FDA Eliminates Hearing Aid Medical Clearance Regulation – Effective Immediately

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December 7, 2016

WASHINGTON, D.C. — Today during the National Academies of Science, Engineering and Medicine Dissemination Meeting, Hearing Health Care for Adults: Priorities for Improving Access and Affordability, Eric Mann, Chief, Ear, Nose and Throat Devices Branch of the U.S. Food & Drug Administration (FDA) announced that it does not intend to enforce the requirement for adults to obtain a medical evaluation before obtaining most hearing aids. This guidance is effective immediately.  As many know, the majority of individuals waive this requirement prior to purchasing hearing aids.

In addition, the FDA announced its continued commitment to the possible creation of a category of over-the-counter (OTC) hearing aids. The rapidly aging population,  and both the low uptake & high retail price of hearing aids were cited by the FDA as reasons new, lower cost products  are needed. These types are new products are thought by the FDA and others to create more consumer choice and foster greater competition and innovative among manufacturers. The FDA per today’s press release reaffirmed it is committed to seeking additional public input before proposing a new category of OTC devices.

Robert Califf, MD

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourages innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf in the FDA press release.  


“The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”  –Robert Califf, FDA Commissioner


In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) issued recommendations intended to facilitate hearing aid device innovation, and improve affordability and patient access. And, this past June the National Academies of Sciences, Engineering and Medicine (NAS) published a comprehensive study examining the affordability and accessibility of hearing care for adults.

Over the past 15 months two organizations, PCAST and NAS, have cited FDA regulations regarding conditions for sale as a potential barrier to availability and accessibility of hearing aids. Both groups concluded that the regulation was providing little to no meaningful benefit to patients. As hearing care professionals know, since the early 1970s – and until today – the FDA regulation required all prospective hearing aid users obtained a medical evaluation by a licensed physician (or sign a waiver if 18 or older) prior to purchasing hearing aids.

According to today’s FDA press release, under the new guidance, the FDA will continue to enforce the medical evaluation requirement for prospective hearing aid users under 18. Under the FDA’s hearing aid regulations, hearing aid labeling must include information about medical conditions that should be evaluated by a licensed physician. In addition, the FDA requires that information and instructions about hearing aids be provided to consumers before any purchase from a licensed audiologist or hearing aid dispenser.


Guidance Effective Immediately


Since today’s guidance is “Immediately in Effect,” it is implemented without prior public comment “because it presents a less burdensome policy that is consistent with public health.” In their press release the FDA did say the public can still comment on the guidance, and it will consider all comments received and revise the guidance document as appropriate.

Hearing News will continue to report on the reactions of all key stakeholders to this regulation change.


*title image courtesy trendkite


  1. We have established our new practice with this as a given, so now let’s see how well Best Buy can service cerumen laden hearing devices and how long the customer service lines in the store can really get. In the end, this will serve to put a realistic value on care and diagnostics versus something the consumer can pull out of a box and stick in her or his ear. They seem to think reading glasses and hearing aids do the same thing. They are going to find out its not even close.

    1. I’ll be curious to find out if this is the case. With the way medicine is trending (concierge, tele-medicine, etc.) it feels like OTC could disrupt the Audiology market quite a bit.

  2. I’ve been a strong advocate of the medical clearance regulation to ensure individuals were clear of any medical issues before wearing hearing aid. (To address any condition that may worsen if ear canal is closed up w/ hearing aid / ear mold.)

  3. So are these OTC devices hearing aids or PSA (personal sound amplifiers) because there is a difference and I don’t think the general public is aware of the difference.

  4. I applaud the new FDA guidance document that they now recognize the medical requirement is a potential barrier to availability and accessibility of hearing aids. Audiologists have long argued that we can be effective point-of-entry into the hearing healthcare system and do not need physician oversight to recommend, and dispense, air conduction hearing aids. The evidence is that audiologists do an outstanding job of identifying medical necessity and appropriately referring for medical care. There is no public safety issue hear and it is heartening to see the FDA respond favorably to Recommendation #3 of the Hearing Health Care for Adults report from NASEM.

    1. Victor, nice to see your positive endorsement. You have always been a progressive thinker and I admired your work together with fellow audiologist Michael Nilsson when we were all part of Sonic Innovations family. We at BionicSound Inc., are doing some interesting work on Neurally Networked Hearing Aids which will certainly fall within the ambit of Audiologists.

  5. There is a lot of work that goes into patient care, programming, and maintenance of hearing devices. This is a huge mistake. OTC aids could deter many from getting real hearing devices real care and could possibly damage ones hearing further (if not waste consumers money). There was a reason these devices were not OTC to begin with. hearing is a delicate thing and already many people are not seeking the correct medical care for hearing loss as it is.

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