BREAKING NEWS: US Senators Warren and Grassley to Introduce “Over-the-Counter Hearing Aid Act of 2016”

Grassley, Warren Introduce Bill to Increase Pressure on FDA to Issue Final OTC Hearing Aid Rule
November 7, 2016

WASHINGTON, DC — Prominent US Senators, Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), announced today that they will introduce the Over-the-Counter Hearing Aid Act of 2016 when the US Senate returns to session.

Citing recommendations from the recent PCAST and NAS reports on hearing aid accessibility and affordability, the bipartisan legislation would make certain types of hearing aids available over the counter (OTC) and “remove unnecessary and burdensome requirements that currently create barriers for consumers who could benefit from hearing aids”.


Major Changes Proposed for Hearing Aid Industry


According to the press release, the Over-the-Counter Hearing Aid Act of 2016 would allow hearing aids that are “intended to be used by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. Furthermore, it would also eliminate the requirement that people get a medical evaluation or sign a waiver in order to obtain hearing aids.

The bill also requests the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).


grassley hearing aid bill“If you can buy non-prescription reading glasses over the counter, it makes sense that you should be able to buy basic, safe hearing aids, too.  The goal is that by making more products more easily available to consumers, competition will increase and lead to lower costs.  More consumer choice and convenience are what we want to accomplish with this legislation.

This won’t affect those who need professional expertise to be fitted for hearing aids or have hearing aids implanted.  The over-the-counter option is for those who would benefit from a simpler device.”

Sen. Chuck Grassley (R-Iowa)


Over-the-Counter Hearing Aid Act of 2016


According to a Fact Sheet released by the Senator’s office, the proposed legislation seeks to make hearing aids more accessible and affordable for millions of Americans with hearing loss by taking the following steps:


  1. Make hearing aids intended to be used by adults to compensate for mild to moderate hearing impairment available over the counter.
  2. Remove requirement that consumers obtain a medical evaluation or sign a waiver of that examination in order to obtain an OTC hearing aid.
  3. Require the FDA to issue regulations containing safety and labeling requirements for new category of OTC hearing aids.
  4. Require the FDA to update its draft guidance on Personal Sound Amplification Products (PSAPs), which are consumer electronics products that may use similar technology to hearing aids, but are intended for use by individuals with normal hearing.



***Please stay tuned for more on this developing story!

  1. The nature of hearing loss should be diagnosed, and the prescription should be necessary . Thereafter that patient can go wherever the want to get a device.

    The extent of hearing loss, and its cognitive component should be verified with speech audiometry. If the speech score is below 100% (normal), then it would be clear that the patient would need hearing aids of a higher sophistication. The element of brain function affected due to hearing loss is a critical component of how the patient is likely to be affected in the coming years.

  2. Over the counter hearing aids should not be used. Hearing loss is a medical disorder and should be treated by qualified professionals. Hearing loss whether it’s “mild” or “moderate” is unique to each person and should be treated as such. Over-amplification can increase hearing loss over time. With over the counter hearing aids it is very easy to over-amplify sounds because increasing volume for high frequencies sounds, such as “th” and “s” and “sh” will also amplify low frequency sounds and cause hearing loss where there was none before.

    Without medical clearance associated illnesses could be missed. When a person visits an audiologist for hearing loss each ear is tested independently. If the hearing capability between ears is different then the person may have a medical disorder, not just hearing loss.

    Furthermore, a person with normal hearing in the cochlea (the hearing organ) but still experiences hearing loss will not know they have normal hearing in the cochlea. Over the counter hearing aids are not the solution, but if over the counter hearing aids are available it is likely they will not seek the proper medical care.

    These are just a few reasons why over the counter hearing aids should not be manufactured. For more information about the difference between hearing aids and over the counter listening devices aka over the counter hearing aids please reach out to your local audiologist. Hearing is unique and associated to overall health more than the general population truly knows.

  3. I agree whole heartily with the last post. Not to mention for those people that have tried hearing aids and are unhappy with the sound of the hearing aids will continue to be unhappy with the hearing aids because Audiologist are not going to want to service the hearing aids purchased elsewhere. We work to provide the best care possible for our patients by listening to complaints, making changes, and really help to improve the patient’s quality of life. Hearing aids are not a one fits all device. They are medical devices that need to be serviced and purchased from a licensed Audiologist. Audiologists are people who truly care for our patients and want them to be happy and involved in those activities that they once really struggled in. Over the counter hearing aids are not going to be a good fit as the previous person posted. They will under amplify in some areas and under amplify in others. If someone is not doing a hearing test how will the person know that they fit in the “mild” or the “moderate” hearing range. Over the counter hearing aids will be a disservice to the people we help and work for. Over the counter hearing aids are a disgrace!!! Vote this down!! Talk to your state representatives!!! You don’t go to the drugstore to have dentures fit or a tooth filled right? Then don’t go to the drugstore for a one size fits some hearing aid!!! We all know how those one size fits some deals work!!! THEY JUST DON’T!!!!

  4. You know, dentures are really expensive. We should remove dentists from the equation and just make them over the counter. That way more people would benefit from dentures! I mean, why should those be personalized to fit your mouth? One size fits all should be plenty good enough!

    Pacemakers too! Those are super duper expensive! Why can’t we get those over the counter? Why aren’t all medical devices over the counter do it yourself propositions? It would totally lower all the costs and more people would get help without all those pesky regulations saying doctors are the only ones who should fit pacemakers and other medical devices. Consumers should just be able to self diagnose and self treat everything!

    When I put it that way, does it make sense? Why do they use glasses as an analogy for hearing aids so much? Hearing and vision are two vastly different senses and require vastly different technology to correct it and come with vastly different challenges. Glasses don’t require batteries, don’t require programming, don’t require maintenance of itty bitty parts and components, and are vastly simpler and easier to handle. Hearing aids are tiny, consumers cannot adequately clean them, ears get plugged with wax, ears get infected. What’s a consumer to do when their OTC hearing aid gets clogged or breaks? Guess it’s get a new one? Who even knows.

    Furthermore, look at Japan where OTC hearing aids are widely available. They have even worse hearing aid uptake than the US! So obviously cost and OTC availability are the only reasons why hearing aids aren’t in everyone’s ears that need them. (rolls eyes)

    I’m hearing impaired and a hearing specialist. This is the wrong move for patients. Why don’t they force insurance companies to cover the appropriate hearing health care including all the testing, fitting and maintenance services that are truly required for better hearing along with the devices? THAT would be the real solution, but I guess we’re not into real solutions in the US. We like shortcuts and bandaids as long as they’re cheap.

  5. I agree with the responses above. I work with students who have hearing loss. I have about 10 students with mild to moderate hearing loss. There is no way I can interchange their hearing aids as they are so varied! It’s the same for adults – each hearing loss is different and needs to assessed by a qualified audiologist and be fitted with hearing aids by a qualified audiologist so they can get optimum listening value from them.

  6. Obviously most of you do not have hearing problem or you are rich. If companies could develop OTC programmable hearing aids then you could adjust the like adjusting an equalizer on your stereo to your needs. I assume most of you must work in an office that sells hearing aids and afraid of loosing your jobs. Myself for one, have a profound hearing loss and have no financial backing to afford $6000.00 for a pair of hearing aids. If on the other hand, you actually have a hearing loss and you feel you need to be fitted and checked by an audiologist, and have $6000.00 you wish to spend you can do so. But don’t interfere in my personal options to get something I might be ably to afford that could drastically improve my life. What is wrong with giving people options and increasing competition and therefore lowering prices?

  7. Go to Costco. 1/2 the price for similar quality. Tested and fit by someone who is trained.

  8. i agree with no otc hearing aids but they need to do have to be rich to afford them.. when i need them i wont be able to get them as i am on disability. insurance should cover these and also dental for the prices people pay for it

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