 Today I want to address two questions. One is, should we be trying to help people who have no-to-mild or minimal hearing loss? And if so, how do we go about treating them? And are there treatment strategies available for this population? So hopefully by the end of this presentation, you'll strongly believe the answer to both those questions are yes. So I'm going to do my best to convince you and kind of help you understand sort of how we think about this and show a lot of data that we've obtained here at the National Acoustic Laboratories. So for all the audiologists out there in the audience, this is a pretty familiar scenario to you. Someone shows up in your clinic and they say, I'm having hearing difficulty. I think I need help. So what do you do when you're faced with this person? Well, I think what everyone does is we rely on our gold standard diagnostics to understand what their hearing ability is. And primarily we rely on the audiogram to classify their hearing ability and then make decisions around whether or not they have a hearing loss and whether or not the audiologist can treat them. So let me ask a question of all of you. And of course, we look at the audiogram we're talking about the results. So let me ask a question of all of you. What is the least amount of hearing loss? What's the lowest number audiogram on this chart that you would be comfortable fitting a hearing aid to? And normally I ask this question in front of a room full of audiologists and they shout out numbers or raise their hands. So we can't do that here. But I want you to think about it. Which is the lowest number audiogram here that you would feel comfortable fitting a hearing aid to? So if you look at this audiogram number one, the two frequency pure tone average is less than 10 dB. I've hardly found anyone who actually says yes to this. There's always one or two in the crowd, but most people say no. Similarly for this one, the pure tone average here is less than 15 dB. And most audiologists would really not think that a hearing aid could help someone with this audiogram and they wouldn't recommend it. In fact, they would probably say you don't really have a hearing loss. And congratulations to your hearing is normal. Come back in a few years and we'll test your hearing again. It's when we get to number three that most audiologists kind of say, yeah, I think that person needs my help. And I would like to try to fit them with the hearing aid and see if that benefits them. So I think this is pretty universal worldwide that I've found when I've asked this and hopefully that resonates with you and in the audience. So as I said, there's two key questions here that this kind of sets up is those people with that category one and two audiogram, do they actually need hearing help? Do these people who actually have no hearing loss or really mild hearing loss, do they need our assistance? Do they need the attention of clinicians, audiologists, hearing aid manufacturers, hearing researchers? And if the answer to that is yes, can they benefit from hearing aids? And I think in a bigger question, what is a treatment strategy for them if they need help? So let's look at that first question. Do people with let's say even know measurable hearing loss, pure tone average of 10 dB, do they need hearing help? Well, let's look at what the World Health Organization says generally about health disability, not just hearing, but all health. So and these are direct quotes from their guidelines that a person's health and well-being are determined by their body functions and structures. So that really is what the audiogram gets at trying to measure and understand. So take that box, yes, but then it's also determined by daily activities. So that's something different than the audiogram and also participation in the world around them. That's also quite different. That's really how they function, what they're doing with their lives. And that these factors, the factors that influence disability and functioning are modified by the environmental factors. In other words, the world around you, are you always in noisy situations? Or do you tend to always be in quiet situations maybe at home? And then personal factors. Are you confident? Do you have good cognitive abilities? Or do they actually make your situation worse? So there's actually a holistic way of thinking about health care in general with any aspect of health as with hearing. But up until now, we have as a field of really only function on that first bullet point, the body function and structure as measured by the audiogram and maybe a couple other diagnostics. So last year, the World Health Organization issued this landmark report. It's quite long. It's a good read, has a lot of stuff in there that we're already aware of, but it was great promotion for hearing health in general. But this quote really caught my eye here. Where the WHO World Health Organization is saying that the audiogram should not be used as the sole determinant in determining someone's disability or determining whether someone should get a hearing aid or cochlear implant. So again, this is this is quite shocking because I think most of the world does primarily rely on the audiogram to determine someone's ability, disability and whether or not they should be treated with hearing aid or cochlear implant. And this of course begs the question, well, what else should we do? And you know, the World Health Organization doesn't give a lot of advice on that, except as what I showed in the previous slide is saying, look, it's a lot more complicated than just the straight diagnostics such as the the the audiometric measures that we take. So this is this has been supported with a lot of research, some quite recent, some, you know, ages old. This is a report that came out last year that really sent shockwaves, certainly around the US, if not the world. This is a very, very influential task force that looks at all aspects of health care and makes recommendations that are listened to quite strongly by policymakers and doctors. And they looked at the question, should there be regular hearing screening for adults over the age of 50? And of course, all of us, I think would immediately say yes, of course, you should get a hearing screening because hearing is so important causes cognitive issues, social isolation, other comorbidities. Well, their conclusion was no. And their recommendation is that they do not recommend hearing screening for adults over the age of 50. But the reason is quite interesting. The reason they give is that screening is basically a simplified version of the audiogram. And the audiogram is not a good measure to identify who needs help and whether they would benefit from devices. So they're actually saying we don't recommend screening because we don't think measures of pure tone thresholds are useful measures of determining need and determining potential benefit for intervention. That's pretty, it's a pretty strong statement. But I have to say, you know, those of us in the field have actually understood this for a long time, intuitively, probably one of my my first year in the hearing aid industry in the 90s. I remember hearing two people with the same audiogram could have completely different responses to the hearing loss and completely different responses to hearing devices. So so we intuitively have known this as a field. But, you know, we haven't really done much about it to get beyond the audiogram as as indicators of need and benefit. So 40 years ago, there was a publication that that shine a light in this looking at a very large epidemiological study, you know, thousands of people and concluded that 20% of people who reported that they had a hearing loss actually had what we would define as a normal audiogram. So even if you report that you have a hearing loss, you go to a clinic, you talk to an audiologist and say, I have a hearing loss. When you actually measure it with an audiogram, they have what what our field defines as normal hearing. On the flip side, if you look at people who self report as having hearing hearing difficulty or having, you know, good hearing or hearing difficulty, almost half the people who actually have a measurable hearing loss will say they have good hearing. So they have a pure tone average in their audiogram of greater than 25 dB, but they say they're doing just fine. Your hearing is fine. So think about that. Someone comes into your clinic, let's say you measure PTA of 35, you have hearing loss, let's talk about some treatment strategies and they go, what are you talking about? My hearing is perfectly fine. I've got no problems. Thank you very much. Imagine going to see a orthopedic surgeon and having them say, according to my measures, you have knee difficulty and I'm going to recommend you wear a brace for the rest of your life and you're like, Doc, I've got no problems with my knee. Feels fine. I walk fine. I've got no problems. There's no, sorry, my measures say that you have knee difficulty and you can't walk or you have difficulty walking. You know, this is as the same conversation we're having around the audiogram with patients and clients. So I published a couple of years ago, this assessment of the size of the population that we're talking about here, of those who have hearing difficulty, but actually don't have a measurable hearing loss. And in the US, I estimated that to be about 25 million people. And if you look at the number of people who say they have hearing difficulty and actually do have a measurable hearing loss, it's about half that. So this is a big issue. There's a lot of people out there who have hearing difficulty but don't have a measurable hearing loss. On the converse side, you actually have quite a few people who have a measurable hearing loss but don't perceive that they have any problems. So relying on the audiogram in order to determine need and determine the need for treatment, really the evidence doesn't hold up. And I think it's a field we've known about this for a long time. But we still haven't done much about it. And I think this paper last year of Sumit Dar and his colleague summed it up nicely, talking about the arbitrary nature of how we categorize hearing loss with the audiogram. And again, here's a quote from that paper. The audiogram alone cannot adequately predict the impact of an individual's hearing loss. And so just over and over again, the evidence is compelling that we need more information than the audiogram in order to determine need and determine whether we should try to treat them and what the treatment should be. So I don't want everyone to think the audiogram is useless. The audiogram certainly has its purpose if only for record keeping and if only for good clinical practice. But it also tells us something pretty fundamental. And that's what sounds are inaudible for that person. And this is important because it provides guidance if you do end up treating them with a hearing aid. It gives you a good indication of how much gain you should provide for them in order to restore audibility. We also know that measures of inaudibility are correlated with difficulties with speech understanding. The problem is, is it's not a really strong correlation. So here's some data from quite a long time ago showing on the X-axis, the high frequency average of hearing loss on the Y-axis, percent correct in the speech score. And you see this general trend that as hearing loss gets worse according to the audiogram, speech scores get worse. But look at this group of people here between 45 and 50 dB of high frequency hearing loss and you have quite a large spread in speech capability, speech understanding ability. So again, there's a correlation, there's an indication, but it's not sufficient for you to make a strong determination of how someone is doing and how you should treat them. So Larry Humes last year addressed this really in the context of over-the-counter hearing aids, where someone wouldn't have available to them a proper audiogram. And the question of, well, how do you determine whether someone should get an over-the-counter hearing aid if you don't have an audiogram to guide you? So his recommendation is to use a very simple screening questionnaire, the hearing handicap inventory for the elderly HHI, which is 10 simple questions, very easy to score. And you end up with the total number from zero to 40. And his suggestion is you use that as a good indicator of self-assessment of the impact that hearing is having on their lives or hearing difficulties having on their lives. Here are the questions. And if you look at the questions, these are very similar to the kind of questions you would ask a patient if they walked into a clinic about their hearing difficulties. So obviously, in addition to the diagnostics, you would say things like, well, where are you having problems? Do you have problems hearing your friends when you're socializing with them in a noisy situation? Do you have problems hearing a TV and so on? So 10 questions, each question gets a score from zero to four. So you end up with a total of zero to 40. And Larry recommends that you use a criteria of 10, that if you have 10 or worse, 10 or higher on this survey, then you have some level of hearing difficulty due to your hearing. And there should be a consideration of help. So he looked at a very large scale. He pulled together several epidemiological studies. So he got thousands of data sets of data points of individuals where they had both their audiogram and they had their HHE score. And so here's the joint analysis of both where you see the general trend. This is the audiogram on the bottom axis here going from zero to 80. This is the HHE score going from zero to 40. Again, where zero means no difficulty at all and 40 means you're having the greatest difficulty in the world with your hearing. And you can see the general trend that as hearing loss increases, the HHE score increases. But there's still not identical assessments. So what do we do today? Well, we look at the audiogram only primarily. And we say, okay, if you're to the left of this line, 25 dB, you have hearing loss, you do my help. If you're to the right, you know, your hearing is pretty normal. Fine, don't worry about it. There's nothing I can do for you. Larry recommends that you look at it this way. That if you're below this line, your HHE score is greater than 10, then you have hearing difficulty. There's no denying it. And there could be a potential for help. But if your score is less than that, you know what, you're not experiencing much difficulty because of hearing in your life. And it's questionable whether you need help or whether you would benefit from help or whether you would even use the help that's given to you. So let's look at the combination of these two and how they compare. So there's that dotted line with the HHE score. Here's our 25 dB pure tone average measure. So this group right here are those who we would say according to the audiogram, you have a hearing loss. And if we measure the HHE score, yes indeed, you have hearing difficulty. So the majority of people who have hearing loss fall in here and we'd be doing the right thing using either criteria saying yes, you need help. But look at this group here. They have hearing loss worse than 25 dB, but they have very minimal scores on the HHES. They seem to be doing just fine in their lives. But think about the conversation that you're having with this client or patient if you don't understand what their HHE score is. You're saying boy, you have a 35 dB, 40 dB hearing loss. You really are having, you're struggling with hearing. I'm going to recommend a hearing aid for you. And they're saying, what are you talking about? I've got no problems with my hearing. I'm just fine. I just came in because my spouse told me to come in or my work made me. Thank you and goodbye. So we're wasting a lot of time, in my opinion, on this population because they don't self perceive as needing help. They don't want to hear about it. They don't want a solution. If you give them a solution for free, they're not going to use it. But now what about this group down here? There are people who have less than a 25 dB hearing loss. We're going to say, great, you have normal hearing. You don't need help. But they are struggling. They are getting very high scores on the HHES. They are struggling because of their hearing. They need help, but we're not acknowledging it. And we're telling them, don't worry about it, and not trying to solve the problems, not trying to improve their lives that are being impacted by their hearing ability. So this is the population, I think is really the focus here, where we have an opportunity and there's quite a large number of them. We have an opportunity to help people who right now aren't getting help for a variety of reasons, one of which is we aren't measuring their hearing difficulty in the best way that we can. So the summary so far to answer this question, the audiogram is a pure indicator of need for hearing helper, hearing aid, and many people with this minimal hearing loss have significant hearing difficulty and they need hearing help of some sort. So now that begs the second question, can this population benefit from hearing aids or more broadly, how do we help them? What is a treatment that can help them? But we were quite interested at NAL to look at the question of can hearing aids help this group, because I think the intuition of most people around the world is no. Hearing aids, no one wants hearing aids, you really have to struggle to get people to use hearing aids and sometimes they don't benefit. There's no way someone with no measurable hearing loss is going to benefit from hearing aids, I think would be a standard response from most people to this question. Well, we decided to test that. So one of our researchers, Joaquin, at NAL, did an investigation to one to understand the attitudes of people with these minimal hearing losses towards hearing aids. And then we actually did, we measured the benefit that hearing devices were giving for these people. Well, we fit them with RIX, we measured in the laboratory speech tests, listening effort, I think we may have done some EEG, we did extensive field trials with our environmental momentary assessment app to see how people are doing in the real world. Then we had extensive surveys at the end of the study. So a ton of data that I'm not going to get into here because there's going to be a separate sound bites where Joaquin will go through the details of that and another related study. The highlight though for me and what it's important for you, I'll give you here. So we had two groups in this experiment. One group was fit with a traditional RIC from a major manufacturer. We fit them with 8 dB flat insertion loss so that what they're hearing, sorry, 8 dB flat insertion gain, sorry, so that what they're hearing is the amplified sound. We activated noise reduction, directional microphones and beam forming to help them in noise. We had another group similarly matched in age and size and an audiogram. We also fit them with the exact same hearing aid, but for this group, we fit them with 0 dB insertion loss and we turned off all of the noise features. And the reason for this control group is sometimes in these kind of studies, people report benefit just because there's a halo effect or they think they should or they're guilty if they don't. And so we didn't want to conclude that hearing aids can help people if it's really a placebo or a halo effect. So we actually gave people a placebo hearing aid and if both groups get the same benefit, then I think we can conclude, you know what, hearing aids aren't really helping except with this halo effect. But if we see a strong difference between the two, then we can say the benefit is real. So here's the audiograms of the groups that we tested here. You can see up to 8 kHz on average, 10 dB of hearing loss or so, although a more significant loss up at 12 kHz. But I think most people would look at this population and go, you don't have a hearing loss, don't have a hearing problem, I can't help you. So here's, I'm going to cut to the chase here in the end results. After the end of the study, again, we've got a ton of data which we'll present at a different sound bytes. When we ask them a series of questions on how they did, here we have the results from the control group and the experimental group. And this is a scale from 1 to 5 where 5 is they strongly agree and 1 is they strongly disagree. If we look at a couple key questions here where there's a big difference between the two groups, are you convinced that obtaining your hearing aids was in your best interest? The group that actually got amplification and got the beam forming and noise reduction pretty convincingly said yes, they were convinced that this was in their best interest. The control group basically said no. And if you look at question 6, do you think your hearing aids are worth the trouble? The experimental group again said yes, control group said no. So again, this is really surprising because I think most people would think if someone has normal audiogram, they're not going to, the hearing aids are not worth the effort, not worth the trouble, they're not going to want to wear it. We then asked them the question, which for me is this is the million dollar question. Would you continue to wear your hearing aids now that the study is over? Well, in the control group everyone said no. And primarily when they were able to write in any description reason why they're responding the way they did and basically they all kind of said, they didn't give me any benefit, don't want to wear them. The experimental group, at least half the people said yes, they wanted to continue to wear hearing aids. And when asked why, the reasons were very consistent because they were getting benefit in the situations where they needed help. They weren't getting benefit all the time and they probably didn't need help all the time. But where they were having difficulty, the hearing aids help them. And if you look at the very bottom there, the benefit that I gained from them is too great to not use them. This is pretty strong and compelling evidence that even people with normal audiograms can benefit from hearing aids. Traditional hearing aids, by the way, receivers in the canal. However, traditional hearing aids are not the only solution for a group like this. There's a variety of devices out there, tools, apps that can help them. You see hearables across the top. The bottom left is an attachment for an iPhone that actually the technology was developed at NAL, a beam former that will give really good pick up and beam the sound to either hearing aids or devices. You've got an app on the bottom right that can sort of give hearing aid like functionality. There's a variety of apps. Then you've got, you know, just non-standard hearing solutions. So there's a lot of options out there besides traditional hearing aids. They each have their advantages and disadvantages. Most of them function pretty well and provide speech and noise improvements, but they vary dramatically in terms of the usability, in terms of comfort, in terms of fit, in terms of ease of use, in terms of how they look and feel. And so it's really important to understand the differences in each of these. So we have looked at several of these, one of which are the Apple AirPods Pro. So Jorge Mejia and Nicky Chong White spent quite a bit of time understanding what the AirPods Pro do when they go into what is sort of a hearing aid mode. They don't call it hearing aid mode, but they function very much like a hearing aid. When the AirPods first came out, or soon after they came out, they had a feature called transparency mode. And what this was because the AirPods include your ear and block outside sounds, if you wanted to hear the world around you with the app, you could turn on microphones on the outside so you could hear things around you. Well, it doesn't take a wild imagination to understand if you can have a microphone that picks up sound around and delivers it to you, you could then add some amplification. And that's what came next from Apple. They introduced something called headphone accommodation that then allowed you to create some high frequency gain. And so if you go into the app, you can see on the left here, you can select if you activate headphone accommodations, you could select various different presets that are essentially different amounts of high frequency gain and compression. And you can modify the strength of that gain and compression. Or you can actually enter an audiogram and it will tune the gain and compression to your hearing loss. But it's not a hearing aid, but you can fit it to an audiogram and it'll give you gain and compression to that hearing loss, but it's not a hearing aid. And this is because of the legal definition of what's the medical device and what's not an indication for use, won't get into it here. But it certainly has similar functionality to a hearing aid. And then one last piece of the puzzle here, when they added headphone accommodation, it was still omnidirectional microphones. So think of someone with normal hearing, but needing speech and noise difficulty. Would they benefit from omnidirectional hearing aids? No, because it's not going to help them in noise. So the last piece of the puzzle from Apple was what they introduced last year called conversation boost, where they introduced ear-to-ear beamforming to get good speech-to-noise pickup in noisy environments, or at least that's what they promoted it as. So same kind of beamforming, presumably, that we have in traditional high-end hearing aids today. No directional microphones, though, and they added some strong noise reduction as well. Single microphone noise reduction. So we wanted to understand what are these actually doing? So we did a lot of measures. We used some ANSI standard measures that you would typically do with hearing aids that we've published. We did electrocoustic measures on keymar and on heads. And I'm just going to give you a sense of what we found. We have sound bites coming up that's going to get into a lot more detail on this. So the transparency mode, which was just to allow you to hear the environment, we measured the insertion gain. And here's what you see here. Zero dB insertion gain. So Apple did a really good job of just passing sound through fairly naturally. So that was good. We then looked at these headphone accommodations, where they are applying high-frequency gain. We selected the preset brightness mode. There's three different modes. We looked at brightness. And here you can see for 50 dB input, that's the blue line, you're getting close to 20 dB of gain and above 2000 hertz. And then with compression, the gain goes down as the level goes up until you get up to 80 dB input. And it's about 10 dB of gain. So you think about mild hearing loss, that's probably not bad. It'd be interesting to see how people with mild hearing loss would benefit from this. We actually looked at that. I'm not going to talk about the data today. That'll come in a future sound bites. We then entered some standard audiograms to see what the AirPods did, if you actually enter the hearing loss. So we looked at several audiograms. I'm going to show you the results for a mild sloping loss here. We entered that. And this is the gain that the AirPods gave. The solid lines are the AirPods gain. The dash lines are the NAL NL2 prescription target gains. So if you look for the gain for 65 dB input, that's the red line, you can see that the AirPods are pretty close to the NL2 prescription. But for soft level sounds, the blue line, there's quite a bit less gain than the NL2 prescribes. And for 80 dB input, there's quite a bit more gain in the AirPods than NL2 prescribes. So for conversation level speech, it's about right, for louder sounds, it's too loud than what we would fit a hearing aid to. And for soft sounds, it's not enough gain. But it's not bad for a consumer company that clearly isn't trying to create a hearing aid, but it's just trying to give some people some help if they need it with their consumer relatively affordable device. Finally, we looked at the when conversation boost came out, we looked at the benefit of the beamforming, using again someone sitting in a circle of speakers and target speech from the front and noise from around. This is the speech to noise ratio improvement we saw. You can see the zero line here. So anything above zero is a benefit to speech understanding. The purple curve down here, this is just that omnidirectional mic headphone accommodation. So it's not really helping at all as expected. The noise reduction algorithm, single microphone noise reduction is giving some SNR improvement down at the very low frequencies, which is where we would expect it to be. The beamforming alone was giving quite a bit of speech to noise ratio improvement. You can see up to 12 decibels at 500 hertz, more like four or six at the higher frequencies. And the combination of beamforming and noise reduction was giving quite a bit of speech to noise ratio improvement as well. And this is at the level of what you would get from the most sophisticated hearing aid on the market today. So really good speech to noise improvement. This is laboratory measures. Again, it begs the question, what's the real world experience by people measured both in the lab and in the real world? We've done that test. We recently finished that experiment and we're going to get into a lot of detail on that Joaquin will add a future presentation. So to summarize the results from both the first and the second question now. So many people with this minimal hearing loss do have a significant need for help. And I think we as a profession can help them. And this population, some of them anyways, can benefit from hearing technology, including hearing aids. Not just hearing aids, but hearing aids are helping, as are hearables, as might apps and other hearing solutions that are on the market today. And finally, just a reminder, the audiogram isn't the only way of determining whether someone has need. And it's actually insufficient. It's an insufficient measure of determining need and whether someone would benefit from treatment.