 What I'd like to do today is give it a little bit of an overview of my thoughts on over-the-counter hearing aids, direct-to-consumer products for those with hearing loss. I've spent a lot of my career actually thinking about this topic and developing innovations in this area. Back in 2000, I left GN Resound and helped start a company in Silicon Valley whose goal was to develop products for people with hearing loss who won't wear hearing aids. So we worked to embed hearing aid technology in mobile phones to compensate for hearing loss in streaming music through servers. And finally, we ended up developing what you would today call a hearable back in 2004. A little bit later, the lab I led developed a self-fitting tool for people to adjust their own hearing aids in a very easy-to-use way. And just a few years ago, I found myself providing guidance to the FDA, to the FTC, to members of Congress around hearing aids and the role of audiology in the hearing loss services. So I've been talking a lot about OTC and where our field is going. And I often find that I get similar questions from a lot of people with respect to OTC. So one obvious question is from everyone, particularly people outside of our field, why aren't hearing aids helping the tens of millions of people who have hearing loss in America? Or why is it that such a large percentage of people with hearing loss don't have hearing aids? Or why are hearing aids so expensive for people who need them? And now with OTC imminent in the US in terms of being made legal, will OTC hearing aids replace audiologists fit hearing aids? And this is a concern for people within the hearing aid industry, both audiologists and hearing aid manufacturers and others. And so my response to all of these questions is really that these are the wrong questions to be asking. They're based on a false premise. It's based on the concept that everyone who has hearing loss or everyone who has difficulty is a candidate for hearing aids. And everyone who has a hearing aid who is fit by an audiologist is the candidate for OTC hearing aids. Both of these assumptions are false. So hopefully you'll understand my position on this by the end of this brief talk. So what is the right question to be asking here? Well, what are the unmet needs of the different segments of the population of people with hearing loss? So this is critical in terms of understanding what treatments and what solutions are right for what people. This is fundamental in any company that is going to be successful trying to understand the unmet needs to understand what solutions are needed for them. And then based on those unmet needs, who actually has a need for OTC hearing aids? So that's going to be how I approach this. What are the unmet needs of different segments of people who have hearing problems? So if you consider all the people who have auditory dysfunction, you can segment them in some very simple ways. You can segment them by whether or not they have a measurable hearing loss by the audiogram. And there are people who have normal audiograms but still have hearing dysfunction. So we do have those two categories. But then you also have two categories and whether or not the person perceives that they have hearing difficulty. So this gives us four different categories here of the population to think about in terms of unmet needs. So let's consider them one by one. There's top left one, people who have normal audiograms. They don't perceive that they have a hearing difficulty. They have some auditory dysfunction. I'm going to ignore this group because I don't know what solutions they need. I don't know how to find them. I don't know how to address them. So let's just ignore that segment of the population. Let's consider the top right here now. So this is a group that has a measurable hearing loss of greater than 25 dB PTA. But if you ask them, they say they don't have any difficulty. So this is a challenging group. We know they have a hearing loss, a traditional sensory neural hearing loss. But they seem to be doing fine. It could be because their lifestyle doesn't produce any auditory demands or able to compensate well. They don't notice it. This is going to be a really challenging population to consider to say that they have any need at all for a hearing aid. OTC or audiology fit hearing aid because they don't have a perceived need. Now maybe you could expose them to devices and get them to understand the need, but that's going to be a real challenge, marketing challenge. So for the sake of this talk, I'm going to ignore this population as well because I think they're a really, really difficult group to address. And I think we have other opportunities for solutions for people who do have unmet needs today. So now the bottom left here. These are people who have normal audiograms, but say that they have hearing difficulty. So there's a lot of people who walk into audiology clinics saying they need hearing help. But when you measure their audiogram, it looks normal. And what do you do? You send them away saying your hearing is fine. It's not fine. There's a reason they showed up. I'm going to talk about this group right at the very end because they're not necessarily candidates for hearing aids, but they're candidates for other solutions. Finally, this group in the bottom right. These are people with a measurable hearing loss by the audiogram. And if you ask them, they say they have hearing difficulty. We can split this into two groups. Those who accept professional help and those who accept the use of hearing aids as a solution. And then those who, for whatever reason, are not seeking any help. They're not wearing devices. They're not going to see professionals. So let's consider these two groups as separate segments. So let's consider this group right here. This is the segment that everyone who's in the field knows and understands really well. So this is the population with the measurable hearing loss. And they know they have hearing problems. And they want to see a professional to get treatment. So what do they want? Well, all of us can list what their needs are. This is just a small selection of those. Improved speech understanding. Improved sound quality. Less listening effort. But these are all things that hearing aid companies, device manufacturers are producing and developing innovations year by year. What's important in this list, this group wants improved care from their professional, whoever they are. Audiologists are hearing care practitioner. This is critically important for this group. They know they have hearing loss. They know it's a hearing health condition. They want to see a health care worker. And they want good quality of care from that worker. So we know that this is critical and the level of care is important because there's a lot of data that shows the level of care correlates with the satisfaction with hearing aids. This is out of Sweden where the Y-axis shows the amount of care that they got from their audiologist. The X-axis is how satisfied they are with their hearing aid. You see a very strong relationship between the level of care they got and how satisfied they are with their hearing aids months later. At the National Inclusive Laboratories, we also got similar data where three months after their first fitting, we questioned people on how satisfied they were with their hearing aids, how much benefit they were getting. And you see that the more benefit they get is highly correlated with the amount of care and the level of interest that they got from their clinician. So if clinician isn't giving much attention, if they're not giving much care, the benefit they're getting from their hearing aids later on is low. So there's a relationship between the audiology, the hearing care professionals services, and the outcomes that people get with their devices. And this is just like in any field where you seek professional help, the better the help you get, the more satisfied you are with the outcomes. This really should be no surprise. And so for the population that currently is accepting of going to see a professional, this is really important. So the summary, I think, with this group is hearing care professionals will continue to play a very significant role for this group because for whatever reason they want professional help and the more they get it, the more satisfied they are with their treatment. Now, let's consider this group on the bottom right here. They have an audiogram that shows the hearing loss. They know they are hearing difficulty, but they're not going to see a hearing care professional. So what are the unmet needs of this group? Well, there are a couple reports that came out a few years ago that said that the main issues here are accessibility and affordability to care, to treatment. So if we look at a model of behavior, something that's been applied to healthcare behavior, such as why do people not stick to diets? Why do people smoke? This is a very nice framework for understanding what are the reasons why people behave in a certain way. It's called the COMB framework for capability, motivation, opportunity that influences behavior. So if we think about the behavior of not seeking a hearing care professional, when you know you have a hearing problem, what are the reasons behind that? Well, accessibility and affordability would fall under opportunity. Now, I would question whether these are really true because if you go online, you can get a lot of people who will mail you a cheap hearing aid to your doorstep tomorrow. So is accessibility and affordability an issue? Let's say it is, let's put it on the list. But what the framework tells us is there are a lot of other considerations to think about in terms of why people are rejecting audiologists. So what might those be? Well, stigma, people are just lazy. They don't have confidence that the solution is going to help them. There are people around them who are supporting them and telling them to do the right thing. Or they just want to do things themselves. They don't want anyone else's help. There's a variety of reasons why people may choose not to get a hearing aid. And these can be defined all under that COMB structure. At NAL, we've done a lot of research into what it takes to be successful with self-fitting hearing aids. And to tell you what, it takes a lot of ways that you can fail in getting someone to be successful with an OTC or a self-fitting hearing aid. We did a study of 60 adults, gave them all hearing aids that were designed to be self-fitting, gave them the instructions and said, okay, let's see how you do. And what we found was only about one in four were able to be successful in fitting themselves. Another half were able to be successful if they had professional help assistance. And then another third just weren't successful at all. So getting someone successful with a hearing aid device is not easy as any professional knows. Market Track 10 recently published earlier this year has a lot of data on attitudes towards hearing care professionals and self-fit devices. Looking at the different tasks that are necessary in order to get to a self-fit device, over 3,000 people who have hearing loss, some with hearing aids, some without were asked, their level of comfort in doing things like selecting the right technology, fitting it themselves, learning how to use the features. And about half the people were comfortable and about half of them were not. So there's a bunch of people out there who say, you know what, I think I can do it myself. But a lot of people are like, you know what, I think I'd rather get some help with this. When the population was asked whether they would prefer to get over-the-counter product themselves or go to see a professional if they were to get another hearing aid, those who are current hearing aid owners, almost 90% said, you know what, I'd rather go see a professional. Probably not surprising because they had a good experience. Those who have hearing loss but are not hearing aid owners, about 60%, 56% said, you know, I would probably look at a hearing care professional, but almost half said, you know what, I think I would give these OTC devices a chance and see how they go. So, you know, again, there are different segments of different attitudes towards devices here. When asked whether people with hearing loss when asked whether they think a professional provides value in terms of your success with the device, hearing aid owners, 90% said, yes, of course, they provide value. And again, non-hearing aid owners, it was about, you know, 50%, 60%. I think it was 66% said, you know, I think a hearing care professional does that value. The other said, you know, probably not, I could probably take care of it myself. So again, different segments, different attitudes and different beliefs that are going to drive different behaviors in terms of whether people seek professional fit devices or not. So if we look at the Combee model, there are a variety of reasons why people might choose to go and get an OTC device instead of seeing a professional. If they're socially acceptable, if they get support from others, again, if they're affordable, if they have activities that are being limited because of their hearing in terms of capability, if they feel that they're able to select the proper device, if they're able, if they're capable in terms of fitting themselves and managing any apps or technology that goes along with it. And then if they are motivated to do so, they believe that the devices will help them if they're not concerned about stigma, if it fits their lifestyle and so on. So there's a lot of things that you have to get right in order for OTCs to work for someone. And conversely, there's a lot of reasons why people are not going to see professionals. And I think they're really nicely described by the factors in this model. So in summary, for this population, there are a lot of challenges to get this population to accept OTC hearing aids, and it's not just accessibility and affordability. There's other things that you need to be successful in order for this population who are rejecting professional care to get them some form of self-help solution. So we'll see how well companies do with that challenge when OTCs become legal within the US. Finally, let's consider this bottom-left group here. These are people who have normal audiograms, if you measure them, with the Houston Westlake procedure, but they proclaim that they have hearing difficulty of some sort and are looking for solutions. So what are the unmet needs of this group? Well, they typically complain about difficulty with speech and noise. They want a solution that is just dead simple to use. They want something that looks really good because they are a very high-demanding group. They're not going to stand for any side effects, whether it's inclusion, discomfort, other things. And then, obviously, for this group, it has to be reasonably priced. I'm not going to pay thousands of dollars for a solution for this. So there are a lot of products on the market already for this group. And they work really well. This was a data from a product that evolved from something that I worked on a long time ago. Showing on the bar on the left is the benefit that a traditional hearing aid provides for speech and noise. The middle bar shows the benefit for speech and noise that a hearable can provide. Just wearing a hearable on your ear. And then the far right bar shows the benefit you can get with a remote microphone connected to a hearable. So they can improve speech and noise. That is without a doubt. You can fit them. They can provide hearing help. But that's not the only need that needs to be met. Otherwise, everyone would be walking around with a hearable. There are over 25 million people, adults in the United States, who fall into that segment of people with a normal audiogram but hearing difficulty, particular speech and noise. So why aren't there 25 million people walking around every day wearing hearables? It's because of those unmet needs. It's not just about putting in good directional microphones for speech understanding improvement. The cosmetics have to be really good. It has to be really easy to use. You can't have occlusion. You can't have discomfort. And you've got to hit all of these. And I would say so far, it hasn't been a manufacturer that has done every single one of these features for people. So and there are other needs as well. If we apply a combi model for this group, other factors will surface in the behavior of why someone would choose to wear a hearable or not. So the summary for this group is it is a very large group out there underserved. They don't need a hearing aid because they have normal audiograms. They do not need amplification. So hearing aids are not for them, but they need a device that can help them with speech and noise. And the challenge is really about that usability, the cosmetics, social stigma, making it easy and acceptable. And this, I think this is an opportunity for hearing care professionals. I think there are people walking through the doors of clinics every day who have normal audiograms, for whom hearing aids are not a solution, but these could help. And I think it's in the best interest of the public, the hearing dysfunction public. And professionals worked this into their portfolio of treatment solutions for this segment of the population who have a hearing need, but it's not a traditional one that can be meant by traditional hearing aids. So in summary, when you think about OTC hearing aids and think about hearables and think about traditional, professionally hearing care, professionally fit devices and services, rehabilitation. It's not one size for everyone. You have different segments with different needs and you have to understand which segment a person is in order to understand which treatment is appropriate for them. And these are very large populations we're doing well with that segment D. People in segment C and E need our help. There are people trying to develop solutions for them. And but it's a big opportunity to expand the role of hearing healthcare for people who need it. So that's my thoughts on OTC and hearables and these emerging market segments in a nutshell. My contact info is there if you want to follow me and I'm happy to take any questions if you have any.