 With the release of the FDA draft regulations for over-the-counter hearing aids, the future of devices for the treatment of hearing loss is becoming clear. What is not clear is what the impact on the hearing aid industry will be and how this will also affect people with hearing loss and hearing healthcare professionals. So leading the discussion today, we have Dr. Brent Edwards, who is the director of the National Acoustic Laboratories, where he is currently leading new innovation initiatives that focus on transforming the hearing healthcare. For over 22 years, he headed research at major hearing aid companies and at Silicon Valley startups that have developed innovative technologies and clinical tools used worldwide. Dr. Edwards is a fellow of the Acoustical Society of America and is an adjunct professor at Macquarie University in Sydney, Australia. Also on the panel is Dr. Stefan Lorner, who studied physics at the University of Würzburg in Germany and is conducted and conducted a PhD thesis in hearing science and psychoacoustics at the University of Göttingen and Oldenburg. He joined Phonak, now Sonova, back in 1995, where he led various teams, including audiological engineering, digital signal processing and microelectronics and acoustic design. In his current role, Dr. Lorner leads the audiology and health innovation programme at Sonova and also holds an adjunct professorship in audiology and hearing instrument technology at the University of Queensland in Brisbane, Australia. I will now hand the floor over to Steph, who will give us a summary of the draft of OTC hearing aid regulations and kick off the panel. Thank you for the introduction and thank you also for organising this little panel discussion on this for all of us, a very important topic. I have to make one comment as I'm working for industry and as this is a draft proposal, I'm basically voicing not an official Sonova voice, but I'm participating as an expert on a personal note today. I think that's important to state, maybe also upfront. I mean, very recently, FDA issued this proposal for a new regulation of hearing instruments that also includes a new class of devices, the so-called OTC devices or over-the-counter devices. This new proposal for a regulation is now out for comments. It can be downloaded and it can also be commented by various organisations or experts or just people who are interested in submitting their comments. Basically, one major takeaway from this new regulation is that FDA will have two major classes of types of hearing instruments if we exclude the middle-year and bone conduction devices from this discussion and the two major classes are the so-called OTC over-the-counter hearing aids and the so-called prescription hearing aids. Now, especially of interest, I think for this discussion is the new group of OTC devices, which will not require a licensed professional to sell these devices. So they can be sold in basically any shop and also by people who do not have any education or background in audiology. That's a major point here and the technical regulation for these devices are such that they are allowed to have a maximum output power of 120 dB without any gain restrictions. So basically with this type of devices they would be suited to fit people with a mild to moderate hearing loss. Regulations from a technical perspective, as they are suggested today, would follow the NC-CTA standards. So there are technical regulations but more from the consumer electronic side. The OTC devices are kind of a class of self-fitting hearing instruments. So they must include tools to modify the settings to the individual needs of a person and these tools can include volume controls, tone controls, programs, switches or any other software tools which would allow the user to modify these devices. There are also some technical or application limitations. For example, the devices are only allowed to have a maximum insertion depth. The ear tips to be used have to be made from a traumatic material and the devices have to assure a proper physical fit. Now in order to sell these devices, manufacturers, companies have to go through a 510K approval process and the devices have to include a pretty strict labeling which includes a lot of information about the proper use of the device, about potential indications or also information about the hearing loss, a lot about red flag conditions when not to use these devices and also a proposal to consider seeking a consultation in the first place. Furthermore, the devices are limited for adults over the age of 18 years. Also, this is discussed at various points in the new regulation. So that's basically the broad overview over this new class of devices that has been introduced. Prescription hearing aids, on the other hand, would be devices that would be fitted by a person with a license or a professional license and audiologist and would be devices that would not be basically self-fittable. Any additional comments or remarks from your end, Brent, to what I just outlined? No, that's a good overview. And I'll tell everyone that Steph and I have a couple times talked and we started talking about the OTC regulation and we stopped because we said we want to share our ideas here on this panel discussion. So I'm really eager to get into a discussion, maybe a little bit of a debate. And I want to pick Steph's brain and what he thinks about some of what I think are a little bit of a puzzling content in the OTC guidelines. So from my end, what I find a little bit puzzling is that I don't understand a couple of the regulations and the rationale behind it. So for example, the output limit is a little bit higher than what I would have expected. And I was surprised to see that there is no gain limitation and the argument for that was from my perspective, not entirely clear, but that's my personal view. The argument of FDA was that most of these OTC devices will include an input compression system, which would allow the games to always be set in a reasonable way. And it would also prevent people from listening to too loud noises. So there would also be no risk of damaging the ear further. So this very broad regulation, which basically really makes these devices applicable to people up to a moderate hearing loss, was a bit of a surprise from my hand. And I would have thought that especially for these types of hearing losses, it would be preferable to include a professional in the fitting process. But that's just my personal opinion on that. Yeah. So I agree with you on that. Maybe we'll dive into the technical details a bit later. But the output limit, the maximum output is defined in there, I think by OSPL90, which is a pure tone max output. So you're going to get even a higher output if you have a broadband signal, which is almost every other sound someone's going to listen to. So the max output could be even more than 120. And that's really surprising. What really surprised me about reading the regulation was, you know, I met with the FDA a couple of times while they were developing this, and I participated in panel discussions. And for me, the big thing was, how are you going to restrict this to mild to moderate hearing losses? So first of all, that was a mistake because they're not restricting it to mild to moderate hearing losses, they're restricting it to perceived mild to moderate hearing losses. And what that means in what's the correlation between perceived level of loss and actual loss, you know, it's probably pretty low. So that was a little disappointing. But I still I thought, well, what are they going to do to really limit it? And my strong guidance to them a couple of times was limit the gain. There was all the talk about limiting maximum output, but you know, you could put it a 50 dB gain system, limit the output and blow people's ears away, and give someone with a severe loss the perception of benefit. But if you limited the gain to say 25 dB, then that sort of more severe loss probably is going to be dissatisfied with their product and go see a professional. So they really haven't given any way to exclude the more severe losses from this. And if you look at the guidance, they're requiring labeling in the package that says, if you have a perceived mild loss, then you will have difficulty with speech and noise and you will, you know, have a few other things. And that's it. They don't tell you however you have all this other stuff, then go see a doctor, except I think difficulty with speech and quiet. So not having a way of really specifying that this is for mild to moderate hearing losses really surprised and disappointed me. Well, this is the point that we could submit to FTA that they have to make the labeling much stricter and maybe much more precise and also exclude maybe warnings for what would be considered a more moderate to severe hearing loss and who would not be appropriate for these devices. What I have to say, what I found interesting and also a little bit puzzling was that on the one hand FTA seems to have relaxed the process of getting the device for the consumer. But on the other hand, at least that's something that is unclear to me. They seem to have increased the burden of having a good device in the market because they require now a full 510K submission process and including some potentially clinical data showing the effectiveness and efficacy of the devices and the device usage. And that's also interesting. So from the process of getting the device it's become easier and as you pointed out maybe a little bit riskier to what the end result will be and who will be using these devices. But for getting devices into the market, the hurdle has become a little bit higher. So this seems to be an empty strike to really have good devices and to assure that. I mean, I don't mind that. That's why the FTA exists, right, in order to protect the health, the safety and the effectiveness and ensure effectiveness of products. So I would expect them to keep that 510K regulation in there. And I think if you are doing a self fitting along with the like a hearing test or something like that, I think you have to provide evidence that it's actually working. And tell you what, there was a lot of misunderstanding when this came out. I read a lot on social media people saying, oh wow, now hearing aids are unregulated. It's absolutely not true. What they're actually doing is layering on proper regulation on direct to consumer devices. And the other thing is, I saw a lot of people saying suddenly now direct to consumer devices will be available. Well, guess what DTC or OTC has been available for 10 years, just not legally, you know, for for probably 20 years, people have been able to mail order order on the internet, order from Amazon, cheap hearing aids from anywhere unrestricted. They just weren't sort of FDA cleared products. But but this doesn't open the door that was previously closed. The door was already open. It just wasn't being enforced. Yes, but I think in the past, it was these devices would have been called PSAP. So personal sound amplifiers, which also now in this document are explicitly excluded. So this class will even continue to exist. But I think this devices that will be called hearing instruments and will target and have the intended use of helping people with the hearing loss this class now, I think is is new and or I mean, we had the self fitting devices, this class now has a new regulation through this OTC ruling. I saw that Todd had to comment that he disagreed with us and the the reading of the device. So Todd, what was your what was your reading? Yeah, sure. So and this is not super clear in the document that I read through this a few times and had a few discussions that the wording is that the they believe most OTC OTC devices will be self fit and therefore subject to 510K, but they don't preclude legacy devices that are not self fit. And so to me, it appears that there's a very large loophole for non 510K protected devices to enter the market under this OTC regulation. Yeah, that's clearly an open point, Todd, which also from my perspective is not fully defined and clearly specified what actually the process is to introduce these products into into the market. That's something where I think FDA needs to provide further clarification and guidance. I mean, the interesting question really is, if we open up this segment of hearing aids for mild to moderate hearing losses and sell them over the counter, what are the implications for our consumers on the one hand, and also for our profession on the other hand, considering that this is probably the biggest chunk of all people in need of hearing devices in terms of of quantities. And from my perspective, sorry, Brent. Go ahead, sir. From my perspective, I have a little bit mixed feelings about it because my personal feeling is that especially for people with more moderate hearing loss, I would have always thought that professional support in the process, professional support in finding the optimal settings, professional support in finding the optimal acoustic coupling schemes and all these topics would be really important to really achieve good success with the hearing instruments. And from my end, I would be worried that people with a moderate hearing loss take these devices, self fit them, are not happy afterwards and then stop using the devices and kind of are burned. They have an experience with hearing instruments, they don't help. So they don't provide benefit and off they go. That would be the fear that I would have. So I'm going to challenge you on that, Steph, because I've been hearing this for a decade, starting with the PSAPs back 10, 15 years ago and hearing the same thing. PSAPs are terrible because people have a bad experience and they'll be put off by hearing aids and they'll wait even longer than the seven to 10 years. So HIA in the US did a study of this attitude to see if this is in fact true. What they discovered makes a lot of sense. If you think about high-end realtors of stores of clothing or jewelry, the fact that there's a Kmart where you can buy clothing doesn't mean that the Macy's or the high-end stores are going to be put out of business. Tiffany's doesn't care if a costume jewelry store opens up. Because the consumer knows, you get what you pay for. And if you're going to buy something off the shelf at a drugstore or a Best Buy, you're not going to get the same level of medical healthcare than if you go to a hearing healthcare professional. So it seemed people were able to differentiate something you buy yourself off the shelf versus something that you get from a professional. So it's not clear to me that a bad experience with an OTC hearing aid is going to make someone not go to see a professional. It could have the opposite effect. This didn't work. Maybe I can't manage it myself or maybe I should go see a professional about it. Well, I agree and I disagree. First of all, with your example with jewelry and clothing, I think hearing instruments typically are something you don't really want to buy. So you maybe have a need but not a strong desire to buy them and that's different from jewelry and clothing. And so if you bought something that you don't really want and you have a negative experience, it might have a different implication whether you're willing to buy, especially if you spend some money and now you have to go to a professional and spend even more money. If you would have a device that you could then take and then you could fit it to your needs, that might be really a more clever solution. But if you would have to buy the device, then again, you might maybe in a first moment really pause depending on how severe your hearing loss is and how strongly you're in need of a device and how maybe also strongly your family supports you or pushes you. That's maybe also a consideration. That's one worry. I mean, we could also argue the other way around. We are opening up the door for more people to start earlier and have a positive experience to begin with in the process and we get more people into the funnel and maybe that's the stronger effect to observe. Yeah. And again, from my perspective, I've talked a lot over the years about the misconceptions about the hearing aid field and about the hearing aid market with the challenging the assumption and it says in the FDA draft guidelines, by the way, that something like 20% of people who could benefit from a hearing aid, only 20% have one. So that's assuming that there's 80% of the population with a hearing loss want a hearing aid but don't have it. And I think that's false. Just because you have a measurable hearing loss doesn't mean that you want or would benefit from a hearing aid. So I think that's a fallacy that was a premise driving this as was the accessibility and affordability of hearing aids which I also have challenged quite a lot as being a fallacy. Again, with my example, you can get online and get hearing aids dropped at your doorstep tomorrow by Amazon for just a few hundred dollars. So Larry Humes had a comment on something we talked about a few minutes ago. Larry, do you want to unmute yourself and contribute to the conversation here? Sure. So first, I agree with your quick summary of some of the problems with the legislation and draft, including the lack of any gain specification, is kind of hard to understand. I think my take on it was the focus was on safety and they viewed output limiting the maximum output is the key thing for safety, which probably isn't too far off, but to have absolutely no kind of surprising. As far as the focus on perceived, they were going by what the federal legislation said very clearly that candidacy was going to be based on perceived mild to moderate hearing loss. Now, one of the challenges, and I think this is related to what both of you were talking about, to me the biggest challenge is there's just no infrastructure available for these devices once they're released. So part of it is defining mild to moderate hearing loss. How exactly do you define that in a standard or uniform way? How do you fit these devices validly if they're self-fit? And Steph was talking about basically the post-fit support and that usually a professional can provide that. Now you can imagine, partly brought on and facilitated by COVID, that there are a lot of remote or video ways in which you could provide the support, but again, those tools don't really exist and haven't been validated for this category. So it's kind of like the genies out of the box here and we have this device, but we don't have a lot of the infrastructure needed to make sure that in fact they are most likely to have a positive experience when they select these devices. I think the worst thing that could happen would be to have a negative experience. So now you've taken somebody who might have an interest, might be a candidate, and they've had a terrible experience, and now they're going to be even more reluctant to try hearing aids from a professional. At least that's my take on it, so I just wanted to make that comment. Yeah, and Larry, given the work that you've done over the past few years, I'm surprised that the FDA didn't include some of your guidance and recommendations, such as even referencing the HHIES as perhaps a way of identifying whether someone has perceived mild to moderate loss or not. I would think if someone scores a 36 on HHIES, you should say, no, no, no, go see a professional. Yeah, so Larry, you know what I found really interesting also based on what you just outlined, that there is a regulation for an OTC device, and then there is a regulation for a prescription device. One is self fitting, and the other one is fully involving a fitter, but there is no kind of hybrid model, which I think we discussed also a couple years back already that this is probably the preferred solution. So a solution where you can do maybe start off yourself, but then seek help afterwards. What type of a device would that be, and would it be allowed for a professional to fit an OTC device to begin with? I don't know, that's not clear to me. No, that's interesting, Steph, and I think you or maybe Brandt mentioned Best Buy, but anyway, some kind of electronics firm, but I actually think that what may happen is that just like at Best Buy, you can buy the product, and then you can pay for additional services. And so I see that as a possibility is that some people who think they can do it themselves, they don't need the support, they'll buy the device, save some money, but you can get the Geek Squad some support to help you use the device, pay for so many post-fit sessions. And so I think people will be pretty creative, companies will be pretty creative in how they provide the products and the support that people might need, but it's all speculation. I really don't know how it'll play out, but I agree, some kind of hybrid would be probably a pretty good model. And I think it's all about how cost-effective it's going to be. You have hybrid models like lively out there, but those hearing aids are pricey because you get audiological support. And Steph, I don't think there'll be anything keeping audiologists from giving support for people who want help with their OTC hearing aids. I think there may be a resistance on the audiology side in providing that help. If you bought a cheap off-the-shelf hearing aid, they're going to charge what's baked into the price of a hearing aid, which is something like 150 to 200 bucks an hour. And if someone has gone the affordability route of an OTC hearing aid, are they going to now start paying 200 bucks an hour to get help? And I also think that the market for OTC hearing aids are people who are not getting help today. So they're going to get some benefit, I think. Like if you give someone who has a moderate loss, say 15 dB of gain, it's going to be better than not wearing a hearing aid at all, I think, as long as it's a quality hearing aid. So they'll get some benefit. Will it be as good as a finely tuned NL2 prescription hearing aid with audiology counseling and support? Probably not. But I think this is people who aren't in the game anyways. They're not going to see audiologists already. And this is an offering that's going to get them into hearing technology. That's my prediction anyways. It would be the hope to really motivate with this new regulation, to motivate people and to tap into another market and to expand the market. From my end, talking about the services to be offered for OTC devices, the question that I would have, would that require a licensed professional or not? These are things that need to be discussed and sorted out. Who provides this help? Or do we only really need licensed professionals for the people with the more profound and severe hearing losses in the consultation process? And Steph Rich Tyler says he has an issue he'd like to raise. Go ahead, Rich. Sorry. Greetings everybody from Iowa. Happy Thanksgiving. Oh yeah. So I wrote an article about six or seven years ago when this was becoming more prevalent or possible called the end of audiology, maybe. And my main concern was that a lot of people will get hearing aids and they'll be happy, but they won't hear as well as they could and they won't know it. And hearing is really important. And I think it'll be sad that people will get some of these devices. They may hear a little bit better, but they weren't what will not hear as well as they could do. And I think that will be very unfortunate. Hearing is really important. It is. And again, my perspective, if they're not getting any help already for whatever reason they're choosing not to see an audiologist, at least this gets them in the game a bit and gets them a part of hearing help. We have a conversation in chat with Michael Ackroyd and Kevin Monroe. And Kevin, it looks like you raised some research that you've done recently. Do you want to unmute yourself and chat about it? Thank you, Brent. Hi from Manchester in England. I was just responding to Ian's question about looking at the evidence. So we haven't published this yet, but we've carried out a systematic review to compare the outcome or benefit of hearing aids with prescriptions and REMs versus alternative methods. And it's somewhat surprising that when you search around you realize there's not much good quality evidence to underpin much of what we do. But there are different alternative methods. One of them is self-fitting. And our conclusion based on a small number of studies, limited quality, is that self-fitting hearing aids have the potential to provide equivalent or more benefit than those currently at prescribed using REM. A lot more work needs to be done. Actually, while I'm unmuted, I might just make the point about the uptake of devices. Because in the UK with socialised healthcare, it doesn't cost anything to go along and get your hearing aid. You get your batteries free, you get your repairs free. But the uptake of hearing aids in the UK is no higher than anywhere else. So I'm rather skeptical that reducing the price on its own is going to make much difference. Unless it's not medicalised in the way it is in the UK. People have to go to their family doctor and be referred. And I suspect that may impact on it. But I would place a bet that it's not going to make a huge difference to the uptake. Also, I'm not sure the numbers of people out there are as high. I think you made this point, Brent. At as high as we think. There are people who have an audiometric hearing loss, but it doesn't mean they have a disability. They recognise a problem. So, you know, I'm just kind of watching it from this side of the pond to see what happens. I'm curious when you said that they might actually be better with self-fit, Kevin. Yeah. Well, it's a systematic review and we'll go through the review process and we'll see what the reviewers think. But most of the studies, you know, use a variety of different outcome measures. So it might be in different domains, but then the tools they use are different. But at least, and I don't recollect all the facts right now, I almost hesitate to type in the chat box, but it seems to my mind that when you look at it, there are some of the outcomes look to be pretty compatible or potentially higher. But not many studies and it will go through the peer review process. The question for me would be, Kevin, what types of hearing losses were that? Did that include moderate hearing losses or was that more focused on the mild losses? I mean, moderate hearing losses, I'm not aware of too many studies on that. I'm only aware of studies looking more onto the mild. But that's only my recollection of the data. And Cathy just raised another important point, which is the hearing and the communication problems are not only solved by the technology, but from my perspective, you know, I think maybe consultation could also be provided in different forms. And maybe we should also look at this approach as an attempt to open up new ways to find new ways to reach a broader group. And we should think about how could we leverage that and new technologies to provide good quality services to people and maybe involve the experts in a different form than in the past. But Cathy, do you want to bring your point? No, I think you caught the essence of it wonderfully, Saul. Thanks. Great. And maybe with that, at this point, we'll end the sound bites portion of the webinar and say goodbye to our viewers. And we can continue the discussion among our IKRA members. Can I? Yeah, go ahead, Seth. I just wanted to say as a last comment to the sound bite sessions, there was a nice comment by Jan Wauters in the church who said, you know what, it's important to really now create evidence and look at the different approaches and test them and see what's happening and what evidence we find. Yeah. And as a researcher, this opens the door for so many interesting research questions about how this will impact hearing health care. And that brings us to the end of the sound bites season two session with IKRA members and what might be just another meeting for IKRA members has certainly been insightful and enlightening for all of us. So thank you so much on behalf of the sound bites producers and our audience. I hope you have enjoyed today's webinar series. See you next time and take care.