What is the current status of the bill to allow over-the-counter purchase of hearing aids?

What is the current status of the bill to allow over-the-counter purchase of hearing aids?

The OTC hearing aid provision was part of the FDA Reauthorization Act of 2017 which was signed into law August 18 by President Trump. FDA now has 3 years to develop safety and labeling regulations for the new OTC category of hearing aids for adults with mild-to-moderate hearing loss.

Basically, this will allow PSAPs (which are already available) to be called “hearing aids” and be regulated by the FDA. This would allow Bose, Sony, etc. to create “hearing aids” that are no better than current PSAPs, but with a new marketing designation. It would also allow hearing aid manufacturers to produce low-end devices in this category.

Whether this is good for consumers or is just government-supported marketing by big consumer electronics companies is an open question.

I am very skeptical that this will be a boon for potential hearing aid customers.

This is incorrect. A new distinct category of devices will be created through the rulemaking process, with the only difference between OTC aids and traditional aids being the output limits, labeling requirements, etc. The PSAP category will likely still exist to include those devices that are intended for situational hearing problems (not hearing loss related). Hearing Review sums it up best:

… the bill includes provisions related to the safety and efficacy of OTC hearing aids, output limits, and labeling, as well as a provision that would preempt all state laws that restrict the sale of OTC hearing aids. It would also require FDA to decide upon and establish the regulatory structure for OTC hearing aids, including whether 510(k) clearance is required before an OTC hearing aid is cleared for sale. FDA is also directed in the bill to update and finalize its 2013 Personal Sound Amplification Product (PSAP) Guidance to clarify which products on the basis of claims, marketing, labeling or advertising meet the definition of a hearing aid.

I need to respond to this too:

This is pure speculation. The OTC category isn’t even defined yet, and we have no idea what companies like Bose and Sony may bring to market, much less what hearing aid companies may release for OTC sale. I expect the OTC market to be highly competitive, and fully expect the big 6 hearing aid companies to bring their best signal processing algorithms, etc, to the table to compete with other established consumer electronic brands. Resound and William Demant have already signaled that they may enter OTC, and with remote adjustments already available in some Resound and Signia models, there is no reason to think that trained technicians at these companies won’t be able to work with consumers at home with their flagship technologies.

Re the OTC bill, see full language here:

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I appreciate your opinion, but i disagree about the outcome. As you say, however, it’s impossible to say what the FDA will come up with. I doubt it will end up being very good for consumers, but we’ll see.

Also, certain online sellers already provide professional in-home adjustments on almost all modern hearing aids. And it can be done in real-time, rather than the clumsy means that, for example, Resound uses.

I’m not sure where I suggested it would be good for consumers… I think it’s more complicated than that… just my predictions about the direction the technology will take… you can disagree about that if you want :wink:

“Remote care” technology is in its infancy. I wouldn’t base my predictions about the future on any current technology.

I appreciate all the very prompt responses. I am a 25-year user of hearing aids, and am always wondering why they are so expensive…6 or so times more costly than the most powerful and versatile cell phones, and maybe 3 times the price of the most powerful personal computers.

I am guessing that this will energize the creation and application of some startling new disruptive technologies that will, at some point, have significant benefits for consumers like myself. Or, maybe I am just engaging in wishful thinking.

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A change in business models will affect prices more than any technological changes, I suspect. New channels of distribution, perhaps OTC hearing aids, etc. Already, you can find brand-name hearing aids at half of full retail price.

Found this response to somebody asking a question on Quora about what happened to the OTC Hearing aid act.

Justin Brader
, Have programmed every major brand of hearing aids.

Answered 7h ago

It is still in the works. But you have to understand what it is. It will not lower the price of hearing aids. All it will do is create a new class of devices that are essentially in between personal amplifiers and hearing aids. But they will be allowed to market them as if they are the same as actual hearing aids. It will simply muddy the waters further for the average consumer and damage the reputation of hearing aids due to high expectations of an inferior product.