Are Over-The-Counter Hearing Aids in our Future?

Which would you pick?. BSIP/UIG/Getty Images

The President’s Council of Advisors on Science and Technology (PCAST) recently issued their report on “Aging America and Hearing Loss: Imperative of Improved Technologies.” Let’s take a closer look at the report’s recommendations and what this means for people with hearing loss.

Before we get started, it is important to note that there is not an audiologist or ear specialist on this council. A list of council members and their qualifications can be found here.

Recommendation 1: The Food and Drug Administration (FDA) should approve a “basic” class of hearing aids for over the counter sale.

This recommendation would remove the need for consultation with a medical provider before a consumer purchases a hearing device and sticks it in his or her ear. Is this really in the consumer’s best interest? Hearing loss can be caused by ear wax, ear infections, foreign bodies in the ear canal, middle ear growths called cholesteatomas, noise exposure, viral infection, autoimmune inner ear disease – just to name a few. By taking away the requirement to see a professional for a hearing evaluation, it places the burden of responsibility on the consumer to determine whether or not to seek advice about their hearing loss. Many consumers are not educated about the types of hearing loss that can be medically treated or should be medically treated to prevent permanent loss.

PCAST would like to see many choices of these over the counter hearing aids available at the pharmacy, online, or in retail stores.

Recommendation 2: The FDA should withdraw its 2013 guidelines on Personal Sound Amplification Products (PSAPs).

The issue here is that PSAP manufacturers want to make claims about how their products work, but the FDA guidelines would forbid those claims in order to prevent consumers from thinking these products are hearing aids.

Keep in mind that PSAPs are not hearing aids and the FDA guidelines are to prevent the PSAP manufacturers from misleading the public.

Recommendation 3 and 4: The Federal Trade Commission (FTC) should require that audiologists and hearing aid dispensers provide a copy of hearing testing and any hearing aid fitting information to the customer at no additional charge.

Under The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy rule, you already have the right (with a few exceptions, such as psychotherapy notes) to view and receive a copy of your own medical record – even if you have not paid for your services. A provider can charge a reasonable fee for making copies for you.

What did PCAST get right?

I agree with PCAST’s findings that age-related hearing loss is a national problem. They clearly spell out how issues such as social isolation, depression, dementia, falls, and lack of physical activity may be helped by improving hearing. They also note that only 15%-30% of Americans with hearing loss seek help in the form of hearing aids.

What did PCAST get wrong?

I disagree with their assersion that cost is the largest barrier to people using hearing aids. If we look at England and Wales (with a government health care system that pays for hearing aids) we see a very similar percentage of people who choose to use hearing aids – and these are people who are not paying for the hearing aids!

According to Frank Lin, M.D. ,Ph.D. from Johns Hopkins University, the overall percentage of people with hearing loss in England and Wales who use hearing aids is 17.3%. The United States overall percentage is 14.2%. Obviously, cost is not the largest barrier.

PCAST goes on to discuss that there is a need for better technology and more fashionable choices. Hearing aid companies focus on making their technology small, comfortable, and attractive. The technology is compatible with remote microphones and smart phone apps. As an audiologist who works with patients every day, most patients come in and just want a hearing aid to do it’s job without them having to fuss with it.

The Bottom Line.

While I commend PCAST for taking the implications of untreated hearing loss very seriously and recognizing it as a national problem, their recommendations fall short and serve to underscore that there is a lot about treating hearing loss that is not understood well, even by a panel of presidential advisors. I would encourage PCAST to work with the American Academy of Audiology and practicing audiologists to understand better the problems faced by consumers and the audiologists serving those consumers, and learn about the history of what has been tried to figure out where we need to go in the future.


President’s Council of Advisors on Science and Technology (PCAST) Public Meeting Transcript (9/18/2015). Retrieved 11/03/2015 from

PCAST members (n.d.). The White House. Retrieved 11/03/2015 from

Aging America & Hearing Loss: Imperative of Improved Hearing Technologies (10/2015). Retrieved 11/03/2015 from

Johnson, J., Xu, J., Breitbart, D., and Cox, R. (2015). Laboratory Comparison of PSAPs and Hearing Aids. Refereed poster presented at the Annual Meeting of the American Auditory Society, Scottsdale, AZ. Retrieved 11/03/2015 from

Your Medical Records. U.S. Department of Health & Human Services. Retrieved 11/10/2015 from

Lin, Frank (2015). Hearing Loss in Older Adults: A Public Health Perspective.  Presented to the NC American Academy of Audiology Conference, Wilmington, NC. Retrieved 11/10/2015 from

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