the present methods that the audiologist uses in detecting the type of hearing aid that should be used in a given individual. So I feel that at the present time there is no one way or one specific way that a hearing aid can be selected. Briefly, I would like to talk about the otolaryngologist. Otolaryn- gology is a broad field encompassing the ei~tire head and neck. It re- quires 5 years of training after leaving medical school. One aspect of otolaryngology is the study of the diseases and problems of the ear. I feel that any otolaryngologist is capable of making medical de- cisions regarding the ear. However, at the present level of training in otolaryngology departments across the country, all residents or trainees in otolaryngology do not necessarily have good training in the use of hearing aids and which individuals would be best suited for a hearing aid. So at the present time I do not necessarily think that the otolaryn- gologist could give an accurate estimation in all cases of who would benefit from an aid and who would not. I would like to present to you a plan that I consider would be work- able for the future. I believe that the Federal Government should sponsor a program to certify otolaryngologists, audiologists, and hearing aid dealers. This program would be administered in cooperation with the American Council of Otolaryngology, the National Hearii~g Aid Society, and ASHA. The purpose of this program would be to standardize the method of hearing aid selection taking into account the knowledge of the hearing aid dealers and the ASHA members. The method of hearing aid selection would have to be worked out by a board consisting of these individuals. The method or methods would be endorsed by both groups and would become the standard on which the aid could be selected. Otola.ryngologists would have to become more familiar with the hearing aids and their use. The graduates of this program would be certified that they had met the requirements necessary to become part of the hearing aid delivery team. They could be assigned a certificate number. PAGENO="0090" 84 The logical place to start I think with this team. approach would be with medicare patients, branching out to other individuals with more time and with the initiation of the national health insurance program. The otolaryngologists would be the entry point of the hearing impaired individuals into the system. Working with the audiologist, the otolaryngologist would determine the type and extent of the hear- ing loss. He would establish a medical diagnosis based upon the hear- mg tests, his physical examination, and any. laboratory studies that might be necessary. Once the diagnosis was made, the otolaryngologist would decide whether the individual had a medically or surgically correctional hearing loss. If not, he would refer the individual to an audiologist who would counsel the patient concerning his hearing loss and whether it was amenable to amplification. The audiologist would supply the dealer with a complete audiomet- nc study and recommendations for a specific aid. The dealer would be responsible for supplying that aid but would have the privilege of changing the aid with the cooperation of the audiologist if the aid were not satisfactory for the patient. In this manner, the hearing aid dealer and the audiologist could work together to select the best aid and adjustment for the hard-of- hearing individual. The dealer would be responsible for servicing the aid and for repairs that might be necessary. The audiologist would work with the patient to supervise his reha- bilitation. The hearing aid would not be considered sold until the patient had been able to accept the aid and wear it with success. A trial period of 30 days should be sufficient for this. So in summary, I would say that the hearing aid is a medical prothe- sis and can be of great value to some individuals who have hearing handicaps. Neither the hearing aid dealer nor the audiologist should be the entry point for the hard-of-hearing individual into the health delivery system. The aid should never be placed on an individual without proper medical diagnosis established by the otolaryngologist. The audiologist and hearing aid dealer should work together for the benefit of the hearing aid users. Only those otolaryngologists, audiolo- gists and hearing aid dealers who have been certified as to competency in the knowledge of hearing aids should be allowed to become a part of this hearing aid delivery team. From a practical standpoint, the logical place to start is with medi- care patients. As the system grows and becomes practical, it could be easily integrated into a national health system. Senator PERCY. Thank you very much, Doctor. Referring to page 3 of your testimony, why is it that so relatively few medical schools have a department of otolaryngology when there are 20 million hearing-impaired people in the United States? It is one of the most common physical disabilities in America. . . Why is it that medical schools are not providing adequate training in this field? Dr. GLASS000K. I wish I could answer that, Senator. But I simply don't know. PAGENO="0091" 85 Senator PERCY. Maybe, in this case, the market has to be created. If we can determine the need, we have got to somehow provide the stimulus to put the professionalism into the delivery system. But it is discouraging to hear that you have a field of great need here with rela- ~tively few training facilities available. I would like comments from any of our other panelists on that par- ~ticular point. Do you know why it is that we don't have adequate facil- :itjes now? Dr. RuBEN. I can only answer one man's feeling. I am in the univer- ~sity situation where we don't have a department as Dr. Simmons will :speak. I think the problem is severalfold. It is not a simple issue. I think one part of the problem that in many medical schools emphasis ~has been given on teaching of some areas which are really not neces- sarily pertinent to the fundamental delivery of health care as primary physicians or even as secondary and tertiary physicians. These come from problems with the curriculum committees. The second, 1 think, has been territorial disputes between otolaryn- gologists and other departments within the medical schools who by their very nature are somewhat larger and have essentially made it very difficult for a reasonable academic department to be set up. The situation is really much different in Northern Europe and to some extent Great Britain where there are otolaryngology departments `in every medical school that teach exactly what Dr. Glasscock had been ~proposmg. Dr. SmIMoNs. I would add only one or two things. One is the "peck- ing order." Who decides what is important in the medical curriculum? Doctors are no different than the lay public when it comes to the sig- nificance of hearing loss. I dare say if there is a physician or two on a committee that has a hearing loss and direct experience with it, that hearing would be part of the curriculum. But deafness is still underplayed as an important issue. Until that is corrected, this is going to be the way things are. Senator PERCY. I have asked the question before as to what propor- tion of the 20 million hearing-impaired Americans would be helped by a hearing aid. Would any of you be able to give an estimate based on your own experience, very roughly? We have had ranges from 10 percent to 40 percent. Do you think the range is that wide? Are you able to narrow it down any? Dr. SIMMONS. I think the range is that wide. For example, in my ex- perience, in a medical school, where patients have been highly screened, There are mainly problem patients. I would say 80 percent of the pa- tients I see with an untreatable medical or surgical hearing problem :are candidates or borderline candidates for hearing aids. Senator PERCY. Eighty percent are candidates? Dr. SIMMONS. At least. Senator PERCY. Potentially could be helped? Dr. SIMMONS. That is correct. But that is not a primary practice, either. That is a tertiary care medical care practice. Dr. RUBEN. Your question has already been noted down to try to get you the information. I think the question is a complex question because `what do we mean by hearing aid? If you are just putting `a hearing aid on the individual, then the figures are going to be somewhat lower if PAGENO="0092" 86 we are talking about a total system of rehabilitation or in the case of a child, habilitation. Senator PERCY. The reason I am asking the question is a very practi- cal one. How big is this market? If sufficient technology is not avail- able, if sufficient research and development is not going on, if we are sort of at a standstill in our learning process in this field, it is discouraging. The potential for the profit system is the market. If the market is big, we want to know that. We want the industry to know that. Because I am going to ride herd on this problem as long as I am in the U.S. Senate. I am going to be the biggest promoter of research and development in this field. I have done a great deal through the years with the mili- tary in upgrading their medical services. There is a good body of evi- dence that my hearing loss was attributed to simple negligence on the part of myself and the U.S. Navy. For 3 years, I was around machinegun fire, 20-millimeter cannons and aircraft engines. My work was always on the airfield, and that noise was just pounding away at me. It was almost as damaging to the eardrums as rock music is today. I urge my children to protect themselves against the hearing loss they can experience if they sit there with the pictures vibrating on the wall, and this very, very loud music pounding their eardrums. You shouldn't be on the airfield without protection for your ears. You shouldn't fly a helicopter without that kind of protection. Certainly, we are emphasizing prevention on the one hand, and o~ the other, we are trying to see how large the market is so we can justify the private sector spending more private money. Maybe there are more Federal research funds available from NIH, that we can use to develop the necessary technology. We want to encourage that. Dr. RUBEN. I think the second part of your question, the need for more highly developed technology, I think could not be more obvious. In answer to your first question of earlier this morning somewhat in- directly, from 1970 I have some statistics from three areas in Scan- dinavia, that run from 200 to 444 aids per 100,000 population. We can then do some arithmetic to see where we are in the United States. Probably we can get somewhat better data, but I think an important aspect would be for finding out really how many people can be helped. We have to define what we mean by help, what we have now and what technology is. I think this would be exceedingly substantive contribution to the quality of life of our citizenry. Senator PERCY. I am going to introduce into the record at this time as exhibit 25 a letter to me from Alexander Schmidt. Commissioner of Food and Drug Administration, in which he says that the task force medical clearance proposal is based solely on the testimony of the American Council of Otolaryngology. The task force's position is that anyone over 18, as has been indicated, can buy a hearing aid if they sign a waiver stating they don't wish to be examined by a physician. It also assumes that a dealer can tell when a person has a medical problem and will make the proper medical referral. PAGENO="0093" 87 [The document referred to was marked "Exhibit No. 25" for refer- ence and follows:] EXHIBIT No. 25 NOVEMBER 11, 1915. Hon. ALEXANDER M. SCHMIDT, Commissioner, Food and Drug Administration, TVashington, D.C. DEAn CoMMIssIoNER SCHMIDT: On October 21, the Senate Pernianent Sub- committee on Investigations issued a Staff Study of the State Licensing Laws and Training Requirements for Hearing Aid Dealers. A copy of the staff study is attached for your perusal. The study concluded that hearing aid dealers were improperly trained and that most of the states were not exerting an aggressive effort to police the more than 5,700 dealers under their jurisdiction. As a result of these findings, the staff study recommended that the Food and Drug Administration "immediately declare hearing aids to be prescription de- vices." The study went on to say that such action was "the only certain method available to the Federal Government to insure that hearing-impaired persons are protected from dealers who are neither adequately trained nor competent to diagnose disorders of the ear." This study seems to me to lend new urgency to the need for the F.D.A. to step in and insure that a tough medical clearance requirement be initiated as soon as possible. A modest medical clearance proposal is embodied in the Health, Education and Welfare Department's Hearing Aid Task Force report, but I do not believe it goes far enough, considering the facts now before us. The F.D.A. must fulfill its responsibility to protect the 14.5 million Americans with hearing handicaps. That can only be accomplished by requiring all per- sons, regardless of age, to obtain before purchase an affirmative medical judg- ment that a hearing aid will help them. Sincerely, CHARLES H. PERCY, U.S. Senator. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, PuBLIc HEALTH SERVICE, FOOD AND Dnua ADMINISTRATION, Rockville, Md., January 2, 1976. Hon. CHARLES H. PERCY, U.S. Senate, Washington, D.C. DEAR SENATOR PERCY: Thank you for your letter of November 11, 1975, in which you address the recommendation for declaring hearing aids prescription devices made in the Senate Permanent Subcommittee on Investigations' "Staff Study of the State Licensing Laws and Training Requirements for Hearing Aid Dealers." I am sorry that your letter was inadvertently misrouted which caused an in- ordinate delay in the preparation of this reply. I think the best way to respond is to bring you up to date on what has occurred since the publication of the "Final Report to the Secretary on Hearing Aid Health Care." On September 26, 1975, Secretary Mathews accepted the final task force report and assigned lead responsibility for overseeing implementation of its rec-. ommendations to the Office of the Assistant Secretary for Health. In the final report, the task force found that neither hearing impaired con- sumers, audiologists, nor hearing aid dealers are capable of diagnosing the medi- cal cause of a bearing impairment and correctly prescribing the proper treat- ment. Consequently, the task force recommended that the Food and Drug Admin- istr.ation (FDA) promulgate a regulation which would require a medical clear- ance from a physician to assure that a hearing aid is both safe and effective for its intended use. The purpose of a medical clearance is to assure that all medically treatable conditions which may affect hearing are identified and treated before a hearing aid is purchased. The task force's medical clearance provision would not require the physician to prescribe or recommend a certain kind of hearing aid. PAGENO="0094" 88 The Food and Drug Administration has developed, but not yet published, a~ Proposal for Professional and Patient Labeling for Hearing Aid Devices, closely' following the task force's advice. The proposal is intended to define and clarify the information that manufacturers should incorporate into the labeling of' hearing aids, in order to provide hearing aid users with adequate directions for the safe and effective use of these devices. Upon final promulgation, the Rule for Professional and Patient Labeling for Hearing Aid Devices would require a medical clearance, but not a specific product prescription, as a condition for sale of a hearing aid. As a provision to the medical clearance recommendation, the task force further' determined that any person eighteen years or older purchasing a hearing aid should have the option to waive preliminary medical examination and diagnosis. Such a waiver was not intended to diminish or rescind the recommendation that medical clearance be instituted as an initial step in purchasing a hearing aid. In my judgment, the waiver provision represents a reasonable compromise among the differing opinions expressed by the various interest groups, such as the National Hearing Aid Society, the Hearing Aid Industry Conference, the Ameri- can Council of Otolaryngology, the Retired Professional Action Group, and the Greater Philadelphia Hearing Aid Guild. During the open comment period on the Preliminary Task Force Report, we- received many comments urging that the prescription recommendation be amended to allow for such factors as the inconvenience of securing medical assistance in rural areas, and the right of the hearing impaired to determine for themselves whether or not they require, or desire, medical intervention. The American Council of Otolaryngology indicated that a person should have the right to waive- a mandatory medical clearance provided that none of seven otological conditions were evident at the time of sale of a hearing aid. The task force in its final report, and the FDA in preparing its proposed rule, have adopted the suggestion of the American Council of Otolaryngology and have qualified the waiver provision to pertain only to those persons who do not exhibit any of the seven specifically designated conditions. Because these condi-~ tions may indicate that hearing loss is symptomatic of a more critical medical dysfunction and thus warrant treatment other than a hearing aid, a person exhibiting any of these conditions cannot employ the waiver and must secure- medical clearance prior to the purchase of an aid. Although there are certain instances in which excessive amplification may result in a harmful threshold shift in hearing, the primary health concern underlying the medical clearance recommendation is not directly related to the- safety of the hearing aid, per se. Rather, this recommendation is essentially based upon the recognition that unnecessary or partially effective hearing aids may be substituted for primary medical or surgical treatment, thus depriving the hearing impaired individual of the benefits to be derived from appropriate medical diagnosis and care. In addition to delaying proper medical diagnosis and possibly- reducing the efficacy of corrective treatment, the purchase of an ineffective aid' ulidoubtedlv involves high and unnecessary cost to the consumer. I hope that this information demonstrates that the FDA is committed to promulgating a hearing aid labeling regulation which would require medical' clearance as a condition for sale. Given the current state of the hearing aid delivery system, I believe it is in the best interest of the public health and welfare to permit a waiver to the mandatory medical clearance requirement, provided that none of the seven otological conditions are evident at the time- of sale. The Food and Drug Administration appreciates the interest, concern, and' support you have shown for Agency efforts to correct abuses in the hearing aid health care delivery system. I hope this information will be useful to you, and I welcome your further inquiries. Sincerely yours, ALEXANDEI3 M. SCHMIDT, M.D., Uommi8sioner of Food and Drugs, Senator PERCY. Does the council represent your profession? Dr. Gr~sscocK. Yes. Dr. RtIBEN. Yes. PAGENO="0095" 89 Senator PERCY. It appears from your testimony that none of you really agree with that position. Can any of you tell the subcommittee whether they sought your advice before the council made known its position? I Dr. RUBEN. My advice was not sought. Senator PERCY. Would all three of you respond the same way? Dr. GLASSCOCK. Yes. Dr. SmIM0N5. Yes. Senator PERCY. Do any of you know colleagues not at the hearing agreeing with the task force's medical proposal? Dr. GLASSCOCK. I have some friends that agree with it. But I think the majority of my colleagues do not agree with it. Dr. RUBEN. I would speak for my entire staff. None of them agree with it. I can't think of anyone who I met who really does. But the group of people I have met might be somewhat limited. Dr. SmIM0N5. It is a very complex question. Senator PERCY. Come on now, let's not be political. That is the kind of answer you expect from a politician. Dr. Smr~roNs. I personally want to second what Dr. G-lasscock and Dr. Rose before him said about that. That is my opinion, too. I think that there are people that do agree, some who I know, with the pro- posal of the American Council. Also, I believe I know why they do and that is getting down to the practicalities of a workable system; that is, the question, is there al- ways an otologist or otolaryngologist available to supervise this or give medical clearance? I think the answer to that is both yes and no. For example, I con- sult 1 day a month in the town of King City which is a rural town 50 miles south of Salinas. This is a fairly rich agricultural area, but there is a fair percentage I would say, at least half to two-thirds of the population, in that area whose primary language in Spanish, who have only very limited access to transportation. The nearest full-time hearing test facility is 75 miles away in Mon- terrey. They are frequently booked 6 weeks or more in advance. It is a logistic problem of getting these people to good audiologic facilities for testing and for hearing aid fitting. It is then a good logistics problem in trying to find a hearing aid dealer in immediate access, which I will say a radius of 50 miles is reasonable, to get the kind of quality care situation which is available around the corner in Palo Alto. This, I think, is part of the problem and I expect is part of the reason behind the council's feeling of any physician in the absence of an available otolaryngologist. In theory and most of the time, in. fact, I think is a mistake if we are going to talk about the ideal system of hearing aid delivery. There is no question in my mind whatsoever that when dealing with a physician who has no specialized training in hearing disorders, the patient is better off using a screening audiometer in the hands of a good public health nurse and some simple criteria than without such an audiometer and appropriate guidelines. Mr. CorriN. Mr. Chairman, at this point in the record I think it should be entered that you received a telegram yesterday from Dr. PAGENO="0096" 90 Jack IL Anderson. who is president of the American Council of Otolaryngology. I will read the telegram: This is to inform you that the statement of the American Council of Otolaryn- gology presented to the DHEW Intradepartmental Task Force on Hearing Aids, 7th May 1975, is being reviewed and reconsidered in the best interests of the American Health Care Consumer. That is exhibit 26. [The document referred to was marked "Exhibit No. 26" for refer- ence and follows:] EXHIBIT No. 26 [Telegram] NEW ORLEANS, LA., March 30, 1976. Senator CHARLES H. PERCY, Washington, D.C. This is to inform you that the statement of the American Council of Otolaryn- gology presented to the PHEW Intradepartment Task Force on Hearing Aids, 7th May 1975, is being reviewed and reconsidered in the best interest of the American Health Care Consumer. J. R. ANDERSON, President, American Council of Otolaryngology. New Orleans, La. Senator PERCY. Elsewhere in the task force report the following conclusion is offered. I will still ask for your comments even though that also may be subject to review now. Misevaluation of a patient's need for a hearing aid and the subsequent sale of a hearing aid device which is ineffective and possibly unsafe for its intended use are major problems in the present hearing aid delivery system. In your opinion, does that conclusion seem to contradict the medical clearance proposal in that very same report and actually support the position you have taken rather than the position the council has taken? Dr. SIMMONS. I agree. Dr. RrrnEN. Agreed. Senator PERCY. Dr. Simmons, have you any specific proposal as to what the Federal Government might do to improve hearing aid technology in the delivery system? Dr. SmrMoNs. Yes; I think I do. The reason why I picked this par- ticular point in my presentation is the question of how does one go about fitting a hearing aid? In the testimony before, up to a certain categorization of who needs an aid, and approximately what kind, it is largely a matter of trial and error of fitting one or another hearing aid on the person's ear and guessing which aid seems best. To my way of thinking, from what I know about acoustics and manu- facturing and things of that sort, this is really a ridiculous state of affairs. There is no reason why the same model and brand of a hearing aid should not be acoustically equivalent to another aid from the same manufacturer; none whatsoever. The fact that dealers, audiologists, other people who are actually trying hearing aids on individuals have got to resort to this trial-and- error business is simply that the individual variability in aids is so great that they literally have no choice. PAGENO="0097" 91 This adds a great deal to not only the number of hearing aids that have to be manufactured and stocked for trial-and-error proce- dures, but it adds a great deal to the cost of the delivery system. It is one point in the system where it would be comparatively easy to step into it and make some of these quality control changes without interfering with the politics or the economics of any of the other medi- cal problems or any other of the kinds of things which are much more difficult problems to solve, I should think. Getting down to specific facts about this kind of quality control, the big problem is in the parts, as you, Senator Percy, are well aware. It costs, I believe, $100,000, or somewhere in that ball park, to de- velop an integrated circuit chip. Once this is done it can be produced for $3.50, $4 apiece. If we had the variety in chips to compensate for frequency responses in hearing losses by the chip, not by the hand fit- ting, the soldering of parts, I think in the long haul this would add a great deal to quality control. . There is, for example, only one moving part in the hearing aid and that is the volume control. The volume controls get dirty in use. When they get dirty, they get scratchy or noisy. A hermetically sealed volume control is not an unreasonable thing to ask for in manufacturing proc- esses in these days. But given the fact that every hearing aid manu- facturer is in competition with every other one and they all buy the volume controls from the same companies, we are at an impasse. Two companies supply the majority of hearing aid parts in the United States. This, again, is a technological thing, but a. fairly easy one. It is those kinds of problems that I am addressing for quality control and manufacture because they do affect the delivery system. Senator PERCY. Thank you very much, indeed. Dr. Glasscock, I was rather surprised to learn from you that many of your colleagues may really not Imow enough about hearing aids. Are you suggesting that they be subjected to more educa.tion about the potential of hearing aids? IF-low long would the process of education take? Would you suggest that some provision be made for offering that service as an adult education program after graduation if they haven't had it in medical school? Dr. Gr~~sscocK. I feel that under our current post-graduate course system, our particular field, I think, has done an outstanding job. In our academy, for instance, each year has courses in all different aspects of otolaryngology. We have different universities and founda- tions from around the united States who put on courses. Dr. Shambaugh has put on an international workship. I think that there are many vehicles by which we can make known to our colleagues about hearing aids, what they can and cannot do. I feel that it certainly behooves us to learn more about it as profes- sionals. I think there has been a tendency in our profession to ignore the individual with a sensorineural hearing loss and zero in more on the one with the conductive problem because in the past we have been able to help these indiyiduals more. So we have sort of/neglected the. individual with a nerve deficit. I think there is a tendeney now for all, of us to be more aware of the individual with the nerve problem and that we are becoming more 79-954-76--------7 PAGENO="0098" 92 interested in the whole problem of hearing aids and hearing aid delivery. I think that you will see in the next few years that my colleagues will be much more and much better informed on the situation. Senator PERCY. You propose that each member of the hearing aid delivery system be certified and obtain a number from the Federal agency. I find this interesting. For those of us who are working so mightily to cut down the outreach of the Federal Government, to cut down the paperwork, reform our regulatory agencies, to `scale down government, to make it better rather than just bigger, this might be a contradiction. Would you care' to support your contention further as `to why it is necessary? Also, if you believe in a federal system of government, why do you feel that States couldn't undertake this rather than the Federal Government? Dr. Gr~sscocK. First, let me state I hate redtape more than anybody else in the world. I hate to fill out forms. I hate to be involved in any- thing like that, Yet, I realize in society there are certain aspects of government that reaches in and has to affect us and that there are times when there is a certain amount of redtape we have to submit to. I feel that this could be accomplished quite easily simply `by upgrad- ing the amount of teaching that goes on at the resident level in the departments of otolaryngology in dealing with hearing aids and that this could become a part of the residency training. ,Just as a resident would learn about surgery, he could learn about hearing aids and that individual as he graduates would pick up his number, so to speak, so that he would not be a particular overburden of our system. I think it could be integrated very easily. I feel like we could up- grade the professionalism of the whole system. I was the president of a State society of Otolaryngology for 2 years. I came face to face with a terrible clash between the audiologists of our State and the hearing aid dealers and got involved with their conflict with the local State representatives. It appeared to me that there were other battles going on across the country at the State level and that some laws would be passed in one State that would be good, while other laws would be passed in other States that would not be good. There was a lot of pressure brought to bear on the individual State legislatures. It was my opinion that all of the individuals of the United States should be treated equally and that what is good for the hearing- impaired individual in Florida should be good for the hearing-im- paired individual in Wisconsin. So it should be a uniform application to all of the hearing-impaired people and they all should have a fair break. Senator PERCY. Are State legislatures more susceptible, in your judgment, to manipulation by small vested interest groups that can get to the State legislators easier, work on them, get regulations eased or slanted toward them? I have been' interested, for instance. in the eyeglass field where many States prohibit price advertising. The same eyeglass. same frames, sell PAGENO="0099" 93 for maybe half the price a few miles away in a State where you can advertise prices than in States where price advertising is prohibited. We just find that lobbying groups go to work on their State legisla- tors and get a little special deal for themselves. Every manufacturer, I suppose, wants an item he can sell for $1, and costs him a dime. It can be habit forming. SO you have to assume that competition, though agreed on in prin- ciple, is not necessarily applied in practice. Someone is always trying to get some special advantage. Is there the possibility, that when you develop a national need, a national problem, that maybe you just have to intervene because of the nature of some of our State legislatures? We found that, in the nursing home field, we just could not continue pouring billions of dollars of Federal money into the nursing homes and have the lax inspection system in the hands of the States without any guidance from the Federal Government. Is this the same sort of a situation now, regrettable as it is? Dr. GLASSCOCK. I personally feel that situations of this magnitude that have to do with so many hearing-handicapped people, cannot de- pend on the State legislatures to protect them. I have talked to col- leagues from other States and I have seen the pressure put to bear on the State legislatures. I feel that State legislatures are more susceptible to these special interest groups than is the Federal Government. Senator PERCY. I have just a few brief questions. Dr. Ruben, you appear concerned about the lack of dealer training. Are you in any way implying they ought to be written out of the de- livery system because they do not perform a useful and necessary function? Dr. RUBEN. No; not at all. But I think the shoemaker should stick to his task. I think you need medical, otolaryngological and you need technical. I think perhaps the area where they might improve these would be in the technical end of measurement, maintenance and repair and not to try to subsume that they will learn how to do a medical history, and evaluation of the medica.l history and even a physical examination. I think we have enough troubles just trying to get that through the medical schools. Senator PERCY. In other words, you are really saying that it is possi- ble to educa.te the hearing aid dealers to the point where they can become a more important and professional part of the delivery system; is that right? Dr. RUBEN. Yes. As essentially hearing aid technicians-I don't mean that in the purgative sense-the models I have, some people have really become high expertise at the maintenance, measurement of this, and with a high enough volume then this becomes a reasonable type of activity and certainly is tremendously needed. Senator PERCY. Have you any specific proposals that you would like to offer either now or for the record for training the dealers? Dr.. RUBEN. I would have to 4o that for the record. That would have to be thought out much more than I would care to do off the top of my head. . . PAGENO="0100" 94 [Additional information supplied by Dr. Ruben follows:] ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY, DEPARTMENT OF OTOBI-JINOLARYNGOLOGY, Brona~, iYJ7.,.April 5, 1976. Senator CHARLES H. PERCY, U.& senate, Washington, D.C. DEAR SENATOR PERCY: I would like to thank you very much for the opportunity to testify in front of your committee on Thursday, April 1st. You had given a general assignment of .2 questions. The . first was a reasonable estimate of the population that would be helped by hearing aids. Unfortunately, I have been rather busy since I got back and have not been able to collect any hard data. However, I had the opportunity to speak to very senior audiologists. Much to my surprise and to my satisfaction, their answer was that almost -every person -with a hearing impairment can be helped by means of a hearing aid ~ndhabilita- tion. I want to look into this further as I feel this may be a lacuna . in our knowledge as to just whom we can help and how much we can help each person. I do suspect that there may not be much data. However, we have been looking at sone work from the Veteran's Administration which might prove useful. It * will take me several weeks to get back to you in more, detaiL The person who can help me the most is Dr. Laura Ann Wilber, head of our hearing & speech division, who'is away at the present time. When she returns, I will sit down with her and see what we can present to you and your office. The second matter was the type of training the hearing aid `dealer should have. In my own assessment of the delivery system, the disueneer of hearing aids should have special skills in electronics . and acoustics so that they may. service and repair the hearing aid. This would include acoustical measurements repair and proper fitting. They should also be able to make molds and tailor the molds. The best place for these individuals to work would be within the medical centers which do the'. diagnosis, audiological assessment and the actual hearing aid evaluation on the patients. I know that this may not be true for the country as a whole but it would b,e . a great step forward for large parts, of the population in urban and suburban areas. In less densely populated areas, the same type of work could probably be done in a certain number of private companies. I will be communicatingwith youfurther concerning the question of how many people can be helped. Again, it was a great pleasure and privilege to appear before your subcommit- tee. I do hope that our testimony was helpful. I came away feeling that our time had been well spent in helping to ensure the qualify of life of the hearing impaired citizen of the United .States. Respectfully yours, R. J. RUBEN, M.D., Professor `di": Chairman. Senator PERCY. We certainly will encourage the manufacturers to submit for: the record the training programs that they "offer through their own authorized dealers. Finally, a question for all three of you. Who should be responsible for recommending a type of hearing aid such as an all-in-the-ear, or a body -hearing aid? Who should be responsible for recommending the model and the brand? " - Dr. SIMMON. I think the responsibility for recommending the type hearing aid should rest with the otolaryngologist and the audiologist without question In some circumstances it would be the otolaiyngologist and in othe~rs it would be the audiologists. The brand recommendation, I think is really irrelevant at least at this stage, sincemost of the major manufacturers have aline of instru- *ments which will fit 98 percent of all `hearing losses and to ~o into the PAGENO="0101" 95 business of which brand is better than the other, I think is largely a local kind of problem. For instance, `I know who to stay away from in the Palo Alto area and in the Santa Clara area. I know who the good hearing aid dealers are and who the bad guys are. This is largely because of the brands, but not completely so, but is related to marketing policies of manufacturers. Dr. Rum~N. I would like to start the answer which is negative. It certainly should not be at that pOint the individual who would appear to profit from the sales. I think it is a little like a physician owning his own dispensary. That has been out for a long, long time. Secondly, I think the person should make the recommendation for the hearing aid, the one who knows most about what is going on with the patient. In our own instance, this most times is the audiologist. However, most times the otologist will have to supervise because of the rather physical mechanical problems such as a small canal, such as a.-liole in the eardrum, even the propensity of allergy. So I think it is betwixt the otolaryngologist and the otologist and it has to be a trade off between the two of them. They both'should concur. Dr. Gr~&sscocK. I basically subscribe to the other two. I won't take up your time. Senator PERCY. One other thought that occurs to me. Our educa- tional system is a part of the discovery `process to `determine the physi- cal and mental deficiencies in children. Do you feel, as professionals, that adequate attention is given to hearing difficulties in children and detected early enough in life? Dr. GLASSCOCK. I feel this is a particular interest of mine. I feel as a group, nobody has paid much attention to the hard-of-hearing indi- vidual and particularly the children. We now know that if the diag- nosis of a hearing loss is not made before the age of 2 and if he does not have amplification, that this individual will grow up without speech. There is a major effort, I think, amongst all of the `hearing professions now to make it known to the country and to everyone con- cerned that we must detect hearing loss in children very early and we must get amplification on them and they must have professional teaching. Senator PERCY. What do you think, about the public services offered by some telephone companies, which have a number th'it you c~n dial and they will play various tones, and if you can't hear all four of them, they say you' have a hearing difficulty and you had better see a doctor? Would yOu want to encourage something like that? Dr. RUBEN. I think I wouldn't disencourage it. But I would agree with Dr.' Glasscoëk. I think we have two sets of problems and even having some numbers for you here this time. Where I have medical responsibility is in the Borough of the Bronx. Some years ago, we did a survey as to when was their first encountered diagnosis made of a child with severe profound hearing loss. Much to my chagrin, the mean age was five point some odd years. There are many reasons for that; none of them very good. Second, we have another type of hearing loss which is `a mild to moderate loss. There is an overwhelming amount of evidence that PAGENO="0102" 96 shows that in children that we have these mild to moderate hearing losses during language-formative years, not all, but many of them will have severe impairments in language reading abilities, the abilities that most Americans need to function reasonably well. I just heard the other week within my city and within my borough, we have now cut out all hearing screening programs in the city of New York where they are being so horribly impaired that we just can't test the children and bring them in. So I would say this is again like Dr. Simmons and Dr. Glasscock said, this has been a problem which has been ignored for a multitude of reasons. It is a problem which is very substantive to the well-being of our citizenry, to the economics of this country. It is by and large a treatable, in the instances of the older children, and a very remedial problem in those who are born without hearing. Why should we not then help these people? Senator PERCY. If I were a language teacher, before I started out with my class of 40, I would want to know if they all hear reasonably well. A child with a hearing problem has tremendous difficulty with a foreign language. It just impairs their ability to understand pro- nunciation, and so forth. I think we can do a better job of intercepting. Dr. RUBEN. If I can interject one more thought into this, this prob- lem has bothered many of us. I have talked to people in teacher's col- leges or institutions where they train teachers. No where do you find them ever giving a course in how to detect a child with a moderate to mild hearing impairment, how to handle a child in the classroom with a hearing impairment. There are some courses in visual. I ivoiild think the program that would just give the teachers the information would make substantive changes in the lives of many of our children. Senator PERCY. 1 want to ask whether counsel has further questions? Mr. STATLER. Mr. Chairman, counsel received a series ~f questions submitteñ by the National Hearing Aid Society, pursuant to rule 13 of the subcommittee rules, to be asked of several of the witnesses we have here today and tomorrow. Some of the questions appear to have been asked already by the Chair. Certain others may not be directly germane. If it pleases the Chair, counsel for the majority and minority will go over the questions and without severely inconveniencing the wit- nesses, we will submit them in writing as appropriate. Senator P~1ROY. The Chair would very much appreciate that, if they are submitted, if you could contribute a little extra time to an- swering those for the record. The hearing record will be kept open for that purpose. Before closing the hearings, I want to tell you one of my favorite hearing aid stories. I said to a fellow colleague on the floor of the Senate who I knew had a hearing loss-he saw me with my hearing aid on and came up to me and said, "Does that hearing aid help you~?" I said, "It is wonderful. You get up in the morning, you put it on~ you can hear the birds chirping, practically hearing the grass grow." He said, "That is wonderful. What kind is it?" I said, "It is abou~ 2 o'clock." PAGENO="0103" 97 This has be.en one of the longest hearings I held, except years ago with the Committee on Nutrition. By the time we got around 2 o'clock, believe me, we were thinking about our own nutrition. In closing, I will ask you a question, but I won't permit you to an- swer. When I was with the President a couple of weeks ago in Spring- field, the last question he had from an audience was from a 10-year- old boy who stood up and said, "Mr. President, when you were 10 years old, did you think you were going to be President of the United States?" I will ask you, when you were in medical school, did you think you would ever appear before the Senate ofthe United States, appearing before what was in the fifties, the McCarthy committee? I won't ask for an answer at all. I do want you to imow how much this subcommittee appreciates your counsel, advice, and testimony, which I found extraordinarily helpful. The hearings are recessed until 10 a.m., tomorrow morning. [Whereupon, the subcommittee recessed, to reconvene at 10 a.m., on Friday, April 2, 1976.] [Members present at time of recess: Senator Percy.] PAGENO="0104" I PAGENO="0105" HEARING AID INDUSTRY FRIDAY, APRIL 2, 1976 U.S. SENATE, PERMANENT SuBC0MMIrPEE ON INVESTIGATIONS OF THE COMMITTEE ON GOVERNMENT OPERATIONS, Washington, D.C. The subcommittee met at 10 a.m., in room 3302, Dirksen Senate Of- fice Building, under authority of section 5, Senate Resolution 363, agreed to March 1, 1976, Hon. Charles H. Percy presiding. Members of the subcommittee present: Senator Charles H. Percy, Republican, Illinois. Members of the professional staff present: Howard J. Feldman, chief counsel; Stuart M. Statler, chief counsel to the minority; Jona- than Cottin, investigator to the minority; Howard Marks, investigator to the minority; and Ruth Y. Watt, chief clerk. Senator PERCY. The subcommittee will come to order. [Member of the subcommittee present at time of reconvening: Senator Percy.] [The letter of authority follows:] U.S. SENATE, Co~rMITTEE ON GOVERNMENT OPERATIONS, SENATE PERMANENT SUBCOMMITTEE ON INVESTIGATIONS, Washington, D.C. Pursuant to Rule 5 of the Rules of Procedure of the Senate Permanent Sub- committee on Investigations of the Committee on Government Operations, per- mission is hereby granted for the Chairman, or any member of the Subcommittee as designated by the Chairman, to conduct hearings in public session, without a quorum of two members for administration of oaths and taking of testimony in connection with the Hearing Aid Industry on Friday, April 2, 1976. SAM NUWN, Acting Chairman. CHARLES H. PERCY, Ranking Minority Mem7er. Senator PERCY. We welcome you again to the second day of the hearings on the hearing aid industry. I would like to announce that we will carry on for just as long as we can. Secretary Kissinger is testifying before the Foreign Relations Committee this morning on the Mideast. I will skip testimony, but I will have to go in for the 10-minute questioning period regarding urgent matters on the Middle East. So whenever I am called to go in, we will recess the hearings for a period of 15 minutes. We then. will carry on until we finish. The first witness we will call this morning is Ms. Carol Burke, former employee of a hearing aid dealer from Los Angeles, Calif. (99) PAGENO="0106" 100 Before you are seated, do you swear to tell the truth, the whole truth, and nothing but the truth, so help you God? Ms. BURXE. I do. TESTIMONY OF CAROL BURKE, FORMER EMPLOYEE OF HEARING AID DEALER, LOS ANGELES, CALIF. Senator PERcY. If you would proceed with your testimony, Ms. Burke. Ms. BURKE. Mr. Chairman, my name is Carol Burke and I live at 420 South Madison, Pasadena, Calif. In February 1974 I was hired by Sanford Gertz, the proprietor of four Los Angeles hearing aid sales offices, to be an office manager at a shop he had just purchased in the Crenshaw district of the city. During my first meeting with Gertz, I was struck by two things. First, he never expressed to me any personal concern about the plight and desperation that hearing-impaired people feel, which I had learned about during employment at another hearing aid dealership. Second, he continually stressed, throughout our first interview, that I could make a lot of money in my job as office manager. He told inc thathe had made a large amount of money in the business, and so had his salesmen. While I was concerned with helping people, I did not begrudge Gertz his desire for a fair profit to build his business, but I had a feel- ing that his only motivation was wealth, and I felt uneasy about this. Nevertheless, I accepted the job because. it appeared to offer me greater responsibility than I had previously experienced in my career. As lie explained my duties to me, I understood that I would process MediCal forms and coordinate the movement of paperwork and main- tain the files. Shortly after I began work, Mr. Gertz direc.ted me to learn office pro- cedure in his Huntington Park office, which was managed by Mrs. Edith Leonard. He told me that he wanted me to run the Crenshaw of- fice precisely the same way that Mrs. Leonard operated her office and that I was to take directions from Mrs. Leonard and use her methods when I returned to the Crenshaw office. During a week studying under Mrs. Leonard, I learned about the processing of all the forms necessary to bill MediCal for the purchase of hearing aide. Mrs. Leonard told me that most of the Gertz salesmen canvassed the Los Angeles area convalescent homes. They would test the hearing of the patients at these homes and turn over the results of the audiograins to her. She showe.d me how to transfer the audiograin readings taken by the salesmen on MediCal forms for submissions to the State of Cali- fornia Department of Health. As a general rule, the cards coming in from the salesmen were in- complete. The salesmen did not fill in information on discomfort thresholds, speech discrimination scores and other items which, it was my understanding, the State required before it would authorize payment for a hearing aid. When I asked Mrs. Leonard why these blanks were not filled in, she told me that t.lns was never done in the field. She told me that informa- tion on the forms submitted to the State were made up by the office. staff. PAGENO="0107" 101 She showed me how to fill out the official MediCal forms so that the results of the tests fell within the State guidelines that would authorize payment for a hearing aid. I was shown how to falsify information to show that MediCal bene- ficiaries needed a hearing aid. If the audiogram scores coming in from the field showed a patient to be too deaf to benefit from an a.id, I was directed to change the results so that it appeared as if the patient had enough hearing to benefit from an aid. If the test showed that a patient had normal hearing, I was told to change the results so that it appeared as if the patient had poor enough hearing to have need of an aid. Almost without exception, the blank forms on which I typed up this false information were signed by Dr. Emilio Marquez. Mrs. Leonard had a file full of blank forms signed by Dr. Marquez. There were two types of blank forms that she had on file that were signed by him. One had on it the spaces for the results of audiohogical testing. The other was a prescription form, in which the physician recommends the type of hearing aid t.hat is to be purchased for the patient by the Government. On each of these forms, prior to being sent to the State, we would affix a MediCal sticker provided the salesmen by the patient. These stickers are sent regularly to welfare beneficiaries to pay for their health needs. I knew that Mr. Gertz wanted me to follow the same procedure at the Crenshaw office. Before he sent me to Mrs. Leonard he told me that she was his most trusted employee and had been working for him for many years. Mr. C0TTIN. At this point in the record, Mr. Chairman~ I want to enter as exhibit 27 the testimony of Mrs. Edith Leonard before the Los Angeles County giand jury in which she confirms Ms. Burke's ac- count and, further, that she was given a grant of immunity by a dis- trict judge in Los Angeles County for her testimony before that grand jury. Senator PERcY. Without objection it is so ordered. [The document referred to was marked "Exhibit No. 27" for refer- ence and follows:] EXHIBIT No. 27 The Grand Jury of the County of Los Angeles, State of California (No. A-309,976) AUGUST 19, 1974 THE PEOPLE OF THE STATE OF CALIFORNIA, PLAINTIFF, V. EMILIO H. MARQUEZ, M.D., SANFORD DUFFIELD GERTZ, ERNEST HAMILTON PENNY, GLENTIS ARDELL TUENER, RICARDO JESUS GUTIERREZ, LYDIA MAclAs, JuLIE SELEDON, DEFENDANTS (Reporter's transcript of grand jury proceedings: Wednesday, August 7, 1974; Thursday, August 8, 1974; and Friday, August 9, 1974.) APPEARANCES Barry Sax, and Joseph Slier, Deputy District Attorneys of the County of Los Angeles, representing the Office of the District Attorney. Fernando B. Whorton, duly appointed and sworn as the official shorthand reporter of the Grand Jury. PAGENO="0108" 102 Edith May Leonard, called as a witness before the Grand Jury, was duly sworn as follows: The SERGEANT AT ARMS. Would you face the Foreman and raise your right hand, please. The FOREMAN. You do solemnly swear that the evidence you shall give in this matter iiow pending before the Grand Jury of the County of Los Angeles shall be the truth, the whole truth, and nothing but the truth, so help you God? The WITNESS. I do. The FOREMAN. Would you repeat your name and Spell it for the reporter. And you may be seated. The WITNESS. Edith May Leonard, E-d-i-t-h, M-a-y, L-e-o-n-a-r-d. The FOREMAN. You may be seated. Mr. SAX. Mr. Foreman, at this time I would like marked for identification as exhibit number 94 three documents paper-clipped together. The first one is a petition and request or order. requiring witness to answer questions and produce evidence, under Section 1324 of the Penal Code. I have signed that. The second document is a waiver of issuance of order to show cause on hear- ing, under Penal Code Section 1324. That's been signed by Edith Leonard today. Is that correct, Mrs~ Leonard? The WITNESS. Right. Mr. SAX. The third document is an order requiring witnesses to answer ques- tions under Section 1234 of the Penal Code. That has been signed today by Judge Raymond Choate, Judge of the Superior Court, County of Los Angeles, and `bears the Court Seal. This is, in essence, an immunity order, directing this witness to testify before the Grand Jury, and declaring that she has been given and granted immunity from prosecution for any matters arising out of her testimony. I would like to file a copy with the clerk and include it as exhabit 94 on the exhibit list. The FOREMAN. It may be so marked and accepted into the `record. Mr. SAX. Thank you, sir. EXAMINATION By Mr. SAX: Q. Mrs. Leonard, do you understand what this order is? A. Yes, I do. Q. And now that you have been granted immunity, are you willing to testify? A. Yes. Q. Mrs. Leonard, I want to go briefly into your background and ask you, first of all, when you first began working for Mr. Gertz. A. In 19ii6. Q. in what capacity? A. Well, it was more or less a clerk then, in the office. Q. And did you later rise in the office? A. After that, he made me office manager. It was a one-girl office. Q. When was that? A. It was in either the latter part of 1966, or the first part of 1967. Q. What location? A. In Huntington Park. Q. Is that on Pacific Avenue? A. Yes. Q. What were you doing there? A. At that time? Q. Yes, ma'am. A. Well, I was doing general office work and selling hearings aids. I was just learning to sell hearing aids then'. Q. At some point, did you become a supervisor of other employees? A. Mm. Q. Or a teacher of other employees? A. Just one time. I showed one girl a few things in the office. She was there for one week and-really, only three days because she missed two days. Q. Who was that? A. Carol Burke. Q. When was that? A. It was about-I don't know-two or three months ago, I guess. It hasn't been too long ago. I don't know exactly. PAGENO="0109" 103 Q. Do you know what an audiogram report is? A. Yes, I do. Q. Did you ever get any instructions from anybody on how to handle the audiogram reports? A. Yes. Q. What instructions did you receive, and who did you get them from? A. From Mr. Gertz. Q. What did Mr. Gertz tell you about the audiogram reports? A. In what-I don't know what you mean. Q. What did you do with the audiogram reports? A. We sent them to the Medical Review Board. Q. Did they come to you completely filled out? A. Not always, no. Q. Did you do anything to the ones that were not filled out? A. Yes. Q. What did you do? A. We would-I would fill them in. Q. By filling them in, what do you mean you would add? A. I would-decibels if it needed to be, if it needed to be. Q. Now, if it needed to be what? A. To be built up. Say, for instance, it was 35 DB, I'd build it up to more. Q. To what, for instance? A. Well, maybe I'd add a five, ten more DB's. Q. What was your purpose in doing that? A. To send it to the Medical Review Board to get a hearing aid for the person. Q. Were you familiar with the scores that were necessary to justify a hearing aid being granted under Medi-Cal? A. Not for a long time, I wasn't. Q. How did you know to build the scores up this way or to add the scores? A. I was told. Q. By whôm? A. Mr. Gertz. Q. What exactly did he tell you, if you recall? A. Over the period of time, he would tell me if I took five DB's or ten DB's or fifteen DB's-to add it on to what was on the originaL Q. So gradually you became aware of what was necessary? A. It took a lông time. Q. How long a period of time? A. Well, just-I went to seminars and all and learned it over a period of time, what was correct and what wasn't correct. Q. Do you know what a hearing aid req~iisition and authorization form is? A. Yes, I do. Q. Did you ever see any of those in the Huntington Park office? A. Yes~ Q. Any other office? A. In the Los Angeles office. Q. At811 South Hill? A. Yes. Q. At either of those locations, did you see any of these forms that were signed in blank? Do you know what I mean by that? A. Well, which one did you ask me about? Q. First of all, the hearing aid requisition and authorization form. A. That, I sent in from our office. Q. Where did you get them from? A. From the CBS, California Blue Shield. That is the 161 form. Q. Do you know Dr. Marquez? A. I knowof him. I have never seen him. Q. Have you ever seen his signature? A. Yes. :~Q; Where do you most often see his signature on? A. O~ blank papers, on blank forms. ~. Theseforms I was just referring to? A.No., Q. Which forms? A. The physician's report and prescription. PAGENO="0110" 104 Q. And the prescriptions? A. Yes. Q. Do you know where the blank physician's reports and the blank prescrip- tions came from? A. Usually the consultants picked them up at his office. Q. I didn't mean who picked them up. I meant where did you get them from. A. From the consultants. Q. You got blank forms from the consultants? A. As I understand, yes. Q. Let me back up a little bit. By "consultant," are you referring to the. Medi-Cal consultant? A. Yeah-well, no. The consultant that worked for the hearing aid office. Q. All right. A. Salesman. Q. I got confused by your terms. Who was the consultant who worked for the hearing aid office? A. Usually Mr. Gutierrez would bring them. Q. Would bring them to you? A. Yes. Q. With Dr. Marquez' signature on them? A. Yes. Q. What would you do with them? A. That's when I would fill them out and send them to the Medical Review Board. Q. How about the prescriptions? Who brought those to you? A. They were brought along with the others. Q. By whom? The FOREMAN. You have to get a little closer. The WITNESS. By the consultant. Q. (By Mr. SAX.) Please use the name. A. Mr. Gutierrez. And I think Miss Hurtado brought some ~tt one time. Q. Laura Hurtado? A. Yes. Q. Did those prescriptions have any signatures on them when they came to you? A. Yes. Q. Whose signature? A. Dr. Marquez. Q. Were they brought to you in blank? A. Yes, they were blank, yes. Q. How often did this happen? A. Well, all the time. Q. Did you ever instruct anybody in filing out of the prescriptions? A. I think I did at one time, during the week that Carol Burke was in the office. Q. What do you mean by-what did you do to fill out the prescription? A. We had samples there that we went by. Q. Where did you get the samples from? A. (No audible response.) Q. Who prepared the samples, in other words? A. Well, I did at the last. At the beginning, I. didn't. Q. And do you know who you instructed? Can you give us some names of people that you instructed on the use of these samples, to fill, out the pre- scriptions? A. You mean to type them? Q. Yes, ma'am. A. Well, the typist. I would give them to her, and she would type them out. Q. What did you tell these clerks to do with these diagnoses? A. I would tell them to type them out and return them to me. Q. Did you know whether or not the patients whose nam~s were on the prescriptions had been examined by Dr. Marquez? A. Well, yes, they were examined. They always have to go to the doctor. Q. How do you know what the diagnosis was? A. I wouldn't know. Q. Did Dr. Marquez ever tell you? : PAGENO="0111" 105 A. No. Q. Did Mr. Marquez ever send you a filled in prescription? A. No. Q. That is, with a patient's name, a diagnosis, and his signature? A. No. Q. At any time? A. No, he didn't. Q. What period of time are we talking about, when you first became aware of Dr. Marquez? A. When I first beeame aware of Dr. Marquez was-I think it was in the latter part of 1968. Q. When did be first begin working with Mr. Gertz? A. I think it was around that time. I'm not sure. I couldn't say. Because I'm not sure about that. Q. Do you have any idea approximately how many times you filled out the blank prescriptions? A. (No audible response.) Q. Are we talking in the order of tens, hundreds, thousands, or what? A. You mean over that period of time? Q. Yes, ma'am, from the beginning until the present time. A. I have no idea. It would be in the hundreds. Q. Just in the hundreds? A. Well, when you say "hundreds" that would go up to thousand. Q. Into thousands? A. I don't know. I don't know. Q. How often did you do it? A. Every time someone was sent to the doctor or taken to the doctor or went on their own and he-to the Medical Review Board. Q. Did all the claims that went through Huntington Park go through your hands? A. Yes. Q. Were you aware of how many were Medi-Cal patients and how many were private patients? A. I would say about 60 percent. Q. Sixty percent were Medi-Cal? A. I would say that. I'm guessing. I don't know. Q. Of the Medi-Cal patients, are you aware of how many claims were sub- initted with valid prescriptions; that is, prescriptions that had been filled out after the doctor's eXamination by the doctor? A. That was filled out by the doctor? Q. Yes, ma'am. A. No. Q. I think you have indicated you never got any prescriptions that were already filled out. A. Not from Dr. Marquez, no. Q. Never? A. That I remember, I don't. I can't remember. Mr. SAX. May I approach the witness, Mr. Robinson? The FOREMAN. You may approach the witness. Q. (By Mr. SAX) Mrs. Leonard, I want to show you exhibit 68, which is four pieces of paper clipped together. Are these the diagnoses you were talking about? A. Yes. Q. Are these the actual pieces of paper that you were referring to? A. That the girls typed from? Q. Yes, ma'am. A. Yes, uk-huh. Mr. SAX. Mr. Foreman, these were obtained from the office pursuant to the search warrant. Q. Mrs. Leonard, I'm showing you exhibit number 72, Weekly Time Manager Reports for the period April of 1973, to July of 1973, which is a three-month period. Do you recognize these documents? A. These are from the phone girl when she called. She would make appoint- ments. Q. Do these documents contain appointments that were made by a phone girl working out of your Huntington Park office? PAGENO="0112" 106 A. Not necessarily. The salesman or the consultant would go out. Q. But all of these-all the convalescent homes on this report that indicate dates are- A. For the consultant to go-~-- Q. -are convalescent hospitals which accepted-let me finish my question- are convalescent hospitals which accepted your company's offer to have their people examined; is that correct? A. Right, uh-huh. Mr. SAX. Mr. Foreman, for the record, I would like to state that I made a sum- mary of all the convalescent hospitals listed on these documents. In a three-month period, there were 48 convalescent hospitals which had com- pleted appointments. The FOREMAN. The record will so reflect. Mr. SAX. And I have attached the summary to the documents themselves. Q. Mrs. Leonard, exhibit 69 is a whole pack of documents. Can you tell us what these are, please? A. These are telephone census reports that the telephone girl would make. Q. Are you familiar with the procedures that the telephone girls used for call- ing up individuals and calling up convalescent hospitals? A. She would call and find out if there was anyone hard of hearing at the flumber that she had called. Q. How were the girls to know who to call? A. They would get it from a-you know, one of those- Q. Cross-index directories? A. Yes. Yes. Q. How about the convalescent hospitals? I-low did the girls know which con- ~-alescent hospitals to call? A. They would look in the Yellow Pages. Q. Mrs. Leonard, I'm showing you some hearing aid requisitions and authoriza- ~ions. Have you ever seen these documents before? A. Yes, I have. Q. Where have you seen these before or this kind of document? A. I have seen them in my office. Q. They were obtained from Dr. Marquez' office pursuant to the search war- rant. This is exhibit 75. They are blank, but bear Dr. Marquez' signature on the bottom. A. Uh-huh. Q. The ones you saw in your office, were they blank? A. They were blank like this. Q. They were blank with Dr. Marquez' signature? A. Yes. Q. Were there any in your office at the time the search warrant was executed? A. I believe there was. I don't know. Q. Do you know where they were kept? A. In the desk drawer. Q. Mrs. Leonard, in your entire time at the Huntington Park office, was there ever a time that you became aware of when a convalescent hospital called your office instead of the other way around? A. There were several instances where they called us. Q. Where they called for the first time or called after your people had been there? A. After our people had called them. Q. To ask more precisely, was there ever a time, say, since 1968, when a con- valescent hospital initiated any examinations? A. Not to my knowledge. Q. Mrs. Leonard, the documents that I just showed you, the Week Time Man- ager Reports for the three-month period, 1973, indicate a total of 48 completed or accepted appointments. Q. Do you know whether or not this three-month period is typical or non- typical of other periods? A. No, I don't. Q. Was the procedure of calling convalescent hospitals a continuous one? A. (No audible response.) Q. By that, I mean, did they do it all the time, or did they only do it occasionally? A. Occasionally. PAGENO="0113" 107 Q. Was there any ordinary periods as to when it was done, any set time? A. No. Q. Who determined when the calls were to be made? A. The telephone girl. Q. And I also have from your office a box that is marked exhibit 78. A. Uh-huh. Q. Has on the outside "File Call Box." Do you recognize this box? A. I have seen it, but 1 don't really know what it is. The telephone girl keeps that for her own records. Q. That's the telephone girl's box? A. Yes. And she would call back, I suppose, at different intervals when they told her to. Mr. SAX. Mr. Foreman, for the record, I have summarized and copied down all the convalescent hospitals listed in this box as telephone leads, and I have come up with a total of 65. The FOREMAN. The record may so reflect. Mr. SAX. May I put that summary in the back of the box with the exhibits. Q. Let me make a point clear as to bow you came to use the sample diagnoses to put on the blank prescriptions. How did that originate? A. Well, I was told to do it. Q. Byw~iom? A. Mr. Gertz. Q. Did he give you any samples to begin with? A. They were in the office. Q. They were already there? A. Well, be must-I don't know who had them there. Q. I didn't mean if he made them. But they were in the office; they were in existence when you began working for Mr. Gertz? A. No. Sees I worked-I started to work for him-I worked in the office before he bought the office. Q. What did Mr. Gertz tell you about the sample diagnoses? A. Just to type them and send them to the Medical Review Board. Q. Did you raise the point that-had these people actually been examined by the doctor or whether the diagnoses were proper? A. I assumed they had been sent by the doctor. Q. How did you determine which sample diagnosis to use? A. At the last, when I got to know what an audiogram really was and all, then I'd look at the audiogram, and I could sort of tell by them what type of loss they might have. I'm not a doctor; so I really couldn't say. Q. You couldn't really say? A. Not really. I would have to go by the samples. Q. How about the hearing aid requisitions and authorizations? Did you ever fill any of them out? A. I had to fill those out all the time. Q. How did you know to do that? A. Well, you have to do that to get an authorization. You have to fill them out. Q. Did someone tell you what to do in the beginning? A. Well, it was-you know how to do that. You request a hearing aid. Because you have the other papers there to show they need one. Q. Mrs. Leonard, the test boxes on the hearing aid authorization forms- there are quite a few of them; is that correct? A. The what? the text boxes? See, I'm confused; because the authorization isn't that. Q. Thisdocument, did you ever fill this document out? A. Yes. But that's the audiometric report. That's not the authorization. Q. You're talking about the treatment authorization request? A. Yes. Q. The TAR? A. Yes. Q. This is a hearing- A. Oh. This is what you're speaking of. Yes, un-huh. Q. A hearing aid requisition and authorization? A. Yes. I have filled those out. 79-954-76-8 PAGENO="0114" 108 Q. Now, in the middle of the page, it says audiogram, and it has several boxes, the right ear, and left ear, and below that it says SRT, SDS, and free field discrimination test. Did you ever fill in any of these test boxes or these lines out? A. Yes. Q. Where did you get the information to put on the-in these boxes on these lines? A. I would have copies there in the office. Q. Copies of what? A. Of ones that had been filled out. And then if I could go by the audiogram- I could go by the audiogram in filling it out. Q. Mrs. Leonard, the audiogram cards we've gotten from the office pertaining to the patients have just the one test score, which fills up these boxes? A. TJh-huh. Q. How did you know whether to fill in the lines for the other tests or what to put in? A. I would have to go by the samples that were in the office. Q. In other words, you were not basing the scores on anything the hearing aid dispensers had obtained in the field; is that correct? A. That's right. Q. Did you ever ask Mr. Gertz about that? A. No. He had told me to do it, and I assumed it was my job. I did it. Q. He told you to do it? A. Yes. Q. `When did he tell you for the first time, or when did he tell you? A. When I first started doing them in `68 or `67, whatever year it was. Q. Did you ever question him about it after 1968? A. No. Because he sold the office in `68, and I started to work for Mr. Seymour. I worked for Mr. Seymour for two years. Q. And then what? A. Then I went back to work for Mr. Gertz; because he bought the office back. Q. Do you know Hamilton Penny? A. Yes. Q. What was his position with Mr. Gertz' firm? A. I really don't know. I know he worked in the East Los Angeles office. And I don't know too much about it. Q. Do you know Glen Turner? A. Yes.. Q. In what connection? A. He was a consultant, I think, in all three offices. Q. When you say "a consultant," do you mean a dispenser who goes out and tests people? A. Yes, uh-huh. Q. Did you ever handle any of his claims? A. Yes. Q. And what did you do? A. When I got one of his audiogram cards, the same thing I do with the others. Q. Were his cards complete before you got them, in that they had all the scores indicated? A. No. Q. Did you ever question him about that? . . . . A. No, not really. Q. How about Ricardo Gutierrez? Do you know him? A. I know him. Q. In what connection? A. Just as I worked with him for a while. He was an outside consultant. Q. Did you ever get any of his audiogram cards? A. I don't know. I really don't know whether I did or not. Q. Did you ever work with him as an outside consultant? A. You mean go out with him? Q. Yes, ma'am. A. Oh, I didn't go out, no. . Q. But you knew that he was doing it? A. Yes. Q. Do you know Lydia Maclas? A. Yes. PAGENO="0115" 109 Q. In what connection do you know her? A. I know that she was the office manager in East Los Angeles. Q. Did you ever get any of her claims, any of her audiogram cards? A. No, not to my knowledge. Q. How obout Julie Seledon? A. Just for one month. In the month of April. Q. And were her audiogram cards complete? A. No. Q. What did you do with the cards that she gave you? A. Same thing that I did with the others. Q. What kind of compensation did you get from Mr. Gertz or from Maico? A. My salary, plus what I sold in the office. I got ten percent commission. Q. You didn't get a commission for hearing aids sold in the field? A. No. no. Q. You indicated at one time you trained a girl named Carol Burke? A. For three days. Q. What did you teach her to do? A. The general office procedure, and possibly one of these. I don't know. I did one of these, yes. Q. When you say "possibly one of these," what are you talking about? A. The hearing aid requisition authorization, plus the prescription. Q. Plus the- A. Prescription. Q. What did you teach her to do? A. To change the audio metric report on here. I didn't really teach her. I think I showed her one time. She bad been in the hearing aid business before. Q. And to add the sample prescription? A. I showed her-showed it to her, yes. Q. Mrs. Leonard, I'd like you to look at the photographs up on the board here, and I'm going to point out the individuals and ask you if you can identify any of them for us. No. 1, do you know who this person is? A. (No audible response.) Q. Can you see the pictures OK? A. Yeah, I see it real good. But I can't recognize him. Q. That is Dr. Marquez. A. I don't know him. Q. No. 2? A. That is Mr. Gertz. Q. No. 3? A. Looks like Hamilton Penny. Q.No.4? A. Glen Turner. Q. No, 5? A. Ricardo Gutierrez. Q. No. 6? A. Maria Maclas. Q. Maria? A. Well, Lydia. I don't know why I said Maria. Lydia. Q. No.7? A. Looks like Julie Seledon. Mr. SAX. May the record reflect the witness has completely identified all the individuals except Dr. MarqueE. The FOREMAN. The record will so reflect. Q. (By Mr. SAX). Those four sample prescriptions that I just showed to you, are those prescriptions-Or diagnosis, rather, that were given to you, or did you make them up? A. I would copy them from others. That is my handwriting. Q. They originated from you or from someone else? A. I bad several good, you know, ones that was typed out and all, and if I couldn't find them, I'd write them up. I could remember them, I had written so many of them. Q. Mrs. Leonard, a handwriting expert has testified that many of the docu- ments submitted by the Maico offices with the name Sanford Gertz were not, in fact, signed by Mr. Gertz. Do you know how that came to be? A. What documents were they? PAGENO="0116" 110 Q. The Medi-Cal or Blue Shield service reports, the claims that are submitted. A. You mean the 161 form? Q. The 163 forms. A. The 163? No. He never did sign those. Q. Who signed them? A. Anyone in the office. Me or whoever was in the office, plus others. 1 mean, everybody signed them. You're talking about 163? Q. Yes, ina'am. A. Yes. The ones for the billing, yes. Q. That's the Blue Shield service report? A. Yes,iih-huh. Q. Mi of them have the name Sanford `Gertz on them. Are you saying that other people other than Mr. Gertz signed his name? A. Well, I signed it. Anyone that sent in a billing signed it-would sign his name. Q. I-low was that authorized? Who said you could do that? A. He did. Q. When did lie first say you could do that? A. As far back as I can remember. Q. How many times would you say you signed his name? A. Every time one was sent in that I sent it that was typed. There's been oc- casions that other people-I mean, from my office- Q. Mrs. Leonard, what kind of control did Mr. Gertz exercise over his various offices? By that, I mean, how much was he there? A. I cafl't speak for the other offices. He came in my office once or twice a week. Q. Did he appear to know what was going on in the office? A. Oh, yes. Q. Couldyou amplify on the "oh, yes"? A. Yes. Q. By that, I mean, what did he do to maintain his control? A. Oh. I see what you mean. Well, he would come in and ask, you know, what had been going on, what had happened, how many sales we made, how much money had come in from CBS that we had billed. Q. What did he do with hearing aids that you had in your storO, hearing aids that had been returned? A. What did he do with them? Q. Yes, ma'am. A. I don't know. I didn't have that many returned in my office. Q. How often would you say that Mr. Gertz got around to each of his offices? Or do you know only about your office? A. I really don't know about the other offices. I know how much he came in to my office, but I don't know how often he went into the other offices. Q. Was there an individual bookkeeper at each office? A. No. We have an accountant that takes care of all the offices. Mr. SAX. Thank you, Mrs. Leonard. I have no further questions at this time. Mr. Foreman. Mr. FOREMAN. Mrs. Leonard, I would like to caution you not to discuss or mi- part at any time outside of this hearing room the questions that have been asked of you in regard to this matter or the answers, until authorized by this Grand Jury or the Court to discuss or impart such matters. You will understand that a violation of these instructions on your pert may be the ba~is'for a charge against you of contempt of court. This admonition, of course, does not preclude you from discussing your legal rights with any legally employeed attorney, should you feel that your own per- sonal rights are in any way in jeonardy. Thank you. And you are excused. (Whereupon the witness, Edith May Leonard, was escorted from the Grand Jury Hearing Room b~ the Sergeant at Arms.) Ms. Bu~~*. After my. 1-week training program with Mrs. Leonard, I returned to the Crenshaw office to assume my new job. For about a month after that, I processed the signed audiological and prescrip- tion forms. PAGENO="0117" 111 During this period, I was becoming extremely concerned about this method of doing business. I felt it was possibly illegal, and certainly immoral. Most of the people in the Crenshaw area were poor and almost all the persons visited by our salesmen were on welfare, mean- ing that the State and Federal governments were jointly paying for these hearing aids and basing the judgment on whether to buy them on fabricated data. I felt that I was participating in a deliberate rip-off of tl~e govern- inents of California and the United States, as well as the many unfortunate poor people in the convalescent homes who had ab- solutely no use for the aids that were provided. I was also troubled by other business practices of my employer. He directed me to bill MediCal for hearing aid batteries that were to be dispensed regularly to all MediCal recipients to whom aids had been sold. Every month, we would send letters to all persons on our mailing list, asking them to send a MediCal sticker to us in an enclosed, stamped, and addressed envelope. Without fail, most. people would send back the sticker and Gertz would use it as the basis for making claims to MediCal for batteries, repairs, and tube changes. In the case of battery billing, we charged MediCal for 36 batteries per month for each hearing aid user. There were 12 batteries in each package. But Gertz instructed me only to send one set of batteries a month to these welfare recipients, which meant that MediCal was paying him for materials that he never dispensed. We were instructed to review the file cards on each person with a Gertz hearing aid every month. For every person whose aid had gone unrepaired for more than 6 months, we used their MediCal sticker to bill the State for repairs, or reconditioning, which would cost about $50. The repairs were never done, unless the recipient actually showed up in the office to demand it. But most of the people with aids from Gertz were elderly and infirm. They didn't get around much. They were good about sending in their stickers, but few actually got all the services for their aids for which the government was paying. By the late spring, I realized that I could not work much longer for Gertz. At about the same time, I saw a television news broadcast in which it was reported that a woman had been sold an aid after Dr. Marquez had signed a medical prescription for her. The woman said that she had never seen Dr. Marquez. At that point, I realized that I had to expose, the problem at the Gertz offices and telephoned the television newsman who had broad- cast the story. He referred me to the Los Angeles prosecutor's office who, in turn, sent me to the California Health Department's Inves- tigation Division. I turned over a number of documents to a State investigator and search warrants were subsequently served on all' four of the Gertz hearing aid sales offices. I left Gertz' employment in June 19~T4. I have since testified before ,the Los Angeles County `grand jury concerning my experiences working for Gertz and have cooperated frilly with authorities. PAGENO="0118" 112 Before and after my experience with Gertz, I worked in three other hearing aid sales offices for various employers. While none of them engaged in the kinds of questionable activities that Gertz ~did, none seemed sincerely interested in the welfare of the hearing im- paired. Their only commitment seemed to be to make a sale. I also do not believe the dealers I have worked for have sufficient training to detect medical problems tha.t could be helped by surgery. Most of the people who need hearing health care are elderly. Some are in poor health and lonely. They greatly value communication, since to many it is one of the few pleasures remaining to them. To treat them properly, you must be patient and compassionate. More importantly, you must know what you are doing. My expe- rience suggests that at least some dealers lack the training and business ethics necessary to deliver professional hearing health care. Mr. C~rrIN. Mr. Chairman, we have a number of exhibits with re- gard to the testimony of this witness. First, telegrams were sent to Dr. Marquez and Mr. Gertz, notifying them that this information was going to be testified to and inviting them, if they wished, to either testify or submit a statement for the record. We have received no statements and neither of them are here to testify. Second, I will now enter in the record a series of exhibits, including copies of the indictments of Mr. Gertz and Dr. Marquez as well as disposition of the Marquez and Gertz cases. In both cases they were convicted of various counts of fraud. The amount of the money that these gentlemen will be assessed is still being audited by the California State Health Department. Also being entered are copies of charges brought by the State health depart- ment to delicense Dr. Marquez and Mr. Gertz; as well as a letter from the U.S. attorney in California, declining criminal prosecution of Dr. Marquez in view of the fact that the State of California had already obtained a conviction against him. Senator PERCY. Without objection, those records will be inserted in the record. [The documents referred to were marked "exhibit Nos. 28 through 36" for reference. Exhibits 29 through 36 may be found in the files of the subcommittee; exhibit 28 follows:] EXHIBIT No. 25 [Maligram] WASHINGTON, D.C., March 30, 1976. .T. COTTIN, f~enate Permant &~bcornrnittee on Investigations, Russell Office Building, Washington, D.C. This Mailgram is a confirmation copy of the following message: Washington, D.C., March 30, 1976. SANFORD P. GEI~TZ, Dir., Laurel Grove Avenue, $tudio City, Calif. This is to advise you that testimony will be heard regarding your activites as proprietor of a hearing aid business in Los Angeles during 1974 at a public hear- ing April 2, before the U.S. Senate Permanent Subcommittee on Investigations in Room 3302, Dirksen Building, Washington, D.C. If you wish to appear at this PAGENO="0119" 113 hearing to make a statement regarding this matter, notify me by calling (202) 224-9157. You may instead submit a written statement to the subcommittee on or before May 2, 1976, that will be included in the hearing record. Should you choose neither course of action, this will notify you that the record of your in- dictment and conviction in connection with this matter will be placed in the hear- ing transcript during the hearing. STUART M. STATLER, Chief Counsel to Minority. [Maligram] WASHINGTON, D.C., March 30, 1976. J. COTTIN, Senate Permanent Subcommittee on Investigations, Russell Office Building, Washington, D.C. This maligram is a confirmation copy of the following message: EMILT0 H. MARQUEZ, M.D., Dir., Los Angeles, Calif.: This is to advise you that testimony will be heard regarding your activities prescribing hearing aids for clients of Sanford D. Gertz during 1974 at a public hearing April 2 before the 11.5. Senate Permanent Subcommittee on Investigations in Room 3302 Dirksen Building, Washington, D.C. If you wish to appear at this hearing to make a statement regarding this matter, notify me by calling 202-224- 9157. You may instead submit a written statement to the subcommittee on or before May 2, 1976 that will be included in the hearing record. Should you choose neither course of action, this will notify you that the record of your indictment and conviction in connection with this matter will be placed in the hearing transcript during the hearing. STUART M. STATLER, Chief Connsei to Minority. U.S. DEPARTMENT OF JUSTICE, U. S. ATTORNEY, CENTRAL DISTRICT OF CALIFORNIA, Los Angeles, Calif., February 17, 1976. Re: Proposed Prosecution of Emilio H. Marquez, M.D., Sanford Duffield Gertz, Ernest Hamilton Penny, Glentis Ardell Turner, Richardo Jesus Gutierrez, Linda Maclas and Julie Seledon-Violations re: Social Security Act. Mr. Roy F. NILSSON, Program Officer, Program Evaluation Branch, Department of Health, Education, and Welfare, Social Security Administration, San Francisco, Calif. DEAR Mn. NILssoN: We have received your memorandum of January 29, 1976, recommending that the above-named individuals be prosecuted for various of- fenses under the Social Security Act and the federal criminal code. As you are no doubt aware, the same subjects were recently successfully prosecuted for parallel state offenses. While this is of course a significant matter, it has already been brought to the bar of justice in another forum. We do not have manpower for prosecuting the same individuals for similar offenses in the federal courts. Even if we could afford that luxury it would be non- productive since it has been our experience that any sentences imposed ft the federal courts would run concurrently with those imposed in the state courts. Further, it is the specific policy of the Department of Justice not to seek an in- dictment where the defendants are serving sentences imposed by a state court for an offense growing out of the same transaction which is the subject of the federal charge. For the views expressed above, we are returning your files for any administra- tive action you deem appropriate. Very truly yours, WILLIAM P. KELLER, U.S. Attorney. STEPHEN V. WILSON, Assistant U.S. Attorney, Chief, Fraud and Special Prosecutions. PAGENO="0120" 114 Senator PERCY. Ms. Burke, I want to express the appreciation of this subcommittee of the TJ.S. Senate for your exemplary attitude. The feelings you have expressed, the revulsion against what you saw repre- sent the same feelings that Senator Moss and I voiced last night when we appeared on network educational television to discuss theplight of the poor and the elderly poor and their exploitation. Were it not for your cooperation, and the work that you did as a citizen of California to bring this to the attention of the prosecutors in Los Angeles, they might never have imown of it. Our purpose is to try to determine whether this could be a pattern and what can be done about this problem. I would like to ask about Mr. Gertz being able to make a lot of money in this business. He offered you not the human satisfaction. He said that you could make a lot of money as an office manager. Did Mr. Gertz and his employees seem to live well? Did their life- style apear somewhat beyond what you might think would be possible from income derived in a normal retail service establishment? Ms. BURKE. Mr. Gertz, from all appearances, lived extremely well. He owned a boat that was docked in Marina Del Rey, and he, as well as all the employees that I encountered, seemed to carry a great deal of cash at all times. I know that many, two of the female employees that he had when- ever they felt that they wanted to buy a new dress, or they wanted something that perhaps was a little bit extra, they would say that they had to sell a couple of more hearing aids that day. Senator PERCY. How many employees did he have? Do you have any idea? Ms. BURKE. Yes; he had approximately 10. Senator PERCY. He just had one outlet? Ms. BTJRKE. He had four outlets. Senator PERCY. He owned four outlets? Ms. BURKE. Yes; he did. Senator PERCY. What kind of a person was he? Did you think he acted as if he was aware that he was breaking the law? Did he seem to act in any way guilty, or take great precaution to cover up his tracks? Or did he appear to believe that this was normal business practice; the Lockheed way of doing things, but on a smaller scale? Ms. BURKE. He generated tome the impression that he felt it was his right. Senator PERCY. His right? Ms. BURKE. His right. Senator PERCY. How did lie rationalize that? Ms. BURKE. He couldn't rationalize it to me, but he felt that, you know, it was there and as long as there was a means tO get it, why, he was going to take it. Senator PERCY. Do you happen to have any knowledge as to whether he adopted these practices by having observed them elsewhere or did lie invent the system? Some aircraft companies referred to the Lockheed thing as the Lock- heed system. They seemed to say they may have engaged in bribery of foreign governments, but they didn't invent it. They said they were just adopting what was already being done in order to survive. Did Gertz originate this procedure? PAGENO="0121" 115 Ms. BImKE. 1 would say that he perhaps took it along further and maybe perfected it a little bit better. But I would call it the Gertz principle. It was his way. In fact, I would say that in a sense he was leader because a lot of the other dealers were almost pleased. They would say, gee, he is really getting away with quite a bit and almost in a proud way that here was a contemporary and a fellow hearing aid dealer. They knew it was wrong. Senator PERCY. They knew about each other's practices? Ms. BURKE. They knew about each other's practices and they had no feeling at all that it was wrong. I am not saying that they all were participating, but they certainly didn't try to get him out of the business. Senator PERCY. We had hearings in December 1975 on West Coast Schools regarding practices that were obviously fraudulent. Somehow, there wasn't proper surveillance of these activities at the Department of HEW. You would think any relatively stupid employee, and there aren't supposed to be stupid employees around here, would catch this. You commented that Gertz regularly billed for 36 batteries a month. What is the normal period of time for a battery to be used in a hearing aid? Ms. BURKE. Those amounts of batteries should last, if they are fresh, about 3 months. Senator PERCY. I change mine very infrequently. I use my aid pretty steadily. But here they are providing 36. batteries a month. That is more than. one a day. Who should have caught something like that? Ms. Buui~. The Government; the people that are processing Medi- Cal. But you don't have to have really any kind of authorization for that type of procedure. If it is under w amount of dollars, I believe it is 50, you don't have to have prior authorization. You can just run these things through like a mill.. :~ Senator PERCY. I said last night on educational television that this Government is not ready to implement national health insurance. We don't know how to do it. It would be a monster. We can't even administer a simple little program like this. Wewould in Illinois that 35 to 36 percent of all the medical supplies were tranquilizers for nursing home patients in their seventies. Wouldn't .someone begin to wonder why you need all of those tran- quilizers, which are not curing people at all? No one ever asked the question. We didn't find out about it until we subpenaed the records. You would. have thought that some State or Federal agency would have caught.it. Criminals engage in this; the worst kind of criminals, stealing from their own Government, stealing from people, abusing programs thal are supposed to help people. Part of the responsibility belongs to an indifferent, stupid bureauc- racy that couldn't figure out that someone was openly defrauding the Government. Clearly they were not auditing properly. Would. you say, as an employee, there was just no oversight? You were dishing out, ladling out this money, and people were able to exploit it because there was no surveillance of what you were doing? PAGENO="0122" 116 I-low about the salesmen? Could you give us, the subcommittee, an observation as to what you felt the attitude of the sales people were? l)id they seem motivated by the end objective of their work? Were they concerned? Did they get a satisfaction each day out of having helped a certain number of people with their problems? What moti- vated them? Was it just money? Ms. BURKE. It was just money. They were just salesmen. They would do the same thing if they were selling automobiles, encyclopedias. Some of them didn't even know what different types of hearing aids were. They didn't even know how to give certain tests at all. They would just be sent out unsuspecting on the public and they knew that people, in convalescent homes are lonely, that in the ma- jority of the cases that their families have either abandoned them or they just don't have anymore family. They preyed on this because they knew that that person's contact would make. it very easy to obtain a sticker from them. Senator PERCY. In, your entire experience in the hearing aid busi- ness, did you see any balance in those factors, or was it just a place to make money; whether you sold used cars or hearing aids, the satis- faction of the work wasn't enough? Is that true or false? If you have exceptional cases where you found good people, I would like to hear about it. Ms. BURKE. Yes. I did find some good people who took the. time and who cared about them and elderly people can be nerve racking, especially if they have a hearing problem. They would, some of them, come into one place that I worked at and it was the highlight of their day. They would want you to test their batteries, but what they really wanted was somebody who would listen to them and pay attention to them and fuss over them. They would come in and you felt good when they left because they would just go back to some lonely little room in an old hotel in down- town Los Angeles. That is what made you feel good. or when someone came in who was really getting help from a hearing, aid; a child who had never heard from birth. I know in one instance we were referred, not when I worked at the Gertz office' but at one point a little~ 3-year-old girl and we were to give her a prescribed hearing aid. She came back a year later and she couldn't talk `when she first came. But she said momma as best she could to her mother. That is what I think is the most important thing to get out of it. Senator PERCY. What proportion of the employees that you worked with in the hearing aid business do you' feel were motivated essentially by money? What proportion were motivated, by essentially wanting to he in business where they could be of service to others? Ms. BuiricE. It is purely my own observation and my own opinion. But I would say only a small percentage of the people that I encoun- tered really cared and really took the time; also would even tell people that came in and were tested for a hearing aid, told them that perhaps it was borderline and you Imow, why don't you think it over, or have you been to a doctor or would go out of their way to be totally truthful with the person. PAGENO="0123" 117 Senator PERCY. But your experience was that, your personal experi- ence, was that it was deception? Ms. BURKE. Yes. They all had a quota to meet. Senator PERCY. ~1ake the most money. Ms. BURKE. They had a quota. If you put a salesman on commission only, naturally, that is going to be the way he is going to make a living. Senator PERCY. I feel it is important that we have your testimony. My own hearing aid dealer, I am happy to say, was well motivated, I think. He is hard of hearing himself. 1-le is really anxious to help me. He has been tremendously helpful to me. I don't need a hearing aid dealer to have me feel someone cares about nie. But I will tell you, when you are alone and you are old and you have got these problems, it is important to have a friend, someone who reaches out a helping hand and really makes you feel as though they want to help you with your problem. The rewards a human being can get in engaging in that kind of activity, the service that they can iencler, is a marvelous thing. Certainly the industry has a tremondous challenge now. Under present circumstances, unless the industry attitude changed, do you think you would ever go back in the hearing aid dealer business again? Ms. BURKE. No, I would not; not unless it was taken out of the hands of the salesmen aiid there was more or less a medical thing; in other words, they would come in with the prescribed hearing aid from a physician or audiologist where you were perhaps performing a serv- ice and you were providing them with a product that a doctor and a trained person said they would benefit from. Senator PERCY. Mr. Feldman? Mr. FELDMAN. I have no questions, Mr. Chairman. Senator PERCY. Mr. Statler? I want to thank you very much indeed. We very much appreciate your appearance here today. Have you ever testified before a Senate committee before? Ms. BURKE. No, I haven't. I am glad it was before a Republican, too. Senator PERCY. Thanks very kindly. The Chair will call a panel, Mr. Maurice Byriie~ former assistant attorney general, State of Kentucky, Louisville, Ky.; Mr. Joseph Hodges, staff counsel, Florida Department of Health and Rehabilita- tive Services, Jacksonville~ Fla. Gentlemen, if you would hold up your right hand. Do you solemly swear to tell the truth, the whole truth, and nothing but the truth, so help you God? Mr. BYRNE. I do. Mr. HoDGEs. I do. TESTIMONY OP MAURICE BYRNE, FORMER ASSISTANT ATTORNEY GENERAL, STATE OF KENTUCKY, LOUISVILLE, KY.; AND 3~OSEPH HODGES, STAFF COUNSEL, FLORIDA STATE DEPART- MENT OP HEALTH AND REHABILITATIVE SERVICES Senator PERCY. Mr. Byrne, if you would start out, please. PAGENO="0124" 118 Mr. BYRNE. First of all, I would like to thank the subcommittee for giving me the opportunity to' appear today. I am Maurice Byrne, assistant director of law and legal counsel for the Department of Consumer Affairs of the City of Louisville. I am a graduate of Catholic University of America Law School and, from mid-1974 until the. beginning of this year, I was assistant attorney general of the Commonwealth of Kentucky. As an assistant attorney general, I was responsible for taking legal action in the name of the attorney general to prevent some of the gross abuses in the sale of hearing aids in Kentucky and assisting in develop- ing legislation to provide certain basic minimum protections for our hard-of-hearing citizens of Kentucky. I have submitted a written statement, but at this time I would like to give a brief summary. I will go into as much detail as the subcom- mittee may desire. But instead of reading it verbatim, I would like to submit a general summary and be available for questions. Senator Pnimcy. The full statement will be included in the record. [The statement follows:] STATEMENT OF MAURICE A. BYRNE, JR. Mr. Chairman, my name is Maurice A. Byrne, Jr., Assistant Director of Law and Legal Counsel for the Department of Consumer Affairs of Harvey I Sloane, MD., Mayor of the City of Louisville, Kentucky. I am a graduate of the Catholic University of America, Columbia School of Law, and from mid-1974 to 1976, I served as an Assistant Attorney General of the COmmonwealth of Kentucky. As an Assistant Attorney General, I was responsible for taking legal action in the name of the Attorney General to prevent some of the gross abuses in the sale of hearing aids in Kentucky,. and assisting in developing legislation to pro- vide certain basic and minimum protections for our hard-of-hearing citizens in Kentucky. On October 21, 1975, your Subcommittee released a staff study which very accurately described and documented the "Kentucky Experience" concerning the manner in which the Kentucky Board for Licensing Hearing Aid Dealers has been manipulated by hearing aid dealers to protect their economic interests at the expense of our hard-of-hearing Kentucklans. With a majority of hearing aid dealers controlling its actions, the Board operated as if it was a private trade association cloaked with state powers, anti the Board gave a false sense of security to persons in need of professional health care who conferred unwar- ranted trust on salesmen licensed by the Board. The Kentucky dealer licensing law; passed in 1972, may be considered a very typical state law since it has allowed approximately 108 of some 185 licensed hearing aid dealers in Kentucky to obtain licenses under the "grandfather clause" without, any `examination to determine their ability to fit hearing aids. The few complaints which were allowed to reach the full, Board seem to have been han- dled informally or, in some cases, "lost." On April 2, 1975, I, in my capacity as Assistant Attorney General, filed a law suit to prevent the deceptive practices of .two members. of the Board in operating the National College of Otometry and conferring "Doctor of Otometry" degrees' (Ot.D) upon hearing aid dealers. As noted in the Report adopted by the Ken- tucky Consumers' Advisory Council on January 14, 1975, which I ask to be made a part of this record, the Chairman of the Hearing Aid Board and' another Board member were also listed as staff members of the school. The Attorney General sought a court injunction against the false, misleading and deceptive use of the term. "otometry," "college," "certified otometrist," and the degree of "Doctor of Otometry" in order to prevent serious and irreparable harm and damage to the hearing and psychological health of Kentucky citizens. The Attorney General's complaint and the exhibits. are contained on pages 34-43 of this Subcommittee's staff report. Exhibit C of the Report of the Ken- tucky Consumers' Advisory Council summarizes the legal action by the Attorney General. Attached to this statement as exhibits "1" to "12" are exhibits which PAGENO="0125" 119 were attached to exhibit C of the Council's Report. Exhibit "12" is a copy of the letter sent by the Chairman of the Kentucky Board to the National College of Otometry on Board stationery concerning his support for an involvement in the school. As noted in the Report, the answer of defendants acknowledge all the allega- tions of deception, and the defendants consented to a permanent injunction, against the deceptive practices, and agreed to notify all recipients of their degrees or certifications that they~ were worthless and deceptive. Upon the entry of the agreed order on May 23, 1975, the National College of Otometry ceased to exist. other problems with the Kentucky Board for Licensing Hearing Aid Dealers are documented by the affidavits of Dr. Lilialyce Akers, NormaJean Phillips, and William Green which are contained on pages 27-34 of this Subcommittees staff report. The written testimony of Franklin S. Yudkin which was submitted to the Kentucky Consumers' Advisory Council at the public hearing held Novem- ber 5, 1975, reveals another problem only recently corrected. (Exhibit 13). Mr. Yudkin, a non-dealer member of the Board, explains the battle with the dealer members of the Board to permit a state government address on the Board's sta- tiOnery instead' of the private business addresses of the dealers. The Commonwealth of Kentucky did not close its `eyes to the serious abuses in the sale ~of bearing aids. Attorney Generals Ed W. Hancock and Robert F. Stephens attacked the problem directly and Governor Julian M. Carroll proposed legislation to the Kentucky General Assembly' to protect our hard-of-hearing citizens. Mayor Harvey 1. Sloane of Louisville' endorsed a strong hearing aid bill and worked'hard for its passage. Governor Carroll was subjectedto extremely intense pressure from some hearing aid dealers which was comparable to the pressure tactics some `dealers exert on the hard-of-hearing. Time Hearing Aid Association of Kentucky, Inc. sent "scare letters" to its members (Exhibits 14 and 15) and several members of the trade association filed a law suit in federal court against myself and an Assistant Deputy, Attorney General to attempt to prevent us from enforcing the Kentucky Consumer Protection Act against deal- ers. Of course, the federal suit was dismissed. The Governor of Kentucky received the strong support of members of the hearing health profession and consumer representatives' in working with the 1970 General Assembly to pass House Bill 371 (`a copy of RB 371 and an outline are attached as Exhibits 16 and 17). As a first major step to protect Kentuckians with hearing problems, I `believe that Governor Carroll's legislation provides a basically solid framework to effect positive changes in the hearing aid delivery system in Kentucky. The "new Kentucky experience" demonstrates what can be done to provide certain basic protections for persons with hearing impair- ments. HE 371 is only an initial step since the measure is meaningless unless it is enforced. The opportunity is now there for the Attorney General, many reputable hearing aid dealers and bearing health professionals to insure that the hard of hearing in Kentucky receive protection and assistance. I thank this Subcommittee for the opportunity to testify and I welcome any questions that you may have. Mr. BYRNE. I would like to make four different observations. First of all, I would like to comment on Federal action concerning hearing aids, or if I may say, the Federal inaction. Second, I would like to comment on the Kentucky attorney general's action against the National College of Otornetry which was reported in this subcommittee's staff report released last October. Mr. COTFIN. Maybe at this point `we should enter that staff study, Mr. Chairman, as exhibit 37. Senator PERCY. `Without objection, it is so ordered. ~[The `document referred to was marked "Exhibit No. 37" for refer- ence and may be found in the files of the subcommittee.] Mr. BYRNE. I would like to make a few observations concerning the Kentucky Hearing Aid Dealer Licensing Board. Then finally, at the end of my observations, I would like to consider the new Kentucky experience. PAGENO="0126" 120 Senator Percy, your opening statement yesterday pretty well sum- marized the Federal action. As you mentioned, the Food and Drug Administration since September of 1974, has only been talking about reports concerning what can be done to help the hearing-impaired citizens of our country. The Federal Trade Commission back in June proposed a new trade regulation rule. They will be conducting hearings in the. very near future on that rule. The Senate Subcommittee on Consumer Interest of the Elderly back in 1973, conducted extensive hearings and printed extensive re- ports on problems with hearing aids. This subcommittee issued its staff study back in October. I believe the question is-Can the Federal Government hear the problems of consumers with hearing problems, with hearing difficul- ties? I think the evidence is before this subcommittee. It is before a lot of subcommittees or agencies. I think the problems have been docu- mented. Action needs to be taken. On October 21, this subcommittee's staff study mentioned the Ken- tucky Experience, and that report accurately described and docu- mented the various abuses with the Kentucky Board for Licensing Hearing Aid Dealers. With the majority of the hearing aid dealers controlling its action, the board operated as if it was a private tra.de association cloaked with State powers. The board gave a false sense of security to persons in need of professional health care who conferred unwarranted trust upon salesmen licensed by the board. The Kentucky licensing law, passed in 1972, may be considered a. very typical State law since it has allowed approximately 108 of the 185 licensed hearing aid dealers in Kentucky to obtain a license under the grandfather clause without any examination to determine their ability to fit hearing aids. The few complaints received by the board, as noted in the affidavits contained in this subcommittee report, were handled informally, or in some cases, they were lost. Concerning the National `College of Otometry, I believe this sub- committee's report gave a. good description. I have some additional remarks in my printed statement. I don't see any need to go into de- tails except to state that several dealers, including members of the State board, attempted to establish this college so that they could con- fer a doctor of otometry or Ot.D. degree. The attorney general, as soon as he heard about it, did take action and entered into an agreed order in May 1975 that in effect closed the school. That is not the only problem with the Kentucky Board. The affi- davits I mentioned before from Dr. Akers, Norma Jean Phillips, and William W. Green included in the report, also documented problems with the State board. A statement from Franklin S. Yudkin, a nondealer member of the present board, also notes that at his first meeting, they spent, I `believe, over an hour and four votes in order to have the address of the Corn- monwealth of Kentucky on the stationery of the board. . Of course, the board is an agency of the Commonwealth. But in the past, since the board was founded in or established in 1972, the only addresses on the PAGENO="0127" 121 stationery were the private business addresses of dealers that were on the board. Also, since that action, investigations revealing other abuses, and the issuing of the report by this subcommittee, the Commonwealth did not stand still, but took action. I think Ed W. Hancock, former attor- ney general and the present Attorney General, Robert F. Stephens deserve credit for working with the Kentucky Consumer Advisory Council in developing legislation to provide what I consider very basic protections for our citizens in Kentucky. I want to also give credit to our Governor, Julian M. Carroll, be- cause of his work. I can state that without his support, the new Ken- tucky law would have had no chance of passing our recent General Assembly. I will just mention briefly that on March 19, the House of the Gen- eral Assembly passed the Governor's hearing aid dealers bill and it was signed by the Governor 3 days ago and will be effective in June of this year. I will just run down the major points of it. It requires within 90 days prior to the sale of a hearing aid, medical approval by a physi- cian and a hearing aid evaluation and recommendation by a physician or an audiologist. There is a waiver provision for those over 18. As we know, if it is handled properly, it could provide basic protections, but I am afraid, like other provisions of the law, it could be very easily gotten around. I regret that the medical clearance is not mandatory, but the Ken- tucky law, which will be in effect in June, has a waiver provision for those over 18. Also, it provides a restriction on door-to-door sales, which states that a dealer must obtain prior approval, written approval, before going door-to-door attempting to sell hearing aid devices. There will be a 30-day right to cancel. It is similar to the FTC pro- posed rule, but then different at the same time. Another important aspect of the bill is that each contract for the sale of a hearing aid will state that any complaints should be sent to the Kentucky Board. I think I covered the major points in my testimony. I want to give the subcommittee an opportunity to continue with the hearings. I would be glad to answer any questions. I would like to, if it has not been submitted yet, have the advisory council's study and report intro- duced as an exhibit. Senator Pr~noy. Yes; without objection it will be introduced as a part of the record at this point. [The document referred to was marked "exhibit No. 38" for refer- ence and may be found in the files of the subcommittee.] Senator PERCY. Mr. Byrne, I certainly appreciate your being here very much. As you probably know, Louisville is the home of Mrs. Adlai Stevenson. I have been down there with the Stevensons for a minor horse race engagement and enjoyed visiting the area very much indeed. I would like to ask you first an extraneous question, but one that I can't resist asking because in this very room, we reported out over- whelmingly to the Senate and passed a consumer protection bill called PAGENO="0128" 122 the Creation of the Agency for Consumer Advocacy at the Federa.l level. It passed the Senate. It passed the House. Do you support the concept of creating in the Federal Government an agency for consumer protection with all the functions and duties that that agency should have? . S Mr. BYRNE. I strongly support the concept. I strongly. support the need for the a2ency. Our past experience with regulatory boards, ~ think, emphasizes the need for a consumer protection agency. If our Congress establishes the agency so that it' will be. an' active advocate in the name of the consumer, I think it will be terrific. If it becomes atypical bureaucracy, then it is a waste. of taxpayers' money. Senator, PERCY. It is our job to prevent it from being~ a typical bureaucracy. Mr. BYRNE. I' would just like to mention the Kentucky Consumer Protection Division. Through the work of the past attorneys general, I think it has become an advocate for the consumer in Kentucky. I think it is an example of how Government can represent the interests of consumers. . 5'' Senator PERCY. In our legislation, we made it clear it is not. a regu- latory agency. Its only function is that of an advocate for the con- sumer. It can be the spokesman, the ombudsman, and we have a self- destruct button in it. At the end of 3 years, the authority is subject to the review of the Comptroller General, who will make a' report to the Congress as to its cost effectiveness.. if we find it has not been cost effective, we will disband it.:I think, with that safety mechanism in it, it cannot be a, typical bureaucracy. it will go out of business if it can't justify itself. I would like to ask if you feel, having worked with the Consumer Affairs Department in Kentucky, that any responsible, good business- man who offers adequate service, at a fair and reasonable price, mak- ing a reasonable profit, has anything to fear from such an agency? Mr. BYRNE. I confirm what you said and the point that you were making, I see no problem. i see no problem with the Kentucky Con- sumer Act. ` S ` Senator PERCY. I-low long have you had it in effect? Mr. BYRNE. Since June 16,. 1972. We have had a very active con- sume.r protection division. The law forbids false, misleading and de- ceptive practices. So unless a. person is engaged in those soit of prac- tices, there is no problem; no court is going to enjoin a business from anything but deceptive practices. Senator PERCY. Have you ever, gone after a business because you thought it was making too much money? Did you try to get into that kind of activity at all? ` Mr. BYRNE. Not at all. `Senator `PERCY. You are strictly conflrnng yourself to deceptive practices? Mr. BYRNE. Exactly. Senator PERCY. Which embitter consumers and turn them against the free enterprise system, in a sense. So you are trying to protect good `businesses and protect the good name of business and get out those who are exploiting the economic system under which we work., Mr. BYRNE. My position is that good consumer protection is business protection, the point that you were just commenting on. PAGENO="0129" 12~ Senator PERCY. Having had this experience now, are there respon- sible companies in Kentucky that are still fighting the idea, trying to fold up the department and cut off its appropriations and get it to close up shop? Mr. BYRNE. You mentioned reputable businesses or established businesses. I wouldn't say as much as before. Senator PERCY. Are they fighting the idea now in Kentucky, actively trying to get rid of the department? Mr. BYRNE. No. I think the agency's past experience has established it. Senator PERCY. But originally, did they oppose the idea? Mr. BYRNE. Extremely. Senator PERCY. Did the fears that they expressed at that time about more Government bureaucracy and harassment and witch hunts, did any of those fears materialize? Mr. BYRNE. Not at all. Since I went to Louisville at the beginning of this year, the city has adopted a consumer protection ordinance. We met that same opposition; but again, I think the past experience of the attorney general's office eliminated many fears, and particularly since it is not an administrative decision which decides whether or not some- thing is deceptive. We have to go before a court, and prove to it that practices are deceptive. Senator PERCY. Isn't the very kind of investigation that this com- mittee of the Senate is conducting the very kind of thing that an ombudsman for the hard of hearing, a Government agency represent- ing 20 million hearing-impaired Americans should be looking at, the kind of activity they should be engaged in, rather than legislators doing this kind of business? Mr. BYRNE. I believe so. Senator PERCY. Doesn't it really belong in the executive branch of Government, rather than the legislative? Mr. BYRNE. I would hope so. I would think there would oniy be a need for legislation if the executive branch did not respond to needs. Senator PERCY. Having had as much activity as you have had, hav- ing had at the State level, the kind of practices that you point out, wouldn't it appear to you that some one in the whole Federal executive branch of Government would have looked at Kentucky, at Florida, at Illinois, and California and said there is a national pattern here, some- thing is happening in this industry; millions of people are not getting the services; there is a ripoff someplace ? Shouldn't someone have looked at this as a national pattern, rather than having legislators do it? In other words, do you think these hearings are justified and needed? Mr. BYRNE. I will have to reserve judgment until the results of the hearings, but I think the possibility is there. I respect the intention of the subcommittee in looking into the problems and giving all inter- ested parties a chance to contribute; but I think the results of the hearings will judge' whether or not they have been worthwhile. I do want to mention one thing. In Kentucky when we did our investigation into the particular problems, we did receive the as- sistance of a number of members of the industry, a number of dealers. 79-954-76-----9 PAGENO="0130" 124 Many of them, I believe, were very skeptical of publicly supporting legislation or working on the investigation because of pressures from their peers in the industry. I was very disappointed that the reputable dealers, and I have no question that there are very reputable dealers, very competent dealers, that they were not the ones spearheading our concern, our drive, be- cause, as you mentioned before good consumer legislation or good hear- ing aid legislation is going to protect the ethical, the reputable businesses. I was disappointed because I feel that riot all dealers are responsible for the problems. .As I mentioned, there are some very competent deal- ers. They are, if you want to say, an essential part, as I see, of the hearing aid delivery system. It seems we got into the problem of how many complaints were there, how many complaints compared to how many sales, and what we call the "numbers game." I don'tbelieve that is the issue. I think the evidence that was before us and I think the evidence is before this subcommittee and now let us get on to what can be done. Again, not to try to regulate every little step along the line, you know, sign this and do this, but some basic pro- tections. As I understand legislation, it is to provide those essential things. I will mention that I see the medical clearance or medical ap- proval in our new State law as an absolute first step for our hard of hearing citizens. Senator PERCY. Let us go back, Mr. Byrne, just so I get the chro- nology of what really happened and possibly even a yes or no answer might suffice. Some dealers on the State licensing board actually started the National College of Otometry. Is that correct? Mr. BYRNE. There were actually four-well, all five members were involved in one way or the other. Two members were named as de- fendants in our lawsuit who actually did most of the work in estab- lishing the college. The chairman of the board-there is an exhibit in- cluding his letter on board stationery, noting his participation in the college and his approval of the college. Senator PERCY. To be sure I have that, these same dealers who were officers of the college wrote a letter to the college praising the school. Isthat correct? Mr. BYRNE. On licensing board stationery; yes. Then the college sent out a letter to the people who participated in the conference and also who were to apply for the school, noting that the school was ap- proved by the State board, noting that the board had incorporated to form the school and without any question in my mind, representing that the National College of Otometry was an extension of the Com- monwealth of Kentucky Board for Licensing Hearing Aid Dealers. Senator PERCY. The school officers then, who were the licensing board members, sent but a letter to other dealers on school stationery, saying that the licensing board approved the school and invited them to attend. Is that correct? Mr. BYRNE. Yes. Senator PERCY. Doesn't that amount then, in your mind, to a per- fectly obvious conflict of interest? Mr. BYRNE. Yes. As an assistant attorney general, following a hear- ing by the consumer advisory council, I was delegated to investigate the PAGENO="0131" 125 possible conflict of interest. Conflict of interest is a legal term as far as taking legal action. Under the Kentucky law, in defining conflict of interest, there had to be some monetary benefit from the action and other aspects of the conflict of interest statute. When we conducted the investigation, it was approximately August 1975, the school had been closed and the at- torney general decided not to take any action. In fact, there was not sufficient grounds at that time to take any action. So I wanted to define conflict of interest in that sense. Senator PERCY. What was the campus of this particular college and where was it. located? Mr. BYRNE. It was located at the office of a board member, the ad- dress, I will put it that way. The address was the office of one of the hearing aid dealers who was a member of the Kentucky board. I will note that when the attorney general took action, the school was just getting started. They had not held classes and had not, as such, accepted any applications. I will note. also that we had initially heard about the school in Jan- uary, early January. When Jon Cottin came to Kentucky, I believe in the middle of January, his investigation helped spur us on, although that wasn't how we first heard about the school and wasn't our motive. Of course, our motive was to enforce the Kentucky Consumer Pro- tection Act to prevent deceptive practices. Senator PERCY. But specifically, the campus itself was then a two- room office; was it? Mr. BYRNE. There were at least two rooms. Senator PERCY. And it belonged to one of the hearing aid dealers who was a college officer, who also was a licensing board member? Mr. Bm~. Yes. Senator PERCY. That is what the campus consisted of and what the college physically consisted of. Doesn't that in itself provide the ap- pearance of deception? Mr. Bnnn~. Concerning the purpose or, if you want to say motive, our lawsuit did not go into motive. It was not necessary to prove motive to establish that practices are false, misleading, and deceptive; but I have no question that the motive was to provide a means of be- coming a doctor, a doctor of otometry for members of the profession. Senator PERCY. What was promised in the catalog of the college? Mr. BYRNE. The catalog mentioned the doctor's degree. The catalog is included as an exhibit in the report of the staff and as I recall, it said that a graduate of that school could perform any treatment of the hearing, the treatment of any hearing diseases that are not medical. I think that was a general statement of their claims as far as what a graduate of that school could do. Senator PERCY. HOW much time was required in the curriculum? To get a doctor's degree, what did an individual have to do? What performance level did they have to achieve? Mr. BYR~. The school was closed down by the attorney general before they actually had anyone go through. They had conducted several seminars or at. least one seminar where they conferred a cer- tificate saying that a person was a certified otometrist. They did grant them to, I think, approximately 60 people. But that is. different and PAGENO="0132" 126 distinct from the doctor of otometry and from all of the evidence. that I am aware of, they did not grant a doctor of otometry to any- one before the attorney general got to them. Senator PERCY. What does someone normally think of when they see a "doctor of"- isn't the implication that it is a medical doctor? Mr BYRNE. A doctor to me still applies to a medical doctor. I know others are using doctor in other fields, but first of* all, to me it is a medical doctor. Then, second, also someone that has had extensive training in hearing, extensive experience. Our normal understanding is high school degree, college degree, master's and doctorate. Senator PERCY. The implication is you have gotten a bachelor's, a master's, and now you are getting your doctorate. And even if the implication is not medical, a doctor of psychology requires bachelor's, master's, thesis preparation, passing of a thesis, and oral tests and so forth, and completion of 7 years of higher education at a minimum. Mr. BYRNE. By a school that is regulated by the Commonwealth or by the State or by other governments. Senator PERCY. What are the minimum educational standards that an individual could have in order to get one of these doctor of otornetry degrees? Mr. BYRNE. Their catalog, as I mentioned, is included as an exhibit. In order to enter the school, they must have either a high school diploma or equivalency. Then they have an Outline of courses. In them- selves, if they were good courses and taught by people who were trained in those fields, I would think maybe it would provide good training. As far as a doctorate, I have some questions; but I must note that I don't have the experience to give you the answer that I think you are looking for or that you are asking as far as the academic requirement for a doctor in the hearing field. Our State does regulate audiologists. Senator PERCY. Do they provide a certificate to the individuals when they finish this program? Mr. BYRNE. During the investigation when I visited Marion Roberts' office in Richmond, he showed me a copy of the certificate which I suppose was about this size, a very large certificate. Senator PERCY. So it could be visibly seen on a wall, not just tucked away in your personal folder at home? Mr. BYRNE. In fact, my reaction when I looked at that and I looked at my small, little law degree, I thought "wow". Senator PERCY. It was done for the purpose of impressing someone? Mr. BYRNE. I have no doubt, especially in light of their literature sent around, telling them that they will receive a large diploma for hanging on your wall. Senator PERCY. What would you describe as what would be a perfectly acceptable description for what should have been given in title and certification for a person completing that particular course of instruction? What do you think they should have been certified as so it would not be misleading and it would be understandable? Mr. BYRNE. My opinion is that someone who took the course and took all of the courses as explained in the catalog, and they were taught by professors with degrees, that maybe someone could be called a hearing aid specialist, someone that has special training. Senator PERCY. Or authorized hearing aid representative or dealer. PAGENO="0133" 127 Mr. BYRNE. Something like that. I don't want to get into that whole area about the word "specialist", but someone who has had training. If the school had been accredited or would become accredited by the State, then whether or not if it met the standards for a master's degree, that is another question. As far as I know, there was no contact with the State. Senator PERCY. Finally, what is your impression of the hearing aid delivery system in Kentucky and could you give the subcommittee your opinion on whether, based on your experience in this area, you believe the dealers ought to be the first stop for a person with hearing impairment? You have already answered part of that. I would like to have that as a final comment. Mr. BYRNE. Comments on the delivery system in Kentucky, without going into detail, I believe are incorporated in the council's report that does go into specifics. There is an exhibit attached as appendix C. It gives a list of the particular types of abuses in Kentucky. Numerous cases where the purchaser of a hearing aid got no benefit from the hearing aid, and also at the hearing held on November 5 in Kentucky, numerous examples from not only so-called consumer repre- sentatives, but from doctors, otolaryngologists, from also hearing aid dealers, to substantiate the abuses. As far as what I considered to be-I won't say the best, but what I would consider a minimum or minimum protection for purchasers of hearing aids, the Kentucky Otolaryngology Society, Dr. Larry Hall is the president, at our hearing in Frankfort on November 5, stated his position as requiring a medical clearance. The Louisville Otolaryngology Society also appeared at that hear- ing. They did not submit written testimony. They did submit a copy of what is known as the McCurdy document concerning observations on the system. But I agree with the Kentucky Society and what was verified by numerous other doctors, by consumer representatives and other pro- fessionals working in the hearing aid system, that at least, there must be a medical clearance or medical approval by a physician to deter- mine if a hearing aid be harmful and, secondly, to determine if there are signs of diseases of the ear or treatment that needs to he corrected. Senator PERCY. The Chair would like to announce that I will be leaving now to go up to question Dr. Kissinger. I would like to have Mr. Feldman and minority counsel, Mr. Cottin and Mr. Statler, for any questions of Mr. Byrne that they would like. Then we will have Mr. Hodges go right ahead with his testimony, summarize it or give the entire testimony. At the completion of your testimony, the hearing will be recessed until I return, which by then should just about be simultaneous. [At this point Senator Percy withdrew from the hearing rOom.] Mr. FELDMAN. I have no questions. Mr. STATLER. I have no questions. Mr. FELDMAN. Why don't you go ahead with your statement? Mr. HODGES. Mr. Chairman, I am J. E. Hodges, staff counsel to the Department of Health and Rehabilitative Services in Florida. ii have spent considerable time in the past 3 years working with the bureau and the health program specialist assigned to this office. In effect, I PAGENO="0134" 128 have spent most of the last 3 years prosecuting hearing aid dealers throughout the State for violaitons of law. Florida Department, Health and Rehabilitative Services, chapter 468.120 through 468.138, part III of the Florida statutes created the hearing aid law, effective January 1, 1968. The act provides for the licensing of hearing aid dealers within the State of Florida and places the authority for the administration of this law under the division of health of the department of health and rehabilitative services. The duties assigned to the division of health include the licensing of hearing aid dealers through written examinations. The act also sets forth educational requirements and training necessary for an appli- cant to be admitted to the examination, and defines unethical conduct on the part of hearing aid dealers. The division of health has employed a health program specialist and a. secretary to carry out the provisions of the law, including the calibra- tion of equipment for hearing aid dealers, the investigation of com- plaints, and the inspection of facilities. When the law first took effect, anyone already practicing in the State was allowed to continue for a period of 2 years during which time they were required to pass a written examination. Their previous experience was substituted for the required training. There were approximately 350 practioners who were licensed during the 2-year period. Prior to 1972, there had been only about four or five revocations of licenses under the authority of this act which required that a hearing examiner be appointed to receive the evidence, conduct the hearing, and enter a recommended order to the agency for the entry of the order of revocation. The aggrieved party may appeal the order in court. In 1972 a revocation proceeding was filed against a dealer in central Florida. This dealer was charged with 14 violation. They included sell- ing a hearing aid without giving the proper audiometric tests and with- out proper inspection of the ear canal with an otoscope, and selling a hearing aid when the individual had a correctable medical problem rather than a sensory neural loss. He was also charged with having sold a hearing aid which was un- usable and impractical, for the purpose represented and that he had sold a hearing aid without giving a pure tone audiornetric test by air and bone conduction; without giving an appropriate test to determine speech and reception threshold and speech discrimination; without proper fitting to insure proper physical and operational comfort of the aid, and by failing to observe a significant difference between bone con- duction and air conduction, and that he sold a used hearing aid which the purchaser believed to be a new hearing aid by virtue of the repre- sentations made and the fact. that the sales contract as issued stated a. new hearing aid. The dealer filed a countersuit against the health program specialist and the State of Florida for $1 million. I felt this lawsuit was an effort to intimidate the health program specialist and the State of Florida to discontinue the proceedings. During the course of the libel suit and revocation proceedings, suits were filed against some of the witnesses. One of the witnesses was a doctor in Orlando who was sued for $5 million for reporting this deal- er's conduct to the State. Also, two of the other witnesses who testified PAGENO="0135" 129 against the dealer were sued for libel. All these suits were eventually dismissed. As a result of the suit against this dealer, an order was entered re- voking the man's license. Appeals in both the circuit court and the dis- trict court of appeals were dismissed. Another revocation proceeding was started against two other hear- ing aid dealers. This same pattern of lawsuits was commenced against the witnesses. Three suits were filed against an 80-year-old woman witness who had purchased a hearing aid. All three were ultimately dismissed. Nonetheless, because of the harassments inflicted upon her, this woman felt compelled to move from Florida. These revocation proceedings consumed more than 10 days and over 2,000 pages of testimony. They currently are on appeal and the li- censees are operating under a supersede as bond. In still another suit against a dealer, he was charged with selling re- built hearing aids as new ones to elderly people in central Florida. He has threatened suits against witnesses, the health program specialist, and the State. If this case follows the pattern of the others, it will prob~. ably be 2 more years before it is resolved. The hearing aid dealers against whom we have brought suits cover the areas in central, southeast, and southwest Florida, where most of the retired people reside. While our authority is limited to licensed dealers, we have found unlicensed people selling hearing aids, and have reported this to various State attorneys who have taken criminal action against them. As a result of these prosecutions, the health program specialist has become, out of necessity, a full-time investigator of hearing aid dealer abuses. The cooperation and diligent efforts of the investigator are largely responsible for our successes in the prosecution of these un- ethical dealers. Since this act went into effect, we have revoked approximately 15 li- censes and have more cases pending under investigation. In some cases, the dealer has attempted to continue selling hearing aids even after we have given him notice of revocation. In one instance last year, a dealer would sell hearing aids to elderly persons, receive payment, and never deliver the hearing aid. After a move to revoke the man's license, the State attorney brought grand larcency charges against him which have resulted in a guilty plea and probation with restitution being made. We have charged other dealers with using a registered trademark in advertising in that it implied a relationship with the company which did not exist and was misleading, deceiving and untruthful. One dealer was charged with advertising new hearing aids without having a sufficient stock of the advertised brand and while not having arrangements to stock this particular brand in sufficient quantities to meet reasonable and anticipated demands. This same dealer ad- vertised in the yellow pages of a telephone directory under the head- ing "Hearing Analysis-Audiologist." Such advertising by the respondent connoted professional services by an audiologist which was not accurate. He was charged with violat- ing both the law and the Florida Administrative Code. PAGENO="0136" 130 Many reported cases go unprosecuted. Often we have run into the problem of elderly victirn~ who do not want to get involved in the un- familiar court proceedings. Some of them probably would not be strong witnesses since their accounts are confused. Many of these older citizens are suffering from poor health, and I do not believe they would be able to withstand `a vigorous cross- examination by `a defense attorney. This vigorous cross-examination often almost `borders `on `harassment and certainly amounts to intimi- dation. Also, many of these elderly witnesses are intimidated by the threats of suits against them. At the present time, we have approximately 425 licensed deulers in Florida. Because of the influx of hearing aid users or potential users to Florida, surveillance of the industry must be kept up. We have also cooperated with the various consumer offices in sonic of the larger counties toprotect these people from being'preyed upon by unscrupu- lous hearing aid dealers. The `State law does not `provide for licensing of manufacturers of hearing aids. It `has come to our attention that some manufacturers can sell a hearing aid for approximately $30 and the dealer can sell it for $400 or more. The. tremendous markup on hearing, aids can attract individuals who are more interested sin making money than serving the' hard-of- hearing public. A reputable dealer's markup is not exorbitant, if he provides services such as counseling, adjustments, further testing, and minor rep'air of hearing aids. We fear people who come in, get licensed, sell `a large number of `hearing aids, and then move `on to another State or another area, leav- ing the hearing ai'd users with no recourse for service of any type. We have discovered that most of the manufacturers will sell' hear- ing `aids to anyone whether they are licensed in Florida or not. Thus, an unlicensed person can go in and buy 15 or 25 hearing aids from a manufacturer and then go out and sell them door-to-door. To pre- vent this, we feel an amendment restraining a manufacturer `from selling to anyone but a licensed dealer is necessary. Recently, we had a license application from a man who manufac- tured hearing aids in t'he Florida Keys. An investigation of this man revealed that he had previously had a manufacture and sale operation in Canada and New York State, at which time he entered into a con- sent order with the Federal Trade CommissiOn to cease and desist from the false advertising of his hearing aids. Our office turned over to the Federal Trade Commission a' number of affidavits concerning what we felt were violations of the consent order. After more than a year, the Federal `Trade Commission has done nothing to enforce the 1964 consent order. We would not issue this man a license until lie furnished us with a statement from the Federal Trade Commission that lie was not in vio- lation of this consent order. After his `attorney was advised of this, we heard nothing further on `his application. it `appears to me and from my experience in these matters that un- `less the Federal Trade Commission is going to be diligent and aggres- sive in its enforcement' of its orders and other regulations, the pro- mulgation of further rules `controlling the industry would `be useless. PAGENO="0137" 131 I feel that this problem could have been handled at the Federal level swiftly and expeditiously. Mr. STATLER. Thank you. As per the chairman's request, he should be back in approximately 10 minutes, so we will recess the hearing until such time as he returns. Thank you. [Brief recess.] [Members of the subcommittee present at the time of reconvening after `a brief recess: Senator Percy.] Senator PERCY. Mr. Cottin? Mr. COTTIN. Mr. Chairman, a couple of exhibits to introduce in the record at this time: first, a copy of the rules of the State of Florida Department of Health and Rehabilitative Services, with regard to dispensing hearing aids; Secondly, the complete record of the efforts of Mr. Hodges to alert the Federal Trade Commission to the violations of a hearing aid dealer and manufacturer in the Florida Keys which are Exhibit Nos. 39 and 40. Senator PERCY. Without objection, they will be entered as exhibits. [The documents referred to were marked "Exhibits Nos. 3~ and 40" for reference and may be found in the files of the subcommittee.] Senator PERCY. Mr. Hodges, I would like to first on a personal note indicate that I lived in Jacksonville at the Naval Air Station, had a home there while I was in the Navy, and someone asked me last night from a group of hig~h school students whether I was in World War I. It wasn't in World War I; it was World War II. I was there in 1943, February, March, something like that. I would not recommend being there in the summer. It is very humid, very hot; but a wonderful community. I was born in Florida, in Pensacola. So I follow with `a good deal of interest the problems of older people who have been attracted to the State by the climate and a lot of other factors. I wish to congratulate you for your diligent efforts to insure that the hearing' aid profession is run as professionally as possible. Do you know if licensing agencies in the other States have attorneys working full time in a capacity similar to yours? Mr. HODGES. I don't `believe they are. I was amazed at Mr. Byrne's comment about Kentucky. Apparently he was handling that through the Attorney General's Office. We don't have that in Florida. Senator PERCY. From what you have seen, how many other States would' be of sufficient size, would have the same kind of prthlem and sufficient volume to warrant at least one full-time staff person work- ing in that same area? Mr. HODGES. I really couldn't `say. `We have, I think, a bigger prob- lem in Florida than possibly California does because of retired people coming there. There are some States, as you know, that do not have a licensing law. It is just sort of an open field for everybody. Senator PERCY. Do you think this situation that you found is unique to Florida, or do you feel that if every State assigned someone full time or at least part time to directing their activities in this area, that they would be able to profitably spend their time as yOu have? Mr. HODGES. Yes, I think so. I think th'at they could expend it very well. PAGENO="0138" 132 Senator PERCY. What is your general impression of the hearing aid delivery system as it presently operates in Florida? Do you think that dealers should be the first stop for people with hearing impairment? Mr. HoDGEs. That is rather hard to answer. I think possibly they need a further education program for the dealers before they are li- censed. I think as has been talked about here yesterday and today, the profit motive is the predominant thing in the hearing aid business. There is not the professionalism that exists in the doctor's or lawyer's or other professions. They get into this `because it is apparently a means to make money and the profit is rather high for unscrupulous dealers as I pointed out in the statement. If they do what they are supposed to do, the profit is not exorbitant. If they just come in and sell and move out of an area and leave the user where he has no help at all, it is not going to work. Senator PERCY. There seems to be a pattern in what you and Mr. Byrne have been* telling us regarding these suits by dealers agaiust the State. Do you see these suits and the dealer action against wit- nesses in your prosecutions as an effort by the dealers to avoid trying your cases on the merits? Mr. HODGES. Yes. They do intimidate witnesses. As I mentioned here, one doctor got sued. That was Dr. Holloway that you had here yester- day. He got sued for $5 million. But it didn't seem to deter him. But I think it `has deterred other doctors that I have attempted to use. I might add that last Friday I got sued myself in Federal Court for violating a dealer's civil rights. He sued me in Federal Court un- der the Civil Rights Act. I think the State is going to furnish me a counsel for it, but that, too, this is a dealer that I have been very actively prosecuting. He thinks that he is going to intimidate me in some way and enjoin me, if you please. Senator PERCY. George Eliot admonishes-as I recall-"Have us not inquire into the motivations of man," but to the extent that you can, do you feel that these in effect "nuisance" suits are designed to discourage further State action against unprofessional dealers? Mr. HODGES. Yes, I do very definitely. Senator PERCY. You say in your statement that you have been com- plaining to the FTC for more than a year about a dealer in the Florida Keys and they have done nothing. What is their excuse for not enforcing their consent order? Mr. I-lODGES. I have received no' excuse concerning it. The corres- pondence I believe has been put in `the record there, my and their answers. Some of it has been on telephone calls. This man was charged and `entered into a cease-and-desist order back in 1968 or 1964,1 forget which, but it appears here. As I understand under the provisions of the Federal Trade Com- mission for violation of one of their consent orders, the penalty is $5,000 per day, or up to a maximum of that. I had furnished the Trade Commission with a number of violations of their order. They are well conducted, I believe. I think this man could have been dealt with by them. I have no authority to, under the State law, deal with someone that is unlicensed. PAGENO="0139" 133 This man was not licensed. He was trying to get in and be licensed and we re fused his license. I wanted him out of the State, if I could, get him out of our jurisdiction. I felt that the Federal Trade Commis- sion had him in a position where they could deal with him and deal with him very effectively, but they did not act on it. It leaves me in a position of, I have to carry the ball all by myself and I have done as much as I can do. We won't license him. When we catch him, we are going to the State attorney's office, I have to co- operate with them, it is a misdemeanor under the Florida law and a criminal action in which they can go in and pay a $250 fine and go back and do it again. So the real effective way to have handled this situation was through them. Senator PERCY. Finally, you indicate that some of your complain- ants are too elderly or infirm to facilitate~ the bringing of a case. If you could bring all the cases presented to you, would you need addi- tional staff? Aren't you telling us that there are many more complaints out there that wenever really hear about? Mr. HODGES. Yes, there are. There are a number of them. For the general reason, the most predominant reason that they don't want to testify, is first they are elderly people. They are infirm not only from liearing but from someother physical difficulty. They have never been in court before. They are reluctant to go in. They fear going in and being a witness and being subjected to cross- examination by a defense attorney. it is an unknown thing to them. Also, we had one fellow that was retired on the east coast of Florida and apparently was quite a success- ful businessman. He was living in a high rise apartment that was rather expensive.. He talked to him. He says, "Yes, I got taken." But he says, "I am not going to tell it to anybody. I don't want my friends to know that I have been taken like this. I consider myself too good of a businessman." So he wouldn't testify. But it is that type of thing. Senator PERCY~ As strong advocates of consumer interests, I would like you to both know that I consider your testimony an inspiration and a reaffirmation of the feeling that I have had for many years. Do you feel that we need a Consumer Protection Agency at the Fed- eral level? Mr. HODGES. Yes, if they will be staffed fully and with people that are aggressive in the prosecution of the violations. It needs that. We can't have the law and even have the teeth in it if you don't have ag- gressive prosecution. There is no sense in having it if you don't have that. Senator PERCY. Of course we do have regulatory agencies who have the authority and power. Our problem is to really bring to their atten- tion problems such as this and see that they do something about it. When I say do something about it, I mean not just grind it down in the bureaucracy of inaction and indecision, which is so characteristic of regulatory agencies now. There are so marry factors and forces working on it. There are so ~rnany people placed in the regulatory. agencies by the very industries that they are regulating that are slowing things down. I and members PAGENO="0140" 134 ~of my staff are interested in the problem, have taken up certain cases :and we will continue to take cases. We took early in my Senate career, the baby cribs that were stran- gling babies, calling to public attention the callous attitude of the industry. As lumber prices went up, they increased the size of the distance between the slats. It didn't matter whether a child would wiggle through and hang itself. You had to keep that crib at $19.95, and the hell with what happens to the baby in it. Make money. That is their job. They are moneyrnakers just like some hearing aid dealers. Make money on the hearing aid, whether it helps the person or not. There weren't many crib manufacturers, but enough that you had a terrible situation. We followed it through. Why didn't the FDA that had the power to do something about that, why didn't they do it? It is the bureaucracy. You can't seem to get them to act. There are people from regulatory agencies sitting in this room. I hope they take careful note of the fact that we are not going to let up on this problem. If they think we are just going to kiss this one away, have a. hear- ing and then let it all fade into the atmosphere, let them mark down their notes very clearly. They are wrong. Because we kept on that baby crib one until we got action. Just like the Christmas tinsel, it was determined it was loaded and would cause sickness, possibly even death. They came out with a regu- lation after a lot more pressure by us, but they allowed all the manu- facturers to clean up all the inventory first. No one would be inconvenienced at all by it. It didn't matter that they had made it without researching and testing. But we stopped that. We had better take a look at what happened before; when we put out vaccines that were not helpful. They were actually dangerous, some of them, and the companies didn't dispute it when they were presented with the evidence. Who was looking after the public interest at that particular time? We can't let that happen again, certainly. When I see the number of things that we have taken and followed through on, in a sense we have tried with nursing homes to be the ombudsman, to be a consumer advocate, to be the CPA or the ACA of the Federal Government and follow through and see what we can do about it. We do find the bureau- cracy can respond. The whole purpose of the Federal agencies was not to let those forces that I call forces of evil grind the process to a halt. That is what we have got to do. Your testimony this morning is so utterly valuable in explaining why we need this kind of catalytic activity. I will just assure you that your time here has been worthwhile. And I assure the distinguished members from the executive branch that are in the room today, we are not going to let up on it. I want the industry to know. I am not going to let up on it. I have a couple of more years left in my term. I can sweat them out. We are not going to let go with this issue until we resolve it, so they might just as well make up their minds. They have had 11/2 to 2 years to do it on their own, and they have failed. PAGENO="0141" 135 Now we have to move in. We have to move in and buttress the efforts that you have made in the relatively few States that have really been sensitive to this problem and have done something about it. If they didn't have men of your caliber and character, you could have been ground down. Why shake the boat? Because you didn't give a damn about shaking the boat and ruffling the feathers. You are getting some action and you are protecting the consumer interests, I think. I think we are all very grateful to you. Mr. Feldman? Mr. FELDMAN. No questions. Senator PERCY. Mr. Statler? Thank you very much, indeed, gentlemen. We appreciate your being here. The Chair will call a panel from the National Hearing Aid Society, the National Hearing Aid Society has been given the opportunity to put together their own panel and we call at their suggestion Mr. M. L. Fortner, hearing aid dealer and president, Memphis, Tenn.; Mr. Vin- cent Giglia, chairman of the Consumer Affairs Committee, Philadel- phia, Pa.; Mr. Herbert B. Rickenberg, audiologist, director, heaiing and speech, United Hospital, Newark, N.J.; Dr. John W. Heisse, `Otolaryngologist, Burlington, Vt. Gentlemen, do you solemnly swear to tell the truth, the whole truth, and nothing but the truth, so help you God? Mr. FORTNER. I do. Mr. GIGLIA. I do. Mr. RICKENBERG. I do. Dr. HEIssE. I do. TESTIMONY OP M. L. PORTNER, HEARING AID DEALER AND PRESI- DENT, THE NATIONAL HEARING AID SOCIETY, MEMPHIS, TENN.; VINCENT GIGLIA, CHAIRMAN OP THE CONSUMER APPAIRS COMMITTEE, PHILADELPHIA, PA.; HERBERT E. RICKENBERG, AUDIOLOGIST, DIRECTOR, HEARING AND SPEECH, UNITED HOSPITAL, NEWARK, N.J.; AND DR. JOHN W. HEISSE, JR., OTOLARYNGOLOGIST, BURLINGTON, VT. Mr. FORTNER. Senator, we certainly appreciate your remarks. We feel that we are doing all that we possibly can to correct things in the interest of the consumer. We want to introduce our comments with a brief explanation of the circumstances which have dictated our presentation. We were given very short notice about these hearings. March 24 was the day that we were notified of them by telephone and, to date, we have received no written notice. Just a week `ago, on March 26, we first learned some of the details of the subject matter. This is one of a long series `of hearings involving the hearing aid industry which have been held at State and national level. Some of the major hearings have included Church hearings in the Senate, the I-JEW Task Force on Hearing Aids, the Mcintyre hearings, and of course the forthcoming FTC hearings. PAGENO="0142" 136 Our association has a permanent staff of oniy four persons plus ~two typists. One person joined the staff less than 2 months ago. When you consider the burden placed on this small group, you can ap- preciate some of the problems we have in providing you with all the in formation you seek. The National Hearing Aid Society is prwately funded, and there- fore has limited resources and manpower to respond to requests fo" information from Government officials and private groups and in'.- vi duals. However, we will do the best we can to assist you in an assessment of the hearing ai~I delivery system. In this presentation, we plan to describe our role in propagating high standards. The present condi- tion of the hearing health delivery system Provides the best hearing help that has ever been available in the whole long history of disable- ment from hearing loss. As you probably know, I am Luke Fortner, and I have been presi- dent of the National Hearing Aid Society since October 1975. Despite the short notice about these hearings, we have been fortunate in obtain- ing several other leaders in the field to provide you with insight into questions and issues raised by your committee. At this time, I would like to introduce my. colleagues, Herbert Rickenberg, who is director of hearing and speech for United Hospital of Newark, N.J.; John W. Heisse, Jr., an otolaryngologist from Burl- ington, Vt.; and Vincent Giglia~ a hearing aid specialist, who is chair- man of the NHAS Consumer Affairs Committee. Since consumer protection is your goal, and ours, my presentation will concentrate on the NHAS efforts to promote consumer protec- tion. I want to show you some of the ways we have exerted leadership in that area, and provide data from objective sources which show how successful those efforts have been. I would also like to focus your atten- tion on the critical issues underlying the controversy in the hearing aid delivery system. The National Hearing Aid Society's thrust for consumer protection has been apparent through three major efforts. These are education of hearing aid specialists, a program for licensing hearing aid special- ists. and the NHAS certification program. When used in combination, these have proven very effective in bring- ing about high levels of consumer satisfaction. Recent modifications of them have resulted from studies conducted by consumer groups, Gov- ernment agencies, and market researchers. These modifications promise even greater help for the hearing impaired. Certainly, our goal is a constant forward movement. Licensing laws for hearing aid specialists are a notable example of constructive efforts to make high standards universal. With the en- couragement and support of the National Hearing Aid Society and its affiliated chapters, 40 States have enacted licensing laws and all of them list prohibited acts, provide standards of entry into the occupa- tion, provide recourse for the public, and provide penalties for violations. The existence of these laws has acted as a major force in defining standards, and enforcing these standards by law. A copy of a model bill is being submitted for the record, so you can see that the licensing laws really have teeth in them. [See exhibit 42A.] PAGENO="0143" 137 Our certification program encourages hearing aid specialists to meet and maintain requirements for experience, education, examination, ethics, endorsement, and evaluation. Through the years it has become increasingly rigorous, and we recently added a continuing education requirement as a condition for certification renewal. I am supplying details of our certification program for the record. [See exhibit 43.] Not satisfied, however, that all areas for improvement has been ex- hausted, the National Hearing Aid Society has carefully reviewed sev- eral recent studies of the hearing aid industry, to explore areas for increased consumer service and protection. Let me take a moment to outline for you what these studies have shown. Three major studies have contributed to development of new NHAS policies for improved hearing aid services. These were the Market Facts report issued in 1971, an industry sponsored study to evaluate public attitudes about the hearing aid,. .conducted by Market Facts, Inc.; the study of the Retired Professional Action Group, an arm of Ralph Nader's public citizen organization, conducted in 1973; and the 1974 study by Payne & Payne Consultants, commissioned by NHAS as an audit of the hearing aid delivery system, to seek out areas which need strengthening. [See exhibits 44 and 45.] The 1971 Market Facts survey utilized a comprehensive question- naire which was mailed to hard-of-hearing persons, selected to include a social, economic, and demographic cross section. This showed high consumer satisfaction levels with .the present hear- ing aid delivery system, with only a small percentage dissatisfied with the services they had received. Recent evidence indicates that even that small percentage of dissatisfaction has been reduced since that report was made. However, through this survey, we learned that among persons sur- veyed who do not have hearing aids but believe they have a hearing loss, only 34 percent had had a hearing test, suggesting that more efforts in public education about hearing loss were needed. This study also showed that about 36 percent of the people consulted a hearing aid specialist first about the need for a hearing aid, while 45 percent consulted a medical doctor first. About 6 percent of those who co suited a hearing aid specialist first were referred by them to medical doctors. Those who consulted clinical audiologists first were referred to medical doctors in only 11 percent of the cases, while being referred directly to hearing aid specialists in about 14 percent of the cases. These statistics seemed to indicate that the nonmedical technicians of the hearing health team-the clinical audiologists and the hearing aid specialists-might be assuming too much responsibility for medical screening, and this pointed out an area where improvements seemed needed. With only a small percentage dissatisfied with their services from hearing aid specialists, an adequate sample of the reasons for corn- plaints was not made. However, the competence of hearing aid special- ists was questioned by about 1 percent. Even though this is very small, the National Hearing Aid Society believes that levels of competence must be maintained, and improved, if possible, and that we would take steps to do so. PAGENO="0144" 138 The 1973 study by the Retired Professional Action Group suffered from a lack of statistical accuracy or scientific study methods. In many cases, it used isolated cases to support. very general conclusions. However, several recommendations for consumer protection seemed to merit consideration as possible areas for improvement. These were: 1. A hearing impaired person should consult a medical doctor before obtaining a hearing aid. 2. More public information about hearing loss is needed. 3. Arrangements for a "trial" period of some type may assist some consumers in knowing whether they would benefit from a hearing aid. 4. An efficient system for resolving consumer complaints or questions abOut hearing loss and hearing aids is needed. The study by Payne & Payne Consultants, completed in November 1974, reinforced previous conclusions. It recommended: 1. Medical clearance prior to purchase of first hearing aid. 2. Expanded educational opportunities for hearing aid specialists. 3. Stricter enforcement of licensing laws. However, other areas which had been of possible concern now ap- peared satisfactory, according to what was revealed in this study. The physicians expresed confidence in the hearing aid specialists. The report showed that more than half of the medical doctors inter- viewed said they send at least 75 percent of their patients directly to a hearing aid specialist. The report said: They feel that the hearing aid specialist's procedures in connection with fit- ting and his "fit and modify" method of hearing said selection are satisfac- tory * * * Once the final referral is made, the majority of (medical) ear specialists seem to consider their responsibility to the patient-insofar as hearing amplification is concerned-to be at an end. Some of the physicians interviewed in this study expressed con- cerns about encroachments of clinical audiologists into medical prac- tice. In addition, they generally refuted the notion that prescriptions for hearing aids are possible. These concerns of the physicians are explained in two articles I am submitting for the record, which you can study at your leisure. [See exhibits 46 and 47.] Using these studies as a base, the National Hearing Aid Society un- dertook development of the kinds of policies and procedures which would respond constructively. On May 7, 1975, just about 5 months after the Payne & Payne study was completed, we were able. to announce a four-point consumer pro- tection program. This announcement carried with it a pledge for im- plementation of the policy as rapidly as possible. The key features of this policy were: 1. Mandatory medical clearance for a hearing impaired person prior to obtaining the first hearing aid, with a criteria for medical ref- erral used on subsequent hearing aids. A provision for a waiver was made only to protect the freedom of choice and personal liberties of the hearing aid consumer. This is similar to the recommendation of the American Council of Otolaryngology. For your information, I am submitting a copy of their statement to the HEW Task Force Gommittee on Hearing Aids, so you may review their position on medical clea.rance. [See exhibit 48.] PAGENO="0145" 139 Senator PERCY. I would like to interrupt you at this point. You are inserting into the record the statement of the American council before the Hearing Aid Task Force of HEW. We learned yesterday that that position is now inoperative. A telegram from the president of the council advises us that the previous position is under review. You may submit this document, but its continuing relevance is sub- ject to question in view of what may well be a change of position on t.he part of the council. Mr. FORTNER. With the permission of the committee, Senator Percy, we have as one of our panelists, Dr. John W. Heisse, an otolaryngolog- ist. Could he be permitted to address this subject after I am completed? Senator Piito~. Yes. Would you make a statement on that right now? Dr. HEI5sE. Yes. While the position paper of Dr. McOurdy and Dr. Glorig is being reviewed, Dr. McCurdy informs me it is still in effect and has not been changed as of this time. Senator PEROT. You are speaking on behalf? Dr. Hi~IsSE. I am speaking for Dr. McCurdy, who I talked to this morning. He has authority to speak on behalf of the council. At the present time he is representing it. Mr. STATLER. Mr. Chairman, I think the telegram we received from the president of the council should speak for itself. If the document Mr. Fortner has offered will be accepted for the record, it should be with the caveat that it may be inoperative and we will know more about that in the coming weeks. I understand the council is meeting next week. Dr. HEISSE. I am sure there will be some changes in the position. It has not been changed as yet. Senator PERCY. With that understanding, then, it will be incorpo- rated in the record. Mr. FORTNER. The second part of our four-point program: 2. The second part of our four-point program required all meinber~ of the National Hearing Aid Society to make a rental/purchase option available, which would permit a person to try a hearing aid at reason- able cost, before purchase. 3. Expanded educational opportunities for hearing aid specialists. 4. An expanded program for processing consumer grievances would be developed, to offer gTeater assistance to hearing aid users in resolu- tion of problems. As we pledged, we proceeded as rapidly as possible in a nationwide democratic organization to develop procedures for implementing these policies. At the same time that we recognized the need for haste, we also tried. to build with care, so that this program would have lasting value. We consulted with experts in the medical field, to develop the guidelines for medical clearance which would meet the needs of the consumer for safety, economy, and efficiency. In January 1976, we were able to supply our members with de tailed procedures for complying with the medical clearance and rental/purchase option policies. We are submitting copies of these for the record. [See exhibits 49 and 50.] 79-954-76------iO PAGENO="0146" 140 These strides toward improvement are still in their early stages so their full impact has not yet been realized. However, since they are based on sound study and careful planning, we feel they will succeed. Senator PERCY. Do you want those exhibits to be incorporated in the record at the point you asked for them to be inserted, or can they just follow? Mr. FORTNER. This is the first time I have ever been here. I don't know what the procedures are. Whatever suits the committee is fine with me. Mr. Corrix. Why don't we put them in at the close of your statement in toto? Senator PERCY. They will be incorporated at the close of the statement. Mr. FORTNER. That is fine, sir. It is probably unrealistic to believe that every consumer can be com- pletely satisfied with his hearing aid, regardless of the methods used to insure consumer protection. Prosthetic devices simply are not glamorous or appealing and are often distasteful to the user. However, the hearing aid industry is keenly aware of its obligation and responsibilities to consumers, and intends to do everything in its power to provide optimum help. Objective evidence proves that a lot has been achieved already. The available evidence shows that claims of serious abuses have been greatly exaggerated. When this objective data is coupled with under- standing of the problems encountered by the hearing impaired, then the picture begins to come into focus. As I review these statistics for you, please bear in mind that hear- ing loss, and hearing aids are still the butt of jokes, or an object of ridi- cule. Our society places a stigma on hearing loss, and many hearing handicapped people are greatly embarrassed by their affliction. Often they try to deny that it exists, or hide it as best they can. The compassion that we have for other afflictions is too often denied the victims of hearing loss. Thus, the hearing aid specialist must not only provide hearing aid services, but he must also assist the hearing im- paired person in coping with the attitudes of society. Senator PERCY. Do you happen to know why this is? You have lived with the problem. What is the nature of the hearing loss that causes this kind of reaction in our society? Mr. FORTNER. Senator, this is my personal opinion from experiences having worked with individuals. But usually, this is not always true, but usually a hearing loss is something that an individual incurs over many months, years, that it is such a gradual process that they are really not aware many times that this is happening to them. They refuse to believe that this handicap has descended on them. Many times they take an attitude of why me, God? This, coupled with the number of years that it can take for the hear- ing loss to reach a point where it is a commirnications problem and once it becomes a communications problem, they are sometimes ridi- culed. They are pushed sometimes very aggressively by members of their family to secure some type of assistance with their problem. It is just human nature. Senator PERCY. Go right ahead. PAGENO="0147" 141 Mr. FORTNER. Sometimes, the hearing impaired, who have been placed in such an uncomfortable position by society's attitudes, seek miracles from their hearing aids and their hearing aid specialists. That we cannot provide. We can provide amplification to make use of resid- ual hearing, we can provide support and encouragement, compassion and understanding. But, we cannot work miracles. Senator PERCY. Do you take the position or reaffirm the position that it is highly desirable for hearing aid dealers to take into account these particular and peculiar problems, to have sales representatives function who possess compassion, understanding, patience, knowledge of this kind of afiliction, some basic understanding of the psychology of the situation, and have adequate training? Should those persons be discouraged from going into the field if they don't have it, but do possess a good line and a fast selling type of approach that would be a great disservice to the industry? Mr. FORTNER. It has been my experience-again, let me draw on my personal experiences having performed in this profession for 11 years, I have seen some individuals come into our industry who did not pos- sess these qualities and they do not survive. I have known of individuals who have been extremely successful selling other products who for one reason or the other decided they would like to enter our industry and I have seen them fail miserably in a very few months simply because they did not in my opinion possess these qualities that you speak of. With all of this to overcome, it is not remarkable that hearing aid specialists sometimes fall short of their expectations. The gratifying thing is that so often we are able to provide enough help to restore a person to a useful and productive life. And, the objective evidence which Twill present to you shows that we succeed in the overwhelming majority of cases. While we have not achieved perfection, we are pro- viding significant benefit, for millions of grateful people. Consider this evidence. When the Task Force on Hearing Aids of the Department of Health, Education, and Weif are was conducting its study of the hearing aid delivery system, just last year, they received thousands of letters from hearing aid users. Our review of them showed that 97.8 percent favored the present hearing aid delivery system. Senator PERCY. Could you tell us how the Department of HEW went about getting those letters? Were they voluntarily sent in? Were they encouraged? Did the dealers, hearing aid dealers, participate in giving the names of customers or anything like that? Mr. FORTNER. It is my understanding that the hearing aid dealers did participate in encouraging their clients to contact the Food and Drug Administration. Yes, sir. Senator PERCY. I am not going to make an onerous comparison, but we have developed an understanding of the techniques of letter writ- ing. We are pretty sophisticated down here in this department. We know on gun control, when suddenly the mail is running 99 per- cent on one side of a highly controversial issue, that someone is inspir- ing it. It could be the NRA; it could be gun control people. Of course, we learned during the Watergate phenomena that mass communica- tions responses were controlled and orchestrated. Did HEW ask the hearing aid dealers to perform a service and get these letters in or did PAGENO="0148" 142 the hearing aid dealers just take it on their own initiative to get these letters sent toHEW? Mr. FORTNER. Of course, at the time this was taking place, Senator Percy, I was not in an officer's position of the National Hearing Aid Society. So I cannot speak with exact fact, but it is my opinion that HEW did not request this. Senator PERCY. My own experience, and I have been in the Senate just about as long as you have been in the hearing aid business now, and I started running for it a little before you entered your industry, but it has been my experience that it is pretty unusual for people to write in to say they are really happy and satisfied. Generally, people write because they have something to gripe about. We generally get complaints rather than commendation for our work. So that is why I felt it best to clarify the nature of this writing campaign. Mr. STATLER. Mr. Chairman, may I interrupt to introduce into the record at this point communications we received, dated November 10, 1975. This is a document from Victor N. Thompson, president of the Washington State Hearing Aid Society, addressed to all hearing aid fitters and dispensers, I take it, in the State of Washington. I will read briefly from it. It says- Enclosed you will find 50 letters to send to 50 of your users. These letters have been sent by the National Hearing Aid Society to every State in the Union for distribution to every hearing aid specialist. It is imperative. Italic supplied- that your clients' letters are received by the Federal Trade Commission no later than December 12, 1975. NHAS has suggested that each fitter/dispenser use his office stamp with his phone number on it at the bottom of the page. This letter writing campaign is an absolnte necessity That is emphasized also- that we all That is emphasized- must participate if we want to remain a free enterprise hearing aid delivery system. This is in connection with the proceeding before the Federal Trade Commission that is presently underway and which led to the promul- gation of the initial proposed rule that the Federal Trade Commission submitted. Senator PERCY. The Chair, and I doubt that any member of this com~mttee, had any knowledge of that. I did not know it existed but I think it is appropriate. I suspected it just from common sense. I think it is appropriate that that be made a part of the record at this point. [The document referred to was marked "exhibit No. 41" for refer- ence and follows:] EXHIBIT No. 41 WAsHINGToN HEARTNG AID SOCIETY, INC., Aulurn, Wash., Noven~ber 10, 1.975. To all Hearing Aid Fitters/Dispensers: Enclosed you will find fifty (50) letters to send to fifty (50) of your users. These letters have been sent by National Hearing Aid Society to every state in the Union for distribution to every hearing aid specialist. PAGENO="0149" 143. It is imperative that your clients letters are received by the Federal Trade Commission no later than December 12, 1975. NHAS has suggested that each fitter/dispenser use his office stamp, with his phone number on it, at the bottom of page 2. This letter writing campaign is an absolute necessity that we all must partici- pate in if we want to remain in a free enterprise hearing aid delivery system. Sincerely Yours, Vrc~on N. THoMPsON, President. P.S. Remember-Our deadline is December 12, 1975. WASHINGTON FIEARING AID SOCIETY, Ixo., Auburn, Wash., November 10, 1975. Dear Friend: This is an urgent message! The Federal Trade Commission (FTC) has published in the Federal Register a proposal revising the Trade Rule Regulations of the hearing aid specialists and industry. If these proposed rules and regulations are enacted as written, they will change the entire hearing aid delivery system and destroy the relationship we have had with our clients. Un- fortunately, it will be to the detriment of the hard of hearing persons, not improvement. We hearing aid specialists believe that we are aware of and understand the problems and needs of the hard of hearing more than any bureaucratic agency in Washington. We believe the proposed rules and regulations are not in the best interest of the hard of hearing and our American free enterprise system. Listed below are a few of the reasons: Disruption of services.-continuity of services to the hearing impaired is endangered. Higher costs incurred in complying with FTC rules will result in higher prices to the consumer and/or; hearing aid specialists will decrease services in an effort to absorb higher costs and/or; higher costs will force some hearing aid outlets to close, thus reducing the availability of hearing aids. ProhIbitions against house calls by hearing aid specialists deprive the elderly, ill and handicapped of convenient in-home services. Innovation, development and utilization of improved technology, and progress in service to the hearing handicapped are discouraged. Quite the contrary, the regulations provide negative incentives for diminished services and/or higher costs. state laws are superseded, violating states rights to establish their own stand- ards for internal commerce. Arbitrary and capricious law-making by the FTC exceeds their legal authority and endangers~ the public welfare. The FTC cites no valid reasons why such restrictive rules are necessary; but, the regulations could deprive citizens of their livelihoods (hearing aid specialists), their property and their liberty without due process. Invasion of privacy is legalized by requirement that FTC agents be permitted to examine confidential records of hearing impaired. Unnecessary record keeping w-ill increase costs of business. As a hearing aid wearer, if you feel these proposed rules are not in your best interest, you should make your opinions known by writing to the address given at the close of this letter. YOUR LETTER MUST GO IMMEDIATELY for hearings will begin shortly. If it is convenient, I wOuld appreciate a copy of your letter to the FTC. There is NO WAY the present hearing aid delivery system and services ren- dOred can remain in existence if these rules and regulations are enacted. We hearing aid specialists are doing all in our power to inform the FTC of our services to hearing impaired persons and of our importance in the delivery system. We sincerely believe that our part in the competitive, free-enterprise system `has been and is an absolute necessity in achieving and maintaining the high level of service and care the hearing impaired persons deserve and have come to expect. A's President Ford has stated: "A Government big enough to give us every- thing we want is a Government big enough to take from us what we have." He also said, "Although most of today's regulations effecting business are well- intentioned, their effect, whether designed to protect the environment or the consumer, often does meee harm than good. They can stifle the growth and our standard of living and contribute to inflation." PAGENO="0150" 144 As a person with a hearing problem and a taxpayer of this country, we ask you to express your opinions to the FTC. If you wish further information on the proposed Rules and Regulations hefore writing, please phone me. Write and address your letter to: Trade Re~nIations on Rules for Hearing Aid Industry Special Assistant Director for Rulemaking Federal Trade Commission Washington, l).C. 20580 Your Hearing Aid Specialist, Member of Washington Hearing Aid Society. Senator PERCY. Go right ahead, please. Mr. FORTNER. One thought I would like to make. on this matter before I get back to my prepared text is, I am of the understanding that some of the consumer groups also possibly suggested writing com- plaints against the hearing aid people, Senator Percy. As I stated earlier, at that time I was not president of the National Hearing Aid Society, but I do, to the best. of my knowledge, believe that this effort was made by the people seeking complaints also.. Senator Piu~cy. The Chair has no knowledge of any such activity. It is highly possible. WTould you agree or would you care to clarify as to whether they have any economic interest in so doing? Mr. FORTNER. I would think that they would not, sir, but I would not be in a position to say. Senator PERCY. I think that should he clarified. The record will be kept open for 1 week at this point in the event that it is possible for you to obtaina.ny evidence, such as has been obtained in the hearing aid industry to the effect that there was an organized effort to write in on the complaint side of this. I would say that if you have 97.8 percent favoring the hearing aid side, they are either terribly inifective or, you are almost as pure as Ivory soap on that one. So I don't think they have been very effective and it probably was not very extensive. But to the extent that itmight~ have been carried on, I have no knowledge that it was, I never heard of it., but if you can find any evidence of it, the subcommittee would be very happy to put it in the record at this point. . Mr. F0RTNER. May I ask clarification on the point? You said the record would be kent open for 1 week? Senator PERCY. HOw much time do you need? Mr. FORTNER. Was it not announced yesterday the record would be open for 30 days? Senator PERCY. For 30 da.ys on this particular point, yes; sure. Go right ahead. Mr. FORTNER. In words filled with emotion, they told of their per- sonal frustration with hearing loss, and exnressed their gratitude to their hearing aid specialist, whom many also regarded as a frie.nd. These hearing aid users said that they are not concerned about mis- representation, misfitting misevaluation, or lack of standards. Instead, they repeatedly said that they liked and trusted their hearing aid specialists. They also stressed their fear that too much Government control and int~rference would deny them the `warm, persona.l hearing, aid services which they are accustomed to receiving. The.y also expressed concern PAGENO="0151" 145 that mandatory medical and clinical services would increase their costs and inconvenience. (A. copy of the NHAS presentation to the HEW Task Force is submitted as exhibit No. 51.) Although their letters were often simple handwritten notes, some- times written by the shaky hand of an elderly person, they eloquently refuted claims of abuse by hearing aid specialists. It is urgent that those who contemplate major changes in the delivery of hearing health services also consider what they might be destroying. They must listen to these people who have experienced the personal agony of hearing loss, and who have received relief because of competent hearing aid specialists. Certainly, over many years, it has been the hearing aid specialists who have reached out to them, helped them, and listened to their problems when all other avenues for hearing help were closed. Information from other consumer protection agencies are likewise indicative of how well hearing aid specialists are meeting the needs of consumers. While I review these reports, please hear in mind that neaily 3 million people in the United St'ites use heaun~ aids, von w ill quickly perceive how few complaints are received by consumer pm- tection agencies in proportion to the number of hearing aid users. We have contacted . Virginia Knauer's Office of Consumer Affairs, the better business bureaus, the licensing boards, and a large associa- tion of senior citizens. All of them tell us the same thing. The com- plaints about hearing aids are few and far between. Senator PERCY. In your written testimony, the statement is made it is urgent that those who contemplate major changes in the delivery of health services also consider what they might be destroying. Do you have any evidence that there are responsible parties attempt- ing to make major changes of such a nature that it coulddestroy pres- ent. delivery systems? The Chairhas only seen evidence that those who wish to bring about changes are doing so with the cooperation of the industry, and those changes would improve the service and build on the present delivery system as a foundation. I am not aware of any efforts made to destroy the existing system. If you have evidence that there is anyone trying to destroy the present system, for 30 days we will keep the record open at this point so that it can be submitted. Mr. FORTNER. I, at this point, don't have any evidence of this nature. I will do some research on it a.nd submit some additional information, if such can be obtained. The report from Virginia Knauer's office, letters from the better business bureaus, and a letter from the American Association of Re- tired Persons are included in my exhibits 11, 12, and 13. I am also including a summary of these in a report entitled "i-Tearing Aid Complaints Are Minimal," included as exhibit No. 14. [See exhibits 52. 53, 54, and 55.] I won't read all of this, but let me just give~ you some of the typical comments. 0 From the Rocky. Mountain Better Business Bureau: We received 104 requests for information on the 32 flrms ~1eiitified in 1974, and a total of only 9 written complaints. We feel the small number of complaints is commendable. PAGENO="0152" 146 The BBB in Birmingham, Ala., reported only five complaints in 5 years. Four of these were taken care of to the customer's satisfaction, and one was not a valid complaint and no action was taken. The Better Business Bureau of New Mexico said: In the past 2 years, we have replied to many inquiries on the reputation and reliability of various firms throughout the State. Our records indicate that w~ have received two written complaints and both were adjusted by the firms in- volved. The better business bureau appreciates the record the industry has earned with our office. The Cornhusker Better Business Bureau in Lincoln, Nebr., said that they processed two complaints about hearing aids during an entire year. The BBB of Tulsa said: Our files reflect little or no complaints against the hearing aid profession in the northeastern Oklahoma area. The BBB of Central Oklahoma said that the hearing aid profession has "one of the lowest reports of customer dissatisfaction" of all the businesses on which they keep records. That record is echoed throughout the better business bureau reports. It is summarized by the report of the National Better Business Bureau which said that out of the complaints they received in 86 categories, hearing aid complaints ranked near the bottom in 71st place. The American Association of Retired Persons reported that they received only. about 17 complaints a year. Virginia Knauer's Office of Consumer Affairs reported that they received only 23 complaints over a 7-month period in 1975, and one of these was actually a request for information instead of a complaint. Senator PERCY. For purposes of the record, Virginia Knauer's Office of Consumer Affairs is located in what department of government here in Washington? Mr. FORTNER. This I don't know. Senator PERCY. If you don't know that, how many citizens do you think would know that? I am not surprised. I am rather surprised she go~ 23 complaints. I think if Gallup asked 1,000 citizens, where would you write to a consumer office in Washington, I don't think one: or two out of 1,000 know what department to address a letter to Virginia Knauer other than just to Virginia Knauer. So I am not really surprised at that. .That is probably why we need the visibility of a central ombudsman, a central Office of Consumer Affairs, as you do have in some States. In the State of Illinois, I think it is fairly well known we have got something of an ombudsman there. I think those figures are a~ little more valid. I am not so surprised. But Virginia Knauer's is not a very visible office, taken out of the White House and submerged into the bureaucracy. Mr. FORTNER. The consumer advocate's office in the State of Illinois said they received only one complaint on hearing aids during all of 1975, and none so far in 1976. Stat.e licensing boards also say that they receive very few complaints. PAGENO="0153" 147 So, with all of these agencies inviting consumer complaints, you might expect, from the tales. you hear, that they would be swamped with consumer complaints about hearing aids. Senator PERCY. Could I interrupt there? You cite statistics from not only the consumer advocate's office showing a low number of com- plaints, but your statistics appear to be somewhat in error in a State I know something about, Illinois. The Illinois Association for the Deaf receives 500 complaints yearly. The American Association of Retired Persons, the Illinois Depart- ment of Vocational Rehabilitation and the Governor's Office for the Handicapped; how about them? Have you surveyed those to see how many complaints they have received? Mr. FORTNER. No, sir. Senator PERCY. I think there might be other places that it would be much more pertinent even in the State of Illinois when you have got one office out of several that could be written to, that receives 500 a year, that to me gets a little closer to the kind of feeling we have had for dissatisfaction that does exist. Mr. STATLER. Mr. Chairman, if I may interrupt, this morning we were informed by the Attorney General's Office of the State of Illinois that they received anywhere from 35 to 40 complaints during the past year. We have also talked to the other groups t.hat you mentioned, Mr. Chairman, and we were informed that as recently as March 11, 1976, the consumer advocate's office, which is mentioned in Mr. Fort- ner's testimony, announced that it was about to conduct a major inves- tigation into the hearing aid industry in Illinois because of abuses involving hearing-impaired citizens in that State. Senator PERCY. Thank you. Go right ahead. Mr. FORTNER. That just simply is not so. Even in the marketing of a frustration-prone product, the hearing aid specialists have carved out a record they can be proud of. Those advocating major reforms in hearing aid delivery sometimes flaunt one of those rare persons who is dissatisfied, to try to stampede their ideas through. While this strategy has great dramatic appeal, it dangerously distorts the issues. I hope that this presentation of objective evidence allayed some of your concerns about abuses, and permits you to ask yourselves why all of this uproar is taking place. If there are actually very few complaints, very little abuse, and i~o real need for industry upheaval, then what is at the bottom of all this? Senator PERCY. You asked a question, perfectly appropriately, what is the hearing all about? I haven't heard any evidence at all that would lead me to believe that the hearing is not fully justified, that the uproar, the need for it, hasn't been substantiated. I wonder if you would want to alter this statement in light of the evidence that has been presented? Mr. FORTNER. Senator, I didn't intend to infer that the hearings are not necessary. It does give a forum for expression of views from many PAGENO="0154" 148 different viewpoints. This was not our intention 1:0 insinuate that the hearings are not necessary. Senator PERCY. If we clarify that they are necessary and desirable, how about the industry upheaval? Upheaval is a term that is hard to-it is a revoluntionary term. I don't think we have ever asked for an upheaval of the industry. In my discussions with the industry through the years, manufac- turers and dealers, associations and so forth, I just use the words "re- form, closer surveillance, better control over procedures." What do we do about those that aren't members of it, that hang up the sign and say they are a dealer, but they are not really under any kind of jurisdiction? Would you want to rephrase your feelings, Mr. Fortner, as to whether in your judgment, now in light of all of these things, what you feel the industry has a moral obligation to undertake and do to the extent that it can? Mr. FORTNER. I believe that the industry, the association which I represent, and its members, have a moral obligation to the hearing- impaired individual to deliver to that individual the very best hearing help that is possible and to set forth a code of ethics that applied to our memberships, our membership, that is a main code of ethics and enforce that code of ethics to a point where we do offer a reasonable source of services as well as prosthetic devices to the hearing-impaired population of our country. Senator PERCY. Do you think that the industry, that means mem- bers as well as nonmembers, that the industry as such is basically offering that kind of service and that no improvement or reform is necessary? Mr. FORTNER. Senator, we are in the process right ~0W of undergo- ing major reforms within our industry. Senator PERCY. So that you do agree that major reforms are needed and necessary. * Whether that is an upheaval, I don't know, but major reform I accept. I am not arguing about that term. I think that is good. I think we are right on the same wavelength, no disagreement whatsoever. I am not asking for an upheaval, but major reform requires a dealer to stop exploiting the customer, to start providing the kind of services that your code of ethics and your own statement here insures that you feel lie has an obligation to do. To that extent it is going to cause an upheaval. Maybe his profit margin is going to go down and his costs are going to go up. But I hope his human satisfaction is going to be greater. That is all we are trying tO get at. Mr. FORTNER. We are working for the same end. Senator PERCY. You know, as a former lifelong member of the free enterprise system, I have pleaded with your industry, do it on your own, don't wait for the Government to get in this thing. It is so costly, you end up with regulations that many times are ob- solete, that require constant monitoring. Do it on your own. Then you have got the flexibility. But if you say major reform is still needed, I accept that. I agree with you. PAGENO="0155" 149 Mr. FORTNER. I did not say quite what I think you inferred when I said major reform is still needed. I intended to say, if I did not, that we are in the process of implementing major reform and most of this at this point has been completed. Senator PERCY. Most has been completed? Do you mean that I could go out and survey a good cross-section of all dealers and find that the policies and criteria established for service to be rendered would be university applied by those dealers now? I could find it right today, April 2, 176, in a survey that I would make? Mr. FORTNER. I personally believe- Senator PERCY. I thought you said it was in the process of being implemented? Mr. FORTNER. It is in the process of being implemented. Senator PERCY. It hasn't been totally and completely implemented and in effect today? Mr. FORTNER. Portions of it are, yes, sir. Senator PERCY. Portions of it? Mr. FORTNER. All of it is not in effect today. Senator PERCY. So to the extent that they haven't done a major re- form, it is still needed? Mr. FORTNER. The reform that was needed- Senator PERCY. We want to see you implemment changes, as a steady, ongoing business practice. Until such time it is not on a piece of paper, but into action, then the major reform is still in the future, not in the past and doesn't exist in the present. Mr. FORTNER. The things that have been implemented in our four point consumer protection plan is prior medical clearance on the first time with a waiver available for those persons over-for those persons over 18. I thought that was the word, but I wanted to be sure. A program for continuing education requirements for renewal of certification by our national association has been passed `by our executive cornmmittee and is being implemented. `We have created an institute called The Hear- ing Instrument Institute, which is implementing this point the best they possibly can and as quickly as they possibly can with the limited funding that they have educational programs for the individuals al- ready in our industry. They have completed a curriculum for individuals who contemplate coming into our industry. This particular course has been offered in a 6-week course-excuse me-26-week course, at a community college in Philadelphia. All of these things have taken place within the last 18 months. So we feel that we are making progress. Mr. Giglia, who will make a statement, will cover the consumer pro- tection plan which we feel not only involves the handling of the corn- plaints, but it also includes the education of consumers. Certain basic questions underlie the controversy. One of these is whether or not the hearing aid delivery system shall remain in the domain of private practice, or be totally controlled and operated by Government. Advocates of each viewpoint are diligently trying to make their points about them. PAGENO="0156" 150 The National Hearing Aid Society feels that the answer may lie somewhere in between, in a system in which private enterprise joins hands with Government, in a cooperative arrangement of benefit to all. The National Hearing Aid Society proposed a plan for procurement of hearing aids under medicare to the Church committee in September. [See exhibit No. 56.] Since this plan may provide a useful model of delivery of hearing aid services on n broader scale, I am subinittting a copy for the record of hearing aids under medicare to the Church committee in September [See exhibit No. 15.] Another basic question is who shall deliver services? Under the medicare plan mentioned above, each meinb~r of the hear- ing health team would be involved in providing those services which he is most competent to provide. The medical ear specialists would provide medical services, the hear- ing aid specialists would provide hearing aid services, and the clinical audiologists would be utilized when the physician considers it desirable. In other words, the overall management of hearing loss would re- main in the hands of the medically trained physician. We agree with the HEW Task Force report which said that a mandatory requirement for an audiological evaluation by a clinical audiologist is not feasible at this time. The American Council of Otolaryngology concurs with this in their statement prepared for the HE'W Hearing Aid Task Force, in which they say: The audiologist should be called upon by the M.D. for hearing testing when his services are required, but not mandatorily as a step in the procedure. Such a requirement would be unnecessary and an expensive duplication. Another basic question is whether or not hearing aids are to be pre- scription devices. Physicians, hearing aid specialists, and most hearing aid manufacturers agree with the HE'W Task Force Report that cur- rent audiological tests alone cannot insure that a given hearing aid will meet all of the individual's requirements. In other words, a prescrip- tion for a hearing aid is not possible. Commissioner Alexander Schmidt discussed this in a letter to Sen- ator Percy on January 2, 1976. He said: In the final report, the taskforce found that neither bearing-impaired con- sumers (clinical) audiologists, nor hearing aid dealers are capable of diagnosing the medical cause of hearing impairment and correctly prescribing the proper treatment. We agree, and hearing aid specialists do not attempt diagnosis or treatment, which are proper functions only for physicians. We do not want to diagnose or treat, and this fact is reflected in our medical clearance policy. What we do know is hearing aids, and the kind of support services needed when medical or surgical correction of hearing loss has been ruled out. Most of us have learned the art of fitting hearing aids in the time-honored apprenticeship system, which through the ages has proven to be such an excellent means of learning an art, craft, or skill. Despite our accomplishments, abilities, and expertise in our own par- ticular field, a few advocate that we need to be supplanted. At the PAGENO="0157" 151 Church hearings in 1973, Kenneth Johnson, executive secretary of the American Speech and Hearing Association, advocated an elaborate and expensive system of Government distribution which would eliminate hearing aid specialists completely, and place their members (clinical audiologists) in control. Since then, that organization has made a major effort to bring that into being. This is documented in a paper filed with the FTC titled "The Elimination of the Hearing Aid Specialist," which I submit as an exhibit, and an article telling how their licensing is infringing on the hearing aid specialists and medical practice. [See exhibits 57 and 58.] These critical issues in the hearing health care delivery system are fully discussed in a paper I submit as an exhibit [see exhibit 59]. I think if you will take the time to read it, you will find it helpful in acquiring a full understanding of the curious stresses which exist in hearing health care at this time. I think it is time that we all reexamine these issues, to find a firmer footing for changes in the system than destructive charges and countercharges. The National Hearing Aid Society has had to divert much of its time, manpower, and money to respond to unjust accusations against hearing aid specialists. It is necessary, but it seems so wasteful of energy .and resources which are needed for more constructive programs. I recently had an opportunity to read an interview with Hubert L. Gerstman, who is clinical director of the New England Medical Cen- ter in Boston. He summarized my own viewpoint. He said- My major point is that if (clinical) audiologists-ASHA--is truly concerned with doing the best possible job in the client's rehabilitation, if they want to com- pete in this marketplace in one manner or another, then the degradation of the industry and the reduction in value of the hearing aid must stop . . . I just don't see bow perpetuating acts of litigation, assuming extreme opposing view- points for purposes of negotiation, fighting our problems with the interveiitiofl of government agencies, is the most efficient or wisest way to handle the situa- tion. If we could look upon what's going on now, and will probably exist for the next several years as being a transition period, then we could all share in a more unified vision of what is ideal for the future . I think that we are all here to try to discover that unified vision of the future. Hopefully, such a vision may emerge from the forthcoming FTC hearings, which again raises the same issues I have discussed today. I feel sure that your interest in this matter will cause you to follow those hearings closely, because of their major implications for hearing- impaired people. Our position has been fully documented in our comments to the FTC, and I submit those as an exhibit for your committee. Another exhibit contains our response to a recent study of your staff. [See exhibits 60 and 61.] [The documents referred to were marked "exhibit Nos. 42 through 61" for reference. Exhibits 42A, 43, 44, 46, 47, 51, 52, and 56 to 60 will be found in the files of the subcommittee. Exhibits 42, 45, 48 to 50, 53 to 55, and 61 appear in the appendix beginning on p. 169.] PAGENO="0158" 152 Mr. FORTNER. I thank you for your time in permitting my presenta- tion and I would like to ask at this time that Mr. Vincent Gigha, chair-~. man of our Consumer Protection Committee, report on the status of what we have accomplished in that area. Senator PERCY. If you would hold up just for a few minutes, just a couple of clarifying questions. I was rather surprised at the outset in the opening of your testimony that you mentioned the shortness of time, implying there really wasn't time to get ready adequate testi- mony. I think you have put a body of knowledge together that couldn't have been done just off the top of your head. Isn't it true that the National Hearing Aid Society has known about this investigation through meetings and letters for well over a year and in the last 4 or 5 months, haven't various hearing aid dealers contacted the National Hearing Aid Society and notified it that the members of this staff have been interviewing them about allegations of misfittings in California, Texas, Illinois, Florida, and Maryland? So your notification was hardly just March 24 of this year. Mr. FORTNER. So far as the staff investigation, it is my uiiderstand- ing that well before I became president of the National Hearing Aid Society, that there was known knowledge that there was an investiga- tion being conducted; but I have no knowledge of any date of a hear- ing being given to us prior to this date of March 24. Senator PERCY. I have explained to you that I think these hearings and the work of this subcommittee can be of tremendous help to im- plement some of the objectives and goals that you have so clearly out- lined. The Society does have 2,200 members; but according to present estimates, there are about 15,000 dealers in the United States. Even assuming that the guidelines were enforced among your own membership, what are weto do about the 13,000 other dealers who are not in your organization? How do you propose having them adhere to your policy? Doesn't the role of the State and Federal Government really help your association to carry out and implement the objectives and goals? It is going to be very noncompetitive for your members to adhere to a service standard that can be undercut by someone who of- fers something on a price basis and no service and no foilowthrough. It seems to me it is necessary to have the 13,000 adhere to a certain standard or your 2,200 members are to be driven out of business. Mr. FORTNER. I would like to address two different pOrtions of your question. First of all, we have approximately 2,250 certified members of the National Hearing Aid Society. We have an additional 1,300 State chapter members who are not certified members of the National* Hearing Aid Society. Senator PERCY. What is the difference? Mr. FORTNER. These are people that have elected not tO go through the process of taking the educational, taking and meeting the educa- tional requirements of the National Hearing Aid Society to become certified by this society. Senator PERCY. Do you think the consumer knows the difference be- tween one that is certified and one that is not certified? If you permit them to be members this is new to me I have been hvmg with this thing for quite a while. I had the feeling that someone who is a mém- her really was a part of the whole educational process. PAGENO="0159" 153 Mr. FORTNER. These 1,300 noncertified members are members of the National Hearing Aid Society by lieu of the fact that they belong to one of our State chapters. We do have a provision in our National 1-Tearing Aid Society bylaws for a registered provisional member. We have less than 100 of these menibers that are in existence today. This is noncertified members. Senator PERCY. You are here as the president of the National Hear- ing Aid Society. We admit you are not speaking for those who are not certified and not even members of the State chapter. You can't speak for them, can you? Mr. FORTNER. I cannot speak for the ones who are not members of the State chapters. Senator PERCY. That would number a minimum of 11,500 dealers. To what extent can you speak on behalf of those who are members only because they have State membership? Are you here stating that you can make any representation on their part, even though they can list themselves as members of the National Hearing Aid Society? That would be the 1,500. Mr. FORTNER. They are required to abide by our code of ethics and when we insert into our code of ethics a criteria, for instance, for medi- cal clearance, they must abide by this. Senator PERCY. But they are not required to meet any educational standards or participate in any of the training or educational pro- grams which you conduct? Mr. FORTNER. No, sir. Senator PERCY. Assuming that within the National Hearing Aid Society, which represents about 14 percent of the total universe of hearing aid dealers, only 1 percent of them are bad apples, what can you say about the 13,000 men and women who are not in the National Hearing Aid Society? Mr. FORTNER. Going back just one more reference to the total num- ber of individuals, it is my understanding that of these 13,000 or 15,000 people that are involved in the retail dispensing of hearing aids, this is being clone t.h rough approximately 6,000 retail outlets. We have no way of taking any survey. We have no way of proving these figures. It is an estimate. But we suspect that we do represent the individuals who dispense better than 75 percent of the hearing aids throughout this country. The ones who are not memLers of the State chaptersor of the Na- tional Hearing Aid Society, in areas where they are licensed by hearing aid licensing laws, as a general rule, I feel that they are doing a good job. The 40 States that have a hearing aid licensing law. of course, any emerging professions that has been licensed recently and is trying to expand their educational and professional requirements, does encoun- ter problems. But basically, they are doing a good job, in my opinion. Senator Pi~ucv. Mr. Fortner, you did insert in the record the state- ment of the American Council of Otolaryngology for the Hearing Aid Task Force of HE~V. Did you have anything to add to Dr. 1-leisse's comments about that in that they have made it inoperative? Mr. FORTNER. I am not a member of the Council ~nd I have no ac- cess to any information about what their plans are. PAGENO="0160" 154 Senator PERCY. Did you have any knowledge that they had sent a telegram which, in effect, made the position that they had previously taken, but which you placed in the record, inoperative? Mr. FORTNER. Not until I heard it yesterday, sir. Senator PERCY. I am very concerned about the historic inability of the subcommitee to obtain in a timely and cooperative manner infor- mation requested from the National I-Tearing Aid Society. With re- spect to your four-point consumer protection program, I am going to enter in the record at this time the history of the correspondence re- garding this matter. This includes my letter to your predecessor, Marvin Pigg, on July 28, 1975, asking what was being done to implement the program prom- ised to the Department of Health, Education, and Welfare at a hear- ing on May 7, 1975. In reply to this questionnaire on August 25, 1975, Mr. Pigg answered, but it was clear from his response that next to nothing had been done to implement the program. On February 6, 1976, I wrote you stating the same questions that I had asked 6 months earlier. On March 8, a letter was sent to me by your Detroit counsel, Richard Kitch. He said that the NHAS will not answer these questions until he was assured that this subcommittee was not a tool of the American Speech and Hearing Association. [The documents referred to were marked "Exhibit No. 62" for ref- erence and may be found in the files of the subcommittee.] Senator PERCY. That is a very serious allegation to charge a sub- committee on the U.S. Senate, being a tool of a private organization such as the American Speech and Hearing Association. What evidence do you have to substantiate the charge that was made? Mr. FORTNER. Senator Percy, I can't directly respond to your ques- tion. I would like to address the question in this respect, that at the time your letter with the 17 questions was received in our office, which is by the way, a very small office with four staff members and two typists, we were snowed under with the securing and working with trying to se- cure witnesses for the Federal Commission hearings which have been announced to begin April 12. During the events of working very hard on that, this letter was not given the consideration that it evidently should have been given. For that, we apologize. I do believe that since that date, another re4uest for information was made and we complied with your request for this information. But we were just simply bogged down, and these things happen, Senator, in any business. Senator PERCY. I accept that apology and commend you for it. I think it might be also well because of the implications that have been made and the serious allegations made to afford you the same oppor- tunity to apologize, unless you can corroborate it, for the implication made that this subcommittee is a tool of the American Speech and I-Tearing Association. What evidence do you have that supports that? If you have none, would you care to comment on that? We would accept that. Mr. FOETNER. Of course, Senator Percy, I am not privileged to at this time to have before me all of the information that our legal coun- sel, Mr. Kitch, has. With your permission, of course. I would like to have his advice. PAGENO="0161" 155 Senator PERCY. If the reply had been sent back that you were, over- burdened, you needed more time, and so forth, `that would be an ac- ceptable and understandable request and reasonably made, and I think reasonably responded to. But when the burden of proof is put on the subcommittee to prove that it' is not a tool of the American Speech and Hearing. Association, I don't think I can ever recall an nifront like that to an official Senate committee. I wOuld think you. would want to clarify it at this point, and if it cannot be corroborated-and I give you full chance to put in any evi- dence you want-I think a simple apology on that particular point would clear the point up. Mr. FORTNER. I have no information to my knowledge, so I do apologize. `Senator PERCY. Accepted and forgotten. Mr. Fortner, the fina.i exams that are given to persons who are cer- tified as "hearing aid' audiologists" have not been tabulated on the basis `of a pass-fail ratio. How can you measure how effective this final exam is without a pass-fail ratio being maintained? Mr. FORTNER. This I cannot address at this time, sir, because being new in my position, I don't have these facts. I have not been made aware of this, but I will respond by letter to this question. Senator PERCY. If you would do that and if there is anyone with you on your panel or anyone in the room that could `answer that ques- tion on your behalf, and if you would accept their answer, I would allow that right now. Mr. LEE. Those figures are not here, Senator. I am sorry. We will respond by mail. Senator PERCY. AlT right, the record will be kept open for 30 days. The National Hearing Aid Society confers upon persons passing this test a plaque declaring them to be "certified hearing aid audiolo- gists." I understand that an audiologist is someone with a master's de- gree or better in audiology. Isn't the term "certified hearing aid audio- logist" misleading if, in fact, the hearing aid dealer with such a plaque on his wall does not have at least an M.A. degree in audiology? Mr. FORTNER. Senator P'ercy, very similar to the practice of law where an attorney may be an attorney, but he practices only at board proceedings or he only practices real estate law or many different specialties within a profession, the definition of audiology is the sci- ence of hearing. Senator PERCY. But he may not be a specialist in divorce laws or criminal law, but he must be a graduate of the law school. To prac- tice law, he must pass the bar examinations and be certified before the courts of the State. That is quite different from this certificate on the wall. If a lawyer puts a plaque on the wall, certifying he is a lawyer, and he isn't, that is an offense. He is going to be prosecuted. I am just wondering whether this is somewhat misleading when you call him a "certified hearing aid audiologist?" Mr. F0RTNER. I personally do not believe that it is, Senator Percy. When you trace back the history of audiologists, this terminology was used by hearing aid specialists back prior to World War II, back in the 79-954-76-----11 PAGENO="0162" 156 late thirties and early forties, prior to the birth of the clinical audi- ologists or the research audiologists or the industrial audiologists or the medical audiologists. The first national association of hearing aid specialists was called the Society of Hearing Aid Audiologists. In 1967 or 1968, I have for- gotten. I don't have the dates on this before me, but the National Hear- ing Aid Society applied for and received the rights to use this with the Federal Patent Office. So at this time, I personally do not feel that a person using the title "certified hearing aid audiologist," providing he has met the requirements of the National Hearing Aid Society and is duly certi- fied, is misleading. * Senator PERCY. How many have you failed to certify after they filed application and went through the requirements ~ Mr. FORTNER. Senator Percy, I don't have those figures. We would request to be able to submit, to respond to this question by letter. Mr. COTTIN. Mr. Chairman, we have those figures. They were pro- vided by the NHAS last year in the staff study which is in the record already. Mr. STATLER. If I may interrupt at this point, I think the record should note that under the proposed Federal Trade Commission rule on which hearings are now being held around the country, t.he practice of the National Hearing Aid Society conferring this kind of title- certified hearing aid audiologists-is classified as an unfair and decep- tive trade practice. If the rule is finalized, this kind of practice would be prohibited. Senator PERCY. I would suggest that the National Hearing Aid Society take this under advisement. I think you are on notice now. You just heard two previous witnesses testify about practices that they looked upon as deceptive. I think adequate notice does now appear, that you don't have to wait for more action. Take a. good look at this and let the subcommittee know what you decide to do about this. You do praise State licensing laws that govern hearing aid dealers as being constructive. However, I would like to ask if you see any conflict of interest when officers of local chapters of NT-lAS also control State licensing boards? Do you believe it is helpful to exclude consumers from State licensing boards as is done in some States? Again, it is not just the conflict of interest. It is the appearance of conflict of interest. When we are dealing with a questionable category of health services, that appearance is extraordinarily important, and when revealed underlines consumer mistrust. . Look at the CIA. These fellows undertook these activities. If you ever put the question to yourselves~ "What if we were discovered, how much damage would be done?" They apparently never did. They just never floured anyone would ever look at it. Now ~`a good l~ok is being taken. The spotlight of public attention is being put on some of these practices. It would seem to be the appear- ance of conflict of interest would be very, very important to the in- ~e.grity of the industry. . Do you think consumers ought to be represented on State licensing boards as is done in some States? Do you think they ought not to be specifically excluded? Why would a State go out of its way to exclude PAGENO="0163" 157 consumers' unless someone felt that it muddied the waters, that there might be some upheaval or something? Mr. FORTNER. The response that `I. would make to your question Senator Percy, is I believe any profession, the regulating body should be made up of primarily individuals who are capable to judge how their licensees are performing. I do not object to the idea of having advisory people from other professions, and from the consume~ people. *This'is my personal opinion, Senator Percy. I think there is a definite advantage. I believe that the people from related areas have something to `offer. Senator PEnCY. Do you concur that of the 20 million roughly esti- mated hearing-impaired people in the United States, a significant portion of them have a medical problem that would lead us to believe that' a hearing aid would he of little or no help to them? Mr. FORTNER. I would address the area of the 20 million hearing- impaired individuals as there is a considerable number of those mdi- *viduals who need' medical attention. Their hearing losses can be cor- rected by medication and/or surgery. `Senator PnRCY. Some would be materially helped, no question about it. * I am trying constantly to figure out what proportion that is. I don't believe the 10 percent figure. 1 think it is up closer to 40 percent. It may even be higher than that. . . But there is a significant proportion that we all know just simply will not be helped by a hearing' aid. Their problem cannot be helped by amplification. It is much more basic than that. Is that correct? Mr. FORTNER. First, I would like to give you my answer. Then I would like Dr. Heisse to address this. Senator PERCY. Of course. Mr. FORTNER. My personal opinion of this, of. course, we are looking at 20 million people with a hearing impairment.. Nowhere- and I don't believe this information is available. It may be and I just' have not seen it. But what percentage of these individuals have a communications problem? It is possible to have' a hearing impair- ment that is not of a severeness that would create a communications problem. Of the people who have a communications problem and there is no medical or surgical correction available for them, I am of the opinion that most all can receive some benefit from amplification.. Senator PERCY. Yes. But you have limited it. Let me go back to my specific question and see if you can answer that for me. In fact, I will insist on an answer. I want to find areas where we really agree. Then we can dispose of them an'd get on with the business. Where we disagree is where we are going to have to spend a lot of time together. Of the 20 milliont impaired people, are there a significant number of them that will not be helped in any substantial measure or any measure by just the addition of a hearing aid, the purchase of a hearing aid? Mr. FORTNER. A person who is totally deaf, of course, would not; receive any benefit. The `number of these people I do not know. But there `are a significant number. PAGENO="0164" 158 Senator PERCY. I just said is there a significant number of~ those? Mr. FORTNER. Yes. There is a significant number of people who would not benefit from amplification. Senator PERCY.. Are there a significant number of those who would not benefit that don't know that, that realize they can't hear, but don't know why and are still hoping, searching, might read an ad for hear- ing aids and say there is something that may help me? Mr. FORTNER. I believe that in my written presentation the results of one of the surveys taken :indicate that of the people who had not purchased hearing aids only 34 percent of them had even a hearing test. So, yes, there are a lot of people who would not know what was available for them. Senator PERCY. Taking into account that we have substantial. num- bers of Americans with that condition, nowhere in your statement do you mention that dealers might have an obligation not to sell a hear- ing aid under certain circumstances. We have now said there are a substantial number of people~ for whom a: hearing aid would do no good whatsoever. Why in a business offering services to the health needs of Americans, why this omission? Mr. FORTNER. An oversight, possibly. As one of our exhibits our criteria for medical clearance, we have outlined a list of seven symp- toms that if `my one of those seven symptoms tre p1 esent, a hearing aid must not be fitted. Senator PERCY. In discussing the written response from the pub- lic, and we have spent a lot of time on that subject, on the HEW Hear- ing Aid Task Force, you state, "Hearing aid users said that they are not concerned about misrepresentation, misfitting, evaluation or lack of standards." Are you concerned or should anyone be concerned about these prob- lems? Are ~OU implying that these are not real problems and that we should not be concerned about them, particularly those in t.he industry. whose good name and reputation are being hurt by association with unprofessional, what I consider unscrupulous dealers? A lot of these dealers will not join your association for very good reasons. They don't want to be subjected to this code of ethics. They don't want you breathing down their necks. Maybe you know too much about that industry and business and you are going to be around a long time. They will take all of the benefits they can get from you. ~:ir FORTNER. This is true. Senator PERCY. But they are going to ride along free. That is why unions like to close shop; fight hard to get it. Mr. FORTNER. We are definitely concerned about any unethical practices by a.ny hearing aid dispenser. I believe that our efforts over the past couple of years in trying to implement consumer education as well as hearing aid specialist education, prior medical clearance, I believe this points to the fact that we are making efforts to try to eliminate any of these abuses regardless of how few or how many there are. Senator PERCY. Mr. Fortner, you claim in your statement that re- ports of abuses have been "severely exaggerated." Yesterday, we had testimony and/or affidavits entered in the record from Texas, Illinois, Maryland, California, Minnesota, and Florida which, taken together, PAGENO="0165" 159 suggest a pattern in which the hearing aid dealer is selling aids to persons who are either clinically deaf, have normal hearing or who have hearing impairments that cannot be corrected by any medical procedure or electrical appliance. You have heard Mr. I-lodges, of Florida, tei.l this subcommittee to- day that many persons do not file formal complaints against the dealers because they are ashamed to admit that they have been fleeced. Would you comment on that further, sir? Mr. FORTNER. This, of course, Senator, is a very hard thing to comment on or to try to pin down. I know of no objective way to determine how many unannounced complaints there would be against any profession or industry. The only method I know of of policing an organization or a group of people is tO depend heavily on the number of people that do make themselves known. Senator PERCY. With regard to the Payne and Payne survey, we had the Congressional Research Service, a very highly respected Service in the Congress, make an analysis of that report. I will insert in the record the copy of their full report to us at this point. [The document referred to was marked "Exhibit No. 63" for refer- ence and follows:] EXHIBIT No. 03 THE LIBRARY OF CONGRESS, Congressional Research ,S'ervice, Washington, D.C., May 20, 1975. To: Senate Government Operations Subcommittee on Permanent Investigations. Attn: Jonathan ~ottin From: Daniel Melnick, Analyst, Government and General Research Division (Frederick H. Pauls, Deputy Assistant Chief) Subject: The Payne and Payne Study Entitled "A National Survey of the Hearing Aid Delivery System in the United States" This memorandum responds to your request for an analysis of the methods and procedures used in the Payne and Payne study of the Hearing Aid Delivery System. The study was sponsored by the National Hearing Aid Society and conducted by James and Marjorie Payne. Chilton Research Services of Radnor, Pennsyl- vania advised the Paynes regarding the construction of the sample. The need for their study was summarized by the Paynes in the following way: There has been virtually no dependable information on the attitudes behind the practices of ear specialists, audiologists, and hearing aid specialists as they interface with each other and with hearing aid users, . . . the surveys have been either incomplete or conducted by amateur groups using unscientific methods." [(Report p. 1)1 "To satisfy the need for information and provide insights which might be useful in improving the hearing aid specialist's services to the hearing impaired, the National Hearing Aid Society (NHAS) in the spring of 1974 commissioned a broad natiOnal survey to determine the nature a~id dynamics of the hearing aid delivery system, and the attitudes of those involved." [(p.2)J This memorandum is organized in to three sections: (1) an examination of tlme sampling procedures used; (2) an examination of the interview technique; and (3) an explication of the meaningfulness of the results obtained. THE SAMPLE Accordingly to Payne and Payne's report, "The sample was designed to pro- i ide a systematic cross section of ear specialists audiologists hearing aid special PAGENO="0166" 160 ists, and users throughout the United States". It should be noted that the au- thors make no claim for the randomness of their samples. Without a true random sample the probability of sampling error cannot be estimated. Consequently, it is not possible to use the standard statitical tests which estimate the amount of sampling error. This means that there is no way of knowing the probability that the persons sampled have unique character- istics that are not representative of the population at large. Thus, conclusions drawn from the Payne and Payne study should be viewed as limited to the people with whom they spoke. As is true of every sample used in a social science project, the bias of the sample Payne and Payne used can be seen as originating from two separate decisions: (1) the "universe" from which the sample was drawn, and (2) the method used to draw the sample. DEALER SAMPLE The sample used in this study was based on the membership list of the National Hearing Aid Society. According to a spokesman for the NHAS there are approximately 15,000 persons in the Nation who fit hearing aids. In the 38 States which have licensing laws there are 5,700 licensed hearing aid dealers. Of these (at the time the survey was taken) 3,600 were members of the NHAS, although only 2,200 of them were certified by the NHAS as fully qualified. Con- sequently, you should be aware of the limited nature of the universe used in the definition of the sample. The sampling scheme was quite complex. The NHAS membership list was used to select units known as Primary Sampling Units. The procedure followed as: The NHAS membership list was divided into potential Primary Sampling Units (towns and cities). Members were assigned to these units based on the location of their offices. The units were rank ordered with the units containing the greatest number of members ranked first. Individuals were then selected for the sample using a random start and an internal structure (i.e. every 6th member was included.) If an individual NHAS member was included in the sample, all the NHAS members in his PSU (town or city) were potential respondents. The members in a selected PSU were divided into two groups: (a) the primary group, to be approached to participate in the procedure, and (b) a secondary group, drawn upon in case the members of the primary group refused to participate. The sample was based on the distribution of the members of the NHAS. In the report it is referred to as a "Probability Proportional to Size Sample." The "size" involved is the number of members of the NHAS living in a PSU. Under this sampling procedure, those PSUs which contained a larger number of members had a greater chance of being included in the sample. One of the problems connected with this procedure is that there is no way to determine whether the distribution of NHAS members is similar to the distribu- tion of all hearing aid dealers. Consequently, there is no way of knowing if the sample adequately represents the dealers of the Nation. AUDIOLOGIST AND EAR SPECIALIST SAMPLE ~Furthermore, this problem is compounded by the method used to select audio- logists, ear specialists and users of hearing aids. At least, the dealer sample was derived from a list of dealers, i.e., NHAS members, contrast, the audiologist, ear specialist and user samples were not derived from lists of audiologists, ear specialists, or users. Rather they were selected from PSUs based on the NHAS (dealer) membership lists; that is the procedure for audiologists and ear special- ists was: In Primary Sampling Units where the authors could only find 4 audiologists, or ear specialists, all of them were approached for an interview. In the other Primary Sampling Units, a selection was made. As a result, audiolo- gists and ear specialists practicing in areas where there are more hearing aid dealers have a greater chance of being included in the sample. On the other hand, those audiologists and ear specialists who practice in areas where there are no NHAS members were completely excluded from the sample. This is a major difficulty because several of the questions asked of ear special- ists and audiologists concerned their dealings with hearing aid dealers and the sample under represents audiologists and ear specialists who practice in areas where there are fewer dealers. Audiologists and ear specialists who practice in areas where there is a low concentration of hearing aid dealers might very well have a different view ofdealers. Yet they have not been included in the Payne PAGENO="0167" 161 and Payne sample. One of the main conclusions by Payne and Payne is that hearing aid dealers offer a greater amount of counseling to users than is offered by ear specialists and audiologists. It i.s altogether conceivable that this result may be an artifact of `the sample because the sample over represents hearing aid dealers and under represents ear specialists and audiologists. In other words, the conclusion is likely a consequence of the way the sample was drawn. It is further possible that the kinds of services offered by hearing aid dealers are related to the availability of audiologists and ear specialists. If this is the case, then the sample would be particularly faulty, because it under represents or fails to represent areas in which there are more ear specialists or audiologists. In fact, writing about the audiologists they interviewed Payne and Payne con- cluded, the work loads in some clinics and centers are incredibly heavy-as high as 5,000 clients per year." "Such work loads generate poor client relationships and make rehabilitation or counseling for most of the clients impossible." [p. 51 of Report] USER SAMPLE The method of selecting users of hearing aids also suffers from the defect of having been based largely on the records of NUAS members. For this reason, it is difficult to know bow clients of non-NHAS members regard their aids. A further problem is that those NHAS members who refused to open their lists of clients to sampling were excluded from the procedure as were their clients. While it is not possible to determine the reasons why dealers did not allow their client lists to be sampled, it is conceivable that among the NHAS members re- fusing to participate there might have been a larger than normal number of dealers who had difficulties with their clients. It is not possible to know how important this exclusion problem is because the authors of the study do not report the number of dealers who refused to allow their lists to be sampled and were consequently excluded from the procedure. Moreover, the survey does not show bow many persons have tried to use a hearing aid, but have given it up due to their inability to adjust or because of poor service. Furthermore, the dealers current lists may have been a faulty base for sam- pling the clients of the dealers because some dealers may well have followed the common business practice of culling their files of inactive accounts. Such accounts would very likely contain a higher number of dissatisfied clients than the current list. Payne and Payne do not report whether they attempted to determine if this was the case. SAMPLE SIZE In any case, the size of the samples drawn was too small to allow for valid estimates of the population of hearing aid dealers, ear specialists, audiologists, or users. Accordingly, even if random sampling design had been followed, the errors involved in making estimates from these size samples would have been so great as to have rendered the results of little practical value. The small number of persons interviewed makes the use of percentages quite misleading.' To their credit Payne and Payne report the number of cases associ- ated with each percentage presented. NONRESPONSE RATES According to the report, of 486 persons who were approached for an interview 173, or 36.9 percent, did not fully answer the questions. A conversation with Mr. James Payne (on the telephone May 14) revealed that some of these individuals were non-NHAS member dealers interviewed for "balance." Others were NHAS members, audiologists, ear specialists and users who either refused to participate or did not answer all the questions. Yet, Payne and Payne do not report (1) the number of NHAS dealers who refused to allow their client lists to be sampled or (2) the exact number of dealers, audiologists, ear specialists and users who refused to participate. Instead, they have combined all these who (lid not com- plete the interview into a single category. Furthermore, the following sampling conditions limit the importance of the Payne and Payne* results: 1 For example on page 52, 35.6 percent of the dealers are reported as selling 11 to 20 units per month. Would the effect on the reader have been different If the authors had only reported that 26 dealers are in this category? PAGENO="0168" 162 73 hearing aid dealers were interviewed; compared to 21 ear specialists and 17 audiologists. This means that there was a greater probability of reaching dealers with different opinions. We have no way of knowing what bias might have resulted if (a) the inter- viewers terminated any interviews upon~ hearing that respondents had anti dealer views; (b) the respondent was told the name of the sponsor of the research, or (c) the respondent was told that the research was being done at the request of his dealer. These issues can only be settled by examining the transcripts of the interviews. The above mentioned considerations lead us to question the representativeness as well as the projectability of these samples. INTERVIEWING TECHNIQUES The interviews were conducted by the owners of the Public Relations firm of Payne and Payne: James and Marjorie Payne. The Paynes have an extensive background in the public relations field including experience in the use of indepth interviewing to test consumer reactions, which should not be interpreted as evidence of expertise in the areas of public opinion polling, survey research or statistical analysis. The hearing aid study was an attempt to apply in-depth techniques to a survey sampling design. It involved, (a) selecting respondents according to an organized sampling plan (see supra) (b) asking each respondents a "core" set of questions (referred to in their report as a "questionnaire") and (c) interspersing in-depth probes among the questions asked of everyone. `The in-depth interviewing techniques which they used are most appropriate to studies in which the aim is to generate as many examples and insights as can be gotten from each interview. The "questionnaire' is merely used as a stimulus to a more extensive discussion in which the respondent is asked to respond in great depth. A main advantage of in-depth procedures is that they allow respondents to express their opinions in ways that are closest to their attitudes. When con- ducted by highly trained psychologists or social scientists this technique often produces a result which provides deep insight into the thinking and orientations of the respondents.2 In this case, Payne and Payne did not try to use it to gain deep appreciation of the situation of the respondents. Rather they appear to have used it as a surrogate for a survey. This use is highly questionable. The results of an in-depth interview are not cumulative in the same way as survey results that is to say, it is not valid to count the responses received from such a procedure. This is because such interviews cannot be compared. If they cannot be compared they cannot be added. In a survey interview the researcher controls the order, wording and probing pattern to produce comparable responses from each person questioned. In contrast in the in-depth procedure, the interviewer tries to draw the respondent on each point. Consequently the questions asked in one interview often do not follow the same pattern as the questions asked in any other interview. This means that any attempt to cumulate responses and count the number on one side or the other involves risk. The most valid information about the respondents to be found in the Payne and Payne report is contained in the passages labeled "Depth response." These passages `contain examples of responses which were elicited by the authors. The major limitation of such reporting is that it depends upon the bias of the inter- viewers. They made the selection of material to be presented. They phrased the wording of the summary. To the extent that one agrees with their view of the facts, the depth response portions of the report provide examples to support that view. Opponents of their orientation might question' their selection or whether they used any procedure which tended to elicit responses they pre- ferred. Lacking interview transëripts, there is no way of judging these points. Payne and Payne provide their readers with a very limited description of the interview procedures used. We would like to know: How were the opinions of the respondent recorded? Was the exact wording of the questions labeled "core questions" used or were any modifications in delivery allowed? What was the procedure when a respondent refused an interview? Were call backs made? ` ` `` 2 For example, see Robert Lane, PoUticaZ flZeoZogy, Free Press 19. PAGENO="0169" 163 How many times were questions repeated in the interview if a satisfactory answer was not forthcoming the first time? What procedures were used when the respondent could not hear the questions properly? THE RESULTS It is important, when interpreting the results obtained from this survey, to keep the following considerations in mind: The survey was an appropriate first step in a larger study plan. It could have served well as a pre-test to be followed up by a more scientifically constructed survey. The results obtained are not "projectahie" since they cannot be used to make estimates of a larger population than that surveyed. Those dealers sampled were NHAS member only, which is only about half the universe of hearing aid dealers in the U.S. The technique used does not allow for an adequate representation of ear special- ists, audiologists or hearing aid users who do not live or work in areas of heavy concentration of hearing aid specialists. The interspersing of their "core" questions with other questions (which varied from interview to interview) has introduced important biases into the data which are acceptable for a pre-test but not for a final study. In sum, while the study by Payne and Payne presents some useful informa- tion about hearing aid dealers, audiologists, ear specialists, and users it cannot be regarded as a conclusive or very scientific study of the attitudes of the people who compose these groups in the United States. Senator PERCY. I will quote this. "While the study by Payne and Payne presents some useful infor- mation about hearing aid dealers, audiologists, ear specialists and users, it cannot be regarded as a conclusive or very scientific study of the attitudes of the people who com'~ose these groups in the United States." The review of the Payne and Payne sampling techniques finds also that "the size of the samples drawn was too small to allow for valid estimates of the population of hearing aid dealers, ear specialists, audiologists, or users. "Accordingly, even if random sampling design had been followed, the errors involved in making estimates from these size samples would have been so great as to have rendered the results of little practical value." * I know you are not in the survey business. Congressional Research is not infallible, but it does have a staff of outstanding experts who know the sampling process backwards and forwards. They have lived with it through the years. That judgment on their part is rather, damaging. I don't know if you would like to comment on it. Mr. FORTNER. Not without having time to analyze the report that you speak of. Senator PERCY. We will see a full copy of that report is made avail- able to you. If you care to comment on it, we will keep the record open so that you can. If you really believe in m~dica1 clearance, and I believe that you have taken the position that you believe in medical clearance, why would you allow the waiver? Don't you think it will be abused? So many persons desperate for hearing help will do anything to help themselves, including signing the waiver that may be `put before them by unscrupulous dealers. They are out to make a fast buck. They just may say here, sign this. But is it~ wise to permit that waiver? PAGENO="0170" 164 Mr. FORTNER. I believe that it is wise to permit a waiver. There are individuals in this country who for religious reasons do not wish to go to physicians. They are individuals that for many different rea- sons may prefer not to go to a physician. It could be very possible that they live in a very, very remote area,. where a physician or otolarynologist may not be readily available for them. I think that at this point in the gradual long-term process of chang- ing the possible hearing aid delivery system, I believe that it is im- portant to have a waiver included at this time. Senator PERCY. Are you concerned that the waiver provision might be an invitation to abuse of the medical clearance procedure? Mr. FORTNER. We are in the process of trying to establish some meaningful system for monitoring this. At this point we have not done so. Your committee will be advised when this is accomplished. Senator PERCY. A final question. You say that you have learned from the Retired Professional Action Group and the Payne and Payne recommendations that medical clear- ance must be initiated. If that is the case, why are you supporting such a weak medical clearance procedure? By taking this position, isn't it possible that the reputations of the persons you represent and wish to protect will simply be subject to additional charges of abuse? Mr. FORTNER. I don't believe so, Senator Percy. Mr. FELDMAN. Was Mr. Gertz mentioned by Ms. Burke this morning a member of your society? Mr. FORTNER. I do not know. May I ask Mr. Lee? Mr. LEE. We had no prior knowledge to this hearing that this specific name was to be mentioned. I have no way of checking it in advance. I will advise you. Mr. FELDMAN. Will you check that? I think it goes to the heart of what Senator Percy is talking about-who is under the umbrella of your organization and who isn't. That leads me to a second point,. Mr. Chairman. I am a member of the Wisconsin Bar and a member of. the District of Columbia Bar. I can be disbarred, I can be reprimanded, I can be censored. I am required to belong to those organizations in order to practice my profession. Are you in favor of a mandatory requirement for membership in some organization, it might not be your owfl, but an organization all hearing aid dealers would have to join. As members, they would be subject. to censor, reprimand or loss of their professional license if they do not follow a strict code of ethics or if they do not withstand scrutiny of trained investigators, auditors, or whoever might inves- tigate complaints against them? Mr. FORTNER. I would not object to a program of this nature; no, sir. Mr. CorrIN. Mr. Feldman, we have the 1975 directory of the Na- tiönal Hearing Aid Society. It shows Mr. Gertz to be a member at that time. Mr. FELDMAN. Did you receive any complaints or do you have that knowledge? PAGENO="0171" 165 Mr. LEE. I don't have that knowledge. Mr. FELDMAN. Could you please check your files and see if there are any complaints about Mr. Gertz and how they were handled? Mr. LEE. Yes. Mr. FELDMAN. Thank you, Mr. Chairman. Senator PERCY. Very good. Mr. GIGLIA. I would like to say that from all of the evidence I have, ~OU have a truly outstanding reputation in the Philadelphia area as a very competent hearing aid dealer, one who believes in establishing very high standards for yourself and your industry through the Philadelphia Hearing Guild. Senator PERCY. The staff tells me that you have been of great assistance during the course of the investigation and that you have also cooperated very fully with the Federal agencies working on the problem in the industry. You have the kind of public spirit that we can all be proud of. I want particularly to mention that although, with the very nature of news, you don't report on all the happy marriages, you report on the divorces; you don't report on the good dealers, you report on the bums. Constantly, I have tried through investigations in the nursing home industry and others to point out that there are truly outstanding people who are not exploiting the customers, who really care. I am very pleased indeed to have you here today. We aie reaching a very late hour. I have just a few other ques- tions for Dr. Heisse and Mr. Rickenberg. If there is anything you would like to state and say right now, in a brief manner? We are certainly happy to hear from you. Mr. GIGLIA. Senator, I just wanted to emphasize that I am now the chairman of the Consumer Affairs Committee for the National Hearing Aid Society. A n'iemorandum I directed to Mr. Fortner, president, describing the procedures that we are implementing a~ readily as possible is available for the record. I would like to say this to you so that you will understand how the consumer protection aspect of the four-point program is going to work. I will make this as brief as I can. [The memorandum referred to follows:] GREATER -PHILADELPIIIA HEARING AID GUILD, Philalelphia, Pa., March 1, 1976. To: Luke M. Fortner, President, NHAS From: Vincent J. Giglia. Chairman, Oonsumer Affairs Committee Subject: Consumer Protection Plan In January, 1976, you directed this committee to: (1) Review and evaluate our existing consumer protection programs. (2) Expand and improve where necessary. (3) Implement revisions as soon as possible. A review of our existing programs indicate that while most consumer offices of various citizen and governmental organizations have been pleased with our informal complaint referral mechanism as it has existed over the past years, they would welcome, support, and cooperate with common recommendations iiulicated by our study for improvements. (1) Creation or continuation and expansion of a coordinated organizational mechanism for consumer protection involving the National Hearing Aid Society, consumer special interest groups, and governmental agencies, federal, state and local. PAGENO="0172" 166 ~2) Guidelines to the participating agencies on how to foster immediate `~rclief and aid to a hearing aid user or non-user needing assistance or informa- tion. (3) Greater involvement of all participating groups at local levels to elim- inate duplication of complaints to various agencies resulting in confusion, duplication of work and in many cases, no help at all because each agency thinks the other will act. (4) Increase consumer information and educational programs with better distribution of educational materials. Utilize radio cooperation, consumer group publications, National Institutes of Health, and Better Hearing Institute information programs. (5) Additional consumer and governmental representation on an advisory council to make increased use of consumer calls, inquiries, and complaints as an information tool for policy and program development. Implementation of parts of this program have already begun. We are now preparing regional conferences with our state chapters and local guilds, and have extended invitations for participation on our advisory council to various citizen groups and governmental agencies. I believe we are well along the way toward implementation of a revised consumer protection program which will be efficient, open, and responsive to the hearing impaired, and to all concerned citizen groups and governmental agencies. Sincerely, VINCENT J. Gioi~i~, Cli airman, Consumer Affairs Committee. Mi GIGLI ~ To s'iy some consumer conipl'unts come fiom ques tionable sources is not the same as saying that they do not have any value. We fully understand our obligation to consider substance things as well as source. It is the substance of the complaints you relate to today that we are directing our fullest attention, regardless as to whether or not it is original, hearsay, direct or circumstantial. We will assume, as rational people, that the testimony presented is serious in nature and we shall ascertain all of the facts with respect thereto. Nothing would please me more than to be able to present to you an entire outline of our program. We are putting together and e h'inded out notices of an advisory council including repie sentatives from governmental agencies, consumer protection agencies, the various consumer advocate groups that have been springing up all over the country. My experience as an active consumer advocate has been that in many instances t.he consumer himself is neglected. What we are attempting to do with this program is, first, immedi- ately get aid to that consumer that needs help. We have found instances in researching under the direction of the National Hearing Aid Society that with the advent of this era of consumerism, many of these sincere and dedicated people have formulated their own consumer protection programs. We have found duplication in office after office that resulted in each office thinking the other was tending to the complaint. This has made my ~oh as chairman a little more complex than it would have ordinarily been. But the program we are designing is to insure that all consumer protection agencies. Federal. State, local, as well as all special interest consumer advocates proceed with us in an organized and systematic manner to provide and insure immediate relief and aid to our hearing ciii users. ITt will meet the consumers desire and need to be better informed about hearing health care and we hope to develop methods that will PAGENO="0173" 167 quickly resolve cases of dispute which create undue hardships for the hearing-impaired user. The second part :of the program is to institute programs whereby consumers, industry, and governmental representatives are brought together to discuss mutual concerns regarding specific issues in our industry and delivery systems. Each participant will be asked to in- crease his agency or group effort to establish and maintain meaningful dialog. Information as to number and quality of information calls or complaints will be monitored and distributed widely among persoimel of all agencies and groups for consideration in policy rulemaking and program planning and evaluation. Each member of the advisory council will analyze and compare for coordination of methods and approaches for responding to consumer inquiries and complaints. They would review with each other success- ful techniques which could improve its complaint handing methods. As you can see, the program I have undertaken is very complex. The problem you are relating to today is very complex. In Philadelphia, we have been doing this for the last 2 or 3 years. National has been study~ ing it as a pilot program. We know it can work. It is going to take participation of people like yourself, getting us the information and telling us the areas that you want to specifically key in on. I have extended an invitation to your staff to participate in the advisory council. I don't know whether it is ethical or not, but to my way of thinking, I would like to call a spade a spade. We are both looking to solve a problem. Why can't we all share the information we are getting and immediately direct our attentions to making that complainant a little more comfortable, and getting together and de- vising some sort of program to improve the present delivery system? If I may, Senator, I would like to see your staff, if possible, relate to the defining of the specific areas of the various disciplines invOlved in a good hearing health care delivery system. For example, let us take the basic facts and work with those. Society feels there is no one more competent than a physician to give medical clearance, point No. 1. Point No. 2, there is no one better qualified or better trained to test unaided hearing for medical diag- nostic purposes than the clinical audiologist. No. 3, a fact, there is no one more expert in testing to select an appropriate instrument than a dealer who has been out there 5, 10, 20, or 30 years, dedicated to serving the public. I think an interrelation of these three, but first of all, a specific definition of the areas and the role that they should play, would lead to more meaningful dialog and then we could say let us improve our delivery system, which would be far better than to destroy and rebuild it. Changes, as you know, do not come easily to anyone. Usually, this has been the problem. Our studies have shown, in the last 30 years, the various discipilines have approached each other with a complex dialog and expect the other discipline to answer back as simply as possible. I think more effort into an investigation of the role that the dis- ciplmes play would lead to identif~ mg the exact problem th'~t exists The industry is under microscopic examination. I am sure we will agree sir, that any type of microscopic examination is going to show PAGENO="0174" 168 flaws. We know the flaws are there. We will admit they are there. We are working the best we can to eliminate them. 1 think the specter of governmental intervention has brought about more constructive changes than any rules or lawmaking or any hierachy regulation that we could implement. Senator PERCY. Thank you, very much indeed, for that observation. I think it is extraordinarily helpful and understanding. The spirit of working together, as you evidenced, is just exactly the kind, of a reach out that I have tried to extend. I think we are on the same wave length and we want to accomplish the same thing. I have just a 2-minute-summary statement to wrap up my conclu- ~ions so far as these hearings are concerned. I would like to give it, but I have no further questions of my own. Mr. Feldman, do you have any? Mr. FELDMAN. No, I don't, Mr. Chairman. Thank you. Senator PERCY. Mr. Statler? I would like to say that during the past 2 days of hearings, we have heard from doctors, audiologists, prosecutors of unscrupulous hearing aid dealers, and hearing-impaired persons themselves with the same common message that we cannot ignore. Namely, that 20 million hear- ing-impaired Americans are being denied top-flight treatment by a delivery system that simply is not working. Many caught up in~this system have .paid a high price financially, emotionally, and medically. We hear them loud and clear and we plan to help. To counter this, all I hear from the Food and Drug Administra- tion-I have to base it on the bottom line on* what the end result we get from the numerous requests which have been made-are just promises, promises. In January, the agency said regulations would be out any moment. Yet, 3 months have passed and there is still no action. I will be contacting Commissioner Schmidt next week to make sure he understands the importance that this subcommittee of the `Senate places on adoption of loophole-free medical clearance policy. At the same time, I plan to closely monitor the actions of the Federal Trade Commission to make sure that it acts in a timely manner to ban door-to-door sales of hearing aids and to require a 30-day trial period. Today, we conclude the first phase of our inquiry into problems associated with the hearing aid delivery system. The subcommittee now turns to the issue of hearing aid prices and the technology of hearing aids. I intend to pursue this matter until I am satisfied that the hearing-impaired of this Nation are receiving reasonably priced, quality professional care. That certainly is an objective that I would hope and sincerely believe that many of us in this room share and to the extent that we have helped define in these hearings the common goals and common objec- tives that we have, I think that the hearings have served a very useful purpose indeed. If there are nor further questions, the hearings are adjourned until' further call of the Chair. IWhereupon, at 1 :20 p.m., the subcommittee recessed, to reconvene subject to the call of the Chair.] PAGENO="0175" APPENDIX~ EXHIBIT No. 42 GREATER PHILADELPHIA HEARING AID GUILD, Philadelphia, Pa., March 1, 11176. To: Luke M. Fortner, President, NHAS From: Vincent J. Giglia, Chairman, Consumer Affairs Committee Subject: Consumer Protection Plan In January, 1976, you directed this committee to: 1. Review and evaluate our existing consumer protection programs. 2. Expand and improve where necessary. 3 Implement revisions as soon as possible. A review of our existing programs indicate that while most consumer offices of various citizen and governmental organizations have been pleased with our iii- formal complaint referral mechanism as it has existed over the past years, they would welcome, suppOrt, and cooperate with common recommendations indicated by our study for improvements. 1. Creation or continuation and expansion of a coordinated organizational mechanism for consumer protection involving the National Hearing Aid Society, consumer special interest groups, and governmental agencies federal, state and local. 2. Guidelines to the participating agencies on how to foster immediate i-eUef and aid to a hearing aid user or non-user needing assistance or information. 3. Greater involvement of all participating groups at local levels to eliminate duplication ot complaints to ~ auous agencies resulting in confusion duplication of work and in many cases, no help at all because each agency thinks the other will act. 4. Increase consumer information and educational programs with better distri- bution of educational materials. Utilize radio cooperation, consumer group publi- cations, National Institutes of Health, and Better Hearing Institute Information programs. 5. Additional cOnsumer, and governmental representation on an advisory council to makO increas~d use of consumer calls, inquiries, and complaints as an informa- tion tool for policy and program development. Implementation of parts of this program have already begun. We are now pre- paring regional conferences with our state chapters and local guilds, and have extended invitations for participation on our advisory council to various, citizen groups and governmental agOncies. I believe we are well along the way toward implementation of a revised con- sumer protection program which will be efficient, open, and responsive to the hearing impaired, and to all concerned citizen groups and governmental agencies. Sincerely, VINCENT J. GIGLIA,' Chairman, Consumer Affairs Committee. EXHIBIT No. 45 A NATIONAL SURVEY OF THE HEARING AID DELIVERY SYSTEH IN THE UNITED STATES Based on data collected in eighteen population centers throughout the United States from June 10 to August 16, 1074. Conducted by : Payne & Payne ConsultantS, 929 Littlefield. Building, Sixth and Congress Avenue, Austin, Tex. .. (169) PAGENO="0176" 170 A NATIONAL SURVEY OF THE HEARING Am DELIVERY SYSTEM I. INTRODUCTION The growing controversy over the hearing aid delivery system in the United States, largely centered around the competence, practices, and ethics of the hearing aid specialist (dealer), has been characterized by a lack of bard, de- pendable information. Despite Congressional and state legislative hearings, and a variety of news stories and articles in the popular media, no clear picture has emerged of the practices of ear specialists (otologists and other physicians who specialize in problems of the ear), audiologists, and hearing aid specialists. Even less information has been assembled reflecting the needs and experiences of hearing aid users. Many people have professed to speak for them, but the voice of the hearingaid user has not been heard. I~iost serious has been the absence of information about attitudes: the struc- ture of motivations,: emotions, and rationalizations which stimulate behavior and characterize individual responses. Specifically, there has been virtually no dependable information on the attitudes behind the practices of ear specialists, audiologists, and hearing aid specialists as they interface with each other and with hearing aid users, or on the attitudes behind the response of hearing aid users to those practices, The opinions of spokesmen for the various groups have been contradictory; the surveys have been either incomplete or conducted by amateur groups using unscientific methods. The result is that in many parts of the country legislative authorities do not know whom to believe, and hearing aid users or prospective users do not know to whom they can safely turn for help. To satisfy the need for information and to provide insights which might be useful in improving the hearing aid specialist's services to the hearing impaired, the National Hearing Aid Society (NUAS) in the spring of 1974 commissioned a broad national survey to determine the nature and dynamics of the hearing aid delivery system, and the attitudes of those involved. Among its notable features: The survey was national in scope, and covered a systematic cross section of the population. The sample in each population center was designed to include ear specialists, audiologists, and hearing aid specialists, as well as hearing aid users. The survey technique was that of the depth interview; but each interview was built around a standard questionnaire which elicited comparable and measurable data, and at the same time provided free association stimuli leading to broader data on attitudes. The survey was independently conceived, planned, and carried out by Payne & Payne Consultants of Austin, Texas. The firm specializes in attitude research, and analysis of problems involving business and industry, science, and society. The background of the principals will be found in Appendix I. NHAS bad no input in planning the survey, and exercised no censorship over the findings con- tained in this report. Chilton Research Services of Radnor, Pennsylvania, developed the sample and served as a consultant. A description of the capabilities of this organization is also included in Appendix I. A. The sample The sample was designed to provide a systematic cross section of ear special- ists, audiologists, hearing aid specialists, and users throughout the United States. The Primary Sampling Unit (PSU) was defined as a town or city containing one or more members of the National Hearing Aid Society. The PSU selection was made by a Probability Proportional to Size (PPS) method. An nth inter- val was taken through the entire NHAS membership list, the interval being determined by the desired number of PSU's. The population centers in which the hearing aid specialists selected in the nth interval were located became the PSU's for the survey. All hearing aid specialists located in each of the selected PSU's were then randomly assigned to either a primary or secondary sample. The number to be interviewed within a PSU varied from two to six, depending on the total number of sample hearing aid specialists in the PSU. The average number interviewed per PSU was four. (The assignment of interviews was PAGENO="0177" 171 not accomplished by a strict probability method, but was rather an approxima- tion based on a PSU's relative proportion of the total.) The ear specialist and audiologist samples in the PSTJ's were developed in the field. In a PSU where there were three or fewer ear specialists, and/or three or fewer audiologists, their names were taken from the yellow pages of the telephone book and all were approached for interviews. In PSU's where there were four or more ear specialists, and/or four or more audiologists listed in the yellow pages, a random selection method was used. The number of inter- views per PSU ranged from zero to three for ear specialists, with an average of 1.2; and from zero to two audiologists, with an average of 0.94. The thinness of the ear specialist and audiologist samples was due to two factors: the small number who were practicing in certain areas; and in some areas their un- willingness to be interviewed. The hearing aid user sample in each PSTJ was also developed in the field through the use of a random selection method applied to the alphabetical files of the hearing aid specialists interviewed. To prevent ~iny possibility of manip- ulation of records, no hearing aid specialist was advised of ths procedure in advance, and the investigators had direct access to the files. The number of interviews per PSU ranged from five to 16 users, with an average of 10.2. The method of selection biased the sample to some degree in the direction of dealer- riented users, but the random inclusion of 64.1 percent who had visited ear specialists and 14.1 percent who bad visited audiologists provided a reasonable balance. Total number of complete interviews: Hearing aid users 184 Ear specialists 21 Audiologists 17 Hearing aid specialists 73 Total complete interviews 295 An additional 173 incomplete interviews contributed useful ideas and in- sights, but were not incorporated in the statistics. These incomplete interview-s included talks with elderly people whose physical or emotional state did not permit extended queries or discusions; talks with children who were too young to formulate useful statements of experience, opinion, or attitude; and ear spe- cialists and audiologists whose work loads or attitudes limited their cooperation. B. The method The depth interview was built around ~i questionnaire which had two func- tions: to elicit measurable, comparable data on practices, experiences, and opiri- ions; and to provide a set of stimuli which could be used in a controlled way to elicit associations ~nd explore the attitudes behind the practices of ear specialists, audiologists, and hearing aid specialists, and behind the responses of users to those practices. After the primary response to each direct question in the questionnaire was recorded, the individual was encouraged to elaborate on the primary response, with particular emphasis on feelings, emotions, and the rationale behind be- havior or intentions. Depth responses which occurred frequently were cate- gorized and tabulated. Other significant responses which occurred less frequently were used to explain or clarify related attitudes. Hearing aid specialists were interviewed in their offices. Twenty percent of ear specialists, audiologists, and hearing aid users were interviewed in their homes or offices; 80 percent were interviewed by telephone. The average length of the interviews was 60 minutes. To avoid problems of training, language, and approach which might have clouded the accuracy of data and interpretation, all the interviews were con- ducted by the two principal investigators who designed the survey. Interviews were conducted from June 10 to August 16, 1974 in 18 population centers located in 15 states. The towns and cities ranged in size from 11000 to 1.950,000. In this report, the section on the hearing aid user is presented first to estab- lish the nature of the central problems This section is followeci by those profilm~ the ear specialist, the audiologist, and the hearing aid specialist. Each section is divided into two parts: 79-9~4-T6----12 PAGENO="0178" 172 A. A statistical profile and depth interview itnalysis which (1) presents tab- ulations of specific answers to the core questions, and (2) summarizes key attitudes expressed by the respondents in the depth discussions; B. Conclusions of the investigators based on the profile and analysis. Samples of the core questionnaires are incorpor~tted in Appendix II. II. THE HEARING AID USER A. ~t.atistical profile and depth interview analysis (base: 184 interviews) Question 1: (a) How long have you used a hearing aid?. (b) How many aids have you owned? Primary response: Percent 1 year or less (32) 17~ 4 More than 1 year but less than 5 (43)_ 23. 4 5 years or more but less than 10 (38) 20. 7 10 years or more (68) 36. 9 Can't remember (3) 1. 6 Average number of years (181 respondents) (years) 9.9 1 .aid (54) . 29. 4 2 aids (36) 19. 6 3 aids (17) 9.2 4 aids (10) 5. 4 5 or more aids (24) 13.0 Can't remember (43) 23.4 Average number of aids owned (for 141 respondents) - 2.5 Average life of hearing aid (based on information from 141 respond- ents) (sears) 3. 9 Depth response : Of the hearing aid users interviewed, 81 percent bad worn aids for more than one year; 36.9 percent had worn aids ten years or more. They were generally familiar with the operation of their aids, and with the principles of routine maintenance. In most cases they had definite ideas and strong feelings about hearing aids and the hearing aid delivery system, and were willing to.. discuss their experiences with great candor. Question 2: In addition to the hearing aid specialist, whom did you consult about your hearing loss? Primary response: Percent General practitioner (9) 4, 9 Ear specialist (90) 48. 9 Audiologist or hearing and speech (ll&S) clinic (8) . 4. 3 General practitioner and ear specialist (7) 3.8 General practitioner and audiologist or H&S clinic (2) 1. 1 General .practitioner, ear specialist, and audiologist or H&S clinic (4) 2. 2 Ear specialist and audiologist or H&S clinic (12) 6. 5 Hearing aid specialist only (52) 28.3 Of the total sample: General practitioners were consulted by (22) 12. 0 Ear specialists were consulted by (113) 61.4 Audiologists or H&S clinics were consulted by (26) 14. 1 Hearing aid specialists were consulted by. (184) 100. 0 Depth response: Among the users interviewed all but 283 percent had consulted a general practitioner an ear specialist or an audioligist as ~ eli as a hearing aid spe cialist, about their hearing problem. . . in some instances there was a lapse of a year or more between the medical consultation and the purchase of the first hearing aid, but for most users the medical findings were an important factor in their decision. The high percentage (61.4 percent) of those who bad consulted. an ear spe- cialist may~ well be related to the high level of anxiety observed amohg .those. who have hearing problems (see page 15). After the anxiety is allayed by a PAGENO="0179" 173 medical examination, however, interest in the qar specialist diminishes. Only 9.2 percent of users interviewed plan to return to an ear specialist before pur- chasing their next hearing aid (see Question 9, page 19). However, some users reported a continuing and constructive sharing of responsibility between the ear specialist and the hearing aid specialist. In the words of one user: "It is ha- portant if you have a hearing loss to accept it and work with competent pro- fessionals to make the best use of your remaining lienrilig ability. My doctor and my dealer work together to help me." Question 3: How was your loss diagnosed? Primary response Percent Seasorineural (131) 71.2 Conductive (17) 9. 2 Combined loss (8) 4. 4 Don't know (28) 15. 2 Depth response: Discussions with users having sensorineural loss provided a clue to the difficulty of the task of evaluating and fitting hearing aids, and to one of the reasons behind the need for continued counseling (see page 14:). Among the special problems described by users with sensorilleural loss were: varying re- sponse to ~and tolerance for their hearing aid; extreme* sensitivity to sound; the unpleasantness of certain sounds; sounds which were loud but unintelligible; difficulties in understanding speech; and the emotional response to these problems. Users say these problems not only persist; they tend to worsen with time, and the counsel and encouragement of their hearing aid specialist (or, in a few instances, their audiologist) have been the most important factors leading to. a satisfactory solution. Adjustment to wearing an aid may t'ike a month 01 ~ year and e~en aftem it is complete problems tend to recur. At one time, a slight change in the shape of the ear mold may be needed; at another, experimentation with vo'ume or tone settings may be effective; at still another, a modification of listening habits may be required. But the essential ingredients are patience, continued counseling, and the willingness of both user and hearing aid specialist to try and try again. Question 4: What was your first reaction to your hearing aid? Primary response: . P~~CCflt Sounded natural (79) 42.9 Too loud (24) 13. 1 Tinny/raspy (10) 5.4 Other negative comments (51) 27. 7 Tooloud and other negative comments (2) 1.1 Too loud and tinny/raspy (1) . 5 Can't remember (17) 9.3 Depth response: The unexpectedly large ratio of users who said they found the sound of their hearing aid to `be "natural" was puzzling until associations began to emerge. Most users were translating "natural"* into "acceptable," and they fell, into three. distinct . categories which included virtually all these respondents: those who had very mild losses and needed only slight amplification; those with severe losses who were delighted to be able to hear anything at all; and those who bad been carefully indoctrinated before' and during the adjustment period. Users in this last category- were matter-of-fact in their acceptance of an unpleasant truth about hearing aids: At best they are a `crutch, and the quality of sound experi- enced by the user can never approximate natural hearing. Question 5: Have you had trouble with your ear mold? ` ` Primary response: Percent Yes (68) 37. 0 No (107) 58. 1 Don't use mold (9) 4.9 PAGENO="0180" 174 Depth response: According to the responses of users, ear molds are a frequent and, in some eases, a recurring annoyance. They are hard to get used to; they *often cause irritation; they may fall out when the user laughs or coughs or eats; if they are not placed precisely, they are likely to cause the'aid to emit a whistling sound; and they are traps for ear wax. Some users find them hard to keep clean: some find that they harden and crack easily; some find that they cause a feeling of pressure or fullness in the ears despite in all efforts at adjustment and cliiidreii tend to outgrow them faster than shoes. Users report, however, that hearing aid specialists are patient and reliable about adjusting ear molds, and will replace them with little or no charge. Some users report excellent results from mOlds made of soft material; and others report good results from various experiments with valving. Question 6: Who helped you adjust to amplified sound? Primary response: Percent Ear specialist only (1) 5 Audiologist only (3) 1.6 Hearing aid specialist only~ (101) 55.0 Ear Specialist and hearing aid specialist (1) .5 Audiologist and hearing aid specialist (2) 1. 1 No one helped (74) 40.2 Can't remember (2) 1. 1 Depth response: The interviews revealed the crucial importance of early instruction in how, to listen to amplified sound. This is particularly critical for the individual with a serious loss, or with a loss which affects discrimination and intelligibility of speech. Users who have made good adjustments report that by controlling the listening situation; by regulating their position in relation to the sound source; by positioning the microphone; by watching lips and gestures; by attending care- fully to the sense of a conversation and not permitting their thoughts to wander; and in many other ways they can use their eyes aiid brain to assist their ears. But more than 40 percent of the users said they had to learn these things for~ themselves, and some have not learned at all. One user stated: "When I first put on a hearing aid it was not a pleasing sound, and I thought at first I wouldn't be able to stay with it. But there was something the dealer had impressed on me-that I must stay with the schedule hehad given me if I wanted to get the benefit from it-and it worked." In the words of another: "I learned to listen with my eyes as well as my ears. If I can see you, I can hear you." From a user with a severe loss: "I use lip reading and watch people's expres- sions. Also, if I miss a word, I can pick up the meaning from the rest of the sentence." Of the 26 users who bad been through audiological testing and evaluation, only five (19.2 percent) said they had received instruction in listening to amplified sound. Of the 184 users who had been to a hearing aid specialist, only 104 (56.8 percent) said they had received instruction in listening to amplified sound. The record of the hearing aid specialist Is better than that of the audiologist, but both need to reexamine their instruction methods and practices. In the depth interviews virtually all audiologists and hearing aid specialists stated that they give instruction to their clients in how to listen to amplified sound; but appar- ently there are lapses, or the techniques used, in many instances, are ineffective. Question 7: Has the hearing aid specialist been helpful to you when you have gone to him for service? repairs? consultation? Primary response: Service: Percent Yes (153) 83.2 No (10) 5.4 Mixed experience (8) 4.3 No opinion (13) 7.1 PAGENO="0181" 175 Repairs: Percent Yes (125) 67.9 No (6) 3.3 Mixed experience (8) 4.3 No opinion (45) 24. 5 consultation: Yes (137) 74.5 No (5) 2.7 Mixed experience (8) 4. :~ No opinion (34) 18. 5 Depth response: The need for continuing service was emphasized by over 75 percent of those interviewed. Regardless of how long they had worn their aids, users frequently reported that removal of wax from an ear mold, removal of corrosion from con- tract points, or even replacement of worn-out batteries can be an ordeal. Users rely heavily on the hearing aid specialist to take care of such minor problems, as well as more serious adjustments or repairs. Users were generally high in their praise of the quality of service the dealer provides. Of the ten users who were completely dissatisfied, seven bad encountered one or another of the four unethical hearing aid specialists discussed on page 18. Eight other users expressed dissatisfaction with the service provided by one ~hearing aid specialist, but were satisfied with the service of one or more others. Of those interviewed, 67.9 percent approved of the hearing aid specialist's re- pair service. Two users complained about excessive charges for repair jobs; two protested excessive delays ingetting their aids back; two clients of a hearing aid specialist operating under a low-cost plan have repeatedly sent their aids in for repair, but reported that those repairs have not been satisfactory; and eight ~others reported one bad experience along with one or more satisfactory~ experi- ences. Several users expressed puzzlement as to why aids had to be repaired at the factory instead of at the dealer's establishment. But most reported that aids held ~up well after being returned from the factory, and many compared the high cost of hearing aid repairs to the high cost of repairs for everything from watches and radios to washing machines or automobiles. Three-fourths of the users reported favorably on the counseling they. received from hearing aid specialists. Most stated that it was the single most important factor in their adjustment to their aid. Five were dissatisfied because they had received no counseling. Eight others had been disappointed in the quality of coun- seling they had received from one dealer, in contrast to satisfactory counseling they had received from others. Thirty-four had no opinion when first asked, but In the depth discussions they generally expressed approval of the counseling *they had received. Many tended to be shy in discussing counseling, considering it to be a very personal relationship with the hearing aid specialist. There appeared. to be no relationship between the length of time the user had ~worn a hearing aid and the need for counseling. A few, users wear an aid out of the hearing aid specialist's office, and never require counseling to make a satis- factory adjustment-but this is rare. Some users said they visit their dealer for service and counseling as often as once a week; others said they see him no more than once a year. The average was approximately six times per year. Since consultations generally range from 20 to 30 minutes, this is in line with the hearing aid specialist's estimate that his average client requires 11.7 hours of post-fitting service and counseling over the 4.5-year life of the aid (see pages 55 and 56). * A clue to the intensity and persistence of this need for counseling, and the dependence of the average user on the patience and skill of the hearing aid spe- cialist is the high level of anxiety manifested by the majority of users when their hearing loss and their aid were discussed. Four principal sources of this anxiety were revealed in the depth interviews: the mysteriousness of the hearing loss itself; the fragility of the aid; the effects of amplified sound on the abnormal ear; and the possibility of being deprived of the aid through its failure, through an accident, or because of the economic inability to replace it. The most painful source of anxiety seemed to be the fee1in~ that heariiie nrnb lems are inside the head-unlike eye problems, which are felt to be ovtside the head; Problems which.are felt to be inside the head seem to be more frightening. PAGENO="0182" 176 The aid itself is a continuing source of uneasiness. Users think of it as a delicate instrument which requires careful handling, is difficult to adjust, and is easily damaged. They reported that a speck of dust, a drop of moisture, a tiny displacement of the ear mold, or a bad connection can lead to sudden failure, or to a distressing variety of whistles, squeels, pops, and other unpleasant noises- most of which come suddenly without warning, and are often unpleasantly loud. For a few users who have severe or complex nerve losses, even the best aid fitted to perfection may be a borderline solution-sometimes barely tolerable un~ler noisy listening conditions. For others who are unusually sensitive to certain pitches of sound, the apparently simple problem of adjusting the volume or tone control can be a difficult one. To still others, the loudness of sounds is not a prob- lem, but the intelligibility of words and phrases is elusive. Such people are either straining to hear, defending themselves against unpleasant sounds, or groping through a confusing mixture of sounds to find the meaning of spoken words. For many users on reduced incomes, the fragility of hearing aids can pose a serious problem. To replace an aid would mean a financial strain, so they tend to overreact to even slight variations, real or imagined, in the performance of their hearing aids. To these anxious people the easy accessibility of the hearing aid specialist; his understanding of their problems; his skill in problem solving; his willingness to continue working with them until the problem is solved; and the fact that be does not charge for this counseling over and above the price of the aid-all of these factors contribute to their satisfaction and peace of mind. Nearly all those interviewed look only to the bearing aid specialist for counsel- ing and problem solving. Those who bad visited audiologists reported that the audiologist provides some counseling, but that most of this responsibility is car- ned by the hearing aid specialist. The need for home service was emphasized by about 40 percent of those inter- viewed. In the PSU's serving rural areas, the percentage was much higher. Those who are permanently bedridden or housebound, temporarily ill or crippled, or who live in areas remote from the ear specialist, audiologist, or central office of the hearing aid specialist, consider house calls a necessity. They are gratified that hearing aid specialists make home calls. Question 8: Do you feel you had a fair deal in purchasing your hearing aid? Primary response: Percent~ Yes (147) 79.9 No (13) 7. 1 Mixed experience (16) 8.7 Not sure (8) 4. 3 Depth response: Users in most areas were aware that hearing aid specialists have been under attack by consumer groups, and some knew that audiologists have been involved in those attacks. In the depth interviews, these attacks were discussed and users were asked to comment on specific charges-overpricing, exaggerated claims, pressure sales tactics, contract violations, faulty service, gouging on the cost of repairs, and other violations of good business ethics. Of those interviewed, 79.9 percent could remember no instance of unfairness in all their dealings with hearing aid specialists; 8.7 percent said they bad been. treated unfairly by one or more, but not by all bearing aid specialists; 7.1 percent said they bad been treated unfairly by all the hearing aid specialists with whom they had dealt; and 4.3 percent were unsure whether their treatment had been fair or unfair. The reported examples of unfairness ranged from incidents of neglect to a few serious charges of price gouging or dishonesty. *Serious complaints were remarkable for their rarity. There was no evidence of widespread gouging or unethical practices among hearing aid specialists. In the entire sample, only four hearing aid specialists (5.5 percent) were accused of unethical or dishonest practices. The subject of price was frequently mentioned, but usually in the context of inflated prices for everything. One common allegation against the hearing aid specialist made by some audi- ologists is that he often sells two hearing aids (binaural) where one would do. But the investigators found only one user who complained about being sold a binaural aid. In general, those who had bought them were pleased with them. PAGENO="0183" 177 According to one user: "I started with one aid-then I tried the binaural aid. It was wonderful. For me it was worth the cost." In the words of another: ~`The biggest difference was introduction of the binaural aid. Before that I couldn't get a sense of direction." Discussion throughout the user interviews reflected approval of the willingness of the hearing aid specialist to experiment and try new approaches to solving hearing problems. The close working relationship which develops between the user and the hearing aid specialist makes this possible. QuestiOn ~9: When the time comes for a new aid, wifl yon go first to an ear specialist? an audiologist or clinic? a hearing aid specialist? Primary response: percent Ear specialist (17) 9.2 Audiologist or clinic (14) 7. 6 Hearing aid specialist (125) ~ 0 Not sure (28) 1~. 2 Depth response: Perhaps the most revealing judgment of the hearing aid specialist as a member of the hearing aid delivery system lies in the answers to this question. Whereas only 28.3 percent (52) elected to go directly to a hearing aid specialist when they became concerned about their hearing problem (see page 8), 68 percent (125) of current usersnow `make `this electiOn. Whereas 14.1 percent (26) elected to visit an audiologist (or hearing aid speech clinic) below going to a hearing aid special- ist for their first aid, now only 7.6 percent (14) make this election. And whereas 61.4 percent (113) elected to consult an ear specialist, now only 9.2 percent (17) stated they would so elect. Many reasons were advanced for this change in attitude. In many users the dislike of doctors' offices and clinics is strong. Others failed to see the benefit of extensive audiological tests. Still others said that once they were satisfied there was nothing diseased about their ears, they saw no need to return to an ear specialist. But for most users the deciding factor was the hearing aid specialist's counseling and service. As one user stated: "I am not buying a hearing aid; I am buying the kind of service I can't get anywhere else." According to another: "I prefer to work with a dealer-with one man. A hearing aid is a very private thing." Said another: "In the doctors' office I get tied up in knots and can't hear anything." Question 10: How could the hearing aid specialist's service to you be improved? Primary response: Percent Could think of no way (115) 62. 5 Made practical suggestions (27) 14. 7 No opinion (42) 22. 8 Depth response: This question elicited a bitter response from two users who felt they had been severely cheated; the remainder took the question literally and addressed them- selvestO a consideration of practical ways in which service could be improved. In the total sample, 62.5 percent could think of no improvement; 14.7 percent made practical suggestions; 22.8 percent had no opinion. Users' suggestions included: a trial period for new aids; stocking more spare' parts so that the hearing aid specialist can make more repairs himself; improve- ment in ear molds; more and better training in the use of hearing aids; group classes for teaching the use and care of aids; more research in hearing problems;' a telephone service to handle problems which develop over weekends; and a central clearinghouse for complaints. Question 11. Are you now having trouble with your hearing aid? Primary response: ` Percent Yes (33) 18. 0 No (120) 65. 2 Not sure (31) 16. S PAGENO="0184" 178 Depth response: Of the 33 users (18 percent) who reported present problems, only four were having problems which the hearing aid specialist had been unable to solve. Two of these users had purchased their aids through a low-cost plan and had been unable to get satisfactory service and repairs (see page 14). Twenty-four users were having minor problems which they were planning to discuss with the hearing aid specialist or problems which he was already working to solve. Five users had aids out for repair at the time of the interviews. The four with the unsolved problems seemed discouraged; the 24 regarded their problems more or less matter-of-factly; of the five who bad their aids out for repair, two felt that they were having to pay too many repair bills. B. Conclusions of the inivestigators 1. The partial loss of hearing is a uniquely disturbing and frustrating experi- ence, often accompanied by irritability, withdrawal, or intense, persistent anxiety. For reasons which are not entirely clear, many people who have a hearing loss feel that the loss is somehow shameful and socially unacceptable. They refuse to admit it as long as possible, and some never overcome an associated feeling of embarrassment and defensiveness. A complicating and contributing factor is that marital partners, children, relatives, friends, and business associates of a person with a hearing loss often find the handicap irritating, and tend to be impatient and lacking in empathy. In many cases this reaction arouses stubbornness which can delay the decision to use a hearing aid, and make adjustment to the aid more difficult. Depth discussions revealed that hearing problems are felt by many users to be mysterious and frightening. They were willing to talk frankly about their experiences with hearing aids, but the discussions revealed a high level of anxious concern about hearing-connected problems in the majority of those interviewed. Tins anxiety seemed to be more acute in the very young and the very old, especially in those with severe losses. A hearing loss is a source of continuing distress. The person with the loss is likely to feel that he is either: straining to hear; shrinking from unpleasant sounds; straining to separate meaningful sounds from background noise; or straining to grasp the sense of words which are loud enough, but whose meaning is distorted. 2. A hearing aid, at best, is a crutch, and with few exceptions the user must Undergo a lengthy adjustment period before he can wear the aid with optimum sn tisfaction. Unlike eyeglasses which can enable most wearers to see with near normal vision, a hearing aid can only make sounds louder, and restore a fraction of the balance between high and low frequencies. Consequently, the hearing aid user must learn to. accpt a permanent reduction in hearing ability, and in the quality of sound that he hears. Lack of understanding of this fact on the part of the user can delay or make difficult his adjustment to wearing a hearing nicl. Reasonable expectations are almost as important as accurate fitting of the aid itself. The points which need to be stressed prior to fitting and reinforced after fitting include: Hearing aids have definite limitations. Hearing aids cannot restore lost hearing ability. Hearing aids cannot recreate "natural" sound. Hearing aids cannot restore all the ability to separate meaning from back- ground noise. Hearing aids cannot entirely offset the effects of a nerve loss which tend to n~ke speech unintelligible. The greater the loss, the greater the compromise the user must accept. In all but a very few cases, the adjustment period will extend over several weeks or months. During this time the new wearer should be taught not only how to use, adjust, and care for the aid, but also how to listen to amplified sound. Another problem is that in amplifying sound to offset a hearing loss, the hearing aid itself may create new problems. For example, in some forms of less there may be a reduced response to sound up to a certain intensity threshold; PAGENO="0185" 179 then suddenly there is full response. Consequently, if the aid attempts to am- plify the low intensities to audibility, a sudden high intensity sound will be so loud as to be unpleasant or unbearable. As one user phrased it: "Everything is pianissimo or fortissimo, and nothing in between." In other cases there may be greater sensitivity to certain frequencies than to others, and any considerable degree of amplication is likely to produce unpleasant effects. When problems such as these are encountered, the best that can be achieved is a compromise which may involve the design of the aid, the power of the aid, the type of ear mold, the type of valving or venting, precise adjustments of tone and volume controls, and outright avoidance of certain listening situations. 3. But even after an initial adjustment is achieved, most users continue to experience a variety of problems. Perhaps the salient finding of this survey was that. for the average user, continuing counseling and personal service are ab- solute essentials. While it is true that some users will wear an aid for many years with only occasional need for service or repairs, most users experience a succession of problems-mechanical physical. and psychological-which re- quire wise and patient counseling and encouragement, and the ready availabil- ity of service. Specifically: The anxious user needs reassurance and encouragement. The user with a difficult-to-fit loss needs continuing assistance to keep the performance characteristics of the aid in line with the nature of the loss. The user with physical problems-excessive wax or perspiration, sensitivity to the mold, etc.-needs frequent small but essential services. The elderly user who is forgetful or physically unable to carry out simple maintenance procedures needs a wide range of counseling and services. The proud or stubborn user may be difficult to reach, but he may be the most painfully isolated, and the most dependent of all on patient and perceptive counseling. For many users the need for service tends to increase-not decrease-with the length of time an aid has been worn. 4. Users interviewed look almost entirely to hearing aid specialists for counseling and service. Their reasons are: They find clinics and centers are hard to reach and cold and impersonal. Once they p-ct there, they resent the long waits and the feeling of being hurried when their turn comes. They feel that audialogists: have little interest in their post-fitting problems; do not understand their post-fitting problems; discourage them from coming back for checkups after the first few weeks. except for an annual checkup; charge too much for consultations; are unfeeling in refusing to make house calls, especially when the client is ill or bedridden. They find that hearing aid specialists in general: are easily accessible; are friendly and provide personal service; understand their post-fitting problems; are willing to provide countinuing counseling and service at no extra charge; are willing to make house calls. 5. A major source of complaint among users is that repairs take too long. Less frequent but substantial is the complaint that repairs are too expensive. Two factors seem to be at the root of this problem. Hearing aids are not generally designed tO permit easy replacement of worn or defective parts. Few hearing aid specialists are trained or equipped to handle repairs locally; the aids have to be sent to the factory. A comparable situation would be if all eyeelasses, or radios and television sets had to be transported to the factory for repair. A trend toward modular design, and/or the development of local or regional repair facilities would greatly ease this problem, and reduce the "down time' for the average aid. ~. A small percentage of users have been cheated by dishonest hearing aid specialists, but the great majority regard their hearing aid specialist not only PAGENO="0186" 180 as ethical and honest, but also as a friend. They tend to establish strong personal relationships with him, and these relationships are likely to endure over a number of years. It is not uncommon to find an individual who has worn hearing aids for twenty years or more, and has done business with only one or two hearing aid specialists. Nevertheless, stronger efforts need to be made to enforce the licensing laws and laws against fraud, and to increase compliance with the ethical stand- ards established by the National Hearing Aid Society. The unethical hearing aid specialist and consultant must be dealt with and eventually eliminated as a threat to the user. 7. High costs were discussed by approximately one-fourth of the users inter- viewed, but only a handful expressed the opinion that hearing aid costs were out of line with other medical costs-or with costs in general. They know the hearing aid specialist, visit his office or receive his visits at frequent inter- vals, and generally have some knowledge of his standard of living. There was no feeling in evidence that he is making exorbitant or unreasonable profits. 8. Loyalty to the hearing aid specialist was remarkable in its consistency. Once the aid is fitted, the ear specialist and the audiologist fade into the back- ground, and the hearing aid specialist is the one users turn to for advice and service. Few had any practical suggestions for improving his service. 9. Five of the 26 users who had been to audiologists expressed the same feeling of loyalty to them. Three of these users have had excellent experiences with a particular hearing and speech clinic in a large eastern city, and will continue to go there for annual checkups and for recommendations for new hearing aids. 10. In areas where there has been sustained publicity critical of hearing aid specialists, some users have switched to audiologists who are associated with low-cost plans; some have postponed buying a new aid; a few feel that they have been cheated in the past; but most are simply confused and uneasy. Generally, established users have stayed with their hearing aid specialist. A few who switched to low-cost plans have returned to their original hearing aid specialist because of his superior service. Apparently the hearing, aid specialists who are working under low-cost plans cannot provide the level of service most users have come to need and expect from traditional hearing aid specialists. Yet in some areas, these plans are compulsory for welfare and state rehabilitation clients. III. THE EAR SPECIALIST (Otologists and Other Physicians Who Specialize in Problems of the Ear) A. ~tatistieal profile and depth interview analysis (base: 21 interviews) Question 1: Of the patients who come to' you with hearing problems, what percentage are referred by general practitioners? audiologists? hearing aid specialists? Primary response: ` ` Percent Average percentage of patients referred by general practitioners 25. 4 Average percentage of patients referred by audiologists 2. 4 Average percentage of patients referred by hearing aid specialists 4. 2 Depth repsonse: The ear specialists interviewed do not consider themselves an integral part of the hearing aid delivery system. They see their role as that of a medical doctor whose specialty is the diagnosis and medical or surgical treatment of diseases, malformations, or traumata of the outer,' middle, and inner ear. They have established their primary relationships with other physicians, and receive 25.4 `percent of their referrals from them. Only a handful of referrals (6.6 percent)' come from hearing aid specialists or audiologists. Question 2: TYlien a patient has a simple hearing los.q and can benefit by the vse of a hearing aid, what percentage `(10 ~/ou r~fer directly to a hearing aid .~speciahist? an audiologist or hearing and speech clinic? Primary response: PAGENO="0187" 181 tIn percentj Referred to hearing aid Referred to audiologists specialists or clinics 7 ear specialists 100 0 1 ear specialist ioo 1 5 2 ear specialists 100 1100 1 ear specialist 90 10 1 ear specialist 80 20 2 ear specialists 25 4 earspecinlists 0 100 3 ear specialists could not provide a breakdown ------ Average percentage of referrals to a hearing aid specialist 73.3 Average percentage of referrals to an audiologist or -I. & S. clinic 38. 1 1 Some ear specialists refer some or all of their patients first to an audiologist, then to a hearing aid specialist Depth response: When a hearing aid is indicated, 12 of the 21 respondents send at least 75 per- cent of their patients directly to a hearing aid specialist without referral to an audiologist. These ear specialists say they do their own audiosnetric workups, and feel that for these patients no further audiological testing is necessary. They feel that the hearing aid specialist's procedures in connection with fitting, and his "fit and modify" method of hearing aid selection are satisfactory. Four of those interviewed make no referrals to a hearing aid specialist, but leave the decision to an audiologist. Each of these four has a staff audiologist or is associated with a speech and hearing clinic or center which has a staff audiologist. Once the final referral is made, the majority of ear specialists seem to consider their responsibility to the patient-insofar as hearing aids are concerned-to be. at an end. Only one ear specialist among the 21 interviewed makes a systematic effort to determine the long-range results of isis recommendations for bearing aids. Discussion frequently turned to the audiologist and his practices. Seven of the ear specialists interviewed feel that audiologists place too much emphasis on testing and evaluation procedures, and attempt to make it appear that the process is `scientific," and precise; whereas, in fact, much remains to be learned about the hearing process, and precise "prescriptions" for aids and molds are meaning- less. Eight of those interviewed said that they resent any implication that the audiologist's testing procedures are more dependable than those of the ear spe- cialist. They feel that the audiologist is exaggerating his role as he tries to carve a niche for himself at the expense of the ear specialist as well as the hearing aid specialist. Seventeen of those interviewed were flatly against the dispensing of hearing aids by audiologists and clinics. Among this number, four have conducted in-house cost analyses and have concluded that ~1ispensing through a clinic-with its high costs and preponderance of professional and technical personnel-is probably the most expensive method available. They see no way that it can be handled economically by the clinic or center without cutting service to the user. When the discussions turned to the hearing aid specialist, all the ear specialists interviewed shared two serious concerns. First, they believe that stricter licensing and more rigorous enforcement of the law are needed to eliminate the unethical. hearing aid specialist. Second, they believe a medical examination should be a prerequisite to fitting a hearing aid. Question 3: Considering only those hearing ma specialists with wlionm you work, and only those cases in which there is no medical complication, do you believe hearing aid specialists are competent to: (a) Administer hearing tests and evaluations for the purpose of selecting a hearing aid? Primary respOnse: Percent Yes (7) 33.3 No (8) 38. 1 Some yes/some no (3) 14.3 No opinion (3) 14. 3 PAGENO="0188" 182 Depth response: On the subject of testing and hearing aid evaluation by the hearing aid special- ist, the ear specialists were in sharp disagreement. Seven were in favor if there has been a prior medical examination by a general practitioner or an ear special- 1st; eight felt that an otological examination and an audiometric workup should be prerequisites to fitting; two felt that testing and fitting by a hearing aid specialist without a prior medical examination is acceptable in areas where ear specialists and audiologists are not readily available. All but two indicated that. audiologists, too, should be prohibited from carrying out testing and evaluation without a prior medical examination. All but one of the ear specialists said that the education of hearing aid specialists should be improved. The consensus was that a .twoyear course in an accredited institution resulting in an associate degree would satisfy the educa- tional need, and make cooperation between the ear specialist and the hearing aid specialist easier and more productive. Question 3: (b) Make an ear mold? Primary response: Percent Yes (20) 95. 2 Some yes/some no (1) 4. 8 Drath response: hone Question 3: (e) Fit an aid? Primary response: Yes (20) 95. 2 Some yes/some no (1) 4. 8 Depth response: None Question 3: (d) Help the client adjust to listening to amplified sound? Primary response: Yes (14) 66. 7 No (1) 4. 8 Some yes/some no (4) 19. 0 No oninion (2) 9. 5. Depth response: All but three of the ear specialists interviewed spoke favorably of the counsel- ing and service role of the hearing aid specialist, and 17 said that his willingness to provide unlimited counseling and service was a major factor in their sending patients to him. Discussions relating to this question revealed, however, that probably four out of five ear specialists have little firsthand knowledge of the problems of wear- ing a hearing aid, and little feeling of direct responsibility for these problems. Their interest is generally limited to medical and surgical considerations. Question 3: (e) Provide routine service? Primary response: P~flt Yes (18) 85. 7 No (1) 4. 8 Some yes/some no (2) 9 5 Depth response: The consensus among the ear specialists interviewed is that the hearing aid specialist is the logical man to provide continuing service, and that in general he carries out his responsibility in a satisfactory way. There were three dissenting opinions. Question 3: (f). Make repairs? Primary response: Percent Yes (19) 90. ~ Some yes/some no (2) 9.5 Depth response: Similar to question 3(e) above. Question 4: In your experience, are hearing aid specialists: (a) Generally fair in their charges? PAGENO="0189" 183 Primary response: Yes (14) - 66. 7 No (1) ~L S Some yes/some no (4) 19. 0 No opinion (2) ~ Depth response: Most of the ear specialists interviewed were frank to say that their answer to this question was based largely on hearsay, rather than observation or c9m- pl'unts from patients but the consensus was th'it although hearing ud puces * aie high, they are no higher than medical costs in general; and that alththigh a few hearing aid specialists charge unfairly, in general they are not overpaid. Three ear specialists were of the opinion that better and lower cost dispensing methods should be found. When asked about clinic dispensing, however, only two expressed a favorable opinion and two were undecided (see page 31). Question 4: (b) Ethical in their handling of clients' problems? \_L.X/ ~-) Depth response: Similar to question 4(a) above. Question 4: (c) Honest in Fulfilling guarantees and warranties? Primary response: Percent Yes (12) Z7. 2 No (1) 4.8 Some yes/some no (4) 19. 0 No opinion (4) 19.0 Depth response: Same as above, but a larger percentage had no information on which to base sin opinion or a factual response. Question 5: Have you noted improvement of hearIng aid specialists' knowledge ~tnd skills through improved training in recent years? Primary response: Percent Yes (10) 47. 6 ~o (2) 9. 5 No opinion (9) 42.9 Depth response: Nearly half the ear specialists interviewed believe that hearing aid specialists in their communities have definitely upgraded their skills in the last few years. The general feeling was that they like to work with hearing aid specialists, and want to see them improve their skills and their professional standing. B. Conclusions of the inve~tigators Traditionally, the ear specialist has worked closely with the hearing aid special- ist. He has been responsible for examination and diagnosis, medical or surgical treatment, and an audiometric workup if a hearing aid is indicated. The hearing aid specialist has been responsible for further testing in connection with the selection and fitting of a particular aid, and for continuing counsel and service over the life of the aid. This relationship still seems to be the most common, but the advent of the aucTiologist in recent years has brought about changes in practice in many areas. In some instances, the ear specialist has brought an audiologist onto the staff of his clinic or center to handle the audiometric workup; in others, he refers a percentage of his patients to an audiologist not on his staff for testing and hearing aid evaluation before referring to a hearing aid specialist; in a few instances he channels all his patients through audiological testing before they go to a hearing aid specialist; in a very few instances his clinic or center dispenses hearing aids, eliminating the hearing aid specialist entirely. Most ear specialists interviewed doubt that this latter trend will go very far. Generally, they were against dispensing by clinics or by audiologists on their staffs, and four have conducted studies which indicate that dispensing by clinics * Primary response: Yes (11'~ No (1' Some yes/some no (4) No opinion (2) Percent 66. 7 4. 8 19.0 9.5 PAGENO="0190" 184 is not~ economical. A stronger feeling seems to be that it is not a properuse of an audiologist's time to concern himself with hearing aid dispensing and service. Several of the ear specialists interviewed were concerned about the audio- logist's role and attitudes. They are annoyed at what they consider to be the brashness of some audiologists in claiming that their audiometric worküps are superior to those of the ear specialist. They question the claims of other aucliol- ogists that their testing and evaluation procedures are so accurate that they can make precise prescriptions for hearing aids. They feel that basic knowl- edge of hearing mechanisms is still so limited that no known method of testing will replace the painstaking fit and modify method of hearing aid selection. ~early half the eai specialists interviewed feel that their own audiometric workups are sufficient in most cases and that no further audiological testing is necessary before referral to a hearing aid specialist. Most ear specialists make little attempt to follow up on their patients who purchase hearing aids unless subsequent medical complications develop. But those who were aware of the post-fitting problems most users face were* con- cerned with the audiologist's disinterest in counseling, and his consequent, lack of feedback from hearing aid users. They feel that the hearing aid specialist should be encouraged-not dis- couraged-in his assumption of the responsibility for counseling and service. To all but one who had thought about it, the idea of replacing the hearing aid specialist by a system of clinical outlets is neither practical nor desirable. The ear specialists' basic objection to testing by the hearing aid specialist centers around the concept of diagnosis. They feel that if the hearing aid specialist performs hearing tests on a client and fits a hearing aid* without a prior medical examination, he is, in fact, taking the responsibility for saying that there is nothing medically wrong with the client. This, in their view, is medical diagnosis, and should be performed only by a physician. They feel this strongly, and in their judgment the hearing aid specialist has undermined his position by insisting on the right to test and fit without a prior medical examination. The ear specialists had little criticism of the hearing aid specialist on the price of hearing aids. As medical men, they are highly aware of the rise in all medical costs that has taken place in the last ten years. In general,~ they understand that the bearing aid specialist is selling a service package of which the hearing aid is only a part, and that his net profit on his over-all operation is reasonable. In general, the ear specialists interviewed want to see the hearing aid specialist continue in business: work more closely with physicians and audiol- ogists: do more self-policing to eliminate the few dishonest or unethical mem- bers of his group; and upgrade his education. They do not want to see the hearing aid delivery system changed to eliminate the hearing aid specialist in favor of a network of dispensing clinics and hearing aid centers. They do not want to see the audiologist dominate audiometric testing. They want the hear- ing aid specialist to continue to provide a wide range of counseling and service; and some would like to see the audiologist reassume his original role-the testing and rehabilitation of those with difficult hearing problems in which ~`iere are emotional or physical complications. IV. THE AUDIOLOGIST A. ~tatisticaZ profile and depth~ interview analysis (base 17 intervIews) Question 1: How many tests do you give yearly to clients with useful hearing abilitij?* Primary response: Percent 80 to 800 (6) 35 3 1,000 to 1,400 (5) 29. ~ 2,000 (1) 5. 9 3,000 (1) 5,000 (3) 17.6 No response (1) 5.9 Average tests given yearly (among 16 respondents) (tests) ~__ 1,812 * Includes some clients who are given only brief screening tests. PAGENO="0191" 185 Depth response: The majority of audiologists interviewed work in hospital or clinics or cen- ters, either alone or supervising one or more assistants. The work load ranged from 80 to 5,000 tests per year. Ten reported 1,000-5,000; seven reported 1,400-5,000; and four reported 3,000-5,000 tests per year. Those who process large numbers of clients have one or more assistants. Many audiologists' expressed concern about this work load and the causes behind it. Others expressed concern about its effects. Specifically: Causes One audiologist: "Our profession originally was concerned primarily with rehabilitation, and only incidentally with testing and hearing aid evaluation. Somewhere along the line the emphasis shifted to the technology and tech- niques of testing and research, with a strong emphasis on hearing aid evalua- tion-and rehabilitation has gone by the board. I resent the fact that with my work load I cannot do the counseling and follow-up I should be doing." Another audiologist: "We can't make a living in private practice. We have to join a clinic or center, and that means a work load so heavy it is ridiculous. For all practical purposes I have become a technician. I am not really practic- ing my profession." Effects One audiologist: "My job has become a production line. How can I, with two technicians to assist me, do justice to 5,000 clients a year? The answer is, I can't. Oh, I can screen and test them, and make a judgment of the kind of hearing aid they need if one is indicated, and I can offer to see them once or twIce afterward. But frankly, I find myself hoping they don't come back- I simply do not have time for adequate counseling. And in my opinion, post- fitting counseling is more important than testing and evaluation." A second audiologist: "The thing that concerns me most about my job is that with our limited follow-up program I get too little feedback-and without feedback I have no real check on the accuracy of my evaluations, and I don't learn much about hearing aids in use. I envy the dealer. He lives with these people, so he knows much more about hearing aids than I do." Question 2: How many hearings aids do you recommend each year? Primary response: Percent 1 to 100 (5) 29.4 101 to 500 (8) 47. i More than 500 (3) 17. No response (1) 5.9 Average aids recommended yearly (among 16 respondents) aids 288 Depth response: The discussion in several instances turned to the precision of audiological testing. Six of the audiologists interviewed make precise "prescriptions" for hearing aids. Four said that for most clients testing is not accurate enough to permit specific hearing aid prescriptions. Seven stated that they refuse to make specific prescriptions or recommendations under any conditions. Ac- cording to one: "We have gone bananas on testing. I hear some of my colleagues say they can test and prescribe as precisely as an optometrist can prescribe eyeglasses, and I say `nonsense.' At the best, testing can put. you in the ball park, and then it is fit and modify in the traditional way. I make only generic prescrip- tions, and give the dealer full leeway to make suggestions and changes." Question 3: What percentage of your clients are referred by general prac- titioners? ear specialists? hearing aid specialists? Primary response: Percent Average percentage referred by general practitioners 10. 6 Average percentage referred by specialists 47. 4 Average percentage referred by hearing aid specialists 6. 8 Depth response: None. Question 4: What percentage of your clic)its do you refer to general prac- titioners? car spscialists? hearing air specialists? PAGENO="0192" 186 Percent Average percentage to general practitioners 0. 8 Average percentage to ear specialists 1t3. 4 Average percentage to hearing aid specialists 88. 6 Note: Percentages not additive. Some audiologists refer some or all of their clients first to a physician, then to a hearing aid specialist. Depth response: Despite the pressure to break up their association with hearing aid specialists and force audiologists into dispensing, oniy one of those interviewed was actually involved in dispensing hearing aids Eleven of the 17 audiologists in the sample said they would not dispense hearing aids. Four said their clinics or centers had studied the economics of dispensing and concluded that they could not dispense aids as cheaply as traditional commercial dealerships. Three other audiologists were cooperating with low-cost commerical sales plans, but were not dispensing, and all were continuing to work to some extent with conventional hearing, aid specialists. One of the three expressed serious doubts about the quality of service being offered under the low-cost plan with which he was working. Question 5: What is the average time spent per client for conaplete testing and valuation? for post-fitting adjustment? for training and consultation? Primary response: Percent Testing and evaluation 1.6 Post-fitting adjustment . 7 Training and consultation 1.3 Depth response: Most of the. audiologists interviewed were defensive about the small amount of time they are able to devote to post fitting adjustment and counseling seven were frank in their, admission that lack of counseling `means laëk `of féed'biick for the audiologist, and makes their clients dependent on the hearing aid specialist for counseling and problem solving. Four said they believe that counseling and rehabilitation are more critical to the successful use of a hearing aid than precise testing and evaluation. Question 6: Are you staffed and prepared to provide counseling services for hearing aid wearers during the life of the aid? Primary response: Percent Yes (4) 23. 5 No (12) 70. 6 Under some circumstances (1) 5.9 Depth response: Although four audiologists answered "yes" to this question, the discussions revealed that fourteen probably could not handle an average call-back load of more than three or four visits per client over the life of the hearing aid without an increase in staff. Not only does their work load preclude extensive counseling; the cost of audio- logical counseling is also a major concern. In the words of one audiologist: "I don't blame people for not coming back to us. We have to charge $20.00 for a 15- to 30-minute session or the clinic loses money. A lot of these people can't afford it." Question 7: What is your evaluation of the hearing aid specialists in your community? Are they (a) competent? (b) honest in their dealings? Primary response: (a) Competent: Percent Yes (11) 64. 7 No (1) 5.9 Some yes/some no (4) 23. 5 No opinion (1) 5.9 PAGENO="0193" 187 (b) Honest in their dealings: Percent Yes (11) ~ 7 No (1) 5 9 Some yes/some no (4) - 23 5 No opinion (1) 5 9 Depth response: The depth discussions indicated that over 75 percent of the audiologists inter- viewed have not been a party to the attacks on the hearing aid specialist. In most of the cities visited, there is still a reservoir of mutual respect between the hearing aid specialist and the audiologist. Qicestion 8: Should they be permitted to handle testing `in connection with fitting and adjusting hearing aids? Primary response: Percent Yes (9) 52 9 No (5) 29. 4 Only if no ear specialist or audiologist is available (1) 5. 9 No opinion (2) 11. 8 Depth response: Audiologists in large population centers tended to be negative; those in areas serving primarily a rural clientele tended to be in favor of testing by hearing aid specialists in connection with fitting and adjusting aids. Question 9: Should they be permitted to fit aids without a specific evaluation and recommendation from an audiologist or ear specialist? Primary response: Percent Yes (3) 17. 6 No (6) 35. 3 Only if no ear specialist or audiologist is available (6) 35. 3 No opinion (2) 11.8 Depth response: Only three audiologists (17.6 percent) felt that hearing aid specialists without reservation should be permitted to test hearing and evaluate aids without a prior medical examination and audiological recommendation, but 35.3 percent felt that it should be permissible in areas where no ear specialist or audiologist is avail- able. In the depth discussions, however, one consensus was apparent: They felt that neither audiologists nor hearing aid specialists should test and fit hearing aids without a medical (otological) examination as a prerequisite. Question 10: When they work in close collaboration with the medical profession and with audiologists, do hearing aid specialists perform a desirable and ethical service? Primary response: Percent Yes (14) 82. 3 No (1) 5. 9 No opinion (2) 11. 8 Depth response: With the exception of one audiologist who was in favor of eliminating the tra- ditional hearing aid specialist from the delivery system, all approved of a two- year education plan for hearing aid specialists; expressed the hope that the National Hearing Aid Society could provide better internal pohcmg to remove the occasional "bad apple ;" and indicated their willingness to seek greater cooperation between the two groups. B. Conclusions of the investigators Most sudiologists interviewed are highly dedicated men and women, deeply im- mersed in their work. But it soon became clear that somewhere along the line, this relatively new profession has been diverted from its original goal: the re- habilitation of people with hearing or speech disorders. While some audiologists are still concentrating on rehabilitation and doing excellent work, especially with children, the majority of those interviewed are concentrating most of their 79-934-76----13 PAGENO="0194" 188 time and energy on testing and evaluation. A few are carrying such a heavy work load in their clinics that they do not have time to do as thorough a job of testing evaluating, and training as they would like to do, and extensive counsel- ing is out of the question. Some of those interviewed were quite bitter and frus- trated at the turn their careers have taken. All but two of those interviewed acknowledged that a persistent drive is un- derway-spearheaded by a few militant audiologists-to lead them still farther away from rehabilitation: into dispensing hearing aids and-presumably-Pro- viding service. Only one in the sample has yielded to this pressure. But several factors are pushing them in that direction. First, audiologists have not yet created a stable niche for themselves in the hearing aid delivery system. On the one side, the ear specialist is questioning the audiologist's claims for superior ability in testing hearing. On the other, the hearing aid specialist is questioning the accuracy of many of the audiologist s selections of hearing aids, and demonstrating by fit and modify methods that those selections are often wrong. As a consequence, the audiologist feels himself squeezed from both sides. Second, audiologists have not succeeded in convincing the majority of users that their services are necessary. Only one of the audiologists interviewed was mak- ing a living in private practice. The rest were attached to university hearing and speech centers, or hospital hearing and speech clinics. There, as salaried em- ployees, their earning potential is comparatively low, and they resent seeing a bearing aid specialist-with less training than they-making a better living. This generates a strong incentive in some audiologists to invade the hearing aid spe- cialist's business to improve their own income. The rationalization for converting a profession into a business is that it is for the good of the hearing aid user. This rationalization is an integral part of the third factor which is pushing some audiologists toward dispensing: They have convinced themselves that their testing equipment and procedures are so superior that they can make prescriptions for hearing aids as precisely as an optometrist can make prescriptions for eye- glasses; and that once a hearing aid is fitted to this precise prescription the user will need little post-fitting counseling. This chain of thought leads to a seductive premise: If audiologists control the entire procedure, the user will make few de- mands on heir time over the life of the aid; consequently, the cost of the aid can be materially reduced. The fallacy in this thinking is that the post-fitting counseling needs of many users remain high regardless of the accuracy of the fit. But a few audiologists are taking the leap, anyway, either into dispensing or into a new substitute: low- cost plans in which audiologists work exclusively with hearing aid specialists who offer reduced prices and reduced services. It remains to be seen what will happen as more and more users are sold hearing aids at prices which cannot possibly cover the long-range cost of counseling and service. The one dispensing audiologist in the sample stated that users will have to accept the principle of paying for service as the service is needed. However, this ignores a fact which is known to some audiologists and to virtually all hearing aid specialists: If they have to pay for counseling and service each time trouble de- velops, many users will simply give up and their hearing aids will go into cup- boards or drawers. In contrast to the few who want to go into dispensing, a few audiologists want to reduce their involvement with their clients to the minimum. These are audiolo- gists who have no real desire to devote themselves to rehabilitation. They have found that counseling the hard of hearing-particularly the elderly-is one of the most difficult jobs in the health care field. It requires endless patience, it is frustrating and time consuming, and the rewards are often difficult to observe or measure. It is much simpler and easier to do research; to concentrate on per- fecting testing equipment and procdures; and to limit responsibility and contact with clients to the brief testing and evaluation period with a minimum of post- fitting involvement. These audiologists prefer to remain aloof from their clients and leave the entire counseling responsibility to the hearing aid specialist. One major complication for many audiologists in the sample is that they have become victims of their own drive for a protected share in the hearing aid delivery system. Through their efforts it is now legally mandatory that certain welfare and state rehabilitation clients go through not only otological testing, but audio- logical testing as well before they can be fitted with a hearing aid-whether or PAGENO="0195" 189 not the ear specialist thinks the additional tests are: needed. So the work loads in soineclinics and centers are incredibly heavy-as high as 5,000 clients per year. Such work loads generate poor client relationships and make rehabilitation or counseling for most of the clients impossible. Yet some audiologists would make it mandatory that every person fitted with a hearing aid in the United States undergo audiological testing. Despite all of these pressures, most of the audiologists interviewed were friend- ly to the hearing aid specialists they work with. They have two major complaints: They feel that hearing aid specialists should not test hearing and fit hearing aids without prior medical-and preferably audiological-examiflation; and they feel that unethical hearing aid specialists should `be put out of business. Generally speaking, however, they have not joined the war against the hearing aid special- ists, and many are embarrassed by the propaganda campaign which has been waged against them. V. THE HEARING AID SPECIALIST A. Statistical `profile and depth interview analysis (base: 73 interviews) Question 1: What is the total number of people employed by your dealership? Primary response: Percent I to 3 people (47) 64.3 4 to 6 people (18) 24. 7 More than 6 people (4) 5 .5 No response (4) Average number of employees (for 69 respondents) (people) 3. 6 Depth response: The average hearing aid specialist interviewed considers himself a small busi- nessman working in a field in which service is as important as the product he sells. Often he works alone except for a clerk-secretary; frequently `he is in part- nership with his wife; rarely does he employ more than six people, even on a Part-time basis. On the average he has a low capital investment and moderate overhead, but-because of the high cost of providing counseling and service-he makes only a modest profit. As an integral part of the hearing aid delivery sys- tem, he feels a strong sense of professional responsibility to his clients. Question 2: How many hearing aids do you sell a month? Primary response: Percent 1 to 10 units/month (19) 26. 0 11 to 20 units/month (26) 35. 6 21 to 30 units/month (13) 17. 8 31 units/month or more (14) 19.2 No response (1) 1. ~ Average unit sales/month (for 72 respondents) (units) 23. 5 Depth response: Hearing aid specialists who do not employ sales consultants in the field rarely average more than 20 sales per month. Those who do employ sales consultants generally make more sales, but their costs for commissions and transportation are correspondingly high. All but two of the hearing aid specialists interveiewed make house calls; but those who cover rural territories have special problems. A single service call may require a round trip of 100 miles or more-yet a very large percentage of the hearing aid specialists in this category make no charge for this service. In a few instances, high gasoline prices have forced them to make a nominal house call service charge (ranging from $2.00 to $7.50) to cover automobile expenses. The following practices are observed by the hearing aid specialists interviewed who serve rural territories: They have a permanent central address with an office staffed at least five days per week; The central office address and phone number, and the name of the dealer are printed on their calling cards and promotional literature; A service center (a location in a local store, or a motel or hotel room) is oc- cupied by the sales consultant in each town or village on at least one day per month at stated intervals which are advertised in the local newspaper; Calls to the central office for service are honored within two weeks or less, even if it means a special trip from another part of the territory; PAGENO="0196" 190 * Each sale is accompanied by a written guarantee and/or warranty; Service and counseling (except for repairs) are free in most instances over the life of the hearing aid, with the exception of the small percentage of hearing aid specialists who are beginning to make a service charge to cover transportation costs. Questiom$: What is the ratio of inquiries to sales? Primary response: Average number of inquiries/sale (among 61 respondents) inquiries_ 3. 4 Depth response: None Question 4: What percentage of your new clients are referred by general prac- titioners? ear specialists? audiologists or hearing and speech clinics? Primary response: Percent General I)ractitioners 4. 4 Ear specialists 18. 2 Audiologists or H&S clinics 24. 7 Percentage of hearing aid specialists who receive no referrals from: General practitioners (39) 53. 4 Ear specialists (25) 34. 2 Audiologists or H&S clinics (33) 45.2 Any physicians or audiologists (11) 15. 1 Depth response: The interviews revealed that, with the exception of a few who serve primarily rural areas, hearing aid specialists have made little effort to develop a working relationship with general practitioners. They were interested in the experiences of hearing aid specialists who have established such relationships, but most were dubious about their own chances for success in working with general practitioners to screen for early detection of hearing problems. Referrals from ear specialists and audiologists are of significant economic importance to many hearing aid specialists. In areas where there have been intensive propaganda campaigns against the hearing aid specialist, these refer- rals have been greatly reduced. Question 5: What percentage of your clients do you refer to general practi- tioners? ear specialists? audiologists or hearing and speech clinics? Primary response: Percent General practitioners 7. 2 Ear specialists 10. 1 Audiologists or H&S clinics 6. 5 Percentage of hearing aid specialists who make no referrals to: General practitioners (42) 57. 5 Ear specialists (6) 8. 2 Audiologists or H&S clinics (38)_~ 52.1 Depth response: The hearing aid specialists interviewed report that on the average they refer nearly one out of four (23.8 percent) of their clients to a physician or audiolo- gist. These include new clients who need a medical examination or special audio- logical testing, and established clients who have developed medical problems. Question 6: What is the average time spent per client for complete testing anti fitting? for post-fitting consultation and service (ecoclucting repairs)? Primary response: Hours Testing and fitting 1. 8 Post-fitting consultation and service 11. 7 Depth response: The magnitude of the hearing aid specialist's investment of time and effort in counseling and service is a key to his unique role in the hearing aid delvery system. The sale of a hearng aid in most instances is only the beginning of a per- sonal involvement with the hearing-connected problems of the user that may last for many years. With the exception of a very few special situations, the hearing aid specialist is the oniy one who is willing to make this investment to ensure the optimum satisfaction of the hearing aid user. PAGENO="0197" 191 Question 7: Do you charge for these services? Primary response.: Percent Yes (9) 12. 3 No (64) 87. 7 Depth response: The nine hearing aid specialists who reported that they charge for counseling and routine service include those who have been forcedby rising costs to charge a minimum fee, and those who are involved with low-cost plans in which the price of the hearing aid covers only a limited aniount of counseling and service. Question 8: What is your estimate of the average life of the hearing aids you sell? Primary response: Range of opinion: Percent 3 years or less (8) 10.9 More than 3 years (61) 83.6 No opinion (4) 5. 5 Average estimate of hearing aid life years-4. 5 Depth response: The hearing aid specialist~s average estimate of bearing aid life is somewhat longer than users remember: 4.5 years according to the hearing aid specialist; 3.9 years according to the user. These figures include aids which have been ac- cidentally damaged or destroyed, and those which have been traded in or dis- carded because the user's hearing loss worsened or changed. The potential life of an aid is probably considerably longer. Question .9: What is the average number of repairs/unit/year? Primary response: Average repair frequency Twice in 4.5 years Depth response: Hearing aid specialists report that it is not so much the frequency of repairs as it is the delay in getting the repaired hearing aid back to the user that is the source of most of their complaints about repair service. Few hearing aid specialists are equipped to make major repairs in their, own establishments. The aids have to go back to the factory, and this creates delay. Most of those inter- viewed said they provide "loaners," but they reported that many users consider the loaner a poor substitute and tend to be upset until their own aid is returned. Question 10: Will you fit aids on children under 18 years `ivithont medical referral? On a~li~lts over 18 without medical referral? Primary response: Children under 18 years: Percent Yes (2) 2. 7 No (71) 97.3 Adults over 18 years: Yes (69) 94. 5 No (4) ~. Depth response: Virtually all the hearing aid specialists interviewed (97.3 percent) require otological examinations and audiological testing for children prior to fitting a hearing aid. Most adult users interviewed (see page 8) have consulted a medical ear specialist or an audiologist; but except where an' examination or a waiver is required by law, `most hearing aid specialists (94.5 percent), if requested, will fit adults without a prior medical examination. If there is evidence of infection or other medical problems, however, the hearing aid specialist is careful to refer his client to a physician for examination before fitting a hearing aid. Question 11: How many general practitioners do you work with? ear specialists? audiologists? hearing and speech clinics? PAGENO="0198" 192 Primary response: Do work with general practitioners (12) (percent) 16.4 Average number worked with 6 Do work with ear specialists (56) (percent) 76. 7 Average number worked with 5 Do work with audiologists (44) (percent) - 60.3 Average number worked with 4 Do work with hearing and speech clinics (41) (percent) 56.2 Average number worked with 2 Depth response: The hearing aid specialists interviewed, without exception, expressed a strong desire to work in close cooperation with ear specialists and audiologists in the bearing aid delivery system. They stated-and discussions with ear specialists and audiologists tended to support the statement-that where a lack of coopera- tion exists, it is not of their making. Question 12: Are you a member of the local Chamber of Commerce? Of one or more service organizations? Primary response: Percent Member of Chamber of Commerce (28) 38.4 Member of service organization(s) (38) - 52. 1 Depth response: The interviews with bearing aid specialists revealed a serious lack of involve- ment in the affairs of the community. Question 13: How many speeches about hearing did you make last year? Primary response: Percent Made speeches (27) (percent) 37.0 Average number -. Depth response: Same as for question 12. Question 14: How are your relations with general practitioners? with ear spe- cialists? with audiologists? with local hearing and speech cliwics? ,~J_,_,J `S'X"J ~_LL~) -~/ "~`,-, / Primary response: With general practitioners: Good (1~\ Poor (At~\ No opinion (1~)\ With ear specialists: Good (5f1) Poor tins No opinion ~ With audiologists: Good (`~°` Poor "~` No opinion (6) With hearing and speech clinics: Good (41) Poor (25) No opinion (7" 56. 2 34.2 9.6 Depth response: Most hearing aid specialists interviewed (76.7 percent) regard the ear specialist as a traditional friend, and consider their relationship with him to be satis- factory. But although many hearing aid specialists (57.6 percent) still have friendly relationships with the audiologists in their communities, the persistent attacks by the militant audiologists, and the publicity campaigns at the national level and in some cities have begun to cast the audiologist in the ole of. an enemy. All but two hearing aid specialists expressed resentment of this activity~ for they consider the attacks arrogant or uninformed, and detrimental to the best interests of the hearing aid user. They feel that a sharing of expertise and responsibility is preferable to the open warfare that Is being waged against them, and is essential to the improvements of the hearing aid delivery system. Question 15: How many hours/year do you spend updating your knowledge of the hearing aid field by reading? in formal study courses? in seminars and teclini- cal meetings? Percent 20.6 63.0 16.4 76.7 17. 8 5.5 57.6 34.2 8.2 PAGENO="0199" 193 Primary response: Those who reported reading (65) percent_--- 89. 0 Average hours of reading/year bours__- 152 Those who reported attending formal classes (6) percent__-- 8. 2 Average hours of classwOrk/Year bours__-- 66.7 Those who reported attending seminars and meetings (52) .~_percent_--- 71.2 Average hours at meetings/year hours---- 42 Depth response: Hearing aid specialists with few exceptions reported that they spend a sub- stantial part of their free time in upgrading their knowledge and skills. Some complained of the lack of seminars and technical meetings; even more complained about the lack of formal courses for credit. Question 16: Is your hearing test area soundproof? sour~l conditioned? ambient? Primary response: Percent Soundproof (8) Sound conditioned (insulated) (37) 50. 7 Ambient (24) 32,9 No response (4) 5. Depth response: Hearing aid specialists were divided about the need for soundproof test rooms. They do not question that a soundproof room is necessary for the ultimate precision in measurement of responses, and eight of those interviewed have built such rooms for testing. An additional 50.7 percent have sound `~onditioned (in- sulated) their test rooms. However, 32.9 percent are convinced by their obser- vations of users' reactions that ambient testing in normal room conditions tends to bring a truer response in testing and in evaluating a hearing aid. In the final fit and modify period, some take their clients into the street or a crowded store to observe the effects of noise on the response to the aid. Question 17: Would you like to see more ecotensive training courses for hearing aiti specialists? stiffer professional requirements? stiffer state licensing$ Federal licensing? Primary response: Percent In favor of more extensive training (68) 93.2 Opposed 0 No opinion (5) In favor of stiffer professional requirements (63) 86. 3 Opposed (4) No opinion (6) 8.2 In favor of stiffer state licensing (44) 60. 3 Opposed (21) 28.8 No opinion (8) 10.9 In favor of Federal licensing (6) 8. 2 Opposed (53) 72. 6 No opinion (14) 19.2 Depth response: The majority of hearing aid specialists interviewed (93.2 percent) want more education. They are in favor of a minimum two-year course for credit-even though for many it would mean a sacrifice of time and a temporary loss of income. A large number (86.3 percent) favor more rigorous professional requirements, and 60.3 percent want stiffer state licensing; but in general they are against Federal licensing. Without exception, they are in favor of strict enforcement of licensing laws and ethical standards. Question 18: Do you believe it is essential for hearing aid specialists to conduct hearing tests? Primary response: percent Yes (71) 97. 3 No (2) 2.7 Depth response: All but two hearing aid specialists-both associated with low-cost sales plans- stated that it is essential for them to conduct hearing tests in connection with fitting and adjusting, even if the client has had a comnlete otological and audiological workup. In essence: User reactions to testing are complex and infor- mation from testing can only partially be conveyed from the audiologist to the PAGENO="0200" 194 hearing aid specialist through audiograms and recommendations. Responses must be observed by the person doing the fitting; otherwise, serious errors can be made. Furthermore, hearing aid specialists reported that responses to tests vary from day to day-sometimes in ways essential to understanding the nature of the problem. Therefore, tests must sometimes be repeated during the adjust- ment period; for example, when considering a modification in the aid, or a change in the selection. - B. Conclusions of the investigators Interviews with hearing aid specialists and with a random cros.s section of their clients revealed a level of competence and dedication which would reflect well on any profession in our society. The hearing aid specialist's attitude toward his clients was reminiscent of the family doctor of a generation ago. The four men in the sample who were unethical constituted a remarkably small minority. Hearing aid specialists are small businessmen, and their profit on their busi- ness is their livelihood; but rather than being profiteers, in this inflationary era they have generally held the line on prices, and have continued their policy of providing unlimited comiseling, service, and house calls without additional charge. Even those who have large rural territories still are reluctant to charge even a small service fee to cover the cost of gasoline. The hearing aid specialist is criticized for his lack of formal education; for that same lack, his competence to carry out hearing tests and select hearing aids is questioned. But the average hearing aid specialist has something of which few audiologists can boast: a thorough knowledge of hearing aids and the problems of people who wear them-gained through feedback from counseling and service. Over the 4.5-year life of the hearing aid, he spend.s an average of approximately 11.7 hours with each client in post-fitting counseling, problem solving, and serv- ice, much of it in the home, where he has the opportunity to work with the family as well as the client. By contrast, the audiologist spends an average of two hours in post-fitting consultation-and he refuses to make house calls. Hearing aid specialists work closely with ear specialists, and they welcome referrals from audiologists. Under protest, they Will even work with audiologists who insist on making precise "prescriptions" for hearing aids. Most have be- come discouraged in their attempt to work with general practitioners, but in areas where ear specialists and audiologists are rare or nonexistent, the hearing aid specialist and the general practitioner sometime form an effective team. The hearing aid specialists have not provoked trouble with the audiologists, nor do they want the war to continue. They are defending themselves, and their anger is rising as the attacks intensify; but they see the hearing aid delivery system as a triangle, with the car specialist at the top, and the hearing aid spe- cialist and audiologist as the two supporting arms. They criticize the audiologist only when he presumes to make precise. recommendations which he expects the hearing aid specialist to follow to the letter. Three criticisms of major importance can be laid at the door of the hearing aid specialists: their insistence on their right to fit new, adult clients without a prior medical examination or waiver; their failure to develop adequate meas- ures to eliminate unethical hearing aid specialists; and their slowness in develop- ing an educational program adequate to the times and the standards of society. First, the hearing aid specialist has resisted all efforts to restrict his right to administer hearing tests and to fit new clients (except children) without a medical examination or waiver. He feels that a medical examination as a prerequisite to testing would violate the rights of his clients, and would prevent many of them from coming to be helped. He also feels that it would restrict his income. Furthermore, he feels that he is competent to detect signs of injury or disease that require medical or surgical attention, and that his record of referring such clients to physicians for treatment is above reproach. If pressed, lie will admit that there are a few cases on. record in which hearing aids have been fitted when a referral should have been made, but he is convinced that he has made no more errors of judgment than have physicians in their diagnoses. But he misses the point. Where the health and physical well-being of a client are concerned, it is necessary to lean over backward to provide the best possible care: consequently, the judgment of an ear specialist-or, if none is available, a general practitioner-is desirable. When the presence or absence of disease is in question, the hearing aid specialist's principle should be: Let the physician decide. PAGENO="0201" 195 Second, the bearing aid specialist should endorse and cooperate with any practical program involving the National Hearing Aid Society and local and state governments aimed at elimination of the unethical dispenser of hearing aids. The gouger, the fly-by-night, the fast buck artist must be prevented from taking advantage of people with hearing losses These few dishonest men-probably no more than four or five percent of all those in the hearing aid field-are respon- sible for virtually all the "horror stories" which are being used as. propaganda to undermine public confidence in the hearing aid specialist. Finally, the hearing aid specialist needs to "bite the bullet" and make the sacrifices necessary to strengthen his educational base. The experienced bearing aid specialist knows'that the knowledge and insights of greatest use to him have come through feedback from his clients, and that he would learn little from a formal two-year course-but again, he misses the point. This society places tremendous emphasis on formal education, particularly in the health care field, and in thi:s context the hearing aid specialist has been working on borrowed time for a decade. Unless he elects to adopt a compulsory program of education- at least a two-year course in accredited institutions-it is likely that his right to maintain his business and practice his profession will be seriously curtailed. The fact that 93.2 percent of the hearing aid specialists interviewed approved a two-year program, in priuèiple, may be an indication that NHAS members are now ready for such a program to be activated. If these three steps are taken-adoption of a policy of mandatory medical cx- amination or waiver for all new clients prior to fitting; elimination of the unethical hearing aid dispenser; and enhancement of the bearing aid specialist's educational base-the attadis against him will gradually wane, and his role in the bearing aid delivery system will be secure. APPENDIX I Background of Consultants JAMES E. PAYNE-BACKGROUND 1971-4974 Editorial Coordinator, Consumer Product Information Center, Gen- eral Services Administration, Washington, D.C. Responsible for aiding the various- departments of the Federal government in the development of booklets and other materials of practical value to the con- sumer in the marketplace, and for developing impact survey techniques to im- prove readability and measure impact. 1970-1971 Consumer Affairs Specialist, National Bureau of Standards, Depart- ment of Commerce, Washington, D.O. Responsible for developing methods and formats for translating information generated by the Bureau's on-going programs of research into materials of prac- tical value to the broad consumer audience, and for the development of methods for pre-testing manuscripts, and measuring the impact of finished booklets. 1967-1970 Information Specialist for Assistant Secretary for Science and Tech- iiology, Department of `Commerce, Washington, D.C. Responsible for the public information staffs of the Patent Office, National Bureau of Standards, and Environmental Science Services Administration; and for the development of materials and hackgrouid papers for the Assistant Secretary. 1961-1966 Director of Institute Relations, Case Institute of Technology, Cleve- land, Ohio. Responsible for Institute programs in public relations, publicity, community relations, and publications. 1956-1961 Special Assistant to the Chairman of the Board, Republic Steel Cor- poration, Cleveland, Ohio. Responsible for key speeches, special brochures on business economics and technology, and special projects. 1955-1956 Senior Editor, $teeiways Magazine, Hill & Knowlton, Inc., New York, New York. 1950-1955 Managing Editor, ~teelways Magazine. Steel-ways was produced by Hill & Knowlton as a key element of a national public relations program for their client, American Iron & Steel Institute. Manag- ing Editor had full responsibility for planning and upgrading the magazine and writing major editorials and articles. PAGENO="0202" 196 1949-1950 Associate Editor, Steelways Magazine. 1945-1949 Freelance writer, magazine field. MA~J0RIE PAYNE-BACKGROUND 1972-1974 Chief, Public Information, National Cancer Institute, Frederick Cancer Research Center, Frederick, Maryland (Operated by Litton Bionetics, Inc.). Responsible for planning and implementing a public information program geared to the needs of this advanced cancer research center. 1970-1972 Administrative Assistant to the President, Litton Bioneties, Inc., Bethesda, Maryland. Responsible for public relations and publicity. (1969-1970 Administrative Secretary, Committee on Public Engineering Policy, National Academy of Engineering, Washington, D.C. Responsible for editing and handling production liaison of final reports of the Committee. 1966-1968 Administrative Assistant, Brain Research Laboratories, New York Medical College, New York, New York. Responsible for administration and production liaison for technical manu- scripts of the scientific staff. 1962-1965 Freelance research and writing. CHILTON~ RESEARCH SERVICES Chilton Way, Radnor, Pennsylvania Chilton Research Services, a division of Ohilton Company, conducts market research and communications studies for business, industry, and nonprofit groups such as government, foundations, and universities. Its substantial investment in facilities and personnel enables Chilton Research Services to offer the full range of modern technology and procedures in carry- ing out research in motivations, opinions, and attitudes in such fields as economics and business; health and welfare; occupations, professions, and training; and human development. APPENDIX II S'am pies of (lore Questionnaires Hearing Aid User No. HEARING AID DELIVERY SYSTEM-A NATIONAL SURVEY City: Tape Index: How long have you used a hearing aid? How many aids have you owned? In addition to the hearing aid specialist, whom did you consult about your hearing loss? General practitioner __ Ear Specialist Audiologist or H&S clinic Hearing aid specialist only How was your loss diagnosed? Nerve loss Conductive loss Both Don't know What was your first reaction to your hearing aid? Natural Too loud Tinny/raspy Other Have you had trouble with your ear mold? Yes No Who helped you adjust to amplified sound? Ear specialist ~ Audiolo- gist Hearing aid specialist No one Has the hearing aid specialist been helpful to you when you have gone to him for service? Yes No For repairs? Yes No ...~.. For consultation? Yes No Do you feel you had a fair deal in purchasing your hearing aid? Yes No If not, what was wrong? When the time comes for a new aid, will you go first to an ear specialist? An audiologist or clinic? A hearing aid specialist? How could the hearing aid specialist's service toyou be improved? Are you now having trouble with your hearing aid? Yes. ___ No If so, what is wrong? PAGENO="0203" 197 Comments:.. Ear Specialist No. HEARING AID DELIVERY SYSTEM-A NATIONAL SURVEY City: Of the patients who come to you with hearing problems, what percentage are referred by general practitioners? ____ audiologists?____ hearing aid special- ists?____ When a patient has a simple hearing loss and can benefit by the use of a hearing aid, what percentage do you refer directly to a hearing aid special- ist? an audiologist or hearing and speech clinic? Considering only those hearing aid specialists with whom you work, and only those cases in which there is no medical complication, do you believe hearing aid specialists are competent to: Administer hearing tests `and evaluations for the purpose of selecting a hear- ing aid? Yes No _ Some yes/some no ____ No opinion Make an ear mold? Yes No Some yes/some no____ No opinion Fit an aid? Yes No Some yes/some no ____ No opinion Help the client adjust to listening to amplified sound? Yes No Some yes/some no No opinion Provide routine service? Yes No ____ Some yes/some no ____ No opinion Make repairs? Yes' No Some yes/some no ____ NO opinion In your experience, are hearing aid specialists: Generally fair in their charges? Yes No Some yes/some no No opinion Ethical in their handling of clients' problems? Yes ~__ No ~__ Some yes! someno____Noopinion____ ` ` Honest in fulfilling guarantees' and warranties? Yes ~ No Some yes! some no ____ No opinion 1-lave you noted improvement of hearing aid specialists' knowledge and skills through improved training in recent years? Yes No _ Some yes! some no No opinion Comments: HEARING AID DELIVERY SYSTEM-A NATIONAL SURVEY City: How many tests do you give yearly to clients with useful `hearing abil- How many hearing aids do you recommend each year? What percentage of your clients are referred by general practitioners ?___ ear specialists? ____ hearing aid specialists? `What percentage of your clients do you refer to general practitioners? ear specialists? ____ hearing aid specialists? ___ What is the average time spent per client for complete testing and evalua- tion? for post-fitting adjustment? for training and consultation? Are you staffed and prepared to provide counseling services for hearing aid wearers during the life of the aid? Yes ____ No What is your evaluation of the hearing aid specialists in your community? Are they competent? Yes ___ No Honest in their dealings? Yes No Should they be permitted to handle testing in connection with fitting and adJusting hearing aids? Yes ____ No Should they be permitted to fit aids without a specific evaluation and recoin- mendation from an audiologist or ear specialist? Yes No When they work in close collaboration with the medical profession and with audiologists, do hearing aid specialists perform a desirable and ethical, service? Yes No ____ Comments: Hearing Aid Specialist No. PAGENO="0204" 198 HEARING AID DELIVERY SYSTEM-A NATIONAL SURVEY. City: Tape Index: What is the total number of people employed by your dealership? How many hearing aids do you sell a month?____ What is the ratio of inquiries to sales? What percentage of your new clients are referred by general practition- ers? ear specialists? audiologists or H&S clinics ?~__ What percentage of your clients do you refer to general practitioners? ear specialists? audiologists or H&S clinics? What is the average time spent per client for complete testing and fltting?___ post-fitting consultation and service (excluding repairs) ? Do you charge for these services? Yes No What is your estimate of the average life of the hearing aids you sell? What is the average number of repairs/unit/year? Do you fit aids on children under 18 years without medical referral? Yes No On adults over 18 without medical referral? Yes No How many general practitioners do you work with? ~__ ear specialists? audiologists? H&S clinics? Are you a member of the loeaJ Chamber of Commerce? Yes No Of one or more service organization~? Yes No How many speeches about hearing did you make last year? How are your relations with general practitioners? Good Poor with ear specialists? Good Poor with audiologists? Good Poor with H&S clinics? Good Poor How many hours/year do you spend updating your knowledge of the hearing aid field by reading? in formal study courses? in seminars and tech- nical meetings? Is your hearing test area soundproof? ____ sound conditioned? ambient ~ Would you like to see more extensive training courses for hearing aid special- ists? Yes No stiffer professional requirements? Yes No stiffer state licensing? Yes No Federal licensing? Yes _~_ No Do you believe it is essential for hearing aid specialists to conduct hearing tests? Yes ~__ No Comments: EXHIBIT No. 48 STATnMENT OF THE AMERICAN COUNCIL OF OTOLARYNGOLOGY, GIVEN BY HARRY W. MCCURDY, M~D. EXECUTIVE DIRECTOR AND ARAM GLoiuG, M.D. CONSULTANT- PRESENTED TO THE DHEW INTRADEPARTMENTAL TAsK FORCE ON HEARING AIDS- M&y 7, 1975 Mr. Chairman: It is a pleasure to be able to present to this Panel for the first time the views of many of the nation's Otolaryngologists on the complexi- ties and problems of our present hearing aid delivery system. The issues in- volved are complicated, not simple. To rush head long into the adoption of what seems a simple and straight forward set of regulations for this complex system may well create more problems rather than less. The system needs to be im- proved, and hopefully the recommendations of this Panel will provide guidance to do that. Loss of hearing acuity is quite obviously evidence of a pathological change in one of the body's most important sensory systems. It is from the outset a problem in medical diagnosis and treatment. When such a loss becomes notice- able to a patient, it seems obvious again that he should go to the doctor to find out the exact nature and extent of the loss. As there are many different causes for loss of hearing, the initial medical workup must be thorough and complete, taking into account the state of health of the "whole man". This would surely include a general medical exam, including whatever consultations might be indicated, i.e., neurological, cardiovascular, allergic, etc. At some stage in the workup, the loss must be measured accurately and precisely using as many of the sophisticated battery of hearing tests as are indicated. When all the tests are done and the complete data are assembled, the phy- sician then arrives at a diagnosis and prescribes treatment which could be either medical, surgical, and/or amplification. If a given hearing loss requires PAGENO="0205" 199 only amplification, than somebody must provide the patient with a hearing aid, fit it to his ear, service it, provide spare parts, and, very importantly, pro- vide that patient with the instructions, the encouragement, the sympathetic understanding, and the personal reinforcement which will be needed to insure that the new hearing aid will, in fact, be worn and not discarded. This last step is essential, and it has been either ignored or given very little attention in the delivery system as we now know it. * A hearing aid will not restore normal hearing. This is often an unpleasant surprise to a new wearer. It is difficult `to become accustomed to an aid not only because it cannot replace damaged receptors in the ear, but also because it amplifies unwanted sounds as well as desired sounds. As most hearing aid wearers are elderly people, they are less flexible, less patient, and less able to adjust to new things, and so they will generally give up if not carried through this inimensely important rehabilitative phase by knowledgeable~ people. I regret to repeat that this aspect of the present delivery system has been given entirely too little attention. The great success of the Walter Reed Army Audiology Center has been due to the awareness of this rehabilitation phase. Every patient who receives a hearing aid also receives a course of instruction of four to six weeks to teach him what to expect of it and how to use it successfully. Having now mentioned `the sequence of events which transpire in the delivery system, I will now mention the groups who have been responsible for carrying them out. The doctor, and in this instance the otolaryngologist, is the only participant who is medically trained, who can study the symptoms of deafness in the context of the whole patient, who is qualified to make a diagnosis, and who can pre- scribe treatment. He should ideally be the point of entry into the health care system for the hard of hearing patient. There are approximately 5,000 practicing otolaryngologists in the U.S. at present. The training program is four years long after graduation from medical school, during which time heavy emphasis is placed upon diagaosis and the management of diseases of the ear, including the entire subject of audiology. There has been testimony presented here that otolaryngologists do not receive enough training in audiology to be able to perform or interpret audiologic tests- that audiologists alone possess this knowledge. Without belaboring the point, let me say, in the most positive and unequivocal way, that any such impression is incorrect. The fact that an audiologist performs some of the testing procedures does not imply in any way that he is the only one on the team who can interpret the results or make recommendations based on them or to determine whether a patient will benefit from wearing an aid or not. Audiologists comprise the second group of which, according to the 1974 DREW Health Resources Statistical Report, page 303, there were 1,313 who held cer- tificates of clinical competence in audiology, plus another 920 who held certifica- tion in both speech pathology and audiology. The greatest majority of this group hold a Master's Degree. Their training has been specifically aimed at the meas- urement of hearing and, to some degree, auditory rehabilitation. They are not equipped or qualified to practice medicine-that is to say, to diagnose or to prescribe treatment for any human ill. Their contributions in the measurement of hearing have been notable, but they cannot function as the point of entry into the health care system. The third group are the hearing aid dealers numbering about 10,000. The formal educational requirement to be amongst this number is almost none and, in many instances, it is non-existent. It is this group who sell most of the hearing aids, who service those hearing aids, and who have pretty much, by default of the other two groups, have been responsible for the post-fitting period of training and rehabilitation which I referred to previously. It is our firm position that ideally the physician/otolaryngologist should be the point of entry into the system so that every hard of hearing person will be medically and audiologically evaluated by a physician at the time when he first complains of deafness and before he gets his first hearing aid. The audiologist should be called upon by the M.D. for hearing testing when his services are re- quired, but not mandatorily as a step in the procedure. Such a requirement by regulation would be unnecessary and an expensive duplication. The dealer sells and services the hearing aid, but the point must be made here the the selection of `the hearing aid cannot be by "prescription". That word implies a precision which is simply not available in this process at present. PAGENO="0206" 200 There is some predictability possible regarding which hearing aid will be best, but there is a large element of unmeasurable patient subjectivity which. must be taken into account as well. As regards the rehabilitation educational phase, which needs to be improved. upon so badly, this will be done by either audiologists or hearing aid dealers.. It is fair to say that most of whatever has been done has been done by dealers,. but this is no defense of the right of dealers. It will and should fall, in future, to those who understand its importance and who will do it most diligently and successfully. As regards obtaining the second or third hearing aid, we believe that the pa- tient need not~ return to the physician unless there has been some significant change in the state of his hearing. He could go either to the audiologist or the hearing aid dealer as he chose. By using a list of simple questions as "Red Flags", the audiologist or dealer could be alerted to the fact that the patient must return for further medical evaluation prior to getting his next hearing aid. Such questions as: "Has your ear drained since you were last seen by doctor?"; "Has your hearing gotten suddenly worse?"; and "Have you been dizzy?" would be some simple indicators. If the patient answered "yes" to any question, he would be mandatorily referred to an otolaryngologist. If not, then he could carry on simply by replacing the old hearing aid. The above sequence would provide a very good delivery system. How well can it be applied in present circumstances? In the instance where a third party payer is providing the hearing aid, he is in the position of being able to set the terms on which the patient will receive it. This clearly implies that mandatory medical clearance could be imposed and ideally should be imposed. But, in the case where a private citizen, who declines the advice to seek medical clearance, wishes to spend his own money as he sees fit, we feel that regulations which would force him to obtain medical clearance would be a serious invasion of his privacy and it is probably illegal. Furthermore, one must consider the basis on which the sale of hearing aids would be restricted. Clearly, except in the most rare and unusual circumstances could they be said to be dangerous devices, so the argument that they are harm- ful cannot be used. This is in very great contrast, say, to the sale of cigarettes which are not restricted-and the comparison here is not as far fetched as it may seem. The point is that there is a certain amount of protection by regulation which our citizenry should have, but beyond that it becomes a public nuisance. One needs only mention the over-zealous mandatory automobile seat belt regula- tions to cite an example. What then, in summary, does the American Council of Otolaryngology believe and recommend? (1) We believe that there is a role to be played in the Hearing Aid Delivery System by the otolaryngologist, the audiologist, and the hearing aid dealer. (2) The term "prescription" cannot be made to apply to the selection and fitting of a hearing aid at the present time. (3) While the ideal delivery system would have the patient see the otolaryn- gologist first, we cannot and should not, in 1975, force him to have mandatory medical clearance if be wishes not to accept good advice and if he is spending his own money. (4) A third party payer can set whatever terms he wishes and one of these terms should be mandatory medical clearance. (5) A nation-wide educational program should be mounted by private and governmental agencies to inform the hard of hearing public on the nature of deafness, to tell what can be done about it, and to advise how to go about doing so. (6) The Federal Trade Commission should immediately and vigorously move against false and misleading advertising wherever it is found. (7) A program of instruction and rehabilitation for all patients who are fitted with an aid should be implemented. The absence of such training has been the greatest single source of dissatisfaction and complaint within the present system. (8) Institute a system of "Red Flag" questions to be asked by audiologists, dealers, and, indeed, family physicians which would identify the patient who must receive mandatory medical clearance from an otolaryngologist before getting a replacement aid. PAGENO="0207" 201 (9) Give the National Hearing Aid Society's Four Point Program, which was announced earlier at this hearing, a chance to work. There have been many accusations and many assumptions of unethical practices made against hearing aid dealers. One must ask whether we have enough solid evidence to blast this entire group, or are they all being accused unjustly because of the undoubtedly shabby tactics of a relatively small percentage of their number? How much does the deficient rehabilitation program contribute to their woes? Some attempt should be made immediately to answer these questions beyond reasonable doubt. (10) Define hearing aid research needs. (11) Develop, strong model state licensing laws to govern the sale of these devices. A great deal has been done in recent weeks to improve the inadequacies of the system. Hearing aids have been classified `by the Food and Drug Administration's ENT Panel into the category of requiring standards; labeling regulations have been reviewed; standards are being developed by the Food and Drug Administra- tion, the American National Standards Institute, and Industry; and the National Hearing Aid Society has proposed very substantial controls over its members as well as a thirty-day trial rental period. All of these things are certain to improve this `system. We feel that a time for allowing the proposed improvements to work should now be granted rather than to impose mandatory restrictive regulations at this time. EXHIBIT No.49 GUIDELINES FOR MEDICAL CLEARANCE PUBLISHED ron THE USE OF MEMBERS OF THE NATIONAL HEARING AID SOCIETY INTRODUCTION Early in 1975, with the support of its members, the National Hearing Aid Soci- ety began a "medical clearance" policy which will become part of the ethical standards to be met by all Society members. Briefly, this policy requires that a first hearing aid may be fitted only after the client has obtained medical clearance, with a 7-point criteria used for subsequent hearing aids, to alert the client to the need for medical attention if certain symptoms are present. The policy is designed to preserve individual freedom of choice, while insuring optimum safeguards for the person's health. The Medical Education Advisory Council of the National Hearing Aid Society assisted with the development of these guidelines, showing how close cooperation between the medical ear specialists and the hearing aid specialists can lead to improved hearing health care for the hearing impaired. Continued close coopera- tion between these two branches of the hearing health team is necessary and desirable to be sure that each hearing impaired person receives the best care possible. This was described as follows by one of the otolaryngologists whom NHAS consulted: "The type of referral that will give the client the fastest, best and most complete service is desirable." It was felt that overly complicated procedures may only discourage the hearing impaired person from obtaining any help at all. Yet, since hearing aid specialists are a major "point of entry" into hearing health care for many hearing empaired persons, it is believed that the NHAS medical clearance policy will serve the best interests of the hearing impaired. PRovIDERs OF SERVICES Wherever feasible, medical clearance for a hearing aid should be provided by a physician specializing in diseases of the ear (an otolaryngologist). Where such services are not readily available, the services of a physician in general practice may be used. Any hearing aid should subsequently be fitted by a hearing aid spe- cialist, who is qualified to test hearing for the selection, adaptation, and fitting of hearing instruments, as well as provide counseling and instruction in the care and use of the hearing aid. The hearing aid specialist should be duly licensed where applicable. INITIAL CLVENT VISIT When a potential first-time client for a hearing aid comes to the office of the hearing aid specialist for consultation, the client should be informed that medical PAGENO="0208" 202 clearance from a physician within the last 18 months is needed before a hearing aid can be fitted. If the client has objections to consulting a physician based on religions or constitutional convictions, he will be advised that he has the option of signing a waiver. However, it is unethical for the bearing aid specialist to en- courage the client to waive medical clearance. Quite the contrary, to protect the welfare of the client, the hearing aid specialist should encourage the client to take advantage of medical services. Furthermore, the hearing aid specialist should ask the client to show proof of such medical clearance with a form signed by a physician within the previous 18 months, which the hearing aid specialist shall retain with the records of the client. The hearing aid specialist may, however, conduct a preliminary interview with the client for conducting hearing tests, to determine hearing aid candidacy or obtain statistical information. The client should be informed if there is a charge for these services prior to rendering such services. If, during interviewing, cx- amination, or testing, the hearing aid specialist observes any of the seven criteria for medical referral, be or she must again urge the client to seek medical help. (See criteria listed in next section.) If the client refuses, the fact should be noted on the waiver and signed by the client. In fact, it is advised that if any one of the seven criteria is observed, the client should not be fitted with a hearing instrument. REPLACEMENT HEARING AID5 Under these guidelines, the client is not required to obtain medical clearance from a physician for replacement hearing aids. However, if any of the following conditions are found to exist either from observation by the hearing aid specialist or on the basis of information supplied by the client, since the fitting of the first hearing aid, medical clearance will be required again. This criteria for medical referral is as follows: (1) Visible congenital or traumatic deformity of the ear. (2) Active drainage from the ear within the previous 90 days. (3) Sudden or rapidly progressive hearing loss. (4) Acute or chronic dizziness, or tinnitus. (5) Unilateral hearing loss of sudden or recent onset. (6) Significant air-bone gap. (7) Visible evidence of cerumen accumulation or a foreign body in the ear canal. Medical records may be checked on items #1 and #6 to verify whether these conditions were considered at the time of the purchase of the first hearing aid and have not changed. If there has been no change, a replacement bearing aid may be fitted without medical examination. These criteria were developed in consultation with medical ear specialists and are included in some state laws. While they Oo not require the hearing aid special- ist to diagnose, they have proven to be an effective device in screening conditions which require medical attention. PROCEDURES FOR REFERRAL If a client has no personal knowledge of the name or location of a medical ear specialist, the hearing aid specialist should assist the client in obtaining neces- sary information to encourage follow-up care. In areas where a number of qualified medical ear specialists are available, the hearing aid specialist may provide a list of several physicians. It is recognized that many first-time clients for hearing aids are reluctant can- didates, often pushed to time hearing aid specialist by desperation or family pres- sure. In such cases, failure to make a direct referral may result in failure of the client to enter the hearing health care procedure. If this attitude is noted, the hearing aid specialist is justified in making specific referral, and even assisting in arranging an appointment. Referral to a specific physician should be based on the hearing aid specialist's knowledge of the physician's competence, integrity and availability. No financial interest should be involved in any referral. MEDICAL CLEARANCE FORM The following medical clearance form is suggested for use by the physician: PAGENO="0209" 203 "I have examined - and do not find any contraindications for hearing aid usage." Signature of Physician Date The signed medical clearance form should be given directly to the client, to be- come part of his personal record. The physician should make every effort to en- courage the client to return to the referring hearing aid specialist. (The medical clearance form will be valid for no more than 18 months from the date of medical examination by the physician.) (in some cases, although the client may have had such medical examination within the previous 18 months, obtaining the form may be impossible or inconven- ient, due to death or retirement of the physician, or to moving, or for other rea- sons.) In those cases, the client may sign the following statement: I, , have had an examination for my' hearing within the past 18 months, and the physician did not indicate any reason why I should not obtain a hearing aid. I am unable to obtain my medical records because (I moved, the physician moved, retired, etc.) and therefore take full responsibility for obtaining a hearing aid without further medical examina- tion. Client's sign ature Date WAIVER FORM In order to preserve the client's civil liberties, a provision for a waiver is in- cluded in the NHAS medical clearance 1)olicy, which permits the client to waive medical clearance due to religious or personal convictions. The following wording for a waiver is suggested: ~r1ihis is to certify that I have been advised by (name of hearing aid specialist) , a hearing aid specialist, that my best interests would be served by obtaining a medical examination prior to being fitted with a hearing aid. I hereby waive such medical examination." Witnes8 Signature of Client Such a waiver shall not be encouraged merely to avoid the medical clearance provisions of this policy, and evidence of such intent may result in disciplinary action by the National Hearing Aid Society. If wording for the waiver is provided by state law, or rules and regulations, that w-ording may be substituted for the one given above. 1/76 EXHIBIT No. 50 NATIONAL HEARING AID SOCIETY, NATIONAL HEADQUARTERS, Jhvonia, Mich., January 23, 1976. To: All NHAS Members Subject: NHAS Medical Clearance Policy and Rental/Purchase Option Plan Last October, at the Annual Meeting, the NHAS membership approved a policy for medical clearance of clients prior to purchase of the first hearing aid, with a waiver available for certain cases, and a rental/purchase option for clients who need it. After approval of the general policy by the membership, details still 79-954-70----14 PAGENO="0210" 204 needed to be worked out for implementation of these policies, which are to be followed by all NHAS members. These have now been developed, through consultation with the NHAS Medical Advisory Council, the NHAS Board of Governors, and the NHAS staff. We feel that we have made them flexible enough to accommodate many individual and variable situations, yet rigid enough to provide genuine consumer protection. A copy of the Medical Clearance Plan is enclosed, which explains what you need to do to comply with that policy. The Rental/Purchase Option Policy is as follows: "In order to provide a trial period for those clients who desire it, the National Hearing Aid Society hereby requires all its members to make a rental/purchase option plan available on hearing aids. Each member may establish his own terms for such plan, based on the needs of the client and his own operating costs. "Where a specific hearing aid is recommended by anyone other than a NHAS member (such as a medical doctor or a clinical audiologist), the availability of the rental/purchase option plan is not required. In all hearing aid fittings, time individual making the specific recommendation should be responsible, financially and otherwise, for the decision." These policies represent a big step forward in improved hearing health care, and implementation of both the letter and the spirit of the policies will also enhance your relationship with your clients as well as our detractors. This com- pletes ~ of our 4-point consumer protection plan, with the educational part being managed by the Hearing Instruments Institute. The fourth part, the consumer complaint/grievance policy, is now under development, and will be announced in the near future. Sincerely, M. L. FORTNER, President. Enclosure. EXHIBIT No. 53 DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, OFFICE OF THE SECRETARY, OFFICE OF CoNsu~iEn AFFAIRS, Washington, D.C., October 22, 1975. ~lr. LARRY G. ALKIRE, Public Affairs Manager, Beltonc ElectronIcs Corp., 4201 West Victoria street, Chicago, Ill. DEAR Mn. ALKIRE: In response to your request for information regarding con- sumer complaint involving hearing aids received by Mrs. Knauer, I am enclosing a statistical breakdown of the complaints* we have received during the past seven months. The largest hearing aid complaint category deals with sales practices. In many cases, the consumer felt the product had been misrepresented by high pressure salesmen who convinced the consumer that, despite contradictory medical opin- ion, a hearing aid would restore hearing loss. The second largest category, "faulty performance/defective product," involves consumer consternation over repetitive in- and out-of-warranty repairs. The cost of out-of-warranty repairs was a major concern, not to mention the inconvenience. Consumers were also concerned over the short life of hearing aids and batteries, and the high cost of batteries. Judging from some of the follow-up correspondence in our complaint files, it appears von are making an earnest effort to thoroughly investigate and resolve complaints against Beltone. I look forward to hearing more about newly imple- mented policies directed toward your objective_improving consumer satisfaction. I hope the enclosed proves useful to your efforts, and if we can be of further assistance, please let us know. Sincerely, FRANK E. MCLAUGHLIN, Director for Program DeveiopJneflt and Implementation. Enclosure. PAGENO="0211" 205 Consnmer Complaints Involving Hearing Aids (covers a 7-mont/i period) Total complaints received 23 Complaint categories: Peiceiitage Sales practices (7) 30 Prices (5) 22 Request for information (1) 4 Improper packaging and handling (1) 4 Faulty performance/defective product (6) 26 Warranties (1) Batteries (2) 0 EXHIBIT No. 54 NATIONAL RETIRED TEACIIER5 ASSOCIATION, AMERICAN ASSOCIATION OF RETIRED PERSONS, October 30, 1975. i\Ir. RICHARD FRALICIC, Public Affairs Director, National Hearing Aid Society, Washington Office, 2201 Wilson Blvd., Suite 506, Arlington, Va. DEAR DICK: Let me take this opportunity to once again thank you for your fine cooperation in handling the hearing aid complaints of our nlelfll)ers. The Consumer Office has been extremely pleased with your organization's informal complaint referral mechanism as we have know-n it to exist over the past year. We commend your efforts to expand this program into a nationwide system and want to assure you that we will he happy to cooperate iii any way that we can. Assuming that the hearing aid regulations will eliminate some of the com- plaints relating to sales practices, I think it is safe to say that this office will refer approximately 15 complaints to you annually. According to our statistics, in 1973 the Consumer Office received 17 complaints concerning hearing aids. The number of complaints increased to 21 in 1974; 1975 complaints to date num- ber 15. The only addition we might suggest to your present complaint handling procedure is an automatic follow-up system. Once a complaint has been re- ferred to a dealer it should he placed in a suspension file. This will insure that it will be automatically called to your attention in a given time period (one month?) if the dealer has not responded. We are interested in knowing how your complaint center is progressing, Dick. ~f w-e can be of further assistance, please call upon us. Sincerely, KAREN S. BLIJMENBERG. Consumer Program. Specialist. EXHIBIT No. 55 HEARING AID COMPLAINTS ARE MINIMAL From time to time, alarming tales about "great consumer abuse" in hearing aid distribution are circulated. Some, apparently for dramatic effect, claim to have files "bulging" with complaints from hearing aid users. Yet, when asked to pro- duce those "bulging" files they have been uable to do so. Nevertheless, the scare stories persist despite the overwhelming body of evidence proving that hearing aid specialists are doing an exceptionally fine job, and hearing aid consumers are receiving some of the best service available anywhere. Proof of this is reflected in reports from the Better Business Bureaus, Vir- ginia Knauer's Office of Consumer Affairs, state licensing hoards, and other agencies established for processing consumer complaints, as w-ell as ohjective market research. The evidence from all sources is consistent. It shows that very few com- plaints about hearing aids are filed, and when they are, they are usually resolved i)rOmptly and willingly by the hearing aid specialists involved. PAGENO="0212" 206 BETTER BusINEss BUREAU Following is a summary of complaint reports from Better Business Bureaus throughout the country: Southwestern Connecticut Better Business Bnreau.-"In a thorough review of hearing aid files contained in our office, it has been duly noted and confirmed that complaint activity in this singular category have been in a minority and have not demanded the attention that several other areas require. . . . We have noted that where there exists need or cause for formal investigation or action, the Connecticut State Department of Health has been successful in providing the means to deal with offenders, consumer-grievances, questionable practices, and all items of similar nature. It has been the experience of the undersigned that the Advisory Council for the Commissioner of Health, dealing with the aforementioned areas of concern, reacts promptly and effectively when so required." Signed: A. B. Kerstein, President. Better Business Bureau, Birmingham, Ala bama.-"The Better Business Bureau in Birmingham, Alabama advises me that in the past five years, they have had only five complaints . . . against the . . . hearing aid dealers in the city. Four of these were taken care of to the customer's satisfaction. One was not a valid complaint and no action was taken." Signed, L. Louise Walter Better Business Bureau of San Diego, Ltd.-"Our files show only three con- sumer complaints on hearing aid firms handled in the last two years. In order for a complaint to become a permanent part of our files and reporting system, it must be in writing." Signed: Christine Rhea, Consumer Service Division. Rocky Mountain Better Business Bureau. Denver, Colo.-"We received, at the Rocky Mountain BBB, 104 requests for information on the 32 firms identified in 1074, and a total of only 0 written complaints on the industry. We feel the small number of complaints is commendable." Signed: Marilyn Boone, Operations Manager Better Business Bureau of Treasure T7alley, Boise, Idaho-Last year, we had 29 inquiries as to the reliability of hearing aid dealers and we processed 7 com- plaints which does not indicate that we are having a major problem at this time. We did refer some complaints to the Occupational License Department as one or two dealers had been uncooperative with our Bureau. In all, we processed 541 complaints last year. . . . This Bureau is the only one in the State of Tdaho." Signed: Irma Moulton, Manager. An attached report showed that the same number of complaints (7) which were filed against hearing aid specialists were filed against banks and telephone companies. Better Business Bureaus, Kansas.-Letter dated September iT, 1075-"Since January 1. 1975, the Better Business Bureaus in Kansas have received four complaints concerning hearing aids. All four complaints were answered and ad- justments were made or offered in each case. The complaints involved a billing error, alleged misrepresentation in selling, a warranty dispute, and dissatis- 1~action with slow service." Signed: Rollin McCartor, President. Better Business Bureau of Baton Rouge Area, Inc. (Louisiana) -Time Bureau l)egan operations in 1950 and we have files on six complaints. The following is a compilation of our customer experience: Company File opened Complaints A B 1951 1953 0 1 C 1951 2 D E 1962 1973 2 0 F 1973 11 I Advertising. "Based on this file information, we do not see the need for any further regula- tion of the hearing aid industry." Signed: Dale Ramirez, V. President. Better Business Bureau of New Mexico, Inc.-"Our Bureau covers the entire state of New Mexico providing services to both consumer and businessman. During PAGENO="0213" 207 the past two years, we have replied to many inquiries on the reputation and reliability of various firms throughout the state. Our records indicate that we have received two written complaints (about hearing aids) and both were adjusted by the firms involved. In one case, an adjustment was made when the facts of the matter did not warrant a full refund. The Better Business Bureau appreciates the record the industry has earned with our office." Signed: Gunny R.igby, Con- sumer Relations Director. Better Business Bureau of Omaha, Inc.-"We have handled seven complaints (regarding hearing aid dealers). All were taken care of to the complainant's satisfaction. Over the period of September 74 to September 75, this office has handled 6,183 complaints involving all types of complaints." Signed: John J. Henry, General Manager. Cornhusker Better Business Bureau, Inc., Lincoln, Nebraska.-"From Sep- tember 74 to September, 1975, our office processed two complaints on bearing aid companies. One complaint *as settled, and one we referred to the Hearing Aid Licensing Bureau in Omaha. The total complaints filed were 1,659." Signed: Lois Teift, Manager. The Better Business Bureau of Tulsa, Inc.-"Our files reflect little or no complaints against the hearing aid profession in Northeastern Oklahoma area. Those few complaints have been promptly adjusted by regular established firms in our trade area." Signed: Cheston Heath, President. Better Business Bureau of Central Oklahoma, Inc.-"In 1974 our office handled 84,515 contacts from consumers seeking information and assistance. Out of that total, the hearing aid industry represented 210 contacts and only 5 written com- plaints. In the first eight months of 1975, out of over 60,000 instances of service by the BBB, the hearing aid industry accounted for 149 consumer contacts and only 4 written complaints. This is one of the lowest reports of customer dissatis- faction out of the 155 statistical business classifications on which the Bureau keeps daily records." Signed: Forest A. Wilkins, Managing Director. Better Business Bureau of &in Antonio, Inc.-"According to the yellow pages of the telephone directory this city has thirteen (13) hearing aid firms. Of these thirteen firms, the San Antonio Bureau has had complaints filed against only three in the past three years. There were five complaints filed altogether, and all five were answered and adjusted. There are no outstanding complaints."-Signed: Mrs. Dorothea M. Busch, Administrative Assistant. Better Business Bureau of Fort Worth and Tarrant County, Inc.-"We have had very few complaints against the (hearing aid) businesses in our area in the past three years. There have been complaints filed against some businesses, hut the businessman handled the complaint to the customer's satisfaction; tl~ere- fore we feel the businessmen in our area have complied with the Bureau's policy. . . . We feel we have a good relation with the Hearing Aid Dealers in this area, as they have responded to any complaint and/or advertising suggestion which the Bureau has made." Signed: Charles 0. Unfried, President. Better Business Bureau-Arkansas.---"There were 468 complaints registered against hearing aid companies in the United States (from January, 1975 through June. 1975~ with 73.8% of these complaints being settled by the company . according to our Statistical Summary from the Council of Better Business Bu- reaus, these complaints rank 67th of all complaints registered from January 1975 through June, 1975. Locally we have very few complaints on hearing aid com- panies." Signed: Jean Lensing, Customer Relations. Better Business Bureau of Central New England.-"In 1974 there were 48 inquiries, 6 complaints and 3 unsettled. In 1975 there were 24 inquiries, 3 corn- ulaints and 1 unsettled. One settled via voluntary arbitration provided through BI3B Arbitration Tribunal on a complaint from a Lunenburg woman against a Boston dealer." Signed: Donald F. Williams, President. VIRGINIA KNAUER'S OFFICE OF CONSUMER AFFAIRS The following statistics were obtained from the Office of Consumer Affairs, Department of Health, Education, and Welfare, Frank McLaughlin, Director for Program Development and Implementation; PAGENO="0214" 208 "Consumer Complaints Involving Hearing Aids" (covers a 7-month period in 1975) Total Complaints Received 23 Complaint categories: Sales practices (7) Prices (5) Request for information (1) Improper packaging and handling (1) Faulty performance/defective product (6) Warranties (1) Batteries (2) LICENSING BOARDS (As reported by Staff Study of Permanent Subcommittee on Investigations (Committee on Government Operations) U.S. Senate-October, 1975) The Staff Study of the Permanent Subcommittee on Investigations reported that over a five-year period, state licensing boards throughout the country had received a total of only 2,383 complaints from a universe of nearly 3,000,000 hear- ing aid users. These statistics are consistent with reports from other agencies, showing a low level of complaints in the hearing aid field. Also, examination of the complaints filed with the Tennessee Licensing Board showed that most of them were not filed by consumers, but by other hearing aid specialists in a remarkable demonstration of peer group policing promoted by highly competitive conditions in the hearing aid field. MARKET RESEARCH Several years ago, seeking to identify areas for improvement in the hearing aid field, the National Hearing Aid Society (the professional association for hear- ing aid specialists) and the Hearing Aid Industry Conference (the trade associa- tion of manufacturers of hearing aids), commissioned an industry-wide survey by Market Facts, Inc., professional market researchers. The firm has done studies for the DHEW, other government agencies and major industries. In the study of the hearing aid industry, concluded in 1971, they found that a solid 90% of hearing aid wearers are satisfied with the services they received from the industry, while less than 2% rated themselves as "very dissatisfied." Serv- ices surveyed included those provided by hearing aid specialists at the time the customers had their hearing tested by the hearing aid specialist, at the time of purchase, and in the after-purchase period. A more recent study was conducted by Payne and Payne Consultants in 1974. It said, "Interviews with hearing aid specialists and with a random cross section of their clients revealed a level of competence and dedication which would reflect well on any profession in our society. The hearing aid specialists attitude toward his clients is reminiscent of the family doctor of a generation ago. The unethical constituted a remarkably small minority." WHAT THE CONSUMERS THEMSELVES SAY Thousands and thousands of letters from consumers were sent to the FTC and the FDA during their studies of the hearing aid field and 97.8% of them sup- ported hearing aid specialists. The Final Report of the HEW, issued in July, 1975, said, "The opinions expressed in these comments . . . represent strong con- sumer advocacy of the present delivery system. Many consumers regarded the personal attention and understanding, unlimited services, and helpful care ex- tended by the dealers as invaluable and irreplaceable attributes of the existing systems. Hearing aid users, particularly the elderly, depend exclusively on their dealer to provide the device and services necessary to reducing the debilitating effects of their handicap, thus enabling them to lead full and relatively normal lives. Were it not for the continual encouragement and effort exerted by the dealer, many of the hard-of-hearing feel that they would be yet "doomed to the world of silence." Most of the consumers described their dealer as a friend rather than a salesman and expressed explicit trust in his knowledge and expertise in the area of hearing aid health care." PAGENO="0215" 209 Thus, examination of the complaint record from nearly every reputable con- sumer agency in the country leads to the same conclusion-hearing aid specialists are providing top quality service in hearing aids. The facts, as they actually are, prove that claims of "great abuse" in the selection and fitting of hearing aids are unsubstantiated. ExHIBIT No. 61 THE RESPONSE OF THE NATIONAL HEARING AID SOCIETY TO THE "STAFF STUDY OF STATE LICENSING LAWS AND TRAINING REQUIREMENTS FOR HEARING AID DEAL- ERS," TO THE PERMANENT SUBCOMMITTEE ON INVESTIGATIONS OF THE COMMITTEE OF GOVERNMENT OPERATIONS OF THE UNITED STATES SENATE The Staff Study does not accurately reflect present conditions in the hearing aid delivery system. This is due to: (1) Faulty research techniques and investigative methods (2) Selective use of data to support erroneous conclusions (3) Sweeping generalizations based on inaccurate research or isolated cases (4) Numerous errors of fact and interpretation Readers of the "Staff Study" are urged to review it skeptically with the realization that proper research and reporting methods were not observed. This presentation will point out those areas which are false or incomplete, and provide the correct information pertaining to them. It is written and pre- sented in an effort to correct the record. Staff Study.-"Introduction"-page 1-"In hundreds of thousands of cases, electronic amplification can help restore hearing." Correction-Amplification cannot restore the hearing mechanism, but merely compensates for hearing loss. It is improper to imply that a hearing aid will "restore" impaired hearing. Staff Stucly.-"Introduction"-page 1-"As both the Federal Trade Com- mission and the Food and Drug Administration have demonstrated by their recent attention to the hearing aid industry, the delivery system for these devices is not without its flaws. The FTC has brought antitrust actions against six manu- facturers for allegedly engaging in exclusive dealing arrangements. The Commis- sion has also filed complaints against six hearing aid producers for allegedly misleading advertisements." Correction-Although the FTC brought antitrust actions against several manufacturers, and charged several manufacturers with false advertising, no wrongdoing on the part of the manufacturers was proven. In order to avoid costly litigation, the manufacturers signed consent orders, which the FTC clearly says does not necessarily prove wrongdoing. The FTC news summary states, "A consent agreement is for settlement purposes only and does not constitute an admission by respondents that they have violated the law." The American government should hold to the principle that a person is innocent until proven guilty. Unfortunately, in recent years, the system of American justice is being eroded by the assumption that a person is guilty until proven innocent. The hearing aid specialists in particular have been victimized by this misinterpre- tation of justice. Staff Study.-"Introduction", page 1-"Yet, as both the Federal Trade Commission and the Food and Drug Administration have demonstrated by their recent attention to the hearing aid industry, the delivery system for these devices is not without its flaws. These flaws are significant . . . On June 17, 1975, the FTC issued proposed trade regulations governing the marketing and sale of hearing aids that would give purchasers a 30-day trial period and limit house-to- house sales of the instruments." Correction-The attention of the FTC and the FDA to the hearing aid industry has not demonstrated that "the flaws are significant." The FTC rules are only proposed trade regulaitons, not yet approved by the Commission, with hearings still to be held, and modifications may be needed in the light of more evidence. It is debatable whether this draft of proposed regulations will stand up to public scrutiny, and the proposed regulations themselves may actually contain "significant flaws." The FDA experienced the need for modifying their original report not once, but twice, due in part to the overwhelming support con- sumers demonstrated for the present hearing aid delivery system, and presenta- PAGENO="0216" 210 tion of facts which showed that some of their original assumptions about the hearing aid delivery system were incorrect. Staff Study._"Introduction"-Page 1-"The Department of Health, Educa- tion and Welfare in May, 1974 launched a study of the hearing aid delivery system. A final report on the study's findings issued in September, 1975 suggested that the problems in the delivery system centered principally on the dealer." "The HEW Task Force, created by then-Secretary Caspar W. Weinberger, declared that `misevaluation of a patient's need for a hearing aid and the subse- quent sale of a hearing aid device which is ineffective, and possibly unsafe for its intended use, are the major problems of the hearing aid delivery system.'" Correction-This quotation appearing in the original report, which was later revised twice in the light of additional evidence presented. This final report, issued in September, 1975, said, "The Task Force recognizes and appreci- ates the role of the hearing aid specialist as an essential element of the hearing health care team. The various services (e.g. fitting an aid, pre and post- aid counseling, and repairs) provided by these specialists are regarded by many of the hard-of-hearing as indispensable to their welfare. (Emphasis ap- plied.) The Task Force is encouraged by the actions of the hearing aid specialists to develop comprehensive competency requirements for the selection, fitting, and counseling of the hearing impaired. These actions are indications that hearing aid specialists recognize the need to adapt and modernize their role to the con- tinually evolving concepts of professional hearing aid fitting." The final report also said that "Of the almost 5,000 comments received in response to the DHEW Task Force Report and Supplement on the Hearing Aid Health Care Delivery System, approximately 66% of the correspondence was categorized as representative of the consumer population." NHAS analysis of these comments showed that 97.8% of them supported the present delivery system. The Task Force final report said, "The opinions expressed in these comments, although generally based on an incomplete and faulty interpretation of the Task Force Report, represent strong consumer advocacy of the present delivery system. Many consumers regarded the personal attention and understanding, unlimited services, and helpful care extended by the dealers as invaluable and irreplaceable attributes of the existing system. Hearing aid users, particularly the elderly, depend exclusively on their dealer to provide the device and services necessary to reducing the debilitating effects of their handicap, thus enabling them to lead full and relatively normal lives. Were it not for the continual encouragement and effort exerted by the dealer, many of the hard-of-hearing feel that they would be yet `doomed to the world of silence.' Most of the consumers described their dealer as a friend rather than a salesman and expressed explicit trust in his knowledge and expertise in the area of hearing aid health care. "A definite tone of resentment pervaded throughout the comments toward any Federal regulations either restricting or totally eliminating the role of the dealer from the delivery system. Consumers felt that this system was successfully responding to their needs and, if the proposals in the (original) Task Force Report were to be enacted, tragic consequences would ensue for the hearing impaired." Staff Study.-"Introduction"-page 1-"A Subcommittee staff review of several hundreds complaints at the FTC, the FDA and in the files of Senator Charles H. Percy of Illinois, confirmed the Task Force finding. Complainants reported that they were sold aids they didn't actually need. Many dealers who were complained against appeared to lack a strong sense of ethics or a degree of competence sufficient to evaluate the causes of hearing loss, to provide the proper hearing aid if one was indicated, or to refer the client to a doctor special- izing in diseases of the ear." Correction.-The final Task Force report showed that hearing aid users strongly support the present hearing aid delivery system, as quoted previously. NHAS analysis of the "complaints" received by Senator Percy showed that many of them were actually "inquiries", some centered on the price of hearing aids rather than incompetence or unethical conduct of hearing aid specialists, and some were unreasonable demands, as in the case of a person asking for full money-back on a hearing aid purchased four years earlier. (An analysis of all, consumer complaints at FTC, etc., would probably show' the same thing.) It is wholly inaccurate to conclude, as does the Staff, that these "complaints" in any PAGENO="0217" 211 way demonstrate significant sales abuse among hearing aid sellers. Data pre- sented later iii this report will point out some of the serious mistakes the Staff made in interpretation of statistics. Staff $tudy._"Introductiofl"-Page 2-"As many as two out of three per- sons with some form of hearing impairment stop at the dealer first, the HEW Task Force reported. This is because some states do not ordinarily require adults to obtain a written recommendation from an otologist or audiologist that a hear- ing aid is necessary for a patient to achieve better hearing." Cor'rection.-A study of the hearing aid delivery system completed in November, 1974, by Payne and Payne Consultants, showed that most people consulted professionals other than the hearing aid specialists before obtaining a hearing aid. In response to the question, "In addition to the hearing aid specialist, whom did you consult about your hearing loss?", 61.4% of the consumers said that they had consulted an ear specialist, 12% said they had consulted a general practi- tioner, and 14.1% said they had consulted a clinical audiologist or hearing and speech clinic. The report concluded, "The high percentage (61.4%) of those who had consulted an ear specialist may well be related to the high level of anxiety observed among those who have hearing problems . . . After the anxiety is allayed by a medical examination, however, interest in the ear specialist diminishes. Only 9.2% of the users interviewed plan to return to an ear specialist before purchasing their next hearing aid." Thus, the hearing impaired do not "stop at" a hearing aid dealer's office. The hearing impaired must be sought out and persuaded to obtain care. The hearing aid specialists are frequently the point of entry into hearing health care, be- cause they are the ONLY members of the hearing healtl~ team who bother to seek out the hard of hearing and convince them to do something for their hearing loss. But, that is only the first step in their rehabilitation. NHAS endorses the advisability of medical examination prior to obtaining the first hearing aid, and NHAS members have endorsed a policy whereby such a recommendation will be mandatory prior to an initial hearing aid fitting. It should he pointed out that like hearing aid specialists, clinical audioloeists are not medically trained, and should not be considered an alternate to the otologist, as is suggested by the phrase "otologist OR audiologist", and "doctor OR audiologist," used in the Staff Study. Only the otologists or otolaryngologists are qualified and competent to diagnose and treat hearing loss. Some clinical audiologists are misleading the public by falsely implying that they have medical competence and training. staff Study.-"Introduction"-page 1-Many of the 39 State dealer licens- ing boards have little or no staff or funds with which to operate, meet infre- quently, and are in most cases, controlled by the dealers. Some of these dealer- board members by their actions, have demonstrated that they do not appear to have the interests of the consumers uppermost in their minds, giving the appear- ance, if not the reality, of a conflict of interest." Correction-This statement is discredited by the Staff's own statistics. On page 60 of the Staff Study, it showed that only 13 states (out of 40 licensed) states reported no direct staff assistance. However, the tabulation of the licensing questionnaire did not show how many receive indirect staff assistance from the Department to which the Licensing Board is assigned. (2 states did not respond.) Thus, MOST of the states do have some staff help. The low volume of complaints would seem to preclude the necessity for full-time staff for processing complaints. Page 61 of the Staff Study showed that the average annual budget in fiscal 1975 was $12,554 based on 26 states. In addition, if a dollar figure were assigned to the non-compensated time donated by members of the Licensing Boards, it would substantially increase the expenditure for enforcement of licensing laws. Such donated time is a substantial contribution. Page 61 also shows that the Board meets at least four times annually in at least 22 states. (2 states did not report.) The low volume of complaints seems to preclude the necessity for more frequent meetings. The "appearances" of a conflict of interest or lack of interest in the consumer apparently existed more in the minds of the Staff than in reality, because they are unable to present concrete evidence which supports this opinion. In general, the 4ealer members of the licensing Boards have been among the most conscientious and dedicated public servants, donating great amounts of time in a sincere effort to improve the hearing aid delivery system. Most have 79-954-76---15 PAGENO="0218" 212 been a truly constructive force in insuring high quality service to the hearing impaired, and support for their efforts is needed. The National Hearing Aid Society fully supports the concept of adequate funding to permit the Licensing Boards to carry out their duties effectively. However, this may not be as great a problem as the Staff indicates. Some Boards have said their major problem is in convincing the State Attorney Generals to take action against offenders, when requested to do so by the Licensing Boards. The conclusion of the Staff Study that "licensing hoards do not have the interest of the consumers" is wholly unfounded. Staff Study._"Introduction"-page 2-"In terms of professional competence, a hearing aid dealer can be only as good as the quality of his training. The National Hearing Aid Society, the dealer's group, is the only organization offering a national program of instruction for dealers." Correction.-The National Hearing Aid Society is not "the only organiza- tion offering a national program of instruction for dealers." Many manufacturers also offer training programs, and even require them for their hearing aid specialists. Staff Study._"Introduction"-page 2-"To determine how complete the NHAS program is, the Subcommittee asked three expert panels to review the curriculum. The experts reported that the NHAS training is inadequate, inac- curate, and even dangerous." Correct 1 oii.-T he expert panel reviewed only "The Basic Course of the National Hearing Aid Society." This course was designed only to teach the Fundamentals. Neither at its inception nor now is it regarded as a complete training program as the staff study apparently suggested. It is Only Introductory; hearing aid specialists are given innumerable opportunities and every encouragement to pursue advanced training through workshops, advanced courses, seminars, and conferences offered by the National Hearing Aid Society and hearing aid manufacturers. On-the-job training is essential in the education of hearing aid specialists. Two years experience under supervision, in the selection and fitting of hearing aids and the testing of hearing are needed to qualify for certification by the National Hearing Aid Society. Furthermore, the three panels of experts disagreed in their criticism of the basic course, and issued contradictory statements about it. The panel from the American Council of Otolaryngology said that it was "too technical" while the panel from the American Speech and Hearing Association called it "superficial." In addition, the panel from the Veteran's Administration called it "inaccurate" while the panel from the American Speech and Hearing Association said that it is accurate. Such contradictions invalidate the analyses. Staff Study.-~"Introduction"-page 2-"Each of the panels was asked: Does the course equip a hearing aid dealer to properly evaluate hearing loss? Does the course equip a hearing aid dealer to detect and analyze hearing dis- orders requiring medical attention? Does the course equip the hearing aid dealer to make professional judgments on hearing loss and recommend corrective action ?" Correction-Since the staff was erroneous in their impression that this basic course constitutes the total training of hearing aid specialists, they asked incorrect questions about the course. Needless to say, the answers were con- founded by the false ideas of the staff, which lead them th ask the wrong ques- tions. Either intentionally or unintentionally, they contrived to develop answers suiting the theme of their report. Even with such misleading and leading ques- tions they got conflicting answers. Staff Stvdy._"Introduction"-Page 3-"National Hearing Aid Society Dealer Training Program. Correction.-It is worth repeating-The basic course which the staff asked the expert panels to review does not constitute the complete training program for hearing aid specialists. This was not its purpose at its inception, has never been its purpose, and is not the purpose at this time. Staff Study.-"Introduction"-page 3-"The program consists of 20-borne- studylcesons, the answers to which are completed by the applicant in his home. These responses are graded by a firm under contract with NHAS. The 20 lessons consist of readings from three textbooks and a lesson summary prepared by the NHAS." Correction.-The Staff omitted the fact that a final closed-book, profession- ally proctored examination is included as part of the NHAS Basic Course. No PAGENO="0219" 213 one passes the course unless he passes the final exam. The course itself is merely a guide to the other readings. The final exam contains 173 questions including multiple choice, open-ended essay questions, and true-false questions as NHAS reported to the FTC. Staff Study._"Introductiofl"-Page 3-"Persons who successfully complete the lessons are considered non-certified members of the NHAS." Correction.-This is incorrect. Persons often complete the course without becoming members. Out of a membership of over 2,300, the National Hearing Aid Society has only about 50 "Registered/Provisional Members" who are work- ing toward Certification. Completion of the course does not entitle a person to membership in the National Hearing Air Society. However, the NHAS organiza- tion has 50 states and provincial Chapters which establish their own membership requirements. Staff Study._"Introduction"-Page 3-"Those who seek further recognition from the industry group must take a final proctored examination. . . A passing grade on the exam, plus approval from local dealers and other community leaders as to the character and credit rating of the applicant make the candidate eligible for an NHAS plaque, suitable for office hanging. The plaque declares the bearer to be a "Certified Hearing Aid Audiologist." Gorrection.-Despite the fact that on several different occasions, which we can document, the National Hearing Aid Society submitted complete information about NHAS Certification requirements to the staff, they abbreviated the require- ments, and omitted several of the most important. Among these are the require- ment for two years experience, with supervision, in the fitting of hearing aids; affirmation by a physician preferably an otologist, that the person is competent to make the required hearing analysis, take ear impressions, and adjust the hearing aid and earpiece to carry out their functions; a pledge, under oath, to abide by the NHAS code of ethics; and ultimate review of the application by the National Board for Certification. All of these requirements are carefully checked, and despite disparagement of the requirements through the Staff's abbreviation of them, the Certification is now, and always has been a good faith effort of the National Hearing Aid Society to encourage and maintain high standards in the selection and fitting of hearing aids. Staff Study.-"Introduction"-pages 4 and 5-Excerpts from the evalua- tion of the NHAS basic course by the panels of "experts." The VA found the course to be "oversimplified" with some data presented in a very "complex manner." They called some information "incorrect." One VA panelist, Hayes Newby, who is the author of the Textbook, "Audiology," was a member of the group which called the textbooks "outdated." The American Council of Otolaryngology, however said that the Basic Course is "far too technical" but added that they were "unable to determine the adequacy and ability of the National Hearing Aid Society training program to equip their dealers as to the fitting and selling of hearing aids." On the other hand, the American Speech and Hearing Association panel claimed that some of the course "is given extremely superficial treatment," but added that the course is "accurate." (Exhibit 6- page 23-"Although all topics are given superficial coverage, the information is generally accurate in content with no gross errors.") Correction.-Obviously, f or the author of a textbook to say that his own work is "outdated" even though it was revised in 1972, and is on the current book list of the largest textbook published in the world. Prentice Hail, is extremely puzzling. It should be pointed out that Hayes Newby has been paid substantial royalties by many educational institutions, as well as the National Hearing Aid Society, for use of this textbook, which he now claims is not satisfactory. He should have advised all users of the book, including NHAS, of its deficiencies before accepting the royalties from the book. The fact that the various panels gave contradictory opinions of the course indicates a need for further evaluation. A revision to the course has been in preparation, and when completed, NHAS will submit it to the NHAS Medical Education Advisory Council. The members are Aram Glórig, M.D., Director of the Callier Hearing and Speech Center, Charles W. Gross, M.D., Profesor and Chair- man of the Department of Otolaryngology and Maxillofacial Surgery, College of Medicine, University of Tennessee, Maurice Schiff, MD., A. Neil Lemon, M.D. and John W. Heisse, M.D. Staff Study.-The Staff Study says that the VA Panel felt that the descrip- tions of cholesteatoma were "inadequate and misleading" and that a person may PAGENO="0220" 214 risk loss of life due to the hearing aid specialist's inability to recognize this "life threatening" condition. Correction-In testimony at the hearings before the Department of Health, Education, and Welfare lntradepartmental Task Force, Washington, D.C., May 7, 11975, Dr. Aram Glorig, clinical audiologist and otolaryngologist said, "Well, my god these tumors aren't that common, and even if they are there, it takes a ~teain of neurologists, otolarnygologists, and even other people to really make a diagnosis of this." "So, the only thing that I think will work are these red flag systems where you see a sign that something might be wrong, and then you send that person to get the best advice he can." (Page 96, Appendix D, Final Report to the Secretary on Hearing Aid Health Care, prepared by DHEW Interdepartmental Task Force on Hearing Aids, July, 1975.) Dr. Glorig said the "red flags" referred to are ". . . such things as dizziness, sudden hearing loss, sudden change ia hearing loss, running ear, a bone con- duction, air bone gap, and that sort of thing. These are pretty well standardized and have been thought out quite carefully." He added that these could be used by hearing aid specialists, clinical audiologists and family physicians to identify those persons who need referral to a medical ear specialist. These "red flags"-a criteria for medical referral, are being incorporated into the licensing laws and related rules and regulations for hearing aid specialists. A study made in 1973 about the incidence and fatalities from acoustic neuroma showed that the dangers from it have been greatly exaggerated. This study showed that in1968, there were only 19 deaths from cranial nerve tumors (malig- nant neoplasms of cranial nerves, including optic. Acoustic neuroma is classified in this category.) So this condition is very rare. Facts were distorted with the sort of statement made by the VA panel. Staff Study.-"Nearly 50 percent, more than 2,500 of them, have never taken a licensing exam. They have been `grandfathered' into licenses by virtue of their dealer activity prior to the law's coming into being." Correction-The National Hearing Aid Society is unable to verify this statistic, but due to the numerous errors in the Staff Study, this is subject to question. Regardless of its authenticity, it shoud be pointed out that even those persons who were granted licenses through grandfather clauses are subject to regulation imposed by the laws. Most of the laws list prohibited acts, and provide penalties for violations, so even a person licensed under grandfather may have his license suspended or revoked for unethical or illegal conduct, or incompetence. The grandfather clause actually resulted from the reluctance of some legis- latures to pass laws which might legislate persons out of their occupations and livelihoods. In time, the "grandfathers" will have been phased out, and every hearing aid specialists will have shown proof of competency. However, many states did not include a "grandfather" provision at all and all licensees were required to pass the examination. Staff Study.-"A detailed inquiry into how one State licensing board con- ducted its business, while controlled, 5-4 by dealers, illustrates some of the problems occuring in licensing states." Corrcction.-Assuming the Staff analysis of the Kentucky situation is correct, it is improper to make sweeping generalizations about other States based on the alleged experience in one state. Staff Study.-"The Kentucky Experience". The Staff Study relies heavily on an affidavit of Lilialyce Akers, a non-dealer member of the Kentucky Licensing Board. She criticizes the dealer members and accuses theni of improper actions. In one statement, she "also complained that the board chairman does not turn over to her consumer complaints received by the board." In her affidavit, she swore that "they have NEVER provided me with the complaints received by them." Correetion.-The minutes of the meeting of the Kentucky Board for Licensing Hearing Aid Dealers, November 16, 1974, printed as Exhibit 7, page 26 of the Staff Study, show that complaints about three different licensees were reviewed at the meeting, in the presence of Lilialyce Akers, just two months before Ms. Akers signed her affidavit. This refutes her own sworn statement that she ~`never" received such complaints. Furthermore, the minutes show that the Board supported her position regarding the complaints against two licensees in a formal motion on which a vote was taken. PAGENO="0221" 215 The minutes also show that Mary Ann Delaney, Assistant Attorney General for the State of Kentucky, was present at the meeting of November 16, 1974. The minutes show that she provided legal advice and assistance to the Board regarding the legality and propriety of their proceedings. Obviously, the Board was not attempting to operate in an air of secrecy or engage in sub rosa activities, as charged by Ms. Akers. Staff Study.-"Arkansas Almses"-page 8. Sharon Graham, a member of the Licensing Board of Arkansas, is quoted criticizing the enforcement of the Arkansas licensing law by the Board. Correction.-Ms. Graham is a clinical audiologist in private practice, and a member of a national organization (the American Speech and Hearing Associa- tion) which has pursued policies designed to eliminate hearing aid specialists so clinical audiologists can monopolize the hearing aid delivery system. Her degrada- tion of hearing aid specialist licensing as an effective tool for consumer protec- tion is consistent with the ASHA program to eliminate the hearing aid specialists. On page 125 of the Hearings before the Subcommittee on Consumer Interests of the Elderly, September 11, 1973, David Resnick, a member of ASHA, said, "Mr. Miller extracted a statement from me concerning the fact that I would not be satisfied with hearing aid dealers as a group even if they were trained to the same degree as optometrists or audiologists. In retrospect, I must stand on the negative answers given in testimony." This reflects the haughty attitude among some clinical audiologists who viaw themselves as superiors of hearing aid spe- cialists, whatever the circumstances. Staff Study.-"Dealers and Facilities," page 9-Calibration of audiometers. The Staff Study indicates that proper calibration of audiometers is essential to proper measurement of human hearing and suggests that calibration require- ments for hearing aid specialists' audiometers under licensing is inadequate. Correction.-Phe National Hearing Aid Society supports requirements for proper calibration of audiometers. Such requirements are outlined in many state licensing laws of the related rules and regulations. Since this is so important, NHAS believes that calibration requirements for hearing aid specialists' audiometers should apply also to the audiometers used by clinical audiologists, industrial physicians, industrial and school nurses, otologists, otolaryngologists, and any other audiometers used in hospitals, clinics, industrial settings, or schools. Calibration requirements for these audiometers are not defined at this time. Staff St~tdy.-"Dealers control most of the Boards." Uorreetion.-Every licensed occupation and profession has peer group participation. In an opinion rendered in October, 1975, the Attorney General for the State of Michigan said, "Another purpose of the (Michigan) constitu- tional provision, as recognized by the Court of Appeals, is that, if an examining or licensing board of a `profession' is to function successfully, board members must understand the technical and ethical standards of the regulated `profes- sion.' This may best be accomplished by requiring the members of examining or licensing hoards to be members of the respective `profession.' (Nemer v. Michi- gan State Board of Registration for Architects, Professional Engineers and Land Surveyors, 20 Mich App 429, 433; 174 NW 2 d 293 (1969)." Actually, the boards for licensing hearing aid specialists have been very much ahead of their time in inviting participation `by non-members of the occupation. Few other profes- sions have done this. Staff Study.-"In general, boards with the largest budgets, most frequent meetings, and fuiltime staffs received more complaints than the rest." Uorrection.-The implication is that more money, more meetings, and more staff has encouraged the consumers to complain more. This could be true, hut the reverse could also he true. The `low volume of complaints and general com- pliance with the laws may preclude large outlays for licensing enforcement. Likely, there is also a correlation between the size of the state and the amount of budget and staff. Staff Study.-"Of the 2,500 complaints tallied among 29 states between 1970-1974. most dealt with failure to refund or return deposits, dissatisfaction with service and repairs, misleading advertising, and misrepresentation of the product's ability to restore hearing." Correction-This statistic does not speak to the question of whether or not these complaints were reasonable and justified. Neither does it mention that this is an average of 600 complaints a year, out of approximately 600,000 hearing aids PAGENO="0222" 216 manufactured each year. This is actually a miniscule percentage of complaints- 1/10th of 1%. Additional evidence is available demonstrating that the hearing aid specialists are doing an excellent job of serving the hearing impaired and policing their own ranks. Information from the Secretary of the Tennessee states Licensing Board shows that in a five-year period from 1970 through 1974, 31 complaints were filed. Of these, 27 were made by hearing aid specialists themselves, against other hear- lug aid specialists. Only 4 of them originated from consumers in five years. In- formation from other states, such as Florida, corroborates the fact that hearing aid specialists police each other. The fact that rates for malpractice insurance for hearing aid specialists are very low reflects the low incidence of malpractice suits filed against them, as coin- puted by insurance actuarial studies. A prominent insurance carrier has shown no reluctance or hesitation in providing the coverage, since the claims are so low. Staff Study.-"Of 34 states answering the question about the number of dealer suspension or revocations, 16 reported no suspensions or revocations, of any kind. In all, there were 126 revocations and suspensions, of which 24 were for unethical behavior. Almost half-41-were simply failure to renew a license. Since 1970, only seven civil prosecutions by law enforcement authorities were brought against dealers, and these occurred in four states. During the same period, there were 16 criminal prosecutions in 7 states, 10 of which resulted in fines or imprisonment." Gorrection.-The context in which the Staff study uses this data suggests that the licensing boards are not doing their jobs because of the low number of complaints and prosecutions. However, the statistic demonstrates instead that the hearing aid specialists are, by and large, behaving in a highly ethical man- ner, and therefore not generating any substantial amount of consumer dissatis- faction. Statistics can be interpreted in many different ways. The Staff has manipulated the statistic to reflect its own prejudices. Staff Stvdy.-"One suggested method of limiting the risk to hearing-impaired Americans is to require a hearing health professional-an otologist or audiolo- gist-to make the initial determination as to whether an aid is indicated." Uorrection.-As stated before, a clinical audiologist is not an alternate to the medically trained otologist, as implied in the statement "an otologist OR audiologist." Furthermore, there is no justification for implying that a person who earns his living from sales of services and a product is any less honorable or less trustworthy than the person who earns his living by charging a fee. However, in order to assure proper medical attention for hearing loss, the National Hearing Aid Society has a policy whereby a person must have medical clearance for hearing aid usage prior to the purchase of the first hearing aid. However, if the person refuses medical help, based on religious or personal con- victions, the client may sign a waiver. This latter provision protects the personal liberties and freedom of choice of individuals. However, should any of seven symptoms be present. no waiver of medical attention will be permitted. These seven symptoms are' what Dr. Aram Glorig called the "red flags" cited previously. Staff stvdy.-"Federal System", page 11. "The VA as well as the Social Rehabilitation Administration and Medical Services Administration, both within the Department of Health, Education, and Welfare provide funds for the pur- chase of hearing aids. But neither will allocate a penny until a physician or audiologist has examined the patient and determined that an aid is needed." Correction.'-The Staff is greatly mistaken if they believe that a clinical audiologist is qualified to conduct a medical examination for hearing loss. The clinical audiologist, who is not medically trained, must not be considered a satis- factory alternate to the physician. Furthermore, the necessity for audiologica'l examination prior `to every hearing aid purchase is questioned b~ most otologists (medical ear specialists). The `costs of dispensing hearing aids through some gov- ernment agencies are exorbitant, as a VA `cost analysis show~. Perhaps this is due to providing redundant and overlapping services. Although Administrator Richard Roudebush, in a letter to Senator Percy, `de- scribe-i the VA `hearing rehabilitation program as ideal, that is to be expected, since the chief administrator could hardly be expected to say he had failed in his obligations to veterans. However, the National Hearing Aid Society and its mem- her hearing `aid `specialists have cases on file showing that many veteran's are dis- satisfied with the hearing aid services they have received from the Veterans Administration. It has proven extremely inconvenient for the veterans, neces- PAGENO="0223" 217 sitating travel and disruption of life. Furthermore, the VA system has not always resulted in proper fitting of hearing aids. In addition, a National Hearing Aid Society cost analysis shows that the VA system costs more than double as much as providing hearing aids through the private delivery system. Staff study.-Page 12, "Wolkstein (Deputy Director for Program Policy in the bureau of Health Insurance) said that data gathered by Congress and by HEW's Hearing Aid Task Force suggest that a `significant portion of the costs of hearing aids and hearing health care is due to the nature of the hearing aid delivery system. He noted that aids are sold through local dealers, and not through a system controlled by professionals that might .be counted on for self- policing.' Correction.-In September, 1973, the National Hearing Aid Society sub- initted to the United States Senate Subcommittee on Consumer Interests of the Elderly, a plan for Procurement of Hearing Aids under Medicare, which placed the physician squarely in charge of the management of hearing loss. This plan was efficient, and offered adequate safeguards to the public. Obviously, both the staff and Mr. Wolksteia was unaware that this plan was submitted, which is another indication of the superficial nature of the research for this report. Staff study.-Page 13-"Many bearing aid purchasers are dissatisfied with their dealers, charging errors in fitting and ethical lapses. The fact that there have been 2,383 complaints lodged with State licensing agencies in a universe of only 5,700 dealers over a five-year period, in view of the obstacles many boards have placed in the path of filing a grievance, suggests the extent and intensity of user unhappiness with many dealers." Correction-In the manipulation of statistics, the Staff cites 2,383 corn- J)laints lodged "in a universe of only 5,700 dealers" during a five year period. The universe is actually 3,000,000 hearing aid users; again, this is indicative of the high satisfaction levels and shows a remarkable record of service to the hearing impaired. The consumers spoke loudly to the HEW Task Force on Hearings Aids, and indicated great support for the present delivery system, and the Staff's own statistics support this. To say that licensing boards "Have placed obstacles in the path of filing a grievance" is totally unwarranted and unjust. Procedures have been established to insure that the civil liberties of all parties are protected. To prosecute a hearing aid specialist without observing due process or thoroughly investigating the grievance would be a violation of the civil liberties of the hearing aid spe- cialist who are dedicated American Citizens. Staff study.-Iiundreds more flow into the FDA, FTC, Congressional offices, local consumer protection offices and industry-sponsored Better Hearing Institute from bearing aid purchasers who are not aware or feel they cannot count on their state licensing boards." Correction.-Tlie Staff should have clearly distinguished between a "com- plaint" and an "inquiry" and should have analyzed the validity of the "com- plaint." On numerous occasions, the National Hearing Aid Society has asked to review the "bulging files" of complaints, and only a handful have been produced, many of which would not properly be classified as complaints at all, but requests for information. The Better Business Bureau does not receive many complaints about bearing aids, either. Staff Study.-"Follow-up user complaints by State boards :is haphazard atbest. . ." Correction.-The Staff has presented no valid evidence in this study to support this generalization. Staff Stsdy.-"Once on the board, these dealers frequently band together to frustrate consumer members. Affidavits and other documents show that these dealer-board members sometimes act in ways that smack of cronyism and a profound lack of concern for the consumer." Correction.-These documents refute themselves, as mentioned previously. The Staff has presented no valid evidence in this study to support this gen- eralization. Staff Study.-"In nearly half the states, no system exists by which the licensing agency can check on the accuracy of hearing measurement instruments used by dealers. In most of the States requiring calibration, all the dealer need do is file an annual certificate stating* that his equipment has been calibrated. This is hardly a guarantee of accuracy and no assurance w-batever for many bearing impaired Americans that the result of the dealer's test is a true reflection of hearing ability." PAGENO="0224" 218 Correction.-Hearing aid specialists will accept whatever standards are used to assure proper calibration of hearing measurement instruments used by hospitals, clinics, physicians' offices, schools, or any Other institution using audiometers for the measurement of hearing. At present, no such standards exist. Staff Study.-"The insistence by some in the industry that dealer licens- ing laws protect the hearing impaired from abuses at the hands of dealers is wholly unsubstantiated." Correction-The Staff has presented no valid evidence to support this generalization. Quite the contrary, the low number of complaints would in- dicate that licensing has been a very effective tool for protecting hearing aid consumers. Staff Stu~j.-"Efforts by industry officials to secure coverage for their product under any national health insurance law must be considered in the light of the present flaws in the delivery system. While hearing aids are im- portant and medically indicated in many cases, for national health insurance to cover their purchase under the present delivery system could jeopardize the hearing health of millions." Correction-The Staff Study has presented no valid evidence to support this gross generalization. The otologist, not the clinical audiologist, should be squarely in charge of the management of hearing loss, and this was reflected in the plan for Procurement of Hearing Aids under Medicare, which the National Hearing Aid Society submitted to the United States Senate Subcommittee on Consumer Interests of the Elderly, September, 1073. On the other hand, the Executive Secretary of the American Speech and Hearing Association presented a plan which would place their members, the clinical audiologists, in charge of hearing loss, while the hearing aid specialists would be eliminated entirely. Self-interest, rather than concern for the hearing impaired, is their motive. Staff Stvdy.-"In view of the absence of proper education and training for dealers and a less than half-hearted attempt by the States to police the more than 5,700 dealers under their jurisdiction, the Subcommittee staff urgently recommends that the Food and Drug Administration within the Department of Health, Education, and Welfare . . . immediately declare hearing aids to be prescription devices." Correction.-Perhaps this is one of the best examples of how the Staff has misled the Committee. The HEW Task Force Study did not accept the prescription requirement. Since the Staff Study was incomplete, inaccurate, and based on faculty research methods, their conclusions are also inaccurate. Even the concept that hearing aids can be "prescribed" is totally incorrect with the present state of technology, as leading authorities in the field have stated. Staff Study.-"Finally, since three panels of experts in the hearing health field are unanimous in their criticism of the NUAS curriculum . the Subcommittee staff urges that organization to voluntarily withdraw the home study course from circulation immediately and work with the Department of Health, Education, and Welfare to develop a satisfactory training program that does not jeopardize the hearing health of any American." Correction.-The contradictory nature of the opinions of the three panels has been discussed previously, and the inadequacies of the Staff understanding or perception of the course have also been pointed out. Therefore, this recom- mendation is not valid, and even a misrepresentation of their own data. How- ever, in an effort to reconcile differences, and to provide adequate protection of the public, if indeed it is not already provided, the National Hearing Aid Society will submit the Basic Course to its Medical Education Advisory Com- mittee for review and recommendations . . . as soon as the latest revisions are complete. Whatever other revisions are needed will be undertaken. The members of this committee are Aran Glorig, M.D., Director of `the Caller Hear- ing and Speech Center, Charles W. Gross, M.D., Professor and Chairman of the Department of Otolaryngology and Maxillofacial Surgery, College of Medi- cine, University of Tennessee, Maurice Schiff, M.D., A. Neil Lemon, M.D., and John W. Heisse, Jr., M.D. Furthermore, the National Hearing Aid Society would welcome an opportunity to submit `to the Department of Health, Educa- tion and Welfare, a proposal for a complete training program for hearing aid specialists, to be approved and funded~~by the Department of HEW and im- plemented by the National Hearing Aid Society. To date, no government funds have been allocated to the education of hearing aid specialists, and the desir- ability of doing so was expressed in the final report of the HEW Task Force on Hearing Aids, September, 1975. PAGENO="0225" 219 HEAiuNG Am INDUSTRY CONFELENCE, Washington, D.C., April 30, 1976. Hon. CIiAr~LEs H. Puncy, U.S. Senate, TT~ashingtom, D.C. DEAn SENATOR PERCY: The Hearing Aid Industry Conference, a national trade association located in Washington, D.C. and representing manufacturers and distributors of hearing aids is pleased to have this opportunity to submit com- ments for the record on the hearings conducted by the Permanent Subcom- mittee on Investigations of the Committee on Government Operations on the Hearing Aid Industry April 1 and 2, 1976. We understand that the purpose of the hearings was to examine any problems within the hearing aid delivery sys- tem which may exist. The issues of hearing aid pricing and technology are to be addressed in subsequent bearings. However, in the course of the hearings on April 1 and 2, several statements were made concerning hearing aid technology, and HAlO would like to comment on those statements. Our statements follow the chronology of the hearings. Subheadings identify the witness to whose testimony the comment relates. MR. MOHAN RAO MALAVEY Mr. N~alavey indicated in his testimony that hearing aids cannot benefit per- sons with a high frequency loss in the 3000 Hz range. This statement does not take into consideration all the advancements the industry has made to develop instruments to fit this type of bearing loss. The hearing aid industry provides many different types of hearing aids, including models tkat are suitable for low frequency amplification, wide range amplification, and high frequency amplifi- cation. Special high frequency hearing aids are available which are useful in the 3000 Hz range of hearing loss. Filtering and earmold adaptation permit further frequency response modifications which diminish low frequency response and accentuate amplification in the high frequency range. DR. F. BLAIR SIMMONS Dr. Simmons made a number of statements regarding manufacturing processes which indicate an unfamiliarity with current manufacturing technology. Gen- eralizations made by Dr. Simmons on the variability of hearing aids are not sup- ported by fact. Manufacturers of bearing aid set minimum tolerance standards as stringent as ±3dB. These specifications are published and readily available. Hearing aid manufacturers recognize the need for variability of performance in hearing aids and supply adjustable controls within the aid to fit the variability of individual hearing loss. Quality contol within the industry is at a very high level. Dr. Simmons suggestions that a great amount of variance exists within the same make and model of aids is incorrect. Dr. Simmons made several references to quality control and other aspects of manufacturing processes affecting the life of the average hearing aid which were without foundation. Quality control tests in addition to recorded acoustic performance tests on every instrument are regularly performed by manufac- turers of hearing aids including tests for: vibration, shock, perspiration, humid- ity, and temprature. In addition, packaging is designed to withstand rough treat- ment through the mail. Hearing aid manufacturers today utilize high quality electronic devices to standardize performance and insure uniformity of standards for their bearing aids. Despite the high cost of research and development, manufacturers are con- tinually involved in developing and producing new and better bearing aids with- out government funding. With regard to Dr. Simmons comments on component costs, it should be noted that because of their small size, micro-miniature components cost many times more than equivalent components in radios, televisions, etc. Hearing aid ampli- fiers are built from discrete components or a combination of discrete and thin film integrated circuits or discrete and thick film integrated circuits. Uniformity of components used in hearing aids shows no greater variability from tolerances than their much larger counterparts. Clearly, control of quality in hearing aids is related to not only uniformity of components used, but also to design, processing, and production procedures. PAGENO="0226" 220 With regard to Dr. Simmons comments on the use of integrated circuit chips in hearing aids, it is important to recognize that all manufacturers do not use the same chips. In fact, some manufacturers do not use integrated chips. There are several suppliers of integrated circuits and some manufacturers create their own. Each manufacturer determines his own objectives and methods for achiev- ing the type of instrument desired. Dr. Simmons indicated that, following developmental costs for an integrated circuit chip, the cost of the chip could be reduced to $3.50 and $4.50 each. Al- though cost can be reduced based on the level of production, we know of no quality integrated circuit chip which can be purchased for that amount. A quality integrated circuit chip costs up to $14.00. The methods used in the hearing aid in- dustry to modify integrated circuits to alter frequency response are the most efficacious and uniform methods possible today. The comparison of a pocket calculator to a hearing aid is an invalid analogy. It is not possible to compare a calculator, which processes digital information, with a hearing aid, which processes sound. A single pocket calculator manufac- turer probably uses as many chips as the entire hearing aid industry. Concerning Dr. Simmons remarks on the individual variability of hearing aids, most manufacturers make hearing aids in five different power categories, ranging from very mild to very strong. Hearing aids within each category of the same model perform to very strict standards. In addition, hearing aids are equipped with output and gain controls, as well as frequency response controls which can be adjusted to suit the needs of the wearer. Hearing aids are not fitted on a trial and error basis, but rather are selected on the basis of the user's hearing loss and are also modified to suit the wearer's specific needs. Dr. Simmons statement that the only moving part in a hearing aid is the volume control is incorrect. All of the following components have moving parts; microphones; receivers; battery compartments; frequency response controls; and output and compression controls. There are several manufacturers in the 15.5. and abroad who supply volume controls to the hearing aid industry. Among them: Central Lab; Wilbrecht Electronics; CTS; Danavox; and Micro-Electric. Additionally, volume control manufacturers are constantly developing new and better ways to manufacture and seal volume controls for reliability, including research into a potential new miniature volume control utilizing the "Hall effect." We hope these comments will help clarify the record with regard to hearing aid technology. Because of the difficulty in attempting to adequately describe in writing the manufacturing technology involved in the production of hearing aids, HAIC again extends an invitation to you, and every member of the Sub- committee and staff to visit HAIC members' factories to observe manufacturing operations, quality control techniques and research and development projects. HAIC's resources are available to assist you in any way possible on the investi- gation being made by the Subcommittee into the hearing aid industry. Sincerely, JOHN H. BLAKE. III, E~veentive Secretary. Subscribed and sworn to before me this 30th day of April 1976 HELEN P. LOWENSTEIN, Notary Public. My Commission Expires January 2, 1980. PEABODY, RTVLTN, LAMBERT & MEYERS. Washington, D.C., April 16, 1976. Hon. CHARLES H. PERCY, Permanent Sst.bconvrnittee on Investigations, United States Senate, Washington, D.C. DEAR SENATOR PERCY: In view of the announcement by the Subcommittee staff during the testimony of Mr. Luke Fortner on April 2 that the Consumer Advocate Office of the State of Illinois has determined to conduct a formal investiaation as a result of alleged "abuses" involving hearing aids, I hope the following statement may be helpful to your Subcommittee. On November 18. 1975. and February 9. 1976. this office forwarded a request to the Oonsurner Advocate Office of the State of Illinois requesting any information with respect to consumer complaints, particularly in regard to medical devices. Copies of those letters are enclosed. PAGENO="0227" 221 On February 23, 1976, that office responded to our request and advised us, inter alia, that their office bad received one (1) hearing aid complaint during the period 1974, 1975 and 1976 to date. A copy of that letter also is enclosed. We were surprised, therefore, by the Subcommittee staff's announcement. We have delayed this response in order to review the transcript of the proceedings to determine the exact nature of the statement attributed to the Illinois Consumer Advocate Office. We have found conflicting evidence not untypical with respect to the hearing aid industry. The hundreds of complaints alleged to exist never seem to be identifiable. Admittedly, this office did not specifically contact the Illinois Association for the Deaf and the other groups you mentioned. We generally would expect, however, for such groups to forward their complaints to a state office, such as the Consumer Advocate Office. In this regard, we also find it surprising that the 34 complaints received by the Attorney General of the State of Illinois were nor forwarded to the Consumer Advocate Office. (A copy of our February 9, 1976, letter to the Consumer Advocate Office also was for- warded to Howard Kaufman, Assistant Attorney General and Chief, Consumer Fraud Section of the Office of Attorney General for the State of Illinois. No reply has been received from that office as of this date.) Mr. Fortner's statement with respect to consumer complaints stated those facts know to NHAS, the evidence of which is detailed in the NHAS comments to the FTC at pages 12-35. To our knowledge NHAS has never asserted that no problems exist in the hearing aid industry, or any other industry. However, no one has ever documented, other than by extrapolation, that substantial selling abuses do exist in this industry. As Washington counsel for NHAS, we are in the process of testing the substance and source of such allegations in the FTC's rulemaking proceding for the hearing aid industary. In view of the importance of your hearings, however, we concluded that it should be noted that the basis of Mr. Fortner's statement, particularly with respect to the Illinois Consumer Advocate Office, was based on a sincere and specific effort to arrive at the facts. Very truly yours, TIMOTHY J. WATERS. Enclosures. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, FOOD AND DRuG ADMINISTRATION, Roclcville, Md., April 15, 1976. Hon. CHARLES H. PERCY, Ranking Minority, Senate Permanent Subcommittee on Investigations, Com- mittee on Government Operations, U.S. Senate, Washington, D.C. DEAR SENATOR PERCY: I want to thank you for your letter of April 8, 1976, describing testimony presented at the recent Hearing Aid Industry Hearings before your Senate Subcommittee. On January 2, 1976, I wrote to you that the Food and Drug Administration (FDA) was in the process of developing a proposal for professional and patient labeling for hearing aid devices. The Agency has recently completed that work and will publish proposed regulations in the Federal Register within the next two weeks. I am enclosing an advance copy of the proposal for your review. While we anticipate that many comments will be received on this proposal, we are hopeful that the final order will be issued in approximately four months. As you may know, the proposal calls for an effective date of the regulation 180 days after the date of the final order. Of course any part of the proposal, including the effectiveness date, may be changed depending upon the comments received. The proposed regulations would: Prescribe the types of information that must be included in the labeling of all hearing aids to provide hearing health professionals and patients with adequate directions for their safe and effective use; Specify the technical performance data that must be included in the labeling to assure that hearing health professionals have adequate information to cor- rectly select and fit a hearing aid; and Restrict the sale of hearing aids to those patients who have undergone medical evaluation within the past six months, with the provision that fully informed adult patients may waive the medical evaluation if none of seven designated ear conditions is present at the time of purchase. PAGENO="0228" 222 I realize that you have expressed serious doubts about the provision that would permit a waiver of the mandatory medical evaluation. I would call to your attention, however, the differences between the limited provision for waiver in our proposed regulation and that recommended by the National Hearing Aid Society. A close reading of the waiver provision in proposed section 801.421 will reveal that we are requiring medical evaluation requirements that are much stricter than those proposed by the National Hearing Aid Society. The differences are as follows: The FDA proposal would require medical evaluation for every sale of a hear- ing aid to any prospective user. The National Hearing Aid Society proposal would only apply to the first sale of a hearing aid. The FDA proposal would require a medical evaluation within the preceding six months. The National Hearing Aid Society proposal would require a medical evaluation within the preceding 18 months. The FDA proposal does not allow an individual under 18 years of age or younger, or the parent or guardian of such an individual, to waive the medical evaluation. The National Hearing Aid Society would permit a parent or guardian to waive the medical evaluation for an individual under 18. In addition, our proposal would: Require that the seller inform the prospective user that the FDA has deter- mined that a medical evaluation by a physician, preferably by one who spe- cializes in diseases of the ear, would be in the user's best health interest; Prohibit the seller from actively encouraging the prospective user to waive such a medical evaluation; Require the seller to read and explain to the prospective user the caution state- ments required by the proposed regulation; Require the seller to provide the prospective user a copy of the "User Instruc- tional Brochure" for the hearing aid that has been, or may be, selected for the prospective user; and, Require that the seller afford the prospective user an opportunity to read the "User Instructional Brochure." These requirements are intended to impress upon the prospective user the im- portance of obtaining a medical evaluation prior to purchasing a hearing aid. As you are aware, the American Council of Otolaryngolgy, as well as the Hearing Aid Industry Conference, the National Hearing Aid Society,. the Retired Pro- fessional Action Group, and the Greater Philadelphia Hearing Aid Guild, has recommended that a patient be permitted to waive the mandatory medical evalu- ation provided not one of seven designated otologic conditions is evident at the time of sale. The DREW Intradepartmental Task Force adopted such a sugges- tion and explained in its Final Report that the provision for waiver of the medical evaluation requirement was intended to take into consideration such factors as the inconvenience of securing medical assistance in rural locations and the religious beliefs of some individuals which preclude consultation with a physician. Our proposed regulation is based on extensive deliberations of the Task Force, which provided all interested parties ample opportunity to submit views on what steps would be taken to protect the health interests of the hearing impaired. I recognize that there remain disagreements over what steps should be taken to protect the health interests of the hearing impaired. For this reason, you will note that the preamble to the proposed regulation requests specific comment on the following questions: Whether a waiver should he permitted; Whether conditions that should preclude waiver are adequate; Whether hearing aid specialists or clinical audiologists are capable of iden- tifying the existence of the seven designated otologic conditions; and, Whether it is appropriate to require that the medical evaluation shall have occurred within six months prior to hearing aid sale or whether a shorter period should be l)reScribed. As you can see from these questions, the Food and Drug Administration has not adopted a position with respect to the appropriateness or need for the waiver of the medical evaluation requirement. The Agency intends to review sympa- theticaily `all comments on the proposal, including, of course, any new informa- tion filed in behalf of the American Council of Otolaryngology. - I believe that your recent hearings once again demonstrated that the compe- tency and training of hearing health professionals, whether physicians~ audiolo- PAGENO="0229" 223 gists, or hearing aid dealers, are important in the delivery of quality hearing aid health services. As you review the ijroposed hearing aid regulations, you should recognize that our proposed restrictions on the sale of hearing aids are only a partial solution to the Problems present in the hearing aid delivery system. The statutes oi~ the Federal Food, Drug, and Cosmetic Act are directed at assuring the safety and efficacy of the hearing aid device itself. State and local govern- ments are responsible for establishing minimum competency levels for hearing aid dealers and other hearing health professionals. A review of present and pro- posed heaiing aid licensing bills clearly reveals little uniformity from State to State in the requirements for training in measuring hearing loss and selecting and fitting a hearing aid. Many States are now actively seeking to adopt stricter licensing requirements for those individuals who dispense hearing aids. The effort, however, is fragmented and on a State-by-State basis. I think that this is an area in which your Subcommitee may be of assistance in developing a model State licensing bill which establishes nationwide compentency requirements for those who engage in the dispensing of hearing aids. I look forward to receiving your comments on the proposed hearing aid regula- tion. We appreciate the interest, concern, and support you have shown for our efforts to correct abuses in the hearing health care delivery system. I hope thie information will be useful to you, and I welcome your further inquires. To re- peat a point made earlier, we will not hesitate to alter our proposal in light of persuasive comments received within the next few weeks. With cordial best regards, Sincerely, ALEXANDER M. SdH~rIDr, M.D., Conirnissioner of Food and Drugs. Enclosure. IOWA STATE BOARD OF EXAMINERS FOR HEARING AID DEALERS, STATE DEPARTMENT OF HEALTH, Des Moines, Iowa, April 1, 197G. Hon. SAM NUNN, Acting Chairman, Committee on Government Operations, U.S. Senate, Washington D.C. DEAR SENATOR NUNN: This acknowledges your letter of March 24, 197g. You may use this letter as authorization to enter my previous letter to Senator John C. Culver into your record of this investigation committee hearing. Thanks for the opportunity to have these comments a part of these hearings. Sincerely, ED CHAMRERLAIN, Chairman, Iowa State Board of Examiners for Hearing Aid Dealers. IOWA STATE BOARD OF EXAMINERS FOR HEARING AID DEALERS, STATE DEPARTMENT OF HEALTH, Des Moines, Iowa, January 9, 197G. Hon. JOHN C. CULVER, Ujg. Senate, WashIngton, D.C. DEAR SENATOR CULVER: The members of the Iowa State Board of Examiners for Hearing Aid Dealers a.t our last meeting, had just been made aware of the October 21. 1975 news release of Senator Charles H. Percy concerning the `Staff Study of the State Licensing Laws and Training Requirements for Hearing Aid Dealers by the Permanent Subcommittee on Investigations of the Committee of Government Operations, 15.5. Senate-October 1975.' The board feels that this study, and the news release on it, titled: STATUI LICENSING LAWS FAIL TO PROTECT MILLIONS OF HEARING IM- PAIRED OITIZENS-grossly misleading to anyone who read it, and it is our understanding that it was widely circulated in our state government. PAGENO="0230" 224 We are proud to have been appointed by Governor Robert Ray and approved by the Senate of Iowa to serve on this licensing hoard. We feel our legislators have enacted an excellent State Licensing Law. We feel the integrity of the licensing board members was attacked in this report. We enlist your support in halting this intrusion of the Federal Government into State affairs. The only criticism that could be leveled at this board that was contained in the news release is the fact that 3 members are licensed hearing aid dealers, and 2 are public members. This was necessary in order to comply with the Iowa Omni- bus Bill. Our Licensing Board holds open meetings and welcomes any information about now we can give our Representatives and Senators knowledge about how our law is working in Iowa. We would like to call your attention to the enclosures so that you may more readily grasp the significance of the letter. Respectfully yours, ED CHAMBERLAIN, Cha~irman. Enclosures: 1. Hearing Aid Dealers Licensing Law. 2. Senator Charles Percy's October 21, 1975 news release. 3. Staff Study of the State Licensing Laws and Training Requirements for Hearing Aid Dealers. 4. National Hearing Aid Society Response-November 1975. HEARING AID DEALERS Chapter 154A.1 Definitions 154A.2 Establishment of board. 154A.3 Term of office. 154A.4 Duties of the board. 154A.5 Public members. 154A.O Disclosure of confidential information. 154A.7 Meetings and expenses. 154A.S Duties of department. 154A.9 Applications. 154A.1O Issuance of licenses. 154A.11 Examinations. 154A.12 Scope of examination. 154A.13 Temporary permit. 154A.14 Reciprocity. 154A.15 Licenses renewal. 154A.1G Continuing education. 154A.17 Fees. 154A.1S Display of license. 154A.19 Exceptions. 154A.20 Rightso.f purchaser. 154A.21 Notice of address. 154A.22 Deposit of fees. 154A.23 Complaints. 154A.24 Suspension or revocation. 154A.25 Prohibitions. 154A.2G Consumer protection. 154A.27 Penalties. 154A.1 Definitions. As used in this chapter, unless the context requires otherwise: 1. "Department" means the state department of health. 2. "Board" means the board of examiners for the licensing and regulation of bearing aid dealers. 3. "Hearing aid" means a wearable instrument or device designed for or offered for the purpose of aiding or compensating for impaired human hearing, and any parts, attachments, or accessories, including earmold, but excluding batteries and cords. PAGENO="0231" 225 4. `Hearing aid dealer" means any person engaged in the fitting, dispensing and the sale of hearing aids and providing hearing aid services or maintenance, by means of procedures stipulated by this chapter or the board. 5. "Hearing aid fitting" means the measurement of human hearing by any means for the purpose of selections, adaptations, and sales of hearing aids, and the instruction and counseling pertaining thereto, and demonstration of tech- niques in the use of hearing aids, and the making of earmold impressions as part of the fitting of hearing aids. 6. "Dispense" or "sell" means a transfer of title or of the right to use by lease, bailment, or any other means, but excludes a wholesale transaction with a distributor or dealer, and excludes the temporary, charitable loan or educa- tional loan of a hearing aid without remuneration. 7. "Person" means a natural person. 8. "Temporary permit" means a permit issued while the applicant is in train- ing to become a licensed bearing aid dealer. 9. "License" means a license issued by the state under this chapter to hearing aid dealers. (6SGA, ch 1145, section 1) 154A.2 Establishment of Board. A board for the licensing and regulation of hearing aid dealers is established. The board shall consist of three licensed hearing aid dealers and two members who are not licensed hearing aid dealers who shall represent the general public. Members, who shall be residents of the state of Iowa, shall be appointed by the governor, subject to the approval of two-thirds of the members of the senate. A licensed member shall be actively employed as a hearing aid dealer and shall have been so engaged for five years preceding his appointment, the last two of which shall have been in Iowa. However, hearing aid dealers appointed to the initial board shall have not less than five years experience and shall fulfill the qualifications relating to experience for licensure as provided in this chapter. No more than two members of the board shall be employees of, or dealers principally, for the same hearing aid manufacturer. Professional associations or societies composed of licensed hearing aid dealers may recommend the names of potential board members to the governor, but the governor shall not be bound by the recommendations. A board member shall not be required to be a member of any professional association or society composed of licensed hearing aid dealers. (65GA, ch 1145, section 2) 154A.3 Term of Office. Appointments shall be for three-year terms and shall commence on July 1 of the year in which the appointment is made. Vacancies shall be filled for the unexpired term by appointment of the governor and shall be subject to senate confirmation. Members shall serve a maximum of three terms or nine years, whichever is least. For members appointed to the initial board, the governor shall appoint one hearing aid dealer for a one-year term, one hearing aid dealer for a two-year term and one hearing aid dealer for a three-year term; one member representing the general public for a one-year term and one member representing the general public for a three-year term. (65GA, ch 1145, section 3) 154A.4 Duties of the Board. Members of the board shall annually elect a chairman and a secretary- treasurer from their membership. The board shall prepare examinations drawn from comparable examinations given in other states which license hearing aid dealers, direct the department in administering the provisions of this chapter, determine who is eligible for licensure, suspend or revoke licenses or temporary permits for cause, and promulgate rules for the administration of the provisions of this chapter pursuant to chapter 17A within the limits of funds appropriated to the board. (65GA, ch 1145, section 4) 154A.5 Public Members. The public members of the board shall not participate in administering or grading any portion of an examination, except that for the initial examination the public members may participate in administering and grading the examina- tion. (5GA, ch 1145, section 5) 154A.6 Disclosure of Confidential Information. A member ofthe board shall not disclose information relating to the following: 1. Criminal history or prior misconduct of the applicant. PAGENO="0232" 226 2. Information relating to the contents of the examination. 3. Information relating to the examination results other than final score except for information about the results of an examination which is given to the person who took the examination. A member of the board who willfully communicates or seeks to communicate such information, and any person who willfully requests, obtains, or seeks to obtain such information, is guilty of a public offense which is punishable by a fine not exceeding one hundred dollars or by imprisonment in the county jail, for not more than thirty days. (65GA, ch 1145, section 6) 154A.7 Meetings and Expenses. The members of the board shall set their own per them compensation at a rate not exceeding forty dollars per day for the time actually spent in traveling to and from, and attending duly authorized functions of the hoard and its committees, and shall receive all necessary traveling and incidental expenses incurred in the thscharge of their duties within the limits of funds appropriated to the board. The board shall meet at least one time per year at the seat of government and may hold additional meetings as deemed necessary. Additional meetings shall be held at the call of the chairman, or a majority of the members of the board. At any meeting of the board, a majority of the members shall constitute a quorum. (G5GA, ch 1145, section 7) 154A.8 Duties of Department. The department, with the advice and assistance of the board shall: 1. Employ personnel, and authorize disbursemeñth necessary to carry out the provisions of this chapter. 2. Register and issue licenses to persons whom the board deems qualified to enaage in the fitting or selection and sale of hearing aids. 3. Purchase, maintain, or rent equipment and other facilities necessary to carry out the examination of applicants. 4. Designate the time and place for examining applicants, and conduct and supervise the examinations as directed by the board. (65GA, ch 1145, section 8) 154A.9 Applications. Applications for hicensure or for a temporary permit shall be on forms pre- scribed and furnished by the board and shall not require that a recent photograph of the applicant be attached to the application form. An applicant shall not be ineligible for certification because of age, citizenship, sex, race, religion, marital status or national origin although the application may require citizenship thfor- mation. The board may consider the past felony record of an applicant only if the felony conviction relates directly to the practice of fitting or selection and sale of hearing aids. Character references may be required, but shah not be obtained from licensed bearing aid dealers. (G5GA, ch 1145, section 9) 154A.10 Issuance of Licenses. After January 1, 1975, an applicant may obtain a license, if the applicant: 1. Successfully passes the qualifying examination prescribed in section 154A.12. 2. Is free of contagious or infectious disease. 3. Pays the necessary fees set by the board pursuant to section 154A.17. (65GA, ch 1145, section 10) 154A.11 Examinations. Examinations for licensing shall be given as often as deemed necessary by tl1e board, but no less than one time per year. The scope of the examination and methods of procedure shall be prescribed by the board. Any written examination may be given by representatives of the board. All examinations in theory shall be in writing and the identity of the person taking the examination shall he concealed until after the examination papers have been graded. For examinations in practice, the identity of the person taking the examination shall also be concealed as far as possible. As soon as practicable after the close of each examination, a report shall be filed by the board. The report shall show the action of the board upon each application, and the department shall notify each applicant of the result of his examination. Applicants who fail the examination once shall be allowed to take the examination at the next scheduled time. Thereafter, the applicant shall be allowed to take the examination at the discretion of the board. PAGENO="0233" 227 An applicant who has failed the examination may request in writing infor- mation from the board concerning his examination grade and the subject areas or questions which he `failed to answer correctly, except that if the board admin- isters a uniform, standardized examination, the board shall only be required to provide the examination grade and such other information concerning the applicant's examination results which are available to the board. (65GA, ch 1145, section 11) 154A.12 Scope of Examination. The examination required by this chapter shall be designed to demonstrate the applicant's ~adequate technical qualifications including, but not limited to, the following: 1. Written tests of knowledge in areas such as physics of sound, anatomy and physiology of hearing, and the function of hearing aids, as these areas pertain to the fitting or selection and sale of hearing aids. 2. Practical tests of proficiency in hearing testing techniques pertain to the fitting or selection and sale of hearing aids. 3. Evidence of knowledge of the medical and rehabilitation facilities that are available inthe area served, for children and adults who have hearing problems. 4. Evidence of knowledge of situations in which it is commonly believed that a hearing aid is inappropriate. 5. The procedures and use of equipment established by the board for the fitting or selection and sale of hearing aids. 6. Practical tests of proficiency in the taking of earmold impressions. The board shall not require the applicant to possess' the degree of profes- sional competence normally expected of physicians. (5GA, ch 1145, section 12) 154A.13 Temporary Permit. A person who has not been employed as a hearing aid dealer prior to January 1, 1975, may obtain a temporary permit from the department upon completion of the application accompanied by the written verification of employment from a licensed hearing aid dealer. The department shall issue a temporary permit for one year which shall not be renewed or reissued. The fee for issuance of the temporary permit shall be set by the board pursuant to section 154A.17. The temporary permit entitles an applicant to engage in the fitting or selection and sale of hearing aids under the supervision of a person holding a valid license. (65GA, ch 1145, section 13) 154A.14 Reciprocity. If the board determines that another state or jurisdiction has requirements equivalent to or higher than those provided in this chapter, the department may issue a license by reciprocity to applicants who hold valid certificates or licenses to deal in and fit hearing aids in the other state or jurisdiction. An applicant for a license by reciprocity is not required to take a qualifying examination, but is required to pay the license fee as provided in section 154A.17. The holder of a license of reciprocity is registered in the same manner as the holder of a regular license. Fees, grounds for renewal, and procedures for the suspension and rev- ocation of license by reciprocity are the same as for a regular license. (65GA, cli 1145, section 14) 154A.15 License Renewal. Licenses shall be renewed annually in a manner determined by the board. The renewal fee shall be determined by the board pursuant to section 154A.17. The department shall notfiy every person licensed under this chapter of the date of expiration of his license and the amount of fee required for its renewal for one year~ The notice shall be mailed at least one month in advance of the ex- piration date. A person who fails to renew his license by the expiration date shall be allowed to do so within thirty days following its expiration, but the board may assess a reasonable penalty. (O5GA, cli 1145, section 15) 154A.16 Continuing Education. Beginning January 1, 1976, in addition to payment of the annual renewal fee, each hearing aid dealer applying for the renewal of his license shall furnish to the department satisfactory evidence that he has completed at least two days of education programs during the year preceding the date of his application for renewal selected from the following: 1. Education programs conducted by the board; 79-954-76----16 PAGENO="0234" 228 2. Training school conducted by one of the various hearing aid manufacturers for their representatives, which is approved by the board; 3. Periodic training sessions conducted by the national hearing aid society which is approved by the board; or 4. Other educational means approved by the board. The department shall send a written notice to this effect to every person holding a valid license at least thirty days prior to the license renewal date each year, directed to the last known address of such licensee. In the event that any licensee shall fail to meet the annual educational require- ment, his license shall be suspended or withheld by the board. The board shall reinstate the licensee upon the presentation of satisfactory evidence of educa- tional study of a standard approved by the board, and upon the payment of all fees due. (65A, ch 1145, section 17) 154A.17 Fees. The fees for the examination shall be set by the board on the basis of the annual cost of administration. The. fees for the temporary permit, license, renewal of a license, and issuance of a duplicate license, shall be set by the board on the basis of the cost of sustaining the board and the administrative costs of the department. The fees for licensure and permit shall be based upon, but not limited to: 1. Per diem, expenses, and travel of members of the board. 2. Supplies and other expenses. 3. Costs submitted by the department. (65GA, ch 1145, section 17) 154A.18 Display of License. A person shall not engage in business as a hearing aid dealer, or display a sign, or in any other way advertise or represent himself as a hearing aid dealer after January 1, 1975, unless he holds a valid license issued by the department as provided in this chapter. The license shall be conspicuously posted in his office or place of business. The department shall issue duplicate licenses to valid license holders operating more than one office. A license confers upon the holder the right to operate a business as a hearing aid dealer. (65GA, cli 1145, section 18) 154A.19 Exceptions. This chapter shall not prohibit a corporation, partnership, trust, association or other organization maintaining an established business address, from engag- ing in the business of selling or offering for sale hearing aids at retail without a license, if it employs only licensed hearing aid dealers in the direct fitting or selection and sale of hearing aids. Such an organization shall file annually with the board a list of all licensed hearing aid dealers and persons holding temporary permits directly or indirectly employed by it. Such an organization shall also file with the board a statement on a form approved by the board that the or- ganization submits itself to the rules and regulations of the board and the pro- visions of this chapter which the department deems applicable. This chapter shall not apply to a person who engages in the practices covered by this chapter if this activity is part of the academic curriculum of an accredited institution of higher education, or part of a program conducted by a public, or charitable institution, or nonprofit organization, unless the institution or or- ganization also dispenses or sells hearing aids. This chapter shall not prevent any person from engaging in practices covered by this chapter, provided the person, or organization employing the person, does not dispense or sell hearing aids. (65GA, ch 1145, section 19) 154A.20 Rights of Purchaser. A hearing aid dealer shall deliver to each person supplied with a hearing aid, a receipt which contains the licensee's signature and shows his business address and the number of his license, together with specifications as to the make, model and serial number of the hearing aid furnished, and full terms of sale clearly stated, including the date of consummation of the sale of the hearing aid. If a hearing aid is sold which is not new, the receipt and the container must be clearly marked "used" or "reconditioned", with the terms of guarantee, if any. The receipt shall bear the following statement in type no smaller than the largest used in the body copy portion of the receipt: "The purchaser has been advised that any examination or representation made by a licensed hearing aid dealer in connection with the fittting or selection PAGENO="0235" 229 and selling of this hearing aid is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefore, must not be regarded as medical opinion or advice." Whenever any of the following conditions are found to exist either from observations by the licensed hearing aid dealer or person holding a temporary permit or on the basis of information furnished by a prospective hearing aid user, the hearing aid dealer or person holding a temporary permit shall, prior to fitting and selling a hearing aid to any individual, suggest to that individual in writing that his best interests would be served if he would consult a licensed phy- sician specializing in diseases of the ear, or if no such licensed physician is avail- able in the community, then~ to a duly licensed physician: 1. Visible congenital or traumatic deformity of the ear. 2. History of, or active drainage from the ear within the previous ninety days. 3. History of sudden or rapidly progressive hearing loss within the previous ninety days. 4. Acute or chronic dizziness. 5. Unilateral hearing loss of sudden or recent onset within the previous ninety (lays. 6. Significant air-bone gap (greater than or equal to 15dB ANSI 500, 1000, and 2000 Hz. average). 7. Obstruction of the ear canal, either by structures of undetermined origin, such as foreign bodies, impacted cerumen, redness, swelling or tenderness from localized infections of the otherwise normal ear canal. A copy of the written recommendation shall be retained by the licensed hearing aid dealer for the period of seven years. A person receiving the written recom- mendation who elects to purchase a hearing aid shall sign a receipt for the same, and the receipt shall be kept with the other papers retained by the licensed hearing aid dealer for the period of seven years. Nothing in this section required to he performed by a licensed hearing aid dealer shall mean that the hearing aid dealer is engaged in the diagnosis of illness or the practice of niedicine or any other activity prohibited by this chapter. No hearing aid shall be sold by any individual licensed under this bill to a i)erson twelve years of age or younger, unless within the preceding six months a recommendation for a hearing aid has been made by a physician specializing in otolaryngology. A replacement of an identical hearing aid within one year shall be an exception to this requirement. A licensed hearing aid dealer shall, upon the consummation of a sale of a hear- ing aid, keep and maintain records in his office or place of business at all times and each such record shall be kept and maintained for a seven-year period. These records shall include: 1. Results of test techniques as they pertain to fitting of the hearing aids. 2. A copy of the written receipt and the written recommendation. (65GA, ch 1145, section 20) 154A.21 Notice of Address. A licensee or person holding a temporary permit shall notify the department in writing of the address of the place where he engages or intends to engage in business as a hearing .aid dealer. The department shall keep a record of the place of business of licensees and persons holding temporary permits. Any notice required to be given by the department to a licensee shall he ade- qiiately served if sent by certified mail to the address of the last place of business recorded. (65GA, ch 1145, section 21) 154A.22 Deposit of Fees. The department shall deposit all fees collected under the provisions of this chapter in the general fund of the state. Compensation and travel expenses of members and employees of the board, and other expenses necessary for the board to administer and carry out the provisions of this chapter shall be paid from funds appropriated from the general fund of the state. (6SGA. ch 1145 section 22) 154A.23 Complaints. Any person wishing to make a complaint against a licensee or holder of a tem- porary permit shall file a written statement with the board within twelve months from the date of the action upon which the complaint is based. If the board deter- mines that the complaint alleges facts which if proven would be cause for the PAGENO="0236" 230 suspension or revocation of the license of the licensee or holder of a temporary permit it shall make an order fixing a time and place for a hearing and requiring the licensee or holder of a temporary permit complained against to appear and defend. The order shall contain a copy of the complaint, and the order and a CO~~ of the complaint shall be served upon the licensee or holder of a temporary permit at least twenty days before the date set for hearing either personally or as pro- dded in section 154A.21. Continuance or adjournment of a hearing date may be made for good cause. At the hearing the licensee or holder of a temporary permit may be represented by counsel. The licensee or holder of a temporary permit and the board may take depositions in advance of hearing and after service of the complaint, and either may compel the attendance of witnesses by subpoenas issued by the board. The board shall issue such subpoenas at the request of a licensee or holder of a temporary permit. Either party taking depositions shall give at least five days written notice to the other party of the, time and place of such deposi- tions, and the other party may attend, with counsel, if desired, and cross-examine. If the board determines from the evidence and proofs submitted that the li- censee or holder of a temporary permit is guilty of violating any of the provisions of this chapter, or any of the regulations promulgated by the board pursuant to this chapter, the department shall, within thirty days after the bearing, issue an order refusing to issue or renew, or revoking or suspending, as the case may be the hearing aid dealers' license or temporary permit. The order shall include the findings of fact and the conclusions of law made by the board and counsel. A copy of the order shall be sent to the licensee or holder of a temporary permit by regis- tered mail. The records of the department shall reflect the action taken by the board on the charges, and the department shall preserve a record of the proceed- ings in a manner similar to that used by courts of record in this state. The final order of the boardin the proceedings may be appealed to the district court of the county where the licensee or holder of a temporary permit resides, or in which the licensed hearing aid dealer's principal place of business is located. The department shall send a copy of the complaint and a copy of the board's final order to the attorney general for purposes of information in the event the li- censee or holder of a temporary permit pursues a court appeal and for considera- tion as to whether the violations are flagrant enough to justify prosecution. The attorney general and all county attorneys shall assist the department in the en- forcement of the `provisions of this chapter. (G5GA, ch 1145, section 23) 154A.24 SUSPEiNSION OR REVOCATION The board may revoke or suspend a license or temporary permit permanently or for a fixed period for any of the following causes: 1. Conviction of a felony. The record of conviction, or a certified copy, shall be conclusive evidence of conviction. 2. Procuring a license or temporary permit by fraud or deceit. 3. Unethical conduct in any of the following forms: (a) Obtaining a fee or making a sale by fraud or misrepresentation. (b) Knowingly employing, directly or indirectly, any suspended or un- registered person to perform any work covered by this chapter. (c) Using or causing or promoting the use of any advertising matter, pro- motional literature, testimonial, guarantee, warranty label, brand, insignia or any other representation however disseminated or published, which is mis- leading deceptive or untruthful. (d) Advertising' a particular model or type of hearing aid for sale when purchasers or prospective purchasers responding to the advertisement cannot purchase the advertised model or type, if it is established that the purpose of the advertisement is to obtain prospects for the sale of a different model or type than that advertised. (e) Representing that the service or advice of a person licensed to practice medicine, or one who is certificated as a clinical audiologist by the board of examiners of speech pathology and audiology or its equivalent, will be used or made available in the fitting or selection, adjustment, maintenance, or repair of hearing aids when that is not true, or using the words "doctor" "clinic", "clinical audiologist", "state approved", or similar words, abbrevia- tions or symbols which tend to connote the medical or other professions, ex- cept where the title "certified hearing aid audiologist" has been granted by the national bearing aid society, or that the hearing aid dealer has been recommended by this state or the board when such is not accurate. PAGENO="0237" 231 (f) Habitual intemperance. (g) Permitting another person to use his license or temporary permit. (h) Advertising a manufacturer's product or using a manufacturers name or trademark to imply a relationship with the manufacturer that does not exist. (i) Directly or indirectly giving or offering to give, or permitting or causing to be given money or anything of value to a person who advises another in a professional capacity, as an inducement to influence the person or cause him to influence others to purchase products 5Oid or offered for sale by a hearing aid dealer, or to influence others to refrain from deahng in the products of competitors. (j) Conducting business while suffering from a contagious or infectionuS disease. (k) Engaging in the fitting or selection and sale of hearing aids under a false name or alias, with fraudulent intent. (1) Selling a hearing aid to a person who has not been given tests utilizing appropriate established procedures and instrumentation in fitting or selec- tion of hearing aids, except in cases of selling replacement hearing aids of the same make or model within one year of the original sale. (m) Gross incompetence or negligence in fitting or selection and selling of hearing aids. (n) Using an advertisement or other representation which has the effect of misleading or deceiving purchasers or prospective purchasers into the belief that any bearing aid or device, or part or accessory thereof, is a new invention or involves a new mechanical or scientific principle when such is not the fact, (o) Representing, directly or by implication, that a hearing aid utilizing bone conduction has certain specified features, such as the absence of any- thing in the ear or leading to the ear, or the like, without disclosing clearly and conspicuously that the instrument operates on the bone conduction prin- ciple, and that in many cases of hearing loss, this type of instrument may not be suitable. (p) Stating or implying that the use of a hearing aid will restore normal hearing or preserve hearing or prevei~t or retard progressions of bearing impairment or any other false or misleading claim regarding the use of bene- fit of a hearing aid. (q) Representing or implying that a hearing aid is or will be "custom- made", or in any other sense especially fabricated for an individual person when such is not the case. (r) Violating any of the provisions of section 713.24. (s) Such other acts or omissions as the board may determine to be un- ethical conduct. (G5GA, ch 1145, section 24) 154A.25 Prohibitions. A person shall not: 1. Sell, barter, or offer to sell or barter a license or temporary permit. 2. Purchase or procure by barter a license or temporary permit with intent to use it as evidence of the holder's qualifications to engage in business as a bearing aid dealer. 3. Alter a license or temporary permit with fraudulent intent. 4. Use or attempt to use as a valid license a license or temporary permit which has been purchased., fraudulently obtained, counterfeited, or materially altered. 5. Willfully make a false statement in an application for a license or temporary permit or for renewal of a license or temporary permit. (O5GA, ch 1145, section 2o) 154A.26 Consumer protection. Nothing in this chapter shall be construed to limit the right of a person who desires to file a complaint against a licensee or holder of a temporary permit from filing a complaint with the attorney general pursuant to the provisions of section 713.24. (G5GA, ch 1145, section 26) 154A.27 Penalties. `A violation of any provisions of `this chapter is punishable, upon conviction, by a fine of not more than five hundred dollars or `by imprisonment for not more than ninety clays in the county jail, or both such fine and imprisomnent. (O5GA, ch 1145, section 27) PAGENO="0238" 232 STATE OF \VASHINGTO~, PRoFESsIONAL LIcENsING Divisiou, Olympia, Wash., April 9, 1976. Hon. HENRY M. JACKSON, Chairman, Senate Permanent Subcommittee on Investigation, U.S. Senate, Washington, D.C. DEAR SENATOR JACKSON: Thank you fOr your letter of March 23, 1976, which unfortunately was delayed in reaching me from the Professional Licensing Division in Olympia. 1 shall be happy to have you use my letter of December 22, 1975, as YOU requested, in connection with hearings on the "Staff Study on State Licensing Laws and Training Requirements for Hearing Aid Dealers." Further coinmeiits may be sent to ~;OU shortly but 1 did not wish to further delay this reply to prepare them. Thank you for your interest in this important subject. Should further infor- mation be desired I shall he happy to supply it. For convenience, my personal ad- dress and phone number are listed below. Sincerely yours, THORNTON K. SUAW. * STATE OF WASHINGTON, PRoFESsIoNAi~ LICENSING DnrIsIoN, Olympia, Wash., December 22, 1975. Hon. HENRY M. JACKSON, Chairman, Permanent Subcommittee on Investigations, U.S. Senate, Washington, D.C. Di~&n SENATOR JACKSON: In view of the findings and recommendations hicluded in the "Staff Study of the State Licensing Laws and Training Requirements for Hearing Aid Dealers," we thought you should he advised specifically of the operation of the licensing law in your own state-which has one of the best laws in the country in terms of consumer protection. It was developed in close coop- eration with physicians, clinical audiologists and the Consumer Protection Divi- sion of the Attorney General's office. Administration of our law is vested in the Professional Licensing Division, Department of Motor Vehicles. They are assisted by the (Advisory) Council on Hearing Aids consisting of four dealers, one Otolaryngologist, one Clinical Audiol- ogists and one Public member. The following paragraphs relate to findings of the report: (1) ("Nearly 50% of the licensed hearing aid dealers in the country have never taken a state-administered qualifying examination.") Answer: All licensees in our state were required to pass the examination prior to licensure. (2) "Even those who have taken the examination are inadequately trained. .. ." Answer: This finding presupposes that the examination is based strictly on the NHAS course which is not the case in our state; substantial other preparation is required. Each examiner spends approximately 3~ hours taking a written ex- amination and 11/2 hours taking a practical examination. The failure rate has run from a low of 27% on the first examination to a high of 57% on the last examination with the usual rate running around 34%. (3) ("I~'Iany hearing aid purchasers are dissatisfied with their dealers, charging errors in fitting, and ethical lapses . . .") Answer: Please see inclosure 1 for details on complaints in this state, and note that all but two have been satisfactorily resolved. The Council on Hearing Aids takes no part in the complaint process except to advise the Department where necessary; thereby an appearance of conflict of interest is avoided. The Council does request figures by number, type and status at each Council meeting. (4) ("Follow-up of complaints is haphazard at best, since most of the li- censing units have little or no money or resources to police dealers and only a handful have professional staff assistance.") (Emphasis supplied.) Answer: We have a sizeable budget and direct use of three staff persons in ad- dition to general administrative support. (See Inclosure I for details) Follow-up is thorough and prompt. (Incidentally, questionnaire results published in the re- port indicated that 23 of 36 states replying had professional staff assistance- too few, to be sure, but certainly more than a handful.) PAGENO="0239" 233 (5) ("Most state licensing agencies are controlled by dealers. . . often respon- sible for the drafting of loophole ridden laws . . . and sometimes act in ways that smack of cronyism and a profound lack of concern for the consumer.") Answer: The oniy evidence presented in the staff study which might support such a conclusion is that from one state-Kentucky. The letter from the Arkansas Board member is not corroborated and, in fact, is contradictory. In any event, the record will clearly indicate that dealer members of our Council have in all cases acted in a manner that showed proper concern for the consumer. (6) ("In nearly half the states, no system exists by which the licensing agency can check on the accuracy of hearing measurement instruments used by deal- ers.") Answer: In our state, annual calibration and certification by a state-approved facility is required and a state inspector periodically checks the certification and equipment to assure compliance. (Incidentally, no legal requirements exist for the same type of equipment used by physicians, clinical audiologists, school nurses and others.) (7) ("Although only three states require a physician's or audiologist's recom- mendation before sale of a hearing aid to anyone, no Federal agency . . . will spend taxpayers money on an aid until it has such a professional recommenda- tion.") Answer: In this state we require clearance by a physician and also recoin- mendation of services of a clinical audiologist for all persons under 18. Addi- tionally, consultation with a physician must be recommended if certain physical conditions enumerated in the law and in rules and regulations are observed. Also, the client has the privilege of returning the aid for refund within 30 days if a physician gives medical advice against its purchase. Nationally, the National Hearing Aid Society has adopted a policy requiring medical clearance prior to initial purchase of a hearing aid or in any case where certain physical conditions are present. (8) ("The insistence by some in the industry that dealer licensing laws protect the hearing-impaired from abuses at the hands of dealers is wholly unsubstantiated . . .") Answer: Admittedly the study points up the need for improvements in some areas but hardly supports the sweeping conclusion of the author of the report. In our state I believe the record of eternal vigilance against abuses will bear the closest scrutiny. (9) ("Efforts by industry officials to secure coverage for their product under any national health insurance law must be considered in the light of the present flaws in the delivery system.") Answer: This finding does not concern itself with licensing but it should be noted that the National Hearing Aid Society proposed to the Church Sub- committee on Interest of the Elderly (in 1973) a delivery system for this program overcoming the deficiencies claimed here and implied in (8) above. This would require examination by a physician and also by a clinical audio- logist, if recommended by the physician, prior to fitting of a hearing aid. Our law does contain two deficiencies which were not of our making. We had proposed requirements of a high school education or equivalent and good moral character but the legislature rejected these as being exclusionary. Quite properly, the report does point out deficiencies in some laws and/or of their administration which do require correction. Attention should focus on necessary changes. In conclusion, it has been my privilege over the years to meet and talk with many members of Licensing Boards and Councils-both professionals and dealers. Without exception, I have found them to be sincere, honest, dedicated individuals working to carry out the mandates of their laws. Given proper support and encouragement they will succeed. We earnestly request your co- operation toward that end. If you desire more detailed information or substantiation, either the writer or the Professional Licensing Division, Department of Motor Vehicles, will be happy to supply it. Sincerely yours, THoRNToN K. SHAW, Uhairme-~v, Council on Hearing Aids ~S't ate of Washington. Inclosures. Copies to: Seattle Office, Senator Jackson, Subcommittee members, council members. PAGENO="0240" 234 SUMMARY OF COMPLAINTS 1 1969-73 1974 1975 (to Dec. 15) Deealr competence 2 Unethical practices: Advertising, local 2 Advertising, factory-supplied Other practices 5 Warranty 5 High prices 2 Total 16 3 2 7 24 6 4 1 1 3 2 2 5 26 14 1 The years indicated relate to the year of occurrence of the incident where this differs from the year in which the com- plaint was filed. The complaints in the 1st column were unresolved complaints forwarded by the consumer protection division of the Attorney General's office when licensing law became effective July 16, 1973. All have been satisfactorily resolved. 2 Of this number, 3 involved 1 dealership, alleging substitution of a different brand for that which the customer expected to receive. Note: (1) All of the 1975 complaints shown derive from 7 dealerships of a total approximately 100. (2) Total number of licensees, approximately 145 plus 25 trainees. (3) Annual hearing aid sales in State approximately: 30,000. (4) In all but a few cases, the deler has responded voluntarily and immediately; usually all that is required is to establish com- munication. (5) Of the complaints indicated only 2 presently remain unresolved. STAvF AND BUDGET PROFESSIONAL STAFF Assistant Administrator, part time (10-15%) Clerk, part time (approximately 50%) originally full-time; as the examination load lessened, it was possible to have her devote half time to another act. Investigator-inspector part time, (approximately 60%). Budget: ExpenditureS, biennium ending June 30, 1075, approx $50,000 equals $25,000 per year. Budget, biennum ending June 30, 1077, $64,800 equals $32,400 per year. STATE OF MISSOURI, DIVISION OF PROFESSIONAL REGISTRATION Jefferson City, Mo., March 29, 1976. Hon. SA~,I NTJNN, Acting Chairman, Committee on Government Operations, Senate Permanent Subcommittee cii Investigations, United States Senate, Washington~, D.C. DEAR SENATOR NUNN: Thank you for your letter of March 24, 1976 concerning the "Staff Study of State Licensing Laws and Training RequirementS for Hear- ing Aid Dealers." In accordance with your request, you may include my letter of .January 9 to Senator Jackson in your hearing record. The Council and I are most interested in the hearings you plan to hold on the subject. If we can provide additional information for your consideration, we would be most happy to do so. Sincerely, GEORGE W. TJFFMANN, Director, Division of Professional llegistratiocr. STATE OF MISSOURI, DivisioN OF PROFESSIONAL REGISTRATION, Jefferson City, Mo., January 9, 1976. Hon. HENRY M. JACKSON, Chairman, Permanent Subcommittee on Investigations, United States Senate, Washington. D.C. DEAR SENATOR JACKSON: The Missouri Council for Hearing Aid Dealers and Fitters asked me to submit their comments on the "Staff Study of the State Licensing Laws and Training Requirements for Hearing Aid Dealers," October 1975. Recognizing that Missouri's entry into the field of licensing for Hearing Aid Dealers and Fitters is in its infancy, the Council and the Division of Profes- sional Registration (Administrative Agency) have effected several actions to upgrade the overview of this industry. For your convenience and reference, a copy of the Missouri Statute and the Council's Rules and Regulations are here- with provided. PAGENO="0241" C-) Six principal areas where the Missouri operation is considered particularly responsive to the public and consequently in conflict with portions of your study are presented: .1. Legislation was introduced in the 1975 Missouri Legislative session to add a public member to the Council. This bill was supported by the Council and by the Missouri Association for Licensed Hearing Aid Specialists which is a chapter of the National Hearing Aid Society. As the bill was not successful, it was re- introduced in the current session again with support of both the Council and the Association. 2. In drafting and revising the Rules and Regulations of the Council, the con- sumer's position has always been foremost in that formulation. The most signif- icant section deals with medical referral criteria, Section 160-2.050. 3. Three examinations, written and practical, have been administered to date. The success rate has been approximately 50%, suggesting that the entrance cri- teria is not too lax, yet achievable by the serious candidate. 4. The level of complaints addressed to this Council has been extremely low. One of our initial actions was to contact an interested television station and con- sumer groups about the state advising that we were prepared to address any and all complaints and to pursue investigations as necessary. The State of Missouri enjoys a well defined Administrative Hearing Procedure insuring the ability to act with insured protection of the rights of the individual. 5. The Council and the State Association jointly supported the introduction of a continuing educational requirement as a prerequisite to continued licensing. This action is not permissible by rule and regulation and must therefore be the subject of future legislation. In any event, both bodies support the concept and will work toward its enactment. 6. The Missouri Hearing Aid Dealers and Fitters Statute requires proof of annual calibration of employed audiometers, we noted however that such calibra- tion is not required of other users of this equipment. We trust that these comments are beneficial to your study and appreciate the opportunity to respond. Sincerely, GEORGE W. UFFMANN, Director, Division of Professional- Registration. Enclosure. cc: Council for Hearing Aid Dealers and Fitters. BETTER HEARING INSTITUTE, Washington, D.C., March 26, 197G. Hon. SAM NUNN, Acting Chairman, Permanent Subcommittee on Investigations, UJ~. Seiui-te, Washington, D.C. DEAR SENATOR NUNN: As you requested on March 24, 1976, please feel free to include my December 17, 1975 letter to Senator Jackson in your hearing record. Believe that my correspondence adequately summarizes the position of the Better Hearing Institute, and see no need to provide an additional statement at this time. Thank you for your interest and consideration. Sincerely, JOSEPH J. Rizzo, Esecutive Director. BETTER HEARING INSTITUTE, Washington D.C., December 17, 1975. Hon. HENRY M. JACKSON, Chairman, Permanent Subcommittee on Investigations, 711.5. Senate, Washington. D.C. DEAR SENATOR JACKSON: On behalf of the Better Hearing Institute, I seriously question the accuracy and objectivity of the "Staff Study of the State Licensing Laws and Training Requirements for Hearing Aid Dealers" prepared by your Permanent Subcommittee on Investigations. Of great concern is the report's negative implications for persons suffering from uncorrected hearing loss. PAGENO="0242" 236 Hopefully you, and the majority of Subcommittee members, will carefully re- consider how counterproductive this report is to the formidable task of encour- aging people to solve their hearing problems. I do realize that the study reflects the staff work and the thinking of your Subcommittee's minority staff, which in turn reflects the thinking of the ranking minority member. Our primary concern is for more than 11,000,000 Americans with uncorrected hearing problems, most of whom could be helped medically, surgically, or by am- plification-if they could only be encouraged to avail themselves of such help. The activities of the Subcommittee could well hinder the delivery of hearing help to many of these people, the existing user or potential consumer of hearing aids. Considering that the vast majority of hearing impaired people can be helped by hearing `aids, is the Subcommittee report purposeful or in the public interest? The Subcommittee's report could well create new barriers for persons who might benefit from hearing aids, when many are already reluctant to seek this help. Indeed, the reduction of such reluctance, and positive reinforcement about available hearing help, are major thrusts of the public service, information and education programs of the Better Hearing Institute. While we believe the report's overall effect may be to further discourage or inhibit hearing handicapped people from seeking vitally needed help, two sections cause special concern: 1. Page 13, (3): ". . . there have been 2,383 complaints lodged with State licensing agencies in a universe of only 5,700 dealers over a five-year period. . . ." This suggests that the complaint rate is horrendously high, yet it works out to less than one-half complaint for each dealer over the full five-year period. Looked at another way, this is an annual average of 600 complaints out of ap- proximately 600,000 new hearing aids each year-a 1/10 011% complaint average. If we consider that there are an estimated 21,~ million hearing aids in use, the complaint ratio would be even more miniscule-2/lOOth of 1%. We are especially sensitive to the Study's implications regarding complaints, because they are seriously contradicted by the Better Hearing Institute's Hear- in.g Aid Helpline `statistics. Helpline files were subpoenaed by the `Subcommit- tee but apparently were not given proper consideration. HelpLine is a toll-free public service telephone program that welcomer con- smner hearing aid complaints. Yet the results of thi~ program-in operation for more than 21/2 years-drastically refute Staff Study implications. Of the 3,311 total Help Line calls received to date, 3.024 were information requests., 278 were grievances and nine were suggestions. Less than 8% were complaints, while more than 91% were routine requests for hearing help information. 2. Page 1, paragraph 2: "In hundreds of thousands of cases, electronic ampli- fication can help restore hearing." This is grossly misleading to anyone seeking hearing help. It is untrue to say that amplification can "restore" hearing, although it can help many to hear better. . With the knowledge that the majority of Americans with uncorrected hearing problems can receive help ultimately through a hearing aid, Senator Jackson, it is our belief that the Subcommittee's activities could destroy the incentive or the interest that people with hearing problems have in looking for solution~s. If you were to provide some constructive suggestions that would allow more people to participate in the help that is available to them, you would be doing the entire nation a great deal more good than through the report released by your Sub- committee. The Better Hearing Institute suggests a positive approach-a broadened educa- tional effort on behalf of the bearing help consumer. Indeed, the Better Hearing Institute already. has an on-going consumer education program which, with ade- quate funding, could be used as a readily available educational resource to at- tack the problem. We welcome the opportunity to submit a comprehensive pro- posal for an effective national public information and education program, `and would appreciate any support you could give us in this effort. Thank you for the opportunity to comment. Sincerely, JOSEPH J. Rizzo, Evecutive Director. Extra copies: Hon. E. Kennedy, Hon. P. Rogers, Hon. B. Rosenthal, Hon. L. Van Deerlin, Committee on Government Operations. PAGENO="0243" 237 OLLIE B. LIVINGSTON, HEARING AID CENTER, Lubbock, Tea,., April 5, 1976. Senator SAM NUNN, Acting Chairman, U.S. Senate, Committee on Govern4nent Operations, Senate Permanent Subcommittee on Investigations, Washington, D.C. DEAR SENATOR NUNN: In regards to your letter of March 24, 1976 concerning the Staff Study of State Licensing Laws and training requirements for hearing aid dispensers. As a member of the Texas Hearing Aid Dispensing Board I am enclosing our Standard Committee Report, section changes in our law, and three letters from clients for consideration by your committee. If your committee is truly concerned about the hard of hearing and really want the truth I suggest that you contact each state that has a licensing law and talk to them, or contact the Better Business Bureau of each city with a population over 100,000 in regard~ to the number of complaints as compared with other professions. I feel states should be encouraged to pass their own dispensing laws and the FTC should close down mail order hearing aid companies. Each state that has licensing laws have a board make up of the best qualified people in the state, Drs., audiologists, laymen, and hearing aid dispensers. There- fore, I feel that state level control is much better than national control. Sincerely, OLLIE B. LIVINGSTON. Enc'osure. STANDARDS COMMITTEE REPORT It is recommended that any individual license4 by or seeking license under Article 4566, V.A.C.S., shall seek personally or through proper referral channels to obtain the following minimal information on each prospective candidate for amplification: I. Pertinent Case History. II. Otoscopic inspection of the outer ear and drum-head. III. Evaluation of hearing acuity utilizing puretone techniques via air and bone conduction pathways through a calibrated system. IV. Aided and Unaided speech reception threshold and the ability to dlif- ferentiate between the phonemic elements of the language through speech audiometry utilizing a calibrated system. It is understood that other information and the utilization of other instru- mentation may be necessary to the total assessment of hearing function. Further, all procedures shall be conducted in a manner that will identify those condi- tions which would mandate referral for medical followup. Finally, we wish to herein reiterate Section 1.01 "Definitions", sentence (f) of the Rules and Regulations promulgated by the Board of Examiners in the Fitting and Dispensing of Hearing Aids. LUBBocK, TEX., December 9, 197k. Mr. DAvm M. LINK, Bureau of Medical Devices, HEW, Interdepartmental Task Force on Hearing Aid Health Care, Rockville, Md. DEAn Mn. LINK: This letter concerns the proposed regulation of Audiologists and the dispensing of hearing aids. Being a registered pharmacist in close contact with medical doctors I natu- rally consulted an ear, nose, and throat specialist when I became aware of some loss of hearing. Although an excellent physician my doctor was ill advised concerning the benefit of hearing aids and for a considerable time advised m~ against their use. Finally my need became so great that I went to Ollie Livingston, Audiologist, Livingston Hearing Aid Center, Lubbock, Texas. Oflie Livingston checked my hearing thoroughly and sold me a hearing aid. That was ten years ago. In the intervening period Ollie Livingston has checked me a number of times and sold me several hearing aids as the old ones wore out and the new improved. I wear my hearing aids in my eye glasses in both ears and could not work without them. It would be very disturbing to me and a great dis-service if I had to go to some one else for my hearing needs. PAGENO="0244" 238 Also you can not legislate morals. A cheat is a cheat. You can not stop "kick backs" or the use of inferior mdse., by restricting the clinician from dispensing hearing aids. There might easily be an unholy alliance between the clinician and the dispenser. So separation of clinical testing and selling hearing aids would not guarantee the most economical or dependable service or e1uipmeiit. The best guarantee of satisfaction is to deal with well established, reputable businesses. They are not to difficult to find. It would be a very grave error to regulate and restrict the majority of hearing aid audiologists because a very minor percentage of people have been cheated on the purchase of a bearing aid. Especially when there is no proof that such regulation and restriction WOUld correct the matter. The good Lord created man with enough brains and enough sweat to live a life. We make some mistakes and learn some things the hard way but we do not need a wet nurse from the cradle to the grave. Yours truly ART BOWMAN- Copies to: U~S. Senator, John Tower, U.S. Senator, Lloyd Bentsen, and Con- gressman, George Mahori DECEMBER 13, 1974. Mr. DAVID LINK, Hearing Clerk, Food and Drug Administration, Room 4-65, 5600 Fishers Lane, Rockville, Aid. DEAR Mn. LINK: I have recently read a report that is entitled "Hearing Aid Health Care." I'm very disturbed by what I read and that is the reaSon for this letter. I am hard of hearing and have been for a number of years. I can assure you that I did not need a bill passed to make me go to a hearing doctor before I could go to a hearing aid dealer. In fact, I went to a number of doctors and they all told me the same thing "I cannot help you." I had about resolved myself to missing a great deal out of life when I decided to "Take a Chance" on a hearing aid dealer. My only regret in doing so was that I did not do it several years before. I received the most personalized attention you can imagine. First, I was thoroughly tested to determine my degree of loss and then I was fitted for my loss much the same as a person is fitted for glasses. That was six years ago. I have since bought another set of "Over the Counter Aids" from this dealer and will continue to do so. Why? You may ask, because anytime I have the slightest bit of trouble, be is there. His experience and knowledge are worth far more to me than I feel I could ever receive from any audiologist. I might add that all this service after the sale is free of charge. The only charge is to renew my guaran- tee each year of the aid I am wearing. I feel it is unimportant to mention this man's name, because I am sure he is not the exception but part of the general rule of hundreds of dealers across the country. To take this experience, knowledge and integrity away from the public through passage of the "Hearing Aid Health Care" report would deprive the general public of a most valuable service. Therefore, I urge your most careful consideration. Respectfully yours, BARr PIKE. LUBBOCK, PEX., December 15, 1974. MR. DAvm M. LINK, Bureau of Medical Devices, Health, Education, and Welfare, Interdepartmental Task Force on, Hearing Aid Health Care, 1901 Chapman, Rockvihle, Md. DEAR MR. LINK: I am very concerned about the situation which seems to be developing in hearing aid care. For twelve years, I have worn an excellent aid, and have received the very best, and most professional service from the representatives of the company from whom I bought my aid. This excellent service has occasionally involved having the owner open the Center after hours, in order to take care of some problem I had. He was always most gracious and courteous about the inconvenience. PAGENO="0245" 239 The man with whom I do business is a fully qualified audiologist. We have a state law in Texas regulating this, and I feel this should definitely be handled on a state level. If there are unscrupulous dealers, then laws should become more stringent. I feel that handling this matter' on a federal level would create more problems. Federal control would make speedy and excellent servicing most difficult. Matters handled at a state level could be expedited much more quickly. A fully qualified physican told me that I could not wear a hearing aid. I was sent to a hearing clinic in Dallas to be evaluated. They also said that an aid would not hep me. 1-lowever, since I could hear very little, I decided to try one anyway. As it developed, the aid helped me immeasurably. I am able to hold a job, to communicate with people very well, whereas before I was unable to do so. Therefore, for the reasons I have stated, I feel very strongly that qualified hearing aid dealers are indispensable to the welfare of the hard of hearing. Sincerely, (Mrs.) HOPE READ AUSTIN. Copy: Hon. George Mahon, House Office Building, Washington, D.C. CHANGES MADE IN THE TEXAS HEARING AID DIsPmcsING LAW Section 1.01 Definitions. (f) The term "measurement of human hearing," used in section 1.01 (f), includes but is not limited to mean that such measurement must he conducted in an environment not to exceed 55 Db, A scale slow. (Adopted November 23, 1974.) Section 1.10 Refusal to License and Revocation or Suspension of License. (10) Failure to disclose the licensee's full name, business address and tele- phone number in any advertising purchased or secured by the lice:esee may be construed as misleading under section 1.10 (10), Art. 4566, V.A.T.S. (Adopted November 23, 1974.) Section 1.14 Duty of a Licensee. The term "description" shall refer to new hearing aids and includes but is not limited to mean the serial number provided at the time of delivery, the length of warranty on the hearing aid, and whether the warranty is backed by the dealer, manufacturer or repair shop. The term "description" shall also refer to used or repaired hearing aids and includes but is not limited to mean the serial number provided at the time of delivery, the length of warranty on the hearing aid, and whether the warranty is backed by the dealer, manu- facturer or repair shop. (Adopted November 23, 1974.) Section 1.15 Prohibited Acts. (a) (7) The phrase "conducted in person," as used in section 1.15 (a) (7) Art. 4566, V.A.T.S., implies that the sale of a hearing aid by mail is a prohibited act. (Adopted November 23, 1974.) THE BOARD STRONGLY SUGGESTS (1) The Board strongly suggests that a licensee attend a minumum of 15 hours a year of educational seminars approved by national standards. (Suggested November 23, 1974.) OLI~IE B. LIvINGsToN, Hn~RING AID CENTER, Lubbock, Teai., December 12, 1075. Hon. HENRY M. FACKSON, Chairman, Permanent Subcommittee On Investigations, United States Senate, Washington, D.C. Sm: I am concerned about the attack on the integrity of licensing board mem- bers. The Staff study certainly did not reflect the State of Texas Lic. Board. As a Board member I would like for you to know that I have served 6 years. My term will be up Dee. 31, 1975 and I will assure you that I have never worked so hard, done so much and received so little pay in all my life. But when I received PAGENO="0246" 240 the Permanent Subcommittee Investigations, committee of Government Opera- tions, the United States Senate that was the last straw. I have given in hours each month without pay 30 working hours, plus travel time of 16 hours. This I have done for 6 years. My question is who on this com- mittee has done as much for the hard of hearing? The Board is composed of 9 members but the Executive Director brings the in- formation of informal hearings. This Board was appointed by the Gov. of Texas. The law was written by the legislator of Texas. The People of Texas have been well served by the Board of Concerned people and justice does not go undone when the law is violated. I have notice that the Board has received about 40 complaints each yqar. When you consider however that 30,000 hard of hearing have been fitted with aid this is small percent. Sir, as a board member I do not resent receiving credit for a job done, but I do object to the abuse of this committee report which is wholly unsubstantiated. I am enclosing a report I think you will find helpful. Sincerely yours, OLLIE B. LIVINGSTON, Member of the Texas Board of Examiners in the Fitting and Dispensing of Hearing Aids. TEXAS BOARD OF ExA~rINmts IN THE FITTING AND DIsPENSING OF HEARING AIDS, May 30, 1975. To: Members, Texas Board of Examiners in the Fitting and Dispensing of Hear- ing Aids From: Executive Director Re: Informal Hearings, and Legislative matters affecting the Board of Examiners in the Fitting and Dispensing of Hearing Aids On June 12 and 13, and June 17 and 18, 1975, I will initiate a series of informal hearings in Dallas and Houston to seek to gain additional information on com- plaints which have been filed with the Board of Examiners in the Fitting and Dispensing of Hearing Aids. I feel at this time, these informal hearings will give me an opportunity to resolve many of these complaints by bringing the parties in- volved together, and to give me sufficient information to make detailed recom- mendations to the Board. At the present time, based upon the facts in my office, there is insufficient grounds for the conducting of any formal hearings at the June meeting of the Board. This determination had to be made 30 days in advance of the June meet- ing based on the restrictions in Article 4566, Vernon's Civil Statutes. After lengthy considei~ation of this matter, I decided to undertake these investigations, as authorized by the Board, in order to bring these complaints to a reasonable completion, and to report these findings to the Board at the June meeting. These hearings should allow the Board to clear its docket of pending com- plaints, and allow us to begin a new fiscal year with a fresh slate. At the same time, some of the complaints which have been pending for a period of weeks or months will have a greater opportunity for resolution. I am very enthusiastic and encouraged by the possibility of this kind of in- vestigation technique, and look forward to reporting the results to the Board at the June meeting. I am disappointed to report that the continuing education bill, SB 1033, was defeated on the floor of the House on Thursday, May 29th. This defeat came about when our bill, pending on the local and consent calendar, was objected to and knocked off that calendar by five objections from the floor. I worked extensively during the day to resolve those objections, and through great influence and effort, was able to place the bill back on the calendar for re- consideration at the House or Representatives' evening session. During the evening debate, the bill once again was knocked off the calendar by five other objections. The reason for the bill's defeat must he based on three points: (1) the lateness of the hour in the Legislative sessiOn and Legislative procedures, (2) squabbling between the House of Representatives and the Senate, (3) underdetermined sources of opposition. I was greatly discouraged by this late hour defeat of our legislative efforts. but am confident that this matter, when proposed to the next session of the PAGENO="0247" 241 Legislature, will have a good chance of passing. Both the author of the bill, Senator Lloyd Doggett, and our House sponsor, Representatives Carlos Truan, have indicated that the bill would have passed on a regular state or general calendar, but the nature of the Legislative session, and the procedures involved, create a difficulty when we had to resort to the passage of the bill on a consent calendar. House procedures provide that five members may object to any bill being placed on the consent calendar, thereby knocking it off from floor con- sideration. This is what happened to our piece of legislation. I was also deeply concerned about the Legislature's reduction of my salary in the amount of $600. The Legislative Budget Board indicated that the Legisla- ture's intent was to place all the small agencies on the same salary level. I have made my objections known to both the Senate and House Appropriations Coin- mittees for the following reason. The standardization of salaries is a commend- able goal, however, such goal should be achieved through limitations on salary increases, and not achieved through reductions of some salaries. It is my belief that I am the only Executive Director adversely affected by this salary reduc- tion in this category. FrOm the information available, it appears that this re- duction is not intended to reflect upon the Board. I must note, however, that it does effect morale and enthusiasm. As for other staff salary, the Legislature has not cut the salary for my secre- tary, but has provided a very very modest increase in the next years of the biennium. After working thirteen years with the Legislature, I have learned to accept the will and wisdom of the Legislature, and take it for the best or the worst. Accord- ingly, I am resigned to accepting the salary reduction with some degree of under- standing, and a sense of humility. In plain words: I will try to make the best of a bad deal. Efforts are being undertaken to implement the revised examination at the up- coming June meeting of the Board. The dedicated efforts of Dr. Harold Williams, Chairman of the Committee, and Mr. Roy Brakebill and Mr. Hugh Conaughty, members of the Examining Committee, have gone a long way to enabling the Board to upgrade the examination for the June meeting. Further information dealing with the Examination will be forwarded within the next few days. I have been in contact with parties at the Health Department and the Welfare Department concerning tl1e June 10th meeting. It appears that representatives from both offices will be available for that meeting. I would like to request that rather the entire Board attend this meeting, that one or two members of the Board who have particular interest in this area volunteer to represent the Board at this meeting. As I mentioned earlier, there is some question as to whether our agency has the authority to even request such a meeting, however, I felt that communications between the agencies would be valid and important at this time. My reasoning for requesting a limitation on the number of people to attend this meeting is finances. In my evaluation of the meeting possibilities, I highly doubt that any concrete proposals, recommendations, or results will come out of this meeting. I do believe, however, that a free flow of communications can be informative and a value to all the parties involved. Please let me know if you might be interested in volunteer- ing to be one of several participants in this meeting. DALLAS HEARINGS THURSDAY-JUNE 12TH 9 :00 Lola Phillips vs. Eldon Johnson. 10:30 Morgan Muse vs. East Texas I-Tearing Aid Center-Freeman Fuller. 1:00 Farley vs. Treadway. 2 :30 Paterson vs. North Texas Audio-Stanley Bigham. 4:00 Carpenter vs. North Texas Audio-Stanley Bigham. 5:30 Durham vs. Bigham. FRIDAY-JUNE 13TH 9:00 Jones vs. Dal-Worth Hearing Aid Center. 10 :00 Smith vs. Russell 1-learing Aid Service. 11 :00 Garner vs. Wilson (Russell hearing Aid Service). PAGENO="0248" 242 HOUSTON hEARINGS WEDNESDAY-JUNE 18TH 0:00 Patrick Thompson vs. Audiphone-Houston. 10:00 Mueller vs. Ron House. 1 :00 Field Testing. 3:00 Miller vs. T.S.A.-Gaenslen-Sanders. 4:00 Gillum vs. T.S.A.-Gaenslen-Sanders. THURSDAY-JUNE 1 9TH 10:00 Bartoch vs. Lee Brown. 11 :00 Charles Rogers, request for license. 1:00 Appleman vs. Cox. 0