OTC Hearing Aids: Hearing Device Manufacturers Share Perspective on FDA’s Final Regulations

Dave Kemp 0:11
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.

Laurel Christensen 0:36
I’m Laurel Christensen, I’m the Chief audiology officer for GN Hearing, I was asked to answer some questions on the new OTC regulation. And so I will do that. Pardon me while I look down and and read the questions here. So what’s your overall take on the FDA OTC recommended guidelines? I would say my overall take on the guidelines is that I’m very happy that they’re out. This has been a long time in coming, lots of debate, lots of conferences leading up to them. And then once we got the proposed rule, there was over 1000 comments to the proposed rules. So I’m just glad that we see the final rule and then what the FDA will now stipulate for the product. I am extremely happy and we are is ReSound very happy to expand the market. There’s no doubt that having over the counter hearing aids available to all of those more than 50 million people who haven’t done anything about their hearing loss is a good thing. This is creating a new market. It’s a way to have hearing healthcare for many more people. And of course, you know, that’s what we’re all about is is bringing hearing to more people. So overall, very happy to see the OTC regulation come out. The second question is what are your thoughts on the electroacoustic output and gain maximum maximums as it relates to amplification? So you know, my thoughts on gain and output on the OTC regulation, the proposed rule had stated that there would be no gain limitations and that the output maximums would be 115 or 120 dB SPL for compression- input compression. I guess I think those numbers were a little high in the proposed rule. And I am definitely an advocate of having a gain maximum. However, the final rule has lowered the input compression number to 117 as the max output and for non input compression 111. So I definitely think this is good, I think that these numbers needed to come down. I, I wanted to gain limitation, I think from from the perspective of sound quality, and not having some, you know, linear peak clipping devices that aren’t going to sound very good on the market. I was hoping that a gain limitation might help with that a bit. But I think with the 111 on non input controlled compression, I think I think the FDA has made a pretty good decision there. And and I think we at ReSound are overall happy with that. So the next question is what if any foreseeable risks do you see with the legislation? So we don’t see any risks really, with the legislation… I mean, they’re the max outputs are within a good region. Now, I think we are, I was a little uncomfortable with 120 with a linear hearing aid out that could have put some output and gain into ears that I think would have been too high for mild to moderate hearing loss. But bringing it down to 117. I don’t I don’t think that there are risks there. I think the risks go more in in just who comes on the market. What these hearing aids are like- I do think it’s gonna be a little wild wild west out there, I think you’re gonna have some very good products on the market. We intend to put Jabra Enhance Plus on the market as an OTC product and it will be a great product, it sounds good. It has directionality. You know, it does the things that this population needs. But I think that I already see going into my own retail stores that it’s almost impossible for a consumer to choose what’s going to sound good, what’s going to be good. You know, hopefully these things will shake out over time and the remainder will be high quality amplification, because what I hate, you know, what I would hate to see is for consumers to get into have, you know amplification that isn’t as good as what they could get, and then think that’s what all amplification will bring, after trying to notice this product. So, you know, I think those are the risks. I also think, you know, I am an advocate of the hearing healthcare professional. And you’ll always do better with counseling and the advice of a hearing healthcare professional. Hopefully, this is the first step for these people that will ultimately get them in the door to a hearing healthcare professional. So, as you know, my conclusion is, I don’t think there’s a lot of risk here. Just some things I think to watch out for.

The fourth question that you wanted me to answer was, how do you see the overall market developing? Do you think OTC will expand the market? So, you know, what do I think about the overall market? My take and our take for ReSound is that it’s gonna be slow, there’s gonna be slow uptake, this is not going to be crystal clear to the average consumer what’s out there. And it’s going to take time for for people to try these products and to use them. So I think this is going to be very slow uptake in these products. But of course, I hope that a lot of people will get these high quality the higher quality products and get them on I. What we found with Jabra Enhance Plus is that the average user, we’ve had that out there with professional dispensing. The average user is 18 years younger than the average age of a first time hearing aid user today. So these are good things for everyone. overall health. I mean, we we know that there is a correlation between dementia and unaided hearing loss. So I think that we want to get people into hearing aids, we want to serve this unserved population. And I think this creates a whole new market for the this unserved population. And I think they will ultimately get into real sophisticated amplification in the future that will help them as their as the hearing loss progresses. The last question here, do you think this will have any significant impact on the existing prescriptive hearing aid market for those already getting hearing help from a professional, I don’t think this is going to have any impact on those that are already seeing a professional. You’re when you’re seeing a professional, you are in prescriptive hearing aids, hearing aids that have lots of good signal processing, it’s very customized for your hearing loss. You have programs that that steer when you move from a quiet environment to a noisy environment, they turn on directional microphones, and you have the counseling and the support of a hearing healthcare professional, which is is necessary, especially for people who have more hearing loss. So I don’t think current users I don’t think this is going to impact current users at all. And I also think that you know, this is going to be quite confusing to some especially elderly hearing impaired when it comes out and they will still go and seek the help of a professional rather than trying to figure out which OTC product on the market might be right for them. But overall, you know, my conclusion and the conclusion of GN Hearing is this is a good thing. We are excited to see these regulations. We’ve been waiting a long time we’ve worked hard on them. We’re excited to launch Jabra Enhance Plus in this OTC category to help more people. Thanks.

Gary Rosenblum 8:49
Hi, there Gary Rosenblum here, from Oticon, I hope you’re doing well. Thanks a lot for the opportunity to to weigh in on your questions. This is not a very formal video, I have a paper here with my notes. Wanted to get back to you and quit deadline, but I’m happy to do that. So thanks for the opportunity. Let’s let’s just jump in. First question was what’s your overall take on the FDA OTC recommended guidelines? The take is that they haven’t changed much since the draft guidelines. The one thing that obviously changed was the output level and that was good to see that the upper level dropped to 117 dB SPL. But overall we’re we’ve always been in favor of OTC and the guidelines. The rule in general will increase access for patients obviously, significant amount of mild and mild hearing loss sufferers out there and this is obviously geared towards them. So happy to see that this. This is finally being released and some of these patients will have an opportunity and more access to less expensive hearing aids. Second question, what are your thoughts on the electro acoustic output and gi maximums as relates to amplification for individuals with perceived mild to moderate hearing loss, the output maximum, as I said has been lowered to 117 dB- dB SPL lowering the maximum output was based on recommendations from knowledgeable professionals, as well as National Institute of Occupational Safety and Health. So that’s obviously a good thing. I’m very much in favor of a lower output maximum, as excessive output limits, increase the possibility of causing a noise induced hearing loss. The one challenge though, is there are no gain maximums, interesting. There are also no gain minimums, given that patients are filling themselves. Absence of both means, absence of both means that the gain could either be too low support a patient’s loss or much higher than is needed to support the loss itself. So some challenges there. Number three was what if any foreseeable risks do you see what the legislation there’s definitely risks to consumers? First of all, you know, if the patient doesn’t seek appropriate care, and they only use an over the counter device, but they feel satisfied with their over the counter device, are they doing what might be needed? Are they doing all they need to do to support whatever challenges they may have their hearings? So that’s obviously a concern. Lack of consumer protections is also another risk to consumers. The FDA felt like this was outside of their purview. Yes, a lot of retailers have very liberal return policies, but not necessarily always the case. And it’s important that consumers are protected. A lot of these consumers are people over 65 with fixed income, and you know, paying $500 for $1,000 at CVS or Walgreens, that’s a lot of money for them. And if they are not satisfied with this, they can be wasting a lot of money and a lot of their money could be could be lost as a result, risk to professionals. I think there’s a minimal risk there. They just need to be ready to answer a lot of questions, but I don’t really see very much risk. I don’t really see cannibalization effects happening, because really the market is different. You have OTC is really geared towards mild sufferers, and most of the folks who are who are visiting hearing care professionals today are moderate to profound. So I don’t really see very much of a of an overlap there. How do you see the overall market developing? Do you think OTC will expand the overall hearing aid mark, overall hearing in market to get more people seeking help? Or will it simply delay people seeking professional help? Like I said, I really don’t I really see the market developing in a very positive way. Most of us know the statistic that the the average time between diagnosis and actual fitting is about set is about seven years. I believe that that will shrink as a result of OTC and that’s that’s a great thing for the population of of people suffering with hearing loss out there are hearing impaired folks, meaning they’ll actually with increased accessibility, and possibly less expensive hearing aids have a mild hearing loss that could definitely bode well for you. And therefore I really don’t see.

You know, I don’t think it’ll delay people seeking professional help, I think I’ll actually accelerate it because people may try an OTC hearing earlier because it’s less expensive, and it’s more accessible. And then they’re gonna realize that they need more professional help. And they need a more traditional high tech hearing aid that addresses a lot of their concerns that they may not get with an OTC hearing aid. Specifically, you know, speech in noise is probably not something that’s going to be delivered quite as well with OTC hearing. So why … I see being very positive, I don’t see the market developing in a way that will actually hurt professional practitioners out there. Last question, do you think this will have any significant impact on the existing prescriptive hearing aid market for those already getting hearing help from a professional? Just as I said, I really don’t think so I think it’s going to be very positive for them. I think a lot of people will come in with OTC hearing aids and ask HCPs a lot of questions. That’ll be whether or not they should buy one, if they can actually buy one from an HCP. They’ll be asking for them to be repaired. But it also gives our HCP customers an opportunity to trade people up to a prescription hearing aid. So I really don’t I’m not too worried about the existing, prescriptive, prescriptive hearing aid market. I think, I don’t think people are going to trade down to an OTC either. I think, you know, one of the reasons why the hearing care market is so successful the United States is because of the care that hearing care professionals offer. And you know, the satisfaction in the United States is over 90% As in comparison overseas is only 76%. So we actually do a pretty good job – meaning, we, meaning the overall hearing care industry manufacturers as well as hearing care professionals do a really good job delivering quite a good service to patients. So I’m not too worried about that. So overall, I think this is a this is a positive thing for our industry definitely brings a lot more awareness to hearing loss in the United States, which is obviously a big issue. So I look forward, I look forward to seeing how things develop. And that’s it. So thank you for the opportunity to respond to your questions. And sorry, this couldn’t be more formal video. But I appreciate the time. And thank you very much. Take care.

Dave Fabry 15:26
Starkey is very pleased to see that the FDA has released their final regulatory approval for the new category of over the counter hearing aids the differences between the draft guidelines which had been issued earlier this year. And the final rule suggests that the FDA really reconsidered the evidence basis, and lowered the maximum output from 115 and 120 decibels maximum output down to 111 and 117 dB. Now, that’s a lot of jargon. But what that translates to is to a significant reduction in the exposure that individuals with mild to moderate hearing loss may encounter when wearing these devices. And so we applaud the FDA for that reduction in the overall output limitation in the draft guideline. And in the final ruling, the FDA has decided to not incorporate gain limitations, we remain concerned about that issue in that some individuals who have a mild degree of loss may still experience considerable amount of amplification or the difference between the input and the output sounds. But with that reduced maximum output, we hope that it does provide that necessary protection to ensure that the safety and efficacy of these products are in keeping with the improvements in accessibility and affordability. Anything that increases the number of people who could benefit from hearing aids to wear hearing aids is a good thing. One of the issues surrounding this debate is again, really this issue of whether the average hearing aid user really wants to go and purchase a device and fit it themselves whether they have the technical capability to do that. The whole thing boils down to the user experience how easily can patients sell fit these devices or get the physical components and the acoustic properties in a manner that will compare to that of a professional that has fitted the device – 85% of people who are fitted with amplification by a professional find that they’re satisfied with both the technology and the service that they receive. Our concern is if a whole host of inexpensive devices flood the market that are self fitted or require the individual to self in and adjust the devices that will see a reduction in this satisfaction and additional concern that Starkey has relates to the Attorneys General’s authority over being able to exert additional controls and consumer protection at the state level, which is preempted by this national law. Why is that important? Well, for one thing, there’s no real well defined policy for return for credit, or even trial periods that is mandated in the FDAs final regulatory guidelines. So the consumer the buyer needs to be aware, and it does limit the agency’s authority to impose these additional consumer protections at their state level. Many people may say, Well, how are hearing aids and these over the counter hearing aids really any different than eyeglass readers? What’s the fundamental difference? And it’s a great question. Well with eyeglasses also, because of the conductive nature of visual impairment, eyeglasses are really otherwise just refocusing the light onto a healthy sensory system. Therefore, the number of components and glasses really are on the order of single digits or maybe 10 components. Whereas in hearing aids, there’s hundreds of components necessary to provide frequency specific amplification, and preventing loud sounds from being uncomfortable. There’s a whole host of different sophistication, even in those simple devices for mild to moderate hearing loss.

John Luna 19:35
Hi, this is John Luna, CEO of Nuheara Limited, and I’m answering questions on the OTC hearing aid rule publication of the final rule on August 17 2022. For Hearing Health & Technology Matters. Thanks for including us in the conversation, Kevin. I appreciate the opportunity to provide comments. So for the first question, what’s your overall take on the FDA OTC recommended guidelines? From my perspective, this changes the landscape for consumers in America as well as for the hearing aid industry, and their distribution of hearing aids as incumbents, as well as new entrants into the category. The reality is, the FDA, at least in their final rule, publication believes that 90% of products that are currently on the market as exempt products could be re classified as 800.30 over the counter hearing aids. That is quite

a lot of options for consumers. And will that happen? Time will tell. We know that August 17 is the first commercialization date where it’d be legally able to sell OTC hearing aids and retail or online. And the over the counter aspect of that means the retailers will be able to position a hearing aid category or hearing solutions category in their retail establishments. Beginning this October, will that be one product? Will that be a dozen products or more? That’s to be seen. But it does mean that consumers will have the choice for accessible and affordable hearing aids for precede mild to moderate hearing loss. Now, what does that change for the overall rule publication, it means that safety and efficacy are critical. It means that, you know, from our perspective as a manufacturer, we’ve got to make sure that our products meet the standards that the FDA has put out and don’t exceed any of the specifications, we are compliant with that we have actually a 510k in the clearance process with the FDA. And we’re using the substantial equivalent as the predicate against a predicate device in the category for self fitting hearing aid. So for OTC suffering hearing aids that require a 510k process, I think the safety and efficacy side of it is very apparent. That’s the 3305s that come in the those that are currently exempt, that I think the rule, you know, is still putting the onus back on the manufacturers to meet those specifications and document that as well as have a quality management system established for medical devices. The overall guidelines and recommended guidelines. You know, on the labeling side for OTC hearing aids was not a surprise. What I found interesting was the labeling requirements for prescriptive devices that came out of this ruling as well. And that puts then a little bit of burden back on the manufacturers that have those hearing aids that meet a moderate to severe hearing range that are in the prescriptive category with regard to labeling requirements. I think overall, it’ll provide access to consumers. And that access will be proven out over time. Second question is what are your thoughts on the electro acoustic output and gain maximums as it relates to the amplification for individuals with perceived mild to moderate hearing loss? I think it’s fine. The output limits that were proposed, were a little bit higher in the proposal from October of 2021. But the FDA, listening to all the comments, and both the scientific community as well as looking at case studies. And then their experts and made the determination that they were going to move the lower limits to 111 on SPL 90 and 117 dB SPL for the upper limit if you have input compression. So I think that will still meet the needs of consumers for the ability to get benefit or efficacy from the devices in the mild to moderate hearing loss range without the concern that, you know, you damage your hearing over a period of time, I think by reducing it by 3 dB. It allows for a doubling or tripling of the time exposure a consumer could experience in a loud environment with an output or an ambient noise in the upper limits based on OSHA standards. And so they looked at everything from a safety standpoint, while focusing to make sure it was still going to be effective. And I think that that compromise and their determination of 111 and 117 respectively, will still meet the needs of the consumer with again requirements as well as allow for efficacy of the device and enough amplification to meet that moderate hearing loss based on having a volume control and then having some ability to personalize the device subjectively or objectively depending on the type of device that we’re talking about for over the counter hearing devices. Number 3 what if any foreseeable risks do you see in the legislation? in reading the rule A few times, I don’t see a lot of risk, I think it was very thoughtful with regard to

the overall rule, and how it lays out the definitions and the responses that the FDA had for the different comments as bucketed or grouped in the responses in the final rule publication. So I think they were thoughtful, they did make some decisions, to move away from some of the proposed rule guidelines. And I think those responses adequately describe their reasoning. And in also allow the FDA in the future, to modify or amend, or come back and revisit based on safety and efficacy. And you know, some of the things that will play out over the next 12-24-36 months as this OTC category enters retail in the United States.

One of the other things that I see as a potential risk is challenges from states on the preemptions. What I would say there is we’ll just have to wait and see how States Attorney Generals respond. And if there are any challenges to the rule, which I don’t think will have a positive outcome at the state level. But it does define what a licensed professional can do, versus a dispenser in the OTC world that doesn’t require licensure. So I think there’s semantics. And there’s some clarification that needs to be challenged, and perhaps clarified. But there is a informal process for that. And that was laid out in the proposed rule to allow states to states and associations, industry associations and otherwise, to ask for clarification without having to go through a formal legal process or a formal process. And I think the FDA, from my experience, has been more than willing to explain that, and have those conversations with individuals, whether that’s the public, whether that’s the manufacturers, or whether that state legislatures. So I think there, there will be some additional clarification that comes out of this. But I think that’ll be on a case by case basis based on how each jurisdiction response based on their own rules and current rules and past rules, historically, and how they have controlled the industry and control the the licensing side of it, as well as the rules for consumers regarding the conditions of sale, and so I think the conditions of sale are something that have changed here. And that will be changed forever, and how consumers purchase and have access to mild to moderate amplification products and the OTC hearing aid category. Number three, no, sorry, number 4. How do you see the overall market developing? Do you think OTC will expand the overall hearing aid market and get more people seeking help? Or will it simply delay people seeking professional help? Well, I hope it’s not the latter. Regarding, you know, delaying help, you know, most people do delay, right. It’s not like your eyes where you know, you have an issue and you things are blurry. And you have, you know, your vision has changed because in certain situations, and over time, you’ve noticed an acuity change and how you visualize things, whether that’s print on paper, whether that’s on your phone, whether it’s on your computer, whatever that is, vision we take care of we do it for ourselves, right? Because of that frustration factor. Hearing is hidden. Hearing loss is something that, you know, it’s your own reality of the world around you acoustically. And so although it is one of your senses, it’s one of the ones that you have less tangible note to and you know, we second guess ourselves a lot of times, the average consumer, as you know, is five to seven years before they realize they may have an issue. And before they do something about it. I think what we’re going to see is a younger consumer come in and be able to self test, be able to self fit, and be able to try products sooner than later. Our average consumer is in their early 50s. And that shows that in the world of devices that have the ability to do more than just amplify hearing, they have the ability to stream video conferences like this. They have the ability to stream music media have active noise cancellation, as well as hearing amplification, it will allow a consumer to have a different form factor come in at an earlier date at a much lower price point and help themselves if they have you know perceived mild to moderate hearing loss and try devices that in form factor and function can meet their needs. Some consumers will want to use an app, some consumers won’t want to use an app, and they’ll want onboard controls that’ll play out over time. But you have different age groups, you have different

abilities regarding tech savviness, and the willingness to self fit or go higher in technology and, and features. And then you’ve got the simplicity of some devices as well. So I think what you’re going to see is products that raise the water level for all manufacturers in the ability to meet consumers needs and demands with the millions of people that have the need. And I think that it will bring people into their hearing healthcare journey sooner than later. The average consumers, you know, currently in clinical, in the prescriptive side of things historically, has been in the early 70s. And I think that will change, I think we’ll drive it down because of cost accessibility. And the consumers will make their choice and have the ability to see it over and over and retail. It’s not like going to a private practice clinic where you may go once every couple of years, or you may have walked by it and look through the window. But you never want to cross that threshold, because one people don’t want to admit they’ve got a loss, or they want to know what they don’t want to know, in many cases. And, you know, secondly, they they have that perception of cost and the stigma around it or the look of existing devices on the market. Next question number five, do you think this will have any significant impact on the existing prescriptive hearing aid market for those already getting hearing help from a professional? I think that’s a great question. And that will also prove out over time. You know, I don’t know if it’d be a significant impact. I think, you know, as you know, I owned 15, I’ve done a lot in this industry over 30 years. And I’ve owned 15, retail Audiology and Hearing Aid locations that did diagnostics that had physician referrals, that had AuD and master’s degree audiologists and hearing instrument specialists working for me. And I’ve, I’ve been on the industry side, and I’ve been on the consumer side, as well, as I grew up with, you know, hearing impaired parents and grandparents that purchased hearing aids. You know, I know from personal experience, I also know from owning 15 audiology, retail clinics, that, you know, consumers make their choice based on need. And based on a perceived need, and that need in hearing isn’t always brought on by themselves, they may know they have an issue here and in certain situations. And they may know they have difficulty understanding or asking people to repeat, there’s a lot of symptoms of hearing loss that we’re all aware of. But I think one of the things that occurs if somebody else in their life is either frustrated, or asking them to seek help, or someone that they want to interact with in their life, whether that’s adult child, a spouse, or significant other friends, social groups, children, grandchildren, whomever that is, or in their work environment, where they’re missing certain things, that’s when they’re gonna need help, right. But it’s in those environments, that they typically do something about their hearing. And so what I think will happen is there will be an impact on those that are already in the system, so to speak, that already have hearing aids, their owners of hearing aids, they may, at the time of repurchase decide to purchase something that may be better what they currently have that’s available now over the counter at a fraction of the cost. So I think that, you know, having owned retail clinics and knowing that the the resale cycle for consumers, and the repurchase cycle for consumers is typically at the three to five year mark, depending on the level of technology. And if their hearing needs change, I think we’re going to see that impact in the overall resale of existing consumers that already own hearing aids that have seen it professional previously. I think if these consumers are made aware of the OTC legislation, they understand that they have options outside of a professional or professional license, a seller of hearing aids that they have purchased product from before, and they’re know that they can purchase these at, you know, let’s say under $1,000 versus $4,000, or under $2,000 versus six or $8,000. And those professional services are separated, then it’s really, you know, up to that professional, licensed individual that sold that consumer or patient or client however they refer to it hearing aid to understand that value of not only the relationship and all the time spent to get them to be satisfied and successful with their current product, but also then what that value is to keep and maintain their Have their relationship. And those services ongoing as they, you know, graduate to their next device or move to a,

you know, a different style of device. And I think what you’re going to see is some of these professionals offering then OTC hearing aids and unbundling their services. You know, I’ve been in the industry, as I said, you know, for many years, you know, 30 years ago, we were talking about unbundling, it was one of the big topics before even the AuD program came out. And it was we need to unbundle our services, we need to, you know, have professional services separate from devices, you know, 30 years later, flash forward, I mean, we’re here, this is the reality, and the industry is kind of done unto themselves by not unbundling. And also, you know, by having fitting algorithms that are wonderful, right, the first fit algorithms from manufacturers have made, you know, the fitting of devices in clinic, much easier than it ever was previously. And so taking that technology now to the consumer level, and putting it in the consumers hands, and having the ability to fit the product with the touch of a button or a few sequences of things that they need to do to have it automatically fit based on proven algorithms, I think is something that as an industry, we’ve done to ourselves, and I think that, you know, we knew this was coming for seven years. And I think, you know, for those that have been part of this for the last seven or eight years, even going on 10 years from the initial discussions of this, I think that, you know, we should be prepared, and you should have planned for it. So I think that if we haven’t, and we’re surprised that’s on us, but I think that it will impact professional licensed individuals who dispense and sell hearing aids, for the prescriptive audience of moderate to severe, differently than those that have been preparing for this and are prepared to embrace the OTC hearing aid side of it, and help those with mild to moderate hearing loss be successful with it in an unbundled service model. So, you know, retail over the counter is one aspect of it, and then you know, what is the value of that professional interaction if the consumer chooses to have that afterwards. And some of these will be bundled, or not bundled, I should say, but included with some of the products that are going to be available OTC at no additional charge. So, you know, that’s something also that could impact the professional community. So we’ll see what happens we’ll see what age groups and demographics play out by different types of hearing loss, different needs and the ability to value that professional service in that interaction versus those that would prefer to do it themselves in OTC via self fit hearing aids, or OTC self care hearings. All right, I think that’s it. If you have any other questions, please let me know. Appreciate the opportunity to speak to you and give me a call or shoot me an email if you have any questions. Take care