PACIFIC HEARING & BALANCE, INC.
October 17, 2011
Dr. Rhonda Meadows
Gregory J. Frazer PhD, AuD Audiology
Hearing Aids Children and Adults Carissa Bennett, AuD Audiology
Hearing Aids Children and Adults Julie Skille, AuD Audiology Hearing Aids Children and Adults Kathy Harlan, MA Audiology
Hearing Aids Children and Adults
Sofiya Analaryan, RPE/AuD Audiology
Hearing Aids Children and Adults
Chief Medical Officer & Executive VP UnitedHealth Group 701 Pennsylvania Avenue, Suite 200 Washington, DC 20004 Dear Dr. Meadows: I want to commend you and UnitedHealth Care for being the first health insurance company to acknowledge the pandemic of untreated hearing loss, and to enact a program to provide hearing aids to seniors. As you noted, approximately 10% of the US population has hearing loss, but only 20‐25% of those with hearing loss have been treated with hearing aids. The problem is going to escalate exponentially in the future since 10,000 baby boomers will turn 65 every day for the next 19 years and 3 months. Early identification and treatment of hearing loss is crucial since untreated hearing loss is associated with many adverse effects such as depression, anxiety, paranoia, dementia, and social withdrawal. In 1990, Cynthia Mulrow, MD and colleagues at the University of Texas in San Antonio, and the San Antonio Veterans Administration found that, “HEARING LOSS IS ASSOCIATED WITH IMPORTANT ADVERSE EFFECTS ON THE QUALITY OF LIFE OF ELDERLY PERSONS, EFFECTS WHICH ARE REVERSABLE WITH HEARING AIDS”. Furthermore, Dr. Mulrow and colleagues reported, “WE CONCLUDE THAT HEARING IMPAIRMENT IS ASSOCIATED WITH IMPORTANT ADVERSE EFFECTS ON THE QUALITY OF LIFE OF ELDERLY INDIVIDUALS, AND THESE EFFECTS ARE PERCEIVED AS SEVERE HANDICAPS EVEN BY INDIVIDUALS WITH ONLY MILD TO MODERATE DEGREES OF HEARING LOSS. “ With that being said, I want to caution you regarding providing hearing aids directly to enrollees. In the past, several noteworthy healthcare companies such as Bausch & Lomb and Johnson & Johnson have unsuccessfully tried providing hearing aids directly to the consumer. This is why the Better Hearing Institute in Washington, DC is warning consumers of the inherent risks associated with purchasing over‐the‐counter, one‐size‐fits‐all hearing aids instead of consulting a hearing healthcare professional.
PROUD MEMBER OF AUDNET – AMERICA’S AUDIOLOGY NETWORK
11645 WILSHIRE BLVD., STE 600, LOS ANGELES, CA 90025 (310) 477-5558 FAX (310) 477-7281
Furthermore, as a physician, you know that hearing loss may be a symptom of a serious and/or treatable medical condition. For this reason, all 50 states require that consumers use a credentialed hearing care professional to purchase and fit hearing aids. Dr. Sergei Kochkin, Executive Director of the Better Hearing Institute, says, “Today’s state‐of‐the‐art hearing aids should be programmed to the individual’s specific hearing loss requirements in order to provide good levels of benefit and customer satisfaction. The process requires a complete in‐person hearing assessment in a sound booth; the training and skills of a credentialed hearing healthcare professional in order to prescriptively fit the hearing aids using sophisticated computer programs; and appropriate in‐person follow‐up and counseling. This is not possible when consumers purchase one‐size‐fits‐all hearing aids over the internet or elsewhere.” Extensive research shows that individualized hearing health assessments and fittings programmed specific to the needs of the hearing aid user provide the best chance for optimal hearing enhancement and customer satisfaction. Using the current in‐person hearing healthcare model to dispense hearing aids, studies have shown that hearing aids have an 81% consumer satisfaction rating, which is a relatively high rating on par with cars and consumer electronics. So, I hope you will allow me to address some of the reasons that hearing aids direct to the consumer have failed in the past. First, cost is not the primary reason that seniors do not use hearing aids. Many countries in Europe provide free hearing aids as part of their comprehensive healthcare coverage to their citizens, but the hearing aid user rate is approximately the same as the US (See attached sales penetration differences in Europe). The main reason that individuals do not use hearing aids is stigma. Individuals with hearing loss believe that hearing aids reflect aging and handicap. In fact, in focus groups we conducted, individuals correlated hearing aids with death and dying. Thus, getting hearing aids meant you were admitting that you were ready to die. In light of this, it is apparent that we need a nation‐wide campaign to make wearing hearing aids as acceptable as glasses. Second, automated hearing tests that are self‐administered by a patient have not been found to be valid and reliable in many elderly individuals, even when done in a physician’s office. A company called Tympany manufactured a computerized piece of equipment called Otogram that many physicians used in their offices. However, Medicare and Medicaid did not mandate reimbursement for the test due to the validity and reliability of self‐administered hearing tests. One issue is that hearing thresholds are not accurate unless they are conducted in a sound proof booth. Background noise elevates hearing thresholds obtained without a sound proof booth, indicating a greater hearing loss than is actually present. This would also occur with the UHC program if patients are not tested in a sound proof booth, and instead patients tested themselves with a computer, cell phone, etc. Furthermore, you are dealing with an elderly population that will have difficulty understanding the task due to dementia, anxiety, and depression; will have difficulty performing the test since their responses may be slow; will have elevated hearing thresholds since they will not respond at their actual threshold (indicating greater hearing loss than actually exists); will have many false positives due to tinnitus that they think is the test pure tone, etc. In summary, testing protocols need to be modified for each individual by an experienced audiologist in order to obtain accurate thresholds from many elderly individuals. Without accurate hearing thresholds, you cannot program hearing aids for that individual. In addition, the audiologist needs to evaluate the speech understanding for each of the patients to determine whether the aided performance of the patient for speech understanding is optimal. In other words, if the patient can only understand 80% of words presented to him at an optimal intensity level under earphones, testing with the hearing aids on at a normal conversational level through speakers in a sound room should also provide 80% speech understanding.
Third, you cannot fit hearing aids accurately by only using pure tone thresholds. THERE ARE SEVERAL HEARING AID FORMULAS OR TARGETS THAT AUDIOLOGISTS USE AS A “STARTING POINT” TO “FIRST‐ FIT” HEARING AIDS. Audiologists put the pure tone thresholds of each ear for the patient into the manufacturers’ hearing aid fitting software of their computer, and the fitting software generates a frequency response in the hearing aid that the audiologist will then modify for the patient based on the patient’s complaints, wants and/or needs. Many experienced audiologists use their own targets or formulas based on the test results obtained and their experience. Dr. Mead Killion found, “Many hearing aids are programmed using the “First‐Fit” algorithms available in most fitting software (this is what will occur in the UHC program). The person programming the hearing aid often assumes that the First‐Fit option in the fitting software is faithful to the original fitting formula they select. This is a faulty assumption. Some First‐Fit algorithms are nearly exact, while others are not, with the result that patients are often left unable to hear soft sounds.” Frequently, the final frequency response and other parameters in the hearing aids do not resemble the “First Fit” chosen by the computer software in any way. One reason is that Keidser, et al. found that different manufacturers’ “First Fits” for the same hearing loss can vary as much as 30 dB depending on the manufacturers’ fitting formula chosen. This is a major problem since 6 dB is a doubling of sound pressure in the ear. In addition, the manufacturers’ hearing aid fitting software in no way ensures audibility of speech. This was confirmed by a 2009 Consumer Report on hearing aids that found that two‐thirds of the people who were evaluated by an audiologist for Consumer Reports were not fit correctly. Consumer Reports said this occurred since the hearing aid fitting was not validated and verified by Real Ear Measurements (a microphone in the ear canal that measures the frequency response and gain at the eardrum that then goes to the inner ear and brain). They found that the hearing aids amplified too little or too much! A second reason is that the underlying damage that occurs in the inner ear and auditory nerve is not readily apparent in a pure tone audiogram. Studies have shown that you can have normal pure tone thresholds, but up to 75% of the auditory nerve fibers can be missing. Therefore, with the same audiogram, a patient with only 10% of his auditory nerve fibers missing will require less gain than a patient with 75% missing. The patient with less nerve fibers will also perform poorer in background noise and have a poorer prognosis for speech understanding and performance for daily living activities. Harold Schuknecht, MD and colleagues at the Massachusetts Eye and Ear Infirmary at Harvard Medical School in the 1950’s examined over 12,000 temporal bones by light microscopy to determine where the damage occurred for patients with the same pure tone audiogram. He called this new graph a cytocochleogram. Dr. Schuknecht found that the pure tone threshold audiogram could look the same for patients with inner hair cell damage, outer hair cell damage, stria vascularis damage and/or neuronal damage. However, the patient’s speech understanding could vary dramatically depending on where the underlying structural damage occurred. So you say, what does this mean to me? Dr. Sumiko Goldbaum and Dr. Chris Halpin at the Massachusetts Eye and Ear Infirmary at Harvard Medical School based on their laboratory research and clinical work found, “Most patients needing intensive audiology services require an optimally fit hearing aid. Despite all efforts in the clinic and in the laboratory, the fitting of hearing aids remains a constant challenge for audiologists. Although engineers and manufacturers bring the many benefits of electronics to people with hearing loss, the direct application of an electronic solution to audiometric results does not adequately address the complexities of the performance of diseased ears. What is apparent with our current state of knowledge is that an audiogram does not simply reflect either disease in itself or a fractured frequency response, and, therefore, machines that directly compensate on the basis of data taken from audiograms do not always work well. This contributes to the generally low satisfaction with hearing aids. It takes an audiologist, using knowledge of the temporal bone, to add the much‐ needed physiological dimension to the fitting of hearing aids.”
Fourth, you need to understand physics, acoustics and psychoacoustics in fitting hearing aids. The pinna (outer ear) increases sounds in the 2000‐5000 Hz region by 10‐15 dB for most people. However, whenever you place an earmold or dome into the earcanal, you will have an insertion loss. In other words, you will lose some volume and alter the frequency response of the sound that reaches the inner ear. So if you put an open dome into the earcanal, you will have little insertion loss, but the low frequencies (1600 Hz and below) to the ear will be reduced by as much as 29 dB HL. Therefore, the audiologist must make an adjustment to the hearing aid for gain and frequency response in order to counteract this. If you use a closed dome, then more sound will stay in the ear, but the person may feel occluded (plugged), his voice will resonate (sound like he is talking with a plugged Eustachian tube), and he will have an unknown insertion loss of gain and frequency response. Once again the audiologist must make adjustments so the patient will tolerate wearing the hearing aid and hear optimally. There is no way to know apriori how a specific ear will act as far as insertion loss, etc . The only way you can measure precisely what is occurring in the ear of the patient is to put a microphone near the eardrum and to put calibrated speech spectrum stimuli in the ear and measure exactly how much gain is reaching the eardrum (and subsequently the inner ear) at each frequency. Audiologists call this Real Ear Measurements. If the frequency response and gain is not sufficient for audibility of all speech sounds, then the hearing aid frequency response is adjusted at the frequencies that require adjusting. You cannot just raise or lower overall gain. If you put in too much bass (low frequencies), the sounds will be too loud, and the patient will turn down the hearing aid volume thereby lowering the treble which is needed for speech clarity and understanding. HEARING AID FITTINGS REQUIRE REAL EAR MEASUREMENTS TO MAKE APPROPRIATE ADJUSTMENTS FOR LOUDNESS AND CLARITY. Fifth, to make matters more complicated, if you need a custom earmold since the person has a moderate hearing loss or greater, or a small, large or curved earcanal that can’t take stock earmolds or domes, you need to know acoustics and the exact hearing loss of the patient. Although audiologists have historically referred to the earpiece in the ear as an earmold, it is more properly referred to as an acoustic coupler since the response is effected by canal length, venting, and material. If you want to emphasize low frequencies, you will make the canal long, the canal bore small, use small vents, and use soft material like silicone. The reverse is true as well. If you want to increase high frequencies, make the canal length short, canal bore large, vent size large, and use hard lucite material. If you inappropriately keep too much sound in the ear, the occlusion effect can cause the sound pressure in the earanal to be 20‐30 dB greater than it should be making the patient’s own voice intolerably loud, even though other people’s voices are normal in volume. This is a real problem since only 6 dB is a doubling of sound pressure in the ear. Sixth, if you have been told that you can simply program a hearing aid based on a pure tone hearing test and just put it in the ear, the individual who told you this is either uneducated or not truthful. The average ear canal volume is around 2cc with a hearing aid in it. However, if you have a small ear and you put an earmold or dome into the earcanal and the earcanal volume now is only 1cc, then you double the sound pressure in the earcanal, and the hearing aid will sound very loud. Conversely, if you have a large earcanal and put an earmold or dome into the ear and the earcanal volume is 3cc, then you halve the sound pressure in the earcanal, and the hearing aid will sound very soft. In physics, this phenomenon is referred to as the Inverse Square Law. Thus, HEARING AID FITTINGS REQUIRE REAL EAR MEASUREMENTS TO MAKE APPROPRIATE ADJUSTMENTS FOR FREQUENCY RESPONSE AND GAIN. Seventh, hearing aids are not only adjusted for average sounds, they are also adjusted for soft sounds, and loud sounds. This requires Real Ear Measurements by the audiologist with the hearing aid in the patient’s ear measured at different intensity levels across all of the frequencies. The purpose of the test is to make soft sounds (45 dB) audible, average sounds (65 dB) comfortable, and loud sounds
(85 dB) tolerable. This is important, because if soft sounds are not audible, then the patient will turn up the volume to hear the soft sounds, and this will make the average and loud sounds too loud. If the loud sounds are set incorrectly, the patient will turn down the volume and won’t hear soft and average sounds loud enough. Thus, HEARING AID FITTINGS REQUIRE REAL EAR MEASUREMENTS TO MAKE APPROPRIATE ADJUSTMENTS FOR LOUDNESS AND CLARITY. Eighth, by the time a patient has a 35‐40 dB hearing loss, most of the outer hair cells are missing and the patient is unable to hear soft sounds and speech. This is a major problem since 80% of the efferent nerve fibers from the brain go to the outer hair cells and help to reduce background noise. Once these outer hair cells are gone, the patient will have difficulty separating speech from background noise. Thus, the patient will need hearing aids with directional microphone technology. The microphone in the front of a directional hearing aid is omni ‐directional and picks up sound and noise all around the patient. The one in the back of the hearing aid is directional and cancels noise by 50% or more from the sides of the patient and/or behind the patient. This allows the patient to hear and understand speech better in background noise. In order to determine how the patient performs in noise, the patient needs to be tested without hearing aids using a Speech In Noise Test, and then with the hearing aids on. The hearing aids need to be adjusted for maximum performance while the patient is wearing the hearing aids, and then the patient needs to be tested to confirm optimal performance in quiet and noise. Ninth, acoustic feedback occurs when sound from the hearing aid speaker in the ear escapes from the ear and goes into the microphone of the hearing aid. Even a pin hole leakage of sound in the fit of an earmold or dome can result in feedback. This causes that high pitch squeal that patients and everyone around them hate. The latest models of hearing aids have feedback management circuitry that reduces or eliminates acoustic feedback. However, the acoustic feedback system needs to be run with the hearing aid in the patient’s ear. Afterwards, the audiologist needs to check to see if the feedback is sufficiently reduced, or some further modification is required. Many times the frequencies in the 2500‐3500 Hz region need to be reduced slightly as well to reduce feedback. If this is not done, the patient cannot use a phone since feedback will occur when he puts the phone near his ear. Also, he will have problems when people hug him, when he wears a hat, etc. since this will cause feedback. Tenth, elderly patients have difficulty with memory, dexterity, vision, etc. In my 35 years as an audiologist, I can tell you I spend an inordinate amount of time showing patients how to change the battery, put the aid in the ear, take it out of the ear, clean the aid, adjust volume, change programs for different listening environments, etc. I also spend a lot of time counseling patients about realistic expectations based on their wants, needs, degree of hearing loss, and maximum speech understanding in quiet and noise. Eleventh, audiologists also have many assistive listening devices that help patients who have trouble with their cell phone or home phone, cannot understand television, cannot understand in church or movies or the theater, cannot understand in school or lectures, cannot understand in the car or noisy restaurants, etc. Audiologists can provide these assistive listening devices, but many assistive devices require specific makes and models of hearing aids in order to work. Twelfth, the Veterans Administration (VA) is the single largest purchaser of hearing aids. The VA fits and dispenses about 15% of all hearing aids sold in the US. Due to acoustic trauma, the number one medical condition that US armed forces acquire is tinnitus, and the second is hearing loss. The VA has conducted extensive evidence based practice studies to determine the most effective method of evaluating and managing hearing loss in our military forces, and determined that direct access to audiologists to do the testing and fitting of hearing aids was the most efficacious. If the VA had
determined that hiring technicians to test hearing, program hearing aids, and to dispense them like prescription medications was feasible, then the VA would have instituted this protocol. You may not know this, but the profession of audiology was actually started after World War II in order to evaluate and manage hearing loss for our hearing impaired armed forces. After 65+ years of treating our active soldiers and veterans, the VA has demonstrated that audiologists are the best trained professionals to dispense hearing aids. Thirteenth, I could go on and on about all of the nuances of the evaluation and management of patients with hearing loss, and specifically treating hearing loss with hearing aids and assistive listening devices. I cannot stress enough that treating hearing loss with hearing aids is analogous to hip replacements. There is a medical device component to both hearing aids and hip replacements. However, the most important part is the professional component of the surgeon and audiologist, not the device component. You can have the best hip in the world, but if the surgeon doesn’t put it in correctly, the patient is not going to walk. Conversely, you can have the best hearing aid in the world, but if the hearing evaluation is not accurate, the acoustic coupler is not correct, the hearing aid is not programmed correctly, the hearing aid performance is not verified by real ear testing in quiet and in noise, then the patient is not going to hear very well. As you know, only about 20‐25% of the people who need hearing aids use and wear them. There are another 12‐15% who have hearing aids but put them in the drawer. Based on my 35 years of experience, I fear that your well‐intended program will result in a lot of “in‐the‐drawer hearing aids”. Fourteenth, I encourage you to spend a day at an audiology clinic and see exactly what an audiologist does day‐in and day‐out in the evaluation and management of hearing loss in the elderly. I am under the impression that you believe that hearing aids are solely a product that can be dispensed like medication. However, nothing can be further from the truth. Hearing aids, as far as products are concerned, are more analogous to computers and cell phones. I doubt that you would want to send computers and cell phones in the mail to the elderly accompanied by only by a manual. I find that the elderly, in general, are technologically challenged. When my mother was 80, she did not want a cell phone because it was too complicated, and I had to set up the voice message on her answering machine. We gave my father‐in‐law a computer when he was 70, and he never uses it at all. His younger wife does, and so does his teenage daughter. His daughter and wife have tried to show him how to use the computer to pick‐up and send e‐mails, and to surf the net, but he says it is too complicated. This is a common scenario in my practice, and my office is in an affluent, highly educated area of Los Angeles. In closing, I think it is admirable that you and United Health Care want to institute a program to provide better hearing to your enrollees. However, the program you plan to institute has been unsuccessfully attempted many times in the past. I’m certain that you and United Health Care want your enrollees to use and be happy with the value added hearing aid benefit that you have afforded them. In order to ensure a successful program, I encourage you to meet with Therese Walden, AuD, President of the American Academy of Audiology (800‐222‐2336) to develop a program that will include the 11, 000 American Academy of Audiology members in all 50 states to help your enrollees acquire optimal hearing. As a teacher, when I finish a topic, I always leave my students with a quote so that they will remember what to do when they face a similar situation in the future. In regards to UHC’s proposed hearing aid program, I am reminded of quotes by Sir Winston Churchill and Albert Einstein. Churchill said,” Those who fail to learn from history are doomed to repeat it. Einstein said, “Insanity is doing the same thing over and over again and expecting different results.”
Thank you for your time and consideration. If you have any questions, please feel free to call. I would be happy to meet with you in person to discuss this matter. I would also be happy to set up a time for you to visit an audiology clinic in Washington, DC, or the city of your choice. Sincerely, Gregory Frazer, PhD., AuD 310‐477‐5558 Adjunct Professor San Diego State University/UCSD AuD Program Clinical Adjunct Professor University of Texas at Dallas Adjunct Professor A T Still University
