PCAST Issues Eye-Opening Report, HIA Strongly Opposes

October 25, 2015

On Friday, October 23rd the President’s Council of Advisors on Science and Technology (PCAST) released a report entitled, Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. After several public meeting held over the past year, which were reported  previously by HHTM, PCAST members voted and approved the report. It will be published in the near future.

Hearing Loss is a Major Health Problem


The overarching concern expressed by PCAST, according to the teleconference on October 23 was “an urgent need to improve hearing for older adults.” This finding is based on data presented to PCAST indicating hearing loss in older adults in a major health and social problem, growing in importance with the aging population, and, further, few adults with hearing loss are using hearing aids.

The PCAST report outlines several barriers related to the relatively low uptake of hearing aids today, including

  • high cost
  • lack of insurance coverage
  • social stigma
  • complex consumer regulations & restrictions
  • lack of engagement by health providers.


Recommendations for a Market Ripe for Change


A key consideration of the PCAST committee was that new technology is advancing rapidly, making the current marketplaces for hearing care service delivery ripe for change. PCAST provided three goals for their recommendations:

  1. Reduce costs for consumers
  2. Increase the number of people who use hearing technology
  3. Stimulate innovation and technology development

To achieve these goals, PCAST recommended the following, taken directly from their document issued on 10-23:

  1. Open the Market. FDA should designate as a distinct category “basic” hearing aids—non-surgical, air-conduction hearing aids intended to address normal, bilateral, gradual onset, mild-to-moderate age-related hearing loss—and adopt distinct rules for such devices.

a. FDA should approve this class of hearing aids for over-the-counter (OTC) sale, without the requirement for consultation with a credentialed dispenser. FDA should also approve for OTC sale, both in stores and on-line, tests appropriate to the self-fitting and adjustment of these OTC devices by the end user. Such hearing treatments and tests meet the FDA requirements for OTC products, which are that consumers should be able to self-diagnose, self-treat, and self-monitor the condition.

b. FDA should exempt this class of hearing aids from QSR regulation in its present form and substitute compliance with standards for product quality and recordkeeping appropriate for the consumer-electronics industry, developed by an appropriate third-party organization and approved by FDA. Similar actions should be taken with respect to diagnostic hearing tests used to dispense and fit Class I hearing aids.

  1. Open the Market by allowing the FDA to withdraw its draft guidance of November 7, 2013 on Personal Sound Amplification Products (PSAPs)a.  PSAPs should be broadly defined as devices for discretionary consumer use that are intended to augment, improve, or extend the sense of hearing in individuals.b.  PSAP manufacturers should continue to be able to make truthful claims about their use in normal settings.c.  FDA should not require language in PSAP labeling or advertising that excludes their use by individuals with age-related hearing loss no worse than mild-to-moderate.
  1. Enable more Consumer Choice. Analogously to its “Eyeglass Rule,” FTC should require audiologists and hearing-aid dispensers who perform standard diagnostic hearing tests and hearing aid fittings to provide the customer with a copy of their audiogram and the programmable audio profile for a hearing aid at no additional cost and in a form that can be used by other dispensers and by hearing-aid vendors.

a.  Also analogously, the availability of a hearing test and fitting must not be conditioned on any agreement to purchase goods or additional services from the provider of the test.

  1. Enable more Consumer Choice. Similarly in effect to its “Contact Lens Rule,” FTC should define a process by which patients may authorize hearing aid vendors (in-state or out-of-state) to obtain a copy of their hearing test results and programmable audio profile from any audiologist or hearing-aid dispenser who performs such a test, and it should require that the testers furnish such results at no additional cost.

a.  While FTC has the authority to issue new regulations of this sort, action can be accelerated and strengthened by legislative direction. We urge the Administration to work with Congress to initiate bipartisan legislation that would instruct FTC to issue a rule for hearing aids and PSAPs similar to the eyeglass and contact lens rules.


In summary, PCAST believes that a few key changes (recommendations 1-4 above) in Federal regulations could accelerate needed changes in uptake of hearing care by more adults.

Later that day, the Hearing Instrument Association (HIA) issued a strongly words statement opposing the PCAST recommendation for many reasons outlined in their recent report.



  1. What I object to is selling the completely in the canal (CIC) hearing aids to seniors with poor eyesight and arthritic fingers. A personal amplifier would help them engage in one-on-one conversations similar to a Pocket Talker Ultra. Most seniors do not want to advertise their hearing loss even though everyone around them know they are losing their hearing or have dementia. One reason they are labeled with dementia is because they cannot hear well.

  2. It is about time to address the exorbitant cost of hearing aids. The people who are screaming about making available a reasonably priced option for the consumer are the very same ones who have been gouging desperate people for thousands and thousands of dollars over the cost of instruments. Hearing “health providers” have been taking their cue from the soul less Pharmaceutical Industry. Enough already. Break their stranglehold on the market. People have a right to hear at a fair, decent and reasonable price.

  3. This is a win for consumers! We must ensure unscrupulous vendors do not flood the market to take advantage of vulnerable situations. Enforce Telecoil inclusion in psaps and basic hearing aids so consumers can access publically mandated assistive listening systems.
    How will this impact current legislative proposals? Hear Act or Hearing Aid Tax credit?

  4. The proposal for OTC Hearing Aids and the rationale around it is so misguided and uninformed as an answer to any public health need that it almost defies honest discussion. Take the high cost of hearing aids argument–you are not paying a high cost for hearing aids when you buy hearing aids–you are paying for the professional that is heavily invested in your better hearing health. Their expertise is saving you from unwanted acoustic trauma, abnormal loudness growth, and worsened tinnitus (by overfitting), and under-correction of specified frequencies and other needs (by underfitting). Hasn’t 40 years of research, lecture, and publishing relative to the psychosocial and psychological barriers to hearing correction resolved the “cost/benefit” conundrum? Hearing impaired individuals will not wear hearing aids that are given to them free of charge if they do not recognize their impairment. And they, left to their own devices, will usually be the last to know the seriousness or existence of their impairment. I urge any doubters of this to read my book on Hearing Instrument Counseling (IHIS, 1999). To summarize, hearing aids are not costly, just the care is and for good reason, and hearing impaired individuals need the expertise of the community hearing health care team to assure they do not damage their hearing while enjoying the greatest benefit of today’s technology. More over, the comparison of OTC hearing aids to reading glasses is a misnomer in many respects, too numerous to list here. They are not comparable and the potential for damage too great to promote this proposal as a way to get more seniors into hearing aids. They have to first be tested and receive professional guidance and encouragement. If it is as simple as the proponents present here, we can dissolve all licensing boards and laws, and return to the dark ages where few will benefit from better hearing simply because they know not that they are in need of anything.

  5. At one time a stigma was attached to wearing eyeglasses. I cried when I had to wear glasses at the age of 17. Over the years I watched older people refuse to wear hearing aids, struggling to hear, or dropping out socially due to their deafness. Now that I’m older and have hearing loss due to age and Menieres, I’m delighted to have my hearing aids. They aren’t perfect but I’m enabled to function in society. Most of my friends also have aids and we have no hesitation to take them out to show to one another. I sincerely hope that hearing aids will no longer be stigmatized and become as widely accepted as eyeglasses. However, there is the problem of cost for many people. Mine were $4,000, even though they are not anywhere near top-of-the-line aids.

  6. @ Dr. Chartrand. No one is arguing that hearing aids are not a good and necessary thing. But, I suspect that your income entitles you to feel that a “mere” $4,000 hit to the pocket is a small nuisance. For too many of us it is an impossible price. The audiologists and manufacturers have conspired for years to maintain an exclusive “Country Club” marketing model. Pay the elite price for admission or tough luck, you are shut out. The problem is that it is one of the very few products where there is a range available from deluxe to basic. I had a job where I knew the wholesale price of the instruments. It was shocking how inexpensive a basic digital hearing aid was. However, the audiologists always managed to pad the cost with sometimes THOUSANDS of dollars of service fees so that all the hearing aids from basic to deluxe had very little difference in cost. It is immoral and unethical behavior on the level of the Pharmaceutical thug Martin Shkreli. I would love to see an anti trust investigation on the Manufacturers and Audiology Professionals. The prices have been fixed for years. They are welcome to sell as many super deluxe models as they wish, but for pete’s sake they should also be required to offer basic hearing aids at a fair and economical price.

  7. We know that 48 millions of Americans have a hearing loss (or more). We know that with any technologies (including hearing aids, implants, listening systems) many or most need and use and want Quality Captioning, not only on TV, but also on all media, Internet videos, webinars, and Live Events also, of many sorts. Is Captioning a technology too? Yes, in part, and it’s a “universal” resource. We’re not aware of audiologists who talk about captioning, though some may. Access and inclusion please – we’re worth it. CCACaptioning.org (consumers, volunteer advocates).

  8. Hearing aids can not be sold OTC too much is involved in fitting and learning to use them
    Professional help and guidance . My husband’s hearing aids cost $4000.00 and they are not the best on the market which they told us would be $7000.00 which is too high a price for most seniors to have to pay. People of all ages, everyone should be able to communicate with family and friends. Hearing loss is a serious health issue and mental issue.

  9. While I agree with most of the stated goals of the PCAST, especially the need to make hearing aids more affordable, I also agree that the precautionary tone of the HIA’s report must be taken seriously before the FDA acts to deregulate PSAPs. A factor that is being largely overlooked in both the PCAST and HIA reports is the need for objective studies of the effectiveness of PSAPs, or OTC hearing aids, in meeting the needs of the hearing impaired. If a hearing device is not effective for the consumer, its acquisition leads to dissatisfaction and rejection. In June 2008, my co-author Susanna Callaway and I reported a study in the American Journal of Audiology titled, An electroacoustic analysis of over-the-counter hearing aids. Allow me to paraphrase the abstract from that study. Its purpose was to determine whether 11 OTC hearing devices have the flexibility to provide adequate gain and output for 3 common hearing loss configurations: a mild-to-moderate high-frequency hearing loss; a moderate to moderately severe, sloping hearing loss; and a flat moderate hearing loss. The 11 devices were separated into 2 price groups: a low-range group (<$100) consisting of 8 hearing devices and a midrange group ($100–$500) consisting of 3 hearing devices. Gain and output were prescribed for the 3 hearing loss configurations using a National Acoustic Laboratories (NAL) prescriptive procedure that is commonly used in the U.S. and other countries to determine what gain and output levels best match the needs of hearing-impaired individuals. Low-range hearing devices were measured electroacoustically, and technical specifications available from the distributors were used as the source of electroacoustic information for the midrange hearing devices. Although the 3 midrange hearing devices met gain and output targets to a greater extent than the low-range devices, each had relatively high internal noise levels. All low-range devices could be classified as special-purpose hearing aids with low-frequency emphasis, had high internal noise levels, and potentially posed a residual hearing safety hazard. Our overall findings led us to conclude that the low-range OTC devices were electroacoustically inadequate to meet the needs of the hearing impaired, regardless of hearing loss configuration. We suggested that midrange OTC devices are arguably a reasonable solution for the cost-conscious consumer who cannot afford professional audiologic rehabilitation, but only if considered an interim step in the rehabilitation process.

  10. Change IS needed. Consumers deserve a range of viable options, from do-it-yourself OTC products to products prescribed by an audiologist who adheres to best practices and who understands each person’s hearing needs – at home, in the workplace and in the community. With advancements in engineering, we are closing in on the day when an individual will be able to wear a Swiss Army Knife-like devices that does everything from wirelessly connecting to a smart phone, to whispering a person’s pulse-rate into his or her ear, to functions as a hearing aid or even an ear protection device. These “hearables” will also be able to pick up wireless signals from TVs and movie theater sound tracks. And they will become so prolific that everyone will be wearing them and it will be hard to tell who has hearing loss and who does not. So, opening the market to innovation is a good thing. But I agree. Caution/prudence is needed. Despite the future availability of a multitude of hearing enhancement options at varying price points, many people will continue to need the guidance of an audiologist who can, using best practices, properly assess hearing loss and receptive communication needs and devise a solution that meets those needs within the context of the patient’s unique lifestyle. This audiologist will function like a “hearing coach”, providing an expert, empathetic guiding hand as the consumer learns various strategies to live life fully-engaged, despite hearing loss. I personally know many audiologists who welcome this change because it will allow us to show to consumers our true value as hearing health care professionals.

Leave a Reply