OTC Hearing Aids – Consumer Perspective on the FDA Issuing Final Regulations

otc hearing aids consumer opinion
August 29, 2022

On August 16, 2022, the FDA issued its landmark ‘final rule’ to establish a new category of over-the-counter (OTC) hearing aids in the United States. This will now enable consumers with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by a hearing professional.

In this special episode we bring the opinions of four hearing health advocates on what OTC means for consumers and how they anticipate the new OTC hearing aid market will develop over time:

  1. Barbara Kelley
  2. Shari Eberts
  3. Gael Hannan
  4. Andy Bellavia

We also sought out opinions from professionals and from the hearing device industry, which can be viewed here:

Full Episode Transcript

Dave Kemp 0:10
On August 16 2022, the FDA issued its final ruling on the guidelines surrounding over the counter hearing aids. So here at This Week in Hearing, we’ve gathered a variety of different opinions from folks working in and around the hearing industry to weigh in on this historic ruling that has been years in the making enjoy.

Barbara Kelley 0:35
Here at the Hearing Loss Association of America, we are really positive about the FDA opening this new category of over the counter hearing aids for adults with self perceived mild to moderate hearing loss. For many years, our organization has been advocating for accessible and affordable hearing health care. In 2016. HLAA was the only consumer group sponsor of the National Academies of Sciences, Engineering and Medicine report on affordable and accessible hearing health care for adults. Out of that study came many recommendations, but one recommended that the FDA open a new category of over the counter hearing devices for adults. And here we are with the final rules just being published. We know that many people don’t take that first step to paying attention to their hearing health or their hearing loss. Until sometimes it’s really progressed. And it’s disrupted their life, their work life, their family life. So if we can get people to take that first step, sooner rather than later, that’s a really good thing. The over the counter is just a new avenue, a new pathway to hearing health, in addition to the traditional model of care, which is seeing an audiologist or hearing instrument specialist. Now we have a tip sheet on our website at hearingloss.org/otc. Because we’re getting many questions of what to expect, who this is for, how can I tell if I have a mild to moderate hearing loss or if I need to see a hearing health care provider. So we want to be a resource for people, you know, navigating that world of hearing loss is murky enough sometimes, because we all know that when you put a hearing aid in your ear, it needs some adjustment time. And it depends, you know, there’s no one size fits all, for hearing loss, everybody’s hearing loss is different. And as we hear from everybody, there’s no such thing as a small hearing loss. And a great thing about these over the counter products is I think people who just want some situational hearing, people who might not be ready to take that step to wear a hearing aid 24/7 or during the whole day, might need it just in specific situations. For some hearing enhancement, say it’s around a conference table at work, or in a noisy restaurant or maybe even at a family gathering. So we know what happens when people don’t treat their hearing loss. And also, my personal hope is by seeing these devices more in the main screen, you know, everybody’s putting things in their ears nowadays, why not put something in your ear to help with your hearing. So maybe seeing this devices more mainstream will reduce the stigma. Now, that is our hope here at HLAA. And we just want to educate consumers, they especially should look for things like return policies, because we know that you have to really try something out. And it might not work the first time out. Or you might need to try another product or if your hearing loss is progressed enough, you might need to see a hearing health care provider. So having the return policy is really important. And the FDA has left these regulations up to the states and the manufacturer. But they did say that if a manufacturer has a return policy, it’ll be right on the box. And if they don’t have a return policy, there’ll be nothing on the box. We also advocated for that if you need something else to use with this over the counter device like a smartphone, that that should be labeled clearly on the box, especially for seniors who might not feel comfortable fiddling with a smartphone or might not even have one. So we’re very optimistic. I think it’s going to be really interesting to see What the market bears. It’ll be interesting to see the uptake will people adopt a hearing device sooner rather than later and see some technology innovations, of course on October 17, when we see devices, you know, I don’t think every device that’s going to come down the road will be there. But I think we can look forward with optimism to this new market opening. Thank you for letting me talk today. And we are here at the Hearing Loss Association of America for people with hearing loss who wants to use technology to stay in the hearing world.

Shari Eberts 5:48
As a person with hearing loss, I am very excited about the prospect for OTC hearing aids. And with the final rule now in place, we may even see devices on shelves in the fall. OTC hearing aids probably won’t work for me because my hearing loss is too severe. Although they might make terrific backup devices in case my normal pair break down for any reason. But while they’re not right for me now, they might have come in very handy at the start of my hearing loss journey. So I first noticed my hearing loss in my mid 20s. And at the start, it was mild. I first noticed it when I was in business school and I was having trouble hearing in class. I was highly stigmatized by my hearing loss because I have watched my father hide his whole his own hearing loss for years. But I went to see an audiologist anyway, because I needed help hearing in class. Unfortunately, I really got no help at that appointment. After my hearing was tested, I was told that my hearing loss was mild, and that it was too slight to do anything about it so that I was supposed to monitor my hearing. And then when it got worse to come back, which gave me the perfect excuse to deny it and ignore it for many, many years, which I did. This was almost 30 years ago. But I’m not sure that my experience will be that different today. There’s still not that many options for people with situational, mild hearing loss. And the solutions that do exist are pretty hard to find because there are very few audiologists that work with patients of this type. So what a person searched online, or how would they know the seller was reputable or the device safe? And how would people compare models if each one was sold through a different website, OTC hearing aids are going to change all that. Soon, people with mild to moderate hearing loss will have many safe and affordable options to choose from, and they’ll be able to compare them one against the other in real time at a store near them. I know Walgreens CVS and even BestBuy have already announced plans to sell OTC hearing aids for my 26 year old self, that would have made all the difference at the start of my hearing loss journey, allowing me to deal with my situational needs rather than go without which is what I ended up doing. And for the millions of Americans with age related hearing loss, which can often start mild to moderate, this is a game changer. The lower cost is also a big positive, it’s pretty hard to justify hearing help to the tune of $6,000 a pair when you just need it sometimes, OTC hearing aids are a great way to meet consumers where they are now. And once they get used to hearing well, they’re going to maybe trade up over time to prescription devices when they need them. I hope audiologists are really going to embrace these consumers at all stages of their journey. So let’s be clear. OTC hearing aids are not for everybody. And they don’t mean that audiologists are going away or that they’re any less important. But they do fill a missing piece of the hearing care puzzle, and one that I greatly needed way back when.

Gael Hannan 9:01
Hi, I’m Gael Hannan. And I just want to weigh in on the new over the counter program that’s starting. In many ways. I’m thrilled. This is a long overdue move. I have met in my years in working in hearing health advocacy. I’ve met so many people who’ve said I can’t afford a hearing aid. I don’t have the money for the devices that I need. But I’m saving up for it. And you’re not saving up there’s something you do for a new dress or maybe you you want a bigger house, having to save up for something as basic to our health and well being as hearing aids. That’s not right. They should be available to people so I applaud the lower cost that the OTC program will offer to people who need that. I do worry however, that At the hearing healthcare professional who has played such an important role in my life and really should have a role in anyone seeking better, better hearing that or hearing help, I worry that that role is being cut out. On the other hand, the hearing health industry must now rise to that challenge, and it will be interesting to see how that happens. I’m also a little you know, a little sad that this program is not yet available in Canada, but I guess it’s good for us to watch and see how it works out. So it is, with mixed feelings but mostly excitement to see the OTC at finally being introduced and being made available to to Americans who need it.

Andy Bellavia 10:54
I’m optimistic for what OTC will mean in longer term, but I don’t think the impact will be immediate, and the US and other economically developed countries. The low uptake of hearing care is the result of three factors, price or perceived price, access and stigma – OTC won’t help much with stigma because a person must still admit to themselves that they have hearing loss before they will explore OTC solutions. This will limit OTCs immediate impact. I do hope the wave of popular press articles and news reports that came with the final rule will build more awareness of the importance of treating one’s hearing loss. Unfortunately, I think the effect will be short lived and stigma will still be the main barrier to hearing care uptake, with or without OTC. Over time, younger people familiar with and comfortable wearing wireless earbuds may be more likely to do the homework in order an OTC device. There’s already precedent and the increasing popularity of earbuds that administer a hearing test to personalize the streaming music. But today, I don’t think the majority of people with untreated hearing loss will be comfortable choosing and fitting their own devices. Some blame for this rests with the FDA and their lax enforcement. potential users are inundated with ads for cheap. And I use air quotes here “hearing aids” that are ineffective at best and dangerous at worse. Unless the FDA reigns this in with the release of the OTC rule, the average consumer will continue to be confused and therefore hesitant to pick a device. But we’ll also start seeing a range of assisted care options. I am optimistic that some audiologists will actively promote hearing care across the whole spectrum of hearing loss, bringing people in sooner on their journey and providing appropriate devices. OTC will increase their pool of potential customers. There will also be channels of assisted care with lesser stigma. For example, at the Consumer Electronics chain Best Buy has already announced they will launch hearing care centers and hundreds of stores. There are also the big pharmacy chains which will greatly improve access to hearing care in rural areas. Both a big box stores and the pharmacies that are places people trust to advise them on purchases and care. Those stores will also provide a level of screening services which will improve outcomes. I believe those channels will both lower access and stigma barriers while offering only the better products that are appropriate for customers lifestyles, and level of hearing loss. The people who first consider hearing devices by visiting those retail outlets are not the ones likely to have otherwise booked an appointment with an audiologist. But if a person’s hearing test administered by those chains indicates more severe hearing loss. They may very well seek audiological care as a result. Those who are actually OTC appropriate and buy a device will begin their journey sooner. Either way, I think the advent of OTC will not have a negative impact on the overall audiologist profession, but will increase it over time. The wildcard is what the major consumer electronics brands will do. There are a variety of non hearing aid technologies available to improve the speech and noise problem, such as directional microphones and noise reduction. If one or more of the major brands offers and promotes these features in popular earbuds, people who bought them to listen to music are more likely to try out the hearing features. They will experience for the first time how a hearing device can improve their quality of life, and maybe more receptive to professional hearing care later on. I am hopeful that all this together will meaningfully increase the percentage of people who seek hearing care at all levels of hearing loss. So far, I’ve only spoken of the economically developed world and many developing countries there’s virtually no access to audiologist and the price of today’s prescription hearing aids is a real barrier. That is a whole different discussion. So I’ll just mention that as both self fitting devices and mobile screening tools advance Hearing Care could be cost effectively deployed to local health clinics where patients are assessed and devices self fit under the guidance of the healthcare provider. In the case of diagnostic tools I’ll cite hearX’s smartphone based yearning screener in otoscope. Mobile clinical devices offered by hearX and others can make effective hearing care more accessible on global basis. This that and will be the ultimate outcome of the final OTC rule, new channels, diagnostic tools and devices to address all three barriers to hearing care, stigma, access and price around the world.

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About the Panel

Shari Eberts is a passionate hearing health advocate and internationally recognized author and speaker on hearing loss issues. She is the founder of Living with Hearing Loss, a popular blog and online community for people with hearing loss, and an executive producer of We Hear You, an award-winning documentary about the hearing loss experience. Her book, Hear & Beyond: Live Skillfully with Hearing Loss, (co-authored with Gael Hannan) is the ultimate survival guide to living well with hearing loss. Shari has an adult-onset genetic hearing loss and hopes that by sharing her story, she will help others to live more peacefully with their own hearing issues. 


Gael Hannan is a writer, speaker and advocate on hearing loss issues. In addition to her weekly blog The Better Hearing Consumer, which has an international following, Gael wrote the acclaimed book “The Way I Hear It: A Life with Hearing Loss“. She is regularly invited to present her uniquely humorous and insightful work to appreciative audiences around the world. Gael has received many awards for her work, which includes advocacy for a more inclusive society for people with hearing loss. She lives with her husband on Vancouver Island, British Columbia, Canada.

Barbara Kelley is the Executive Director of the Hearing Loss Association of America (HLAA). Hired by Founder Rocky Stone in 1988, Barbara has been a part of the organization’s growth, serving as editor for the award-winning magazine for more than 28 years. Her position as editor allowed her to influence attitudes, establish lexicon, and give people credible, reliable and timely information, and support, through the printed word. She has also helped manage the office team, served as deputy executive director from 2008-2016, and worked on many of the HLAA programs.


Andrew Bellavia is the Dir. of Market Development for Knowles Corp, a leading acoustic solutions provider to the hearables, smart speaker, mobile, and IoT industries. He has been personally involved in supporting the development of many innovative hearable devices since the beginning with pioneers like Bragi and Nuheara. Andrew is also an advocate for the role technology can play in addressing hearing loss, and in the practical use cases for voice in the coming hearables revolution. When not in the office he can usually be found running the roads of N. Illinois, and until recently, the world, often photographing as he goes.

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