The 21st Show

What you should know if you’re considering OTC hearing aids

Chelle Wyatt holds her hearing aid Friday, April 15, 2022, in Salt Lake City. People with hearing loss have adopted technology to navigate the world, especially as hearing aids are expensive and inaccessible to many.

Chelle Wyatt holds her hearing aid Friday, April 15, 2022, in Salt Lake City. People with hearing loss have adopted technology to navigate the world, especially as hearing aids are expensive and inaccessible to many. (AP Photo/Rick Bowmer)

For the first time, over-the-counter hearing aids have become available across the U.S., following a rule change by the FDA in August. It allows for hearing aids to be sold in retail stores, without the need for buyers to see an audiologist first. While some experts are calling it a win for those with hearing loss, others say buyers will need to be a little more cautious about what kind of hearing aid they buy.


Sadie Braun 
Audiologist and Clinical Assistant Professor, University of Illinois Urbana-Champaign College of Applied Health Sciences Department of Speech and Hearing Science

Barbara Kelley 
Executive Director, Hearing Loss Association of America

Marietta Coufal 
President, Illinois Association of the Deaf - Illini Chapter


Brian Mackey: from Illinois public media, this is the 21st show. I'm Brian Mackey last week for the first time over the counter hearing aids became available across the US that followed a rule change by the Federal Food and Drug Administration back in August. It allows for hearing aids to be sold in retail stores without the need for buyers to first see an audiologist. While some experts are calling it a win for those with hearing loss. There's caution buyers to beware as not all hearing aids are created equal. Joining us now to talk about the rule change and whether an over the counter hearing aid might be right for you is Sadie Braun, an audiologist and clinical assistant professor at the University of Illinois, Urbana Champaign City. Welcome to the 21st show. Thanks for being here.

Sadie: Thanks so much for having me.

Brian Mackey: Also with us is Barbara Kelly, the executive director of the Hearing Loss Association of America, a nonprofit that represents consumers with hearing loss. Barbara, welcome to the 21st show to you as well.

Barbara Kelly: Thank you, Brian.

Brian Mackey: And also with us is Marietta Coufal She's the president of the Illini Chapter of the Illinois Association of the Deaf. She was born deaf and has profound hearing loss and we're communicating with her on the show today through a sign language interpreter. Marina, welcome to the 21st show to you.

Marietta: Hi, thank you. Thanks, Brian, for having me.

Brian: Listeners, we also want to invite you to join our conversation today at 800-222-9455. You can also tweet us at 21st show we want to know will over the counter hearing aids be something that you're looking at maybe it could change your life or someone you know who has hearing loss but has been put off by the high price tag on hearing aids up until this point, maybe you just have some questions about the ruling and what it might mean for you and yours. Let us know 800-222-9455 is the number to call 800-222-9455 or tweet us at 21st show at @21stShow. Sadie, I want to begin with you. And so let's just start with the basics. For listeners who might not be familiar with a hearing aid. How does it work?

Sadie: Yeah, that's a great question, Brian. So a hearing aid is an electronic medical device. And all hearing aids work by picking up sound with a microphone and taking that sound and then processing it internally within the hearing aid. It's processed through a sound processor that really filters the sound in ways that we want it to. And then an amplifier which amplifies sound, at different frequencies with varying amounts depending on the individual's hearing loss. And then last, we have a receiver and the hearing aid takes that processed digital sound. And then in the receiver, it changes that back into an acoustic signal that is then delivered to the ear for an individual to hear.

Brian: So a microphone and a speaker but a lot more going on in between those two points, basically.

Sadie: That's absolutely right. Yep. There's a lot that goes on within that little body of the hearing aid.

Brian: All right. So Barbara, let me ask you, then what? From a from the person standpoint, what signs should someone be looking for, if they you know, to know whether they might need a hearing aid?

Barbara: Well, I think it's important to note that this over the counter hearing aid market is just for adults only with mild to moderate hearing loss. So let's talk about some of the signs. If someone has a mild hearing loss or mild to moderate, it could be you're having a problem hearing on the phone because you can't see the visual cues. And sometimes Brian people say you know, I can hear but I can understand, of course turning up the volume on the TV or radio, background noise is a problem. And if your family or friends are telling you you have a hearing loss, I would sit up and take notice. So those are some of the signs of a mild to moderate hearing loss. And of course, you could also have a complete auudiological evaluation with somebody like Sadie and then you would know for sure

Brian: absolutely. How common is it for people to ignore those signs, right? Their son, their daughter, they keep elbowing them and nudging them to to get checked out. Do most people do that? Or do most people?

Barbara: I think generally they do. You know, if you have a mild hearing loss, you can generally get along pretty well and you compensate and hearing losses is insidious as it just creeps up really slowly. So, you know, it's not like, you know, some people do have sudden hearing loss, they wake up and it's sudden and they should get to a doctor but most hearing loss is progressive and sneaks up so people compensate. And that's why we're thinking, you know, the over the counter market might be for somebody who needs a little situational hearing, maybe at work in a conference room. with somebody who might not be willing to take that step to wear hearing aids seven days a week, many hours a day,

Brian: Marietta so far, I want to bring you into the conversation now. Can you tell us a little bit about your experience with hearing loss?

Marietta: Okay, so for for myself, I'm born born deaf. I've been using hearing aids since I was three. So it's really I'm really dependent on lip reading, using sign language quite often. And I do agree with the over the counter for, you know, mild to moderate hearing loss for people that don't maybe have maybe a large hearing deficits. And, and really, it's, it's good for the short term use not long term that wouldn't be set up just for everyone.

Brian: How important are hearing aids into your overall ability to understand and make your way in the world?

Marietta: Well, really, I guess for me the hearing aid, I guess, you know, it does help me when I am talking with people speaking with them directly. I think it it helps with understanding people and liberating an association with a hearing aid, it's better than without going without the hearing aid. So it doesn't help me on the phone. But I do still need it. Speaking face to face with people directly. But if someone's behind me, that doesn't help me at all.

Brian: Interesting. Well, let me take a moment to remind listeners, this is the 21st show. I'm Brian Mackey. We're speaking with Marietta Coufal, president of the Illini Chapter of the Illinois Association of the Deaf and we're speaking to her through sign language interpreter. Also Barbara Kelly, director of the Hearing Loss Association of America, and Sadie Braun, an audiologist and professor at the University of Illinois, Urbana Champaign, and we're talking about the relatively recent change from the federal government, the FDA, that hearing aids can now be purchased over the counter, you no longer need to have that appointment with an audiologist. A lot of advocates say this is going to really lower the price and expand access. But there are some caveats, some important caveats we need to talk to you talk about I should say, so Sadie I want to come back to you. Can you just explain what is in the FDA is rule change? How did this come about? What does it mean?

Sadie: Yeah, that's a great question. So the FDA has been working on these rules for quite some time now. And the main component is really about allowing more accessibility to people who otherwise would not have the ability to have hearing aids. So whether that's because of cost reasons. That's one big reason people do not pursue hearing aids, when they need them, whether it's because of lack of transportation, to get to an appointment, or lack of access to visit with a health care provider. These are all barriers in our traditional model of hearing aid service delivery. So what these over the counter rules have been developed to do is to break down some of those barriers, and to allow the 75 to 80% of people who do not take advantage of hearing aids, or do not use hearing aids, but could benefit from that, to give those people more access to hearing technology. So this has really been in the works for a long time. And now I'm glad that these rules have been finalized. And we can start to see what some of these products are and what some of the effects will be.

Brian: Well, what in I'm glad you brought up that statistic, because I'd seen that elsewhere that it's something like 30 something million American adults have mild to moderate hearing loss, but only one in five has had a hearing aid, what what makes a one of these are the are the over the counter hearing aid is going to be different in some way from the ones that are going to be medically prescribed from here on out.

Sadie: So there will be differences. And it's hard to say right now what all the differences will be I do know generally that there will be some features that will be available in prescription hearing aids that are not going to be available in over the counter hearing aids. But just like prescription hearing aids, over the counter hearing aids will have a variety of features. And that will depend largely on the price of the device. So there will be some of them that are only you know, a couple $100 for a pair. And those will tend to be the devices that are less featured up and then the ones that are more expensive 1000 pair and hire will tend to be the ones that have a larger feature set for individuals to use.

Brian: And Barbara maybe you can talk about some of those features because I my own grandfather who's deceased now. But when he started with a hearing aid 30 years ago, the family story is he went to get it. And they all went out to lunch afterwards, and somebody took a pickle a bite out of a pickle on a table nearby and at about knocked him off his chair, because it wasn't very good at differentiating the sounds. By the end of his life, he had one that if he had a smartphone, he could have paired it with his smartphone and used it that way. Talk about some of those features that are there.

Barbara: Isn't that great? You said at the beginning, you know, not all hearing aids are created equal. But I have to say that not all hearing loss is created equal as well. You know, it's so individual what might work for me and be the best hearing aid might not work for you. But some of the features, you know, that people should look for in an over the counter. First of all, is look for return policy, the FDA does not mandate that, but when the manufactures have them, they'll put that on there. And Sadie described, how we hear and how hearing aids works. And whether it's a prescription hearing aid through the traditional model of care, or whether it's the over the counter hearing aid, it takes a little bit of time to adjust to a hearing aid because all of a sudden, like your grandfather, the pickle crunch is amplified. And so is every other sounds your brain has to adopt to this. So people should make sure that there's a return policy, some of the hearing aids might not look like traditional hearing aids, they might be ear buds, that's adjusted with an app on your phone where you can raise the volume of the speaker and lower the background noise. So that's important, too, that people should look for, you know, do you have to use a smartphone with this device. And you know, most of us are real comfortable fiddling with apps. But maybe some seniors don't have a smartphone or aren't comfortable with apps. So you know what's on the market in this first week is interesting. But it's really going to be how the market plays out over the next couple of years, we can see electronic companies getting into space and innovation happening. And that's what we're excited to see. And we also really have to educate consumers. We want to know what the uptake is going to be that are these barriers broken down. And you know, hearing health is so much a part of overall health and wellness. You know, how we relate to people how we work, how we live is through communication. So if we can get people to take that first step sooner, rather than later, after their hearing loss has progressed. I think that's the good thing about over the counter hearing aids.

Brian: Marietta Coufal, can I ask you, How expensive are the hearing aids you have been using? As you said, since you were three years old?

Marietta: Oh, you know what, they are quite expensive. I think the first one. I mean, gosh, I don't know the first one my my parents bought the first one I was three years old, it was quite a large hearing aid it was on it was on my on a chain on my chest going up to my ears, like, you know, it was quite cumbersome. When I was a teenager, it then changed to a hearing aid over my ear. So through technology has changed. But really to be honest with with my youth, I'm not quite sure how much they were at that time. But I think my most recent one was about $3,000. So it's quite expensive. The insurance did not cover it. So that's the one negative part about the hearing aids today. And really, you know, what really helps with me, is the lip reading and understanding communication more with with the people I'm seeing I do hear better with the hearing aid. I can hear things that go on inside the house, a dog barking. So that does help in addition, but really, you know, it doesn't help the frustration. It doesn't help if there's someone behind me talking to me, I won't I won't understand them.

Brian: Are you hopeful that the new over the counter hearing aids might lower the price overall and for the ones that you will I presume still need to get from an audiologist?

Marietta: No. The over the counter doesn't doesn't help me at all the price change, it doesn't help me a lot. I've got significant hearing loss. This won't help me whatsoever. So it won't hear like the it won't change the price at all. So I think the one thing is I don't believe it will help people with profound hearing loss and you know, it might help the people in the mid range but not people with profound hearing loss.

Brian: Interesting. Sadie, what do you think about that? So this is a, you know, the idea was to reduce prices. But maybe that's only on the margins or maybe or it's not on the margins. I don't know how I want to say that exactly. But you get where I'm going.

Sadie: Yeah, yeah. So I think that the over the counter devices themselves, yes, they will be significantly less expensive than your traditional hearing aids. But I do want to point out that the reason for that and the reason I don't necessarily expect prescription hearing aid prices to change very much is that the a lot of the price difference that you see between the two is that professional service component. So the help that you get from the audiologist in selecting the hearing aid in setting it up for use, programming it the first time you use it, and then the verification measures and validation measures that we complete in the office to really make sure that those hearing aids are doing what they need to be doing in that individuals ears. And then of course,

Brian: then I'm sorry, we need to take a break. We're going to continue this conversation. When we come back. I do want to remind listeners, if you have questions about the new FDA policy, maybe you want to know if you if over the counter hearing aids might be for you. 800-222-9455 is the number to join our conversation. We're going to pick this right up after a short break. It's the 21st show, stay with us.

Brian: It's the 21st show. I'm Brian Mackey, we're talking about the new FDA rules. Well, I guess they're a couple of months old now. But the new policy change has gone into effect allowing for the purchase of over the counter hearing aids. This is intended to help people with mild or moderate hearing loss. It's not intended to replace a visit with an audiologist and a prescription hearing aid for people with profound hearing loss. We're talking about this policy with Barbara Kelly, who's executive director of the Hearing Loss Association of America, Marietta Coufal, is president of the Illini Chapter of the Illinois Association of the Deaf. She was born deaf and has profound hearing loss and using hearing aids and she was three we're communicating on the show with her through an interpreter today. And Sadie Braun is an audiologist and clinical assistant professor at the University of Illinois, Urbana Champaign 800-222-9455. If you have a question or want to join our conversation, that's 800-222-9455. Or you can always email us talk at 21st talk at two one St. City. I'm sorry, I had to rudely interrupt you because we're on a fixed clock in this program, but you were saying right before the break.

Sadie: Yeah, thanks. So I was just alluding to the fact that there are lots of different roles that the audiologist plays in fitting somebody properly with prescription hearing aids. And that is a reason that the prices for traditional prescription hearing aids may not be reduced significantly. With over the counter hearing aids. This is because of that lengthy follow up process that really goes from when the patient walks in the door for the first assessment all the way through their journey with hearing aids and coming into the office on a regular basis. So that professional component is really what patients or individuals are not going to have when they go the over the counter hearing aid route.

Brian: Well, that's a good segway to a listener question we got, who is from Tanya, who or I should say a comment from a listener left a voicemail for us. Let's take a listen to that.

Tonya: I'm very concerned about people like him and his daughter, who's now an audiologist being really economically disadvantaged by this decision. I don't know what the solution is, I think for mild hearing loss, I can see why. You know, people who don't have Medicare, for instance, can really benefit from this. But on the other hand, I also see the advantage of going to somebody who knows what they're doing and being tested every so often and making the necessary adjustments.

Brian: Well, that's a good pivot point. I think Sadie did let me ask you what, what does it consist of, to go visit an audiologist? What does that process like? And are you concerned for people in your profession with this change?

Sadie: Yeah, so when a patient comes in to see me, we start really with a comprehensive needs assessment. So we take a comprehensive case history, we talk about what their hearing needs are and the difficulties they're experiencing. Then we do a comprehensive hearing test. We check their ears to make sure we don't see anything that could be medically going on with their ears. And then we do that for diagnostic evaluation, afterwards, we have a pretty lengthy discussion about hearing aid options where we're educating the patient on what their options are. And then we make a selection. If the patient is ready to move forward between what we're recommending to the patient and what the patient desires, we kind of come to a common ground there. We order hearing aids for the individual. And then a couple of weeks later, we see them back to fit them and do some of those verification measures and counseling them how to use the devices, et cetera.

Brian: Barbara, I wanted to ask you about how this no, this is going to affect people with insurance. Maybe. I know a lot of hearing aids are not covered by people's insurance. Some people who have federal government insurance, maybe they are if you were in the military, for example, my grandfather got his through the Veterans Administration, or at least learned partway through that he could I think I once heard a government officials say that hearing aids were one of the most expensive line items in the Veterans Administration federally. How does all this play out financially for people?

Barbara: I'm sure, first of all, Medicare does not cover hearing aids. Believe it or not, it covers audio logical valuation, if referred, but not hearing aids. And our organization has fought long and hard for affordable and accessible hearing health care, Medicare coverage being one on them. One of them, the VA is the largest purchaser of hearing aids in the country. And yes, that's when the government system does cover hearing aids. Some of the Blue Cross Blue shield's have an insurance coverage and some Medicare Advantage Programs have hearing aid coverage. But you know, that's a supplement people pay for and not always is their full coverage with those services that Sadie's talking about which are really important. I think it's also important to know that it's not an either or situation. It's not either over the counter or seeing an audiologist, people can still see an audiologist find out get a hearing evaluation. And I've heard from some audiologists that they would be willing to help people with an over the counter for fee. Of course, this is when they would unbundle their prices, and some audiologist will cover over the counter. So, you know, I think Sadie talked about a needs assessment. And I think that, you know, we know when someone knows they have a hearing loss, it takes them five to seven years before they take that step to get a hearing aid. And so much can happen in there. And it's really important that if somebody gets used to amplification early on, even if it's situational hearing, and they're working with a hearing healthcare provider, that audiologist or hearing instrument specialist is very likely to have that person for a long time because most hearing loss is progressive. So this isn't an either or the traditional pathway to care is there through a hearing healthcare divided provider. This just opens up another pathway. Oh, it's probably also important to mention mentioned concerning Medicare, that cochlear implants are covered by Medicare and this is a device, it's when hearing aids no longer help somebody where speech does not become understandable. This is where some people get cochlear implants and Medicare covers that, but it is not covered hearing aids. And as far as the cost, I think we're gonna have to see the market play out in the over the counter space and see what innovation happens. But Sadie is absolutely correct. You know, the audiologist model of care is bundled in with the services and the hearing aid is often 1/3 of the cost of those important services. So this just opens up consumer choice. Access. You know, most audiologists are centered around urban areas. And you know, some people don't have access. So overall, it's a good step. Are there risks, I'm sure would somebody be under amplified or over amplified? That could happen? But we think that the benefits outweigh the risk and getting people to start considering hearing health, a habit in the mainstream, where we're going to see these in stores and people start considering Hearing Health, the way they consider their blood pressure, their weight their cholesterol.

Brian: Marietta so far, I want to ask you about the insurance question about this. You mentioned that your hearing aids are not covered by insurance, which is I think probably surprising to a lot of people because for example, if you have somebody has vision, if somebody has vision problems, they can get glasses covered often. Is there advocacy in the community to try and get insurance to cover these devices.

Marietta: You're right about the glass Yeah, we're trying to get that changed. We're trying to get that changed. I think now. Insurance covers children, but not adults. I'd have to double check on the age on that one. But I know that insurance does cover hearing aids for children. But but it's a struggle. It's quite a struggle.

Brian: What has been your experience with audiologists and the system in general? In in navigating it?

Marietta: Really, it's been it's been a wonderful experience with the audiologist. In regards to the deep discussions, we have the testing the evaluation, I know I've, I've always had an audiologist throughout my whole life, for years and years and years. So I know for myself, I've got you know, an assessment that I've had throughout my whole life to see the change of my hearing, and I know the consistency and I know why it's gone up, gone down. So I can see why I need a hearing aid and what kind of hearing aid I need. So as of today, the all adult audiologist has helped me program my hearing aid and I go every single year, I just want to make sure that that hearing aid matches my needs. And also, you know, changing my ear mold as well.

Brian: Sadie are there potential scams to be on the lookout for things that maybe seem like hearing aids but are not when people are doing shopping over the counter?

Sadie: Yeah, people should be aware when they're looking for products over the counter that these devices have to be labeled specifically on the packaging as over the counter hearing aids. I say that because there are also what some people may have heard of as P saps personal sound amplifying products that are meant for amplifying sounds in certain environments, such as birdwatching or hunting, but they are not hearing aids, they are not intended to treat hearing loss. And they are not regulated by the FDA. So those devices have been on the market for a long time now. And I want people to know that when they go out to the stores or online, they may be seeing devices that look like over the counter hearing aids. But if they're not specifically marked as over the counter hearing aids, they may not be so they should be aware of that.

Brian: Anything else people should be looking out for when they're making considerations as to whether to do this?

Sadie: Yeah, definitely. One big thing that I want to amplify is that there are certain medical conditions that can cause hearing loss that individuals need to be on the lookout for there is if you've had a sudden change in your hearing, you absolutely need to be seen by either an ear, nose and throat doctor, an audiologist or both. If you have a tinnitus or ringing in one ear, and not the other, that would be considered abnormal. And that's when we really want to make sure that people go to see an audiologist or a hearing professional to make sure that there's not something more significant going on. In worst case scenarios, there could be something like an acoustic neuroma that could be causing that unilateral or one side of ringing or one sided hearing loss. So these are things that need to be looked at by a medical professional, and definitely before hearing aids are considered.

Brian: We're coming to the end of our time together about four minutes left in our conversation. And Barbara Kelly with the Hearing Loss Association of America, I want to sort of maybe wrap up by asking you what other changes would you like to see from maybe in terms of government policy or other policies as it relates to hearing loss?

Barbara: Well, I think Medicare coverage is critical. And we we worked really long on this. And we were so close in the build back better act, we actually advocated and got language in there for the coverage of hearing aids and services for people with moderate to severe hearing loss. And then of course, we know what happened with the build back better act, it died and then came back as the inflation Reduction Act. And that benefit was stripped. But we will have another strategy. There will be the right time. There'll be the right Congress. You know, when Medicare was passed in 1965, it specifically excluded hearing aids. So we do need an act of Congress to put it back in and back then, in 1965. We didn't know what we knew now about hearing loss, that there are comorbidities there's associated with falls that's the number one reason that seniors go to the emergency room. You know, depression, anxiety, people isolate and withdraw with hearing loss. These are all really Important things. So you know buying an over the counter it for some people, adults only, you know there's good coverage in most states for children, they have it a lot better than adults do when it comes to affording hearing aids. But getting an over counter, you know, might get people to take that first step. And we do have some shopping tips and guides, those red flag warnings that Sadie talked about on our website at hearing If people need more information to help them. Sure thing.

Brian: And Marietta so far, how about you same question, what other government policy changes would you like to see as it relates to people who are deaf or have profound hearing loss?

Marietta: Well, what I would like to see is that hearing aids are actually covered through medical Medicare insurance. Also, you know, I just want to make sure that, you know, everyone's covered, it's the right that everyone has, I want to see them all covered.

Brian: And Sadie the final final question to you same thing, what, what is the next frontier in policy here with regard to hearing aids, or anything in hearing loss, really?

Sadie: Yeah, so I really think that we need to pay close attention to the effects of over the counter hearing aid rules over the course of the next year and several years. And I really hope that we can make adjustments to these models based on what we see. And based on where we see we need some extra support for individuals. So I really hope that we can use this as a jumping off point and then make further changes down the road.

Brian: Okay, I want to thank my guests, they have been Sadie Braun, who is an audiologist and clinical assistant professor at the University of Illinois, Urbana Champaign in the College of Applied Health Sciences in the Department of Speech and Hearing science also Barbara Kelly, Executive Director at the Hearing Loss Association of America, and Marietta Coufal, President of the Illinois Association of the deafs, Illini Chapter, Marietta, Barbara and Sadie, thank you so much for being with us today on the 21st show to talk about this issue.

Brian: And we're going to take a break when we come back we're going to be talking about the LED it's become an essential component of modern life. You can find it in everything from light bulbs to smartphone. The man who invented it, Nick Holonyak Jr. was born in Illinois spent 50 years at the U of I in Urbana. He died last month at the age of 93. We'll be remembering his life and work with one of his longtime colleagues at the University of Illinois. That's coming up after a short break. This is the 21st show stay with us.

Speaker 6: And we're going to take a break when we come back we're going to be talking about the LED it's become an essential component of modern life. You can find it in everything from light bulbs to smartphone. The man who invented it, Nick Holonyak Jr. was born in Illinois spent 50 years at the U of I in Urbana. He died last month at the age of 93. We'll be remembering his life and work with one of his longtime colleagues at the University of Illinois. That's coming up after a short break. This is the 21st show stay with us.