 Thank you everyone for tuning into this session of soundbites, looking at real-world evaluation of over-the-canada hearing aids. We got a fair bit of work done in this space at the National Acoustic Laboratories, so my work can only be seen complimentary to the significant effort my colleagues and now I couldn't try to understand who would benefit, who are the people, and why they would benefit from these type of technologies, and also what are the barriers and limitations of different types of support people might get in relation to improving the ability here in the world as they go about communicating in everyday these situations. For my specific talk, I will cover topics in relation to the O2C hearing aid devices, specifically who needs O2C hearing aids. We will look at one example of self-fitted technologies, some of the metals efficacy and safety issues you might consider when you look at this type of technology, the benefits of O2C hearing aids, and some of the barriers and difficulties some of our participants in research have encountered while evaluating these type of technologies. So we got a fair bit to cover, so let's jump into it and let's start with the introduction that Cheong gave quite eloquently about what are over-the-canada O2C devices. So the FDA definition for O2C is that over-the-canada medical devices are those that may be offered for sale directly to the consumer. So in other words, you don't have to go to a clinician anymore, you might be able to look onto the internet on a website and request one of those devices for yourself and you might be able to wear them. One of the main criteria from the FDA point of view is that these devices need to provide some sort of safety to the user, need to be effective in improving the quality of hearing that person is seeking to resolve and they need to be affordable and therefore the building component means that they don't need to pay for a clinical intervention, a secondary pathway for them to be able to receive these devices. So that is one of the reasons why we need to look at O2C devices. The other reason why we need to see O2C devices is because we call many people around the world that require some sort of assistance in this and O2C devices offer an opportunity for them to have accessibility enough for the ability to these types of technologies to resolve the communication problems. Yes, together there. We went to the next slide. So what are those markets? Well, more specifically, the reason why we have O2C the markets is because we are going to skip the requirements for seeing a clinician to be able to fit these devices. So we're looking at direct to consumer accessibility or pathways. These devices will be managed by the person who purchased them in terms of how to fit them into the gears and how to manage the everyday usage technology with some support, of course, from the product, from the industry that creates technology. Now, but who needs O2C hearing aids? Well, the obvious group of people that may require hearing aids are, of course, those people with some degree of hearing loss. So when you reach the 20 dB hearing loss criteria and you need to have some sort of application, you may be qualified to a hearing aid in general or you may be recommended to wear a hearing aid to resolve your ability issues. But of course, the problem is bigger than that. Let's be trying to illustrate that by this figure here. So what we have here on the X axis is hearing loss. This is the conventional audiogram average across four frequencies that would be the 501K to K and 4K. And on the Y axis, we have essentially a survey, which is called the hearing handicap inventory. And the hearing handicap inventory asks the questions of how frequently you encountered difficulties in everyday communication. So the higher the score, the more difficulty you have in communicating everyday listening. So typically, when we look at the dispensable recommendations of hearing aids, we tend to look at the audiogram because we have a diagnosis of hearing loss and we tend to guide our ability to see hearing aids based on that diagnosis. We got the PTA or the audiogram to product hearing aid devices. So when we actually reached the magical number of 20 dB hearing loss or above, we might consider that the person may be a good candidate for hearing aid devices in general. Now, when you look at the Y score on the other hand, you will see that people encounter difficulty communications when even when they are very near or very normal hearing. And so when we look at potential opportunities for these kind of technologies, we're looking for a larger range of people that may be able to access technology to resolve the communication needs. This group of people may be then there may be a number of reasons why they need the kind of technology. One could be the financial component, but the accessibility to this kind of technology makes a little bit more viable solution for them because without it, they may never reach or they never consider to actually wear hearing aids and resolve communication needs. Now, what's interesting about this group of people and what's interesting about the Y axis is the Y axis queries the frequency of problems people might have, but the basis for them to generate this type of information is actually the hearing loss. So they actually develop a criteria for fitting devices when they score or recommend fitting devices when the score exceeds a certain number in this particular case, 8. When people score above 8, there's a potential recommendation for hearing aids. When people score below 8, there is not. However, with the interesting experiment now, trying to explore these a little bit longer, a little bit more, we do an online survey where we asked several people about this particular type of scoring and we related that to some other aspects of the daily life activities, particularly the personality traits. And what we found using machine learning exploratory tools is that people with a high level of neuroticism, which impacts you essentially life style, tend to score higher in the HHIS, people with low levels of neuroticism, people that are not impacted by these tend to score lower. So there might be some factor influence that influence the everyday activity that may or might be not related to hearing difficulties in noise. What's also interesting is that if you have a lower level of neuroticism, you tend to score more poorly when you look at speech-inteligible assessments than when you have high levels of neuroticism. And of course, that gives them a very indication that perhaps a lower score on the HHIS, as soon as people describe a problem in communication, perhaps those are the people really we need to focus on when we consider all the OTC devices. So as soon as someone has described a problem here, perhaps there could be a potential candidate for this type of technology. And not to remember, by the time people come to us and tell us there is a problem, probably they've been hiding the problem for a long time, trying to manage it themselves. So by the time they actually tell us there is a problem, probably the problem is more severe than what we actually think it is. So let's now explore a second component in relation to this type of technology, and this is the idea of self-fitting. And when it comes to self-fitting, we always think about the friction gains, and we don't know we need to match those gains. If you look at the guidelines we tend to follow, we believe that, or we often think about the targets we need to reach, should be within the 5 dB reference between the 2, 50 and 2,000 kHz in relation to the prescribed indication and the prescriptions, like now NL2, may tell us to achieve. And in the high frequencies it's likely higher to about plus or minus ATV. So if a person is self-fitting their devices, do they achieve this kind of very tight criteria, because I think on the day they need to do it themselves? And as we know, placement in the year canal may influence the ability to how accurate these amplification profiles would be established. And you are an ideologist, you know that even positioning the profile in the year canal is an impact on this match-to-target type of assessment using real year measurements. To actually evaluate that, we conducted a clinical study in collaboration with our company partner sponsor, Paramount New Hero. And we also extended that study as opposed to the study test at the end to determine some of the barriers people might have with this type of technology. So in this clinical study, we actually involved a technology called New Hero acubats. These are the pro devices, and these are here next that are pending clearance, still pending clearance from the FDA at this point in time. Nonetheless, we evaluated them with a group of participants from our lab to 41 participants, and they have near normal and mild hearing losses. But one of the things they have in common is that they all consistently reported hearing noise difficulties. And of course, the devices in the study were self-fitted using the proprietary software that New Hero calls the New Hero ER ID. So these are some of the results we observed in our study. So on the left side you see the actual pure tone audiograms that they were acquired by the clinicians. These were done by a clinical support. So we used red measures to determine these audiograms. And then on the middle line here, what we actually see is the insertion-gain measures in relation to the targets. So we look at the deviations from target, essentially. So the red lines in these figures indicate the plus or minus 5 dB from target, and the different figures indicates the level. So we start from the very low levels of 55, 65, and 80 dB SPL. And what we can see that the most important thing to note in these figures is that the level, the deviation from target is created by the white indicated by the white axis. For the low, middle, and high levels are between the 5 dB range, except when we hit some high frequencies. Now we actually tested how important that was using statistical measurements. And these are tabulated here, where it's actually showed around 4K. We have a significant deviation for target across the participants. And of course, these measurements show the average scores across participants. When you look at individual measurements, there is a slightly larger deviation, of course. But from a group progression point of view, we don't see that the average for the middle range for parallel frequencies has a significant deviation from the prescribed criteria of amplification only in the high frequencies. Okay. So what we did then, once people self-fitted this device, the next step in this clinical study is to allow them to go out in the real world and to tell us how they experience the real-world environments, using something we called the EMA, or Ecologically Momentarial Center Technology, which is essentially an app that tells you that people that serve as the person about the listening experience when they are having the communication, having the difficulty in communications. So the app will actually start when the piece of heaven, when the person has a conversation or the participant has conversations in the real world and the participant needs to enter the experience in the app. The app records the experience and at the same time, it records the environment they are in in terms of acoustic features, environment tests, and the type of environments people find themselves. And then we bring this to the lab and we do some very deep analysis of that data to understand what the person experiences in the real world in the real world. So when it comes to the laboratory assessments we do before people actually go into the real world, we ask people to evaluate these type of technology in relation to listening to sound in front of them using loudspeaker array. So we position noises around them. We simulated some sort of restaurant. We use ambisonic type of reproduction and we present a target speech in front of them. So one of the things we found is that the device when had the directional microphone activated provided the greatest benefit across multiple dimensions of listening. So those dimensions of listening we assess are describing this as by the plot in relation to speech naturalness, being able to follow the tool car, eliminating the annoyance of the background noise in the lens of the background noise, as well as the sound quality. You can see that the more out of the figure the plot, the lines on these aspera plots are the beta for the participants and when people activate the directional microphone, they tend to have beta perception of the naturalness, ease of difficulty, and satisfaction when listened to the background noises as well. So in general the devices in the lab provided a much better experience, although we did not see a significant difference between the aided and the aided condition, although there was a slight improvement for the aided conditions in terms of perception. Now let's move into the real world benefit and to asset the real world benefit. We asked the questions about the frequency of travelled people my head while communicating with others, which is captured by a questionnaire called the AFAP, and it captures these across multiple dimensions. One of the dimensions relates to the ease of communications, the difficulty of reverberation, background noise, and assertiveness, and that is the detection of annoying and pleasing high noises like squealy sounds people often perceive with hearing amplification. So across the main criteria of communication which are the ease of communication, background noise, and reverberation, and we notice a significant difference between the aided condition and the condition when the participant was aided, when we actually saw significant drop in the frequency, in the frequency when people reported problems in those conditions. So in other words, the aided condition assisted the participants in communicating more effectively in these real-world listening conditions. The EMA also captured real-world experience, so we actually saw that in proportion to us, the people reported more benefit when they wear the devices, which is shown by this dark gray area on the plot than where they're not wearing the devices, or when the devices make no difference in the communications in everyday listening situations. So most of the benefits were reported when people were aided, and there were some instances when people, a significant number of instances when people reported benefits also from directional amplifications. What's interesting about these is that people also reported not benefit when we were expecting some benefit, people when directional microphones were on, and the reason we expect benefits is because we saw that in the laboratory of course. Every time you switch to a directional microphone, you expect to see some sort of improvement by listeners. One of the reasons we were observed that people were not perceiving a benefit with directional amplification was because simply the environments were not noisy enough for the directional amplification to provide any advantage in listening, and this is displayed by this figure when we actually show on the x-axis, we show the level recorded by the app in terms of the environment level, and on the y-axis we show the number of times people reported a significant improvement from the devices, and we can see that the improvement was leaning towards when the level was highest and less so when the level was lowest, which isn't as a relation to what people might hear around them in terms of level. Very quickly, I'm just going to show you that we also related the match to target, the addition to target to the actual scores people were reporting through the EMA and also through other means, and that would give us an indication whether people, the difference in match to target was predictive of the benefit and we found that whether or not people have a very good feeling or not did not predict the outcomes for our study, so the fact that people have a few deviations from the target gains that the formula prescribed in this case the NAL M02 did not predict it without people benefited, had received any benefit from these hearing aid devices. The devices were user-friendly and this is clearly described by this figure when we actually look at how easy was the ear ID, how easy was to feed it into the ear, and how easy was to use it. We used the app the device came into and the easiness is described by the yellow and these purple lines covers and you can see that they cover most of the charts across all the different dimensions, so in general the devices were mostly very easy to feed and very easy in the app that came with the device was very easy to manage. One of the interesting people described in terms of wearing devices whether they like it or not, so this is that the cloud figures lab words on how frequently we observe words like usability, denoising amplification when people like the devices in relation to when people didn't like the devices we often saw things like occlusion, bulkiness and a little bit of that tension to the technology. So there are many pros on wearing the devices according to our participants and there were some cons. So just to summarize this the technical message behind this is that hearing aids, these type of hearing aids may offer regular consumer with a clinical intervention, who needs the devices, people with normal tumor hearing losses, and who report hearing difficulties hearing in everyday situations. The software technology the apps were very easy to use, we saw no evidence of adverse events in our studies, and even when we observed some deviation to targets, these did not have an impact on the overall benefit we observed out in the lab or in the real world. We observed significant benefits of the devices in some situations, in many situations, particularly when we had noise around the listener, so there's an indication that people might benefit from some casual usage of these devices, and we saw some barriers in relation to the connectivity to the phones. This is quite typical when you actually have devices that need to communicate with more technology, and also on the sides of the devices there were some reported issues, but very very few listeners in relation to being able to feed the devices into the ears. Okay, I hope this gives you some glance as to what the OTC devices offers to the world, and I would like to acknowledge my collaborators are now and also the sponsor for the clinical study we did, a new hearer team from Australia in the US.