Dementia and Hearing Loss

In Episode 3 of the Hearing Tracker Podcast, we had the pleasure of interviewing Nicholas Reed, AuD, assistant professor in the Departments of Epidemiology at the Johns Hopkins University Bloomberg School of Public Health and Otolaryngology-Head and Neck Surgery at the Johns Hopkins University School of Medicine.

Dr. Reed discusses his recent work with the ACHIEVE Trial, which is exploring the causal effect that may exist between hearing loss and dementia. He also talks about the importance of best-practice audiological care, especially as it relates to the oncoming over-the-counter (OTC) hearing aid era. Lastly, Dr. Reed highlights the importance of hearing loss accessibility in healthcare settings, with some actionable suggestions for administrators looking to improve accessibility.

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Episode transcript

Steve Taddei (Host): This is the Hearing Tracker Podcast from HearingTracker.com. Hello everyone, and welcome. This is the Hearing Tracker Podcast. And I'm your host, Steve Taddei. On this episode, we are joined by Dr. Nicholas Reed and he is an audiologist and assistant professor at the Johns Hopkins University School of Medicine. Welcome, and thanks for being on the show.

Dr Nicholas Reed: Thanks for having me on.

Host: So before we get started, can you tell us a little bit about yourself?

Reed: Yeah. So I'll start with the beginning. I'm born in Baltimore. I work in Baltimore. I don't know if you could come more full circle than I have where my family owned a small fish market right next to Hopkins Hospital about a quarter mile away. And now I'm back. I didn't mean to be back, but I ended up there. So I am an audiologist by training. I did my AuD at Towson University. Fully intended to be a clinical person. Wanted to work with kids actually. And I spent my entire fourth year mostly doing pediatrics at Georgetown University Hospital, but through sort of the research I was pursuing at the time and sort of my passion area for public health, I really found a niche need I think in older adults. And I shouldn't say niche because it's the vast majority of hearing loss, to be honest, and through my sort of love of public health, and sort of being somebody who likes stats and likes thinking about those numbers. I got closer and closer in epidemiology, and eventually became an assistant professor in the Department Of Epidemiology at Johns Hopkins, Bloomberg School of Public Health. So even though I am a clinical audiologist by training, I truly spend my day living in this world with epidemiologists and biostatisticians every day.

Host: You've worked a lot with the ACHIEVE Trial and that's kind of a big topic right now, this correlation or any type of connection between hearing loss and then cognition. So it's been getting a lot of focus the past few years. And that is exactly what this ACHIEVE Trial is looking at. So can you tell us more about the topic, your findings and what it means for people with hearing loss?

Reed: Sure, so it is a hot topic right now. I mean, it's exacerbated too by they just released an update of the Lancet Commission Report where they showed again, the largest attributable risk to dementia is hearing loss and that makes it the largest modifiable risk factor of any, of any other risk factors. So it's larger trivial risk than hypertension, obesity, education, things that we normally would think of. And I think hearing loss is a surprise for being such a large risk, and the way you interpret that, by the way, I think it's always good to sort of talk through that is if you eliminated all hearing loss in the world, you would eliminate 8% of dementia in the world. That's, that's how those big attributable risk models work. So the ACHIEVE Trial itself is built off of years of research. And this research starts with Dr. Lin, who's one of the co-principal investigator with Josef Coresh on the ACHIEVE Trial, showing that hearing loss is what you could refer to as independently associated with cognitive decline and dementia. And when we use the word independent, we mean that over and over again, we meet the criteria for causality. And so there's this idea of causality and there's this criteria called Hill's Criteria, which is really based in epi[demiology]. And it's basically a checklist of things to show that, you can really sort of believe what you're seeing, right? Because it's so easy to just, it's easy to have like these spurious conclusions, right? This is where people often say, Oh, it's correlation, but correlation is not causation. And I think people say that to sound smart, but to be honest with you, if you really are following literature and have a strong grasp of the framework and the epi, I think that that phrase doesn't really make sense anymore. And at its core we can hit the basics, right? There's biologic plausibility, right? We know what hearing loss does. And we have a biologically plausible mechanism for how that would cause cognitive decline and whether it's cognitive load, whether it's brain structural changes from adding a signal to the brain and then atrophy without a signal, or whether it's social isolation, we have pathways that make sense. Then we've seen the same findings repeated in different datasets. We have no reason to believe there's a reverse causation of cognitive decline on pure tone measures, self-report is a different story, but pure tone measures are a reverse pathway on a cognitive decline study, not necessarily a dementia study, but a cognitive decline study is pretty difficult to make a case for. People are doing it, and the truth is though most of that research, I see they're using speech measures of some kind and that's sort of difficult, 'cause that does require some processing that could have a reverse pathway. We see longitudinal data where we see temporality established where hearing loss comes first, before cognitive decline. We also see over and over again, this sort of dose response where if we saw something like, oh, hearing loss is associated with cognitive decline, but then we measured it by, let's say different categories of hearing loss. And we saw that mild is highly related in some way, highly associated, but then severe wasn't, it wouldn't make sense anymore. But instead we actually see a pretty consistent dose response pattern where, a classic paper of Dr. Lin's is he looked at 680 people in the Baltimore longitudinal study on aging over 16 years. And at baseline, no one had dementia. And then they looked at time to event as dementia. So it's a Cox proportional hazards model. You can interpret it as sort of like odds. And it's basically people with mild loss, two times the odds of developing dementia compared to those without hearing loss, those with moderate loss, three times the odds, and those was severe five times the odds and that severe one, I'll put a little caveat in because there's a very small number there of people with severe loss. And so the confidence interval is quite wide, but the other ones are relatively tight confidence intervals and they sort of make sense. I think you could easily make a justification for grouping the severe group in with the moderate group. So that's a long way to introduce the ACHIEVE Trial, which is actually looking at in a clinical trial setting, whether or not hearing aids delay cognitive decline. And you may think to yourself, well, why do we need a trial to show that? If you can show that hearing loss is associated with cognitive decline in these big epi studies that show information across the US with thousands of people, why can't you just look at well, the hearing aid users and see what they're doing. And the answer to that is hearing aid use in the United States is so associated with socioeconomic factors, such as well, race, race and ethnicity, education, income, wealth, those factors are also protective of cognitive decline. And it's a good time to do a little bit of education even than say the race itself is not necessarily what's associated with cognitive decline. When we put race into an epidemiologic model, we're actually putting racism into that model. And we're showing that it's the systematic racism that is actually truly affecting. There's no reason that a black American versus a white American necessarily would develop dementia faster than one another. There are some biologic plausibilities for different diseases, where melanin may affect something, but in this case, we're really, really putting on a population scale, racism into the model. When you have those factors, though, that are associated with hearing loss or hearing aid use, sorry, that are also associated with dementia. It becomes really hard to tease that apart, statistically, no matter how many times you put this into your model and you say, quote unquote, we've adjusted for it. You can't necessarily adjust away bad data. I think you'll hear in science sometimes that, stats are phenomenal, right? To look at observational data, but a well-designed trial is better, right? If you can design it upfront, it gets rid of all of these biases. And so that's where a randomized control trial actually comes into play here. It's the gold standard for measuring this. And so the ACHIEVE trial takes adults with mild and moderate hearing loss who are 70 years and older and randomizes them to best practice hearing aids or sort of a healthy aging equivalent. And then we look at them over a three year period. And that healthy aging equivalent is basically meeting with a nurse. The original intervention is called the 10 keys, but we use it as the nine keys. And you basically talk about healthy aging factors. So you may talk about staying physically active, quitting smoking, diabetes management, nutrition, something like that. We removed the cognition piece because that would directly affect the outcome. And so people are randomized to either side, the best practice hearing intervention is designed by, our team, I think had minimal design in it. I really give the credit to Michelle Arnold, Vicky Sanchez and Terry Chisholm down at University of South Florida, who they sort of took it from several other models and they built this best practice model built around sort of needs and goal setting. And so someone comes in and we basically set goals using a COSI, and then we modify based off that COSI what their counseling is going to look like, and we really focus in on achieving all those goals. We do real-ear measures. We have assistive listening devices, it's best practice in terms of the fitting, but I think what makes it so powerful is that there's so much of that like aural rehab aspect and counseling built in. So it ... You know ... When you have that much of a, of like a representative best practice intervention too, I think it's important to establish that this is an efficacy trial and not necessarily effectiveness. What it means truly is that under this controlled setting, using best practices, do we see a difference? And whether that translates to the real world is actually a question for probably another trial or pragmatically looking at research or data over time to decide if you use like sort of half best practice, like if you're one of these folks who, gives someone a hearing aid and you fit it one time and you don't really do a lot of counseling and you don't have much follow-up and you just say, come back every six months or whatever. Or when you need me, we don't know based off this trial, if that's going to make a difference for cognitive decline. And so after that, we measure cognition at regular intervals three years is the outcome period, at this point the trial has finished recruitment. So we have 977 adults randomized. It's across four sites in the country. It's Minneapolis, Minnesota, Hagerstown, Maryland, Winston-Salem, North Carolina and Jackson, Mississippi. I think what is important is that Jackson, Mississippi site is an almost all black cohort and Winston-Salem, North Carolina also has a large, relatively large black population. We nested this study within the atherosclerosis risk and communities trial, which is a longstanding cohort study originally set out to look at cardiovascular factors, but has become sort of an aging and neurocognitive study over time. And so several of the participants in the study, and when I say several, I mean about a third are actually from that trial. So we have their data going back to 1987. And that is pretty powerful. When you think about it, it's a way to like leverage science, because instead of saying across our whole cohort, we just have three years. For some people we have 30 years of data. I mean, we can really look back and see how their trajectory has changed. And then when we added hearing aid use, did we cause sort of a, you see a change in slope, let's say of cognitive decline at that knee point. So it's pretty powerful. And it's also powerful to, it is a population based study, but it's nice that ARIC thought about the demographics of the United States when they set up that trial so that we have a good representative representation of the US, right. 'Cause generalizability is key in the end, a trial's no good if you only, we're seeing this with vaccines right now, if we do these vaccine approaches only in young, healthy white adults we're not able to generalize the vaccine to the rest of the United States.

Host: So I wanted to clarify a few points for our listeners. So you had mentioned the COSI and best practices and real-ear measures. So the COSI is a questionnaire that can be filled out prior to being fit with a hearing aid, to see how much you're struggling and basically what effect that is currently having on your life. And then you follow up with that COSI during your kind of rehabilitative process. You can better assess the outcomes in what improvements it is having. Would you say that's right?

Reed: Yeah. I think that's accurate.

Host: So for real-ear measures, when you fit with hearing aids, they have preexisting programming in them based on your hearing loss. So basically they will look at your hearing loss and say, here's a correction factor. We will apply this amount of volume to get you hearing as good as possible. Now that's great. But as you were just saying, Nicholas, everyone is going to be different. So real-ear measures allow an audiologist, or a hearing care provider, to measure the resonance inside your ear canals, as well as just the natural acoustics of your ear and program the devices more appropriately for you. So they really are important elements in like you said, best practices and making sure that a device is programmed properly for you and optimized for just your individual needs.

Reed: Yeah. Yeah. I think that's super important. And for your audience, sometimes when I talk about real-ear measures, I actually talk about this idea of like perception, right? And the way sound works and how we tend to perceive the low frequencies. And these, these high frequencies where hearing loss usually is, it's hard for someone to actually notice. So if you don't use real-ear measures and you just rely off of somebody's perceptions purely, you may actually not really let's, I don't want to necessarily make it worse, but it's possible to make it worse. You may start turning up the volume and the bassy sounds because you think that sounds good to you when what you really need is that clarity. So real-ear measures for your listeners out there, who aren't audiologists are sort of vital sometimes to the best practice approach, especially when there's a hearing loss that is highly affected in the high frequencies versus the lows. And that's the majority of age related hearing loss, to be honest.

Host: Another great example of that is television. People generally cannot understand the television. That is one of the main complaints that we have. And there are many reasons for that, including the production quality of videos nowadays, the way televisions are produced. But when we look at pro audio and consumer audio devices, they generally focus on amplifying the very low frequencies and the very high frequencies. Because as, as you were saying, Nicholas, that is what as humans we like. But that's not where speech clarity comes from. So real-ear measures allow us to, again, just actually verify that we are giving you appropriate volume, not based off of a subjective, yes, this sounds good, but what will improve your speech intelligibility as much as possible.

Reed: Yeah, exactly. So the issue is there's a few papers that show hearing aids look very protective, right? There is the Amieva, Hélène Amieva paper from France, where she shows over like a 25 year period those who use hearing aids essentially have the same rate of cognitive decline as those who have, quote unquote, normal perceived hearing. Whereas those with hearing loss are seeing a faster rate. And then ... that's a good paper. Like I said, it's hard to tease apart those socioeconomic factors though, that are protective, those are the factors that make you more likely to own a hearing aid being wealthier, and being wealthier also makes you less likely to experience cognitive decline or onset of dementia. But there are some great studies out there actually that, full credit to observational data. There's, there's a study that Piers Dawes is a coauthor on. And I think the first author's last name is Mahmoudi, [It was Maharani] and I may actually be mixing that up with somebody else. So don't quote me on that. But Piers Dawes is an author on it, and it's a fantastic study where they looked within-subject over time. And so what they really did essentially was they took these adults who had hearing loss and they got a hearing aid and they basically set like a time .0 as when they got the hearing aid. And then they looked pre hearing aid and post hearing aid, and they looked at their cognitive trajectories pre and post. And essentially what you see is if you think of it as a two lines and the slope of those lines, the steeper the slope, the more cognitive decline they're experiencing, the slope levels off a little bit as a group after hearing aid use, meaning that we like literally all of us ... after we turn 25, 30 or somewhere in that area, we start declining cognitively. Like, no matter what your trajectory looks like a slope, except in this group once they got a hearing aid on a group level, they did start to level off a little bit. So that kind of within subject data is powerful because you're, you're controlling for factors such as education and wealth, because it's the same people on each side of that line. So that's a powerful way to look at it. And I think those are the kinds of studies that we need to set up. I think that a randomized control trial though, is sort of like the top of the pyramid, right? It's like that gold standard of evidence of whether or not causally hearing aids actually make a difference now.

Host: And I guess it would be probably a good idea for us to go back and address this. There are lots of things saying that hearing loss does cause dementia. I think it's used very commonly as, almost a scare tactic that hearing loss causes dementia, you need to get hearing aids. From my understanding, that is not the case. So correct me if I'm wrong, it is more so that hearing loss causes changes in your ability to communicate and socialize. You tend to be more isolated when you do have a hearing loss and then it causes your brain to atrophy a little bit quicker, or it can just allow things like dementia and cognitive decline to take hold a little bit faster.

Reed: Yeah. Yeah. That's a good way to explain it. I mean we have hearing loss on one end here and it's the exposure and then the outcome would be cognitive decline or dementia. And then they're not sort of like this one-to-one thing where ... hearing loss itself just means cognitive decline. It's really the pathways there that you're describing where, I think the classic one that's easiest for people to understand is if hearing loss causes a change in communication and you no longer communicate with people and you start to socially isolate, social isolation is highly associated with dementia. So that's the causal pathway. And the belief is that you use a hearing aid and you get back some of that communication, and then you start going out again and engaging socially, then do we modify the pathway? Do we prevent the onset of dementia? So you're absolutely right. It's not sort of this, like, one-to-one like you, you have hearing loss, you get a hearing aid, you correct it and the dementia is gone, right. Or something like that. And, and the scare tactic thing is sort of a good way accurately to describe it because we don't have great evidence yet. And as we're talking about the ACHIEVE Trial, for example, we're talking about that best practice intervention, right? And this is a very important point that I like to make that if we prove in the ACHIEVE Trial that hearing aid use best practice does delay cognitive decline. We haven't really proved that hearing aids alone are what do the trick, we're proving that multiple sessions with an audiologist focusing on your communication goals make a difference. So the hearing aid is a part of that. It's sort of a bigger picture thing of the services that the audiologist also can offer. And sometimes I think it's a little bit difficult for people to think of it this way. Cause we tend to think of hearing aids as these, these products and they're the thing, right? That's it. And the truth is I actually think of hearing aids very much as sort of a consumer device. I put them over here, but I think of them like a car where you buy a car and you can't use your car forever without a mechanic. You need somebody to help you along the way. And I hate to like compare audi... I know audiologists are probably, if they're listening, they're probably going to be offended that I said that, but I don't mean it offensively. I mean that, it's two things that go together. It's the services plus the device. I don't, I actually refused as an audiologist to identify my services as a device. I don't want to mask what I do with that device. So we have these two things. And when you see that sort of salesy tactic of protect yourself from dementia, get a hearing aid. It it's sort of not true. There's no science yet to really back that up. And in the grand scheme of things, I don't think it's what any science will actually suggest. I think it's more of get a hearing aid and get all the best practices that go along with it and sort of get that counseling, get that whole sort of holistic approach to hearing-based communication. We'll call it right? Like it's it's how can we address hearing loss to improve your overall quality of life? And that's, that's sort of a bigger question. So I mean, yeah, you're right. It is sort of a scare tactic, isn't it? I admit that one of the things I've done at Hopkins in the past is when people would send me advertisements and they would cite our research like research from Dr. Lin. Like, as I started as a postdoc with him, I would actually send it on to a legal team at Hopkins and I don't know what they did exactly. But as I understood, they would send a cease and desist letter because you couldn't take the research showing hearing loss is associated with dementia and automatically assume that a hearing aid would do something. Right. So we, we actually as a team, I don't think anybody wants our name associated with that.

Host: Well, there's lots of great information in there. And I do like that you brought up it's about quality of life. So even if it is when fit properly, hearing aids do not slow the progression of dementia, it is still, they still are offering improvements in communication, improvements in just socializing and then overall quality of life. So they do still have benefits, even if all these studies ultimately show that the progression of dementia and cognitive decline cannot be slowed with the use of these devices. So I think that's also an important thing to note for those out there who might be interested or currently wearing. It's not that there's no hope. It's not that these devices have no purpose. It would just be, this is one area where they aren't influencing.

Reed: Yeah. That's a good point. It's not to say that the device alone isn't helpful. It's more to say that what we're proving out is like the whole shebang, everything together is what's sort of effective and getting at this bigger picture than just addressing hearing. But let's also I guess ... if we're really talking about the big picture, there's a really good chance that early intervention via some kind of as we are moving hearing eras into this sort of over-the-counter era, that's sort of emerging where you're not seeing an audiologist in that picture, but let's say you're in your fifties or sixties and you intervene right away because there is some product available to you. And you basically prevent that sort of decline where you're not using a hearing aid and you're starting to withdraw. You don't even hit that because you just, you addressed it right away. You did something and you adapted to it early. that may end up showing that that's just as effective as like the whole best practice. It might be more effective to have early intervention. So, so we don't know these things yet. And, and the device alone, depending on when used in different situations, may make a difference. I guess um ... one of the caveats for your listeners is, as we talk about this, we're really talking about that population level research, right? And it's a huge misinterpretation of epidemiology in general. And this is not just among the public. This is actually something physicians do. If you see a study that says "In this study, people with mild hearing loss had two times the risk of developing dementia." It does not mean one-to-one that when you go to your doctor, your doctor can say, "You have mild hearing loss? You have two times the risk of developing dementia." It doesn't work that way. You really cannot take a population level statistic and then apply it to an individual. The individual is much more complicated and complex. And there are factors that are not the same in the population level model and the individual, right? So for the individual, you would have to take all the coefficients from that model and then start adding them and figuring out how much this person's risk is. It's not a one-to-one of just like cherry picking things. And this is something people, like I said, physicians mess this up all the time even. This is something clinicians mess up, everybody does. It's sort of hard, right? Because it makes sense when you think about it. But I think, I think it's easier for us to see a statistic and say like, oh, ya know nine out of 10 people with whatever develop, something whatever. It's just easy for us to think of it that way, but it's not that simple. So for anyone listening too, I think it's important to tell your listeners that just because you see this research does not mean you yourself are ... You may be at a higher risk overall, but you can not take the numbers that we're talking about and apply them to yourself. Like saying that I have severe hearing loss. I have five times the risk of dementia. And I think it's also key for your listeners to know, I always sort of feel like I gloss over this, but it's so important to realize we're talking about age related hearing loss. We're definitely not talking about like a congenital hearing loss here. We're talking about hearing loss that set in later in life and changed your sort of current state. And 'cause those are the pathways that make sense. It's not the same thing to say somebody born with a hearing loss or developed hearing loss very early in life, or maybe even into their twenties and thirties developed ... ...uh, have this same cognitive decline trajectory. It's very late life.

Host: Yeah. Very complicated as always, right? I did want to address something that you had brought up about over-the-counter devices. We all know there are many alternatives on the market now. Bose is making their Hearphones. There's the Nuheara IQbuds, Apple released their AirPods Pro, and many of these devices also have apps that allow you to personalize your sound where you'll test your hearing, right from your living room on your phone. It provides that correction factor. Like we were talking about before. It's bridging into this world of being these like micro hearing aids, but they don't have the science behind them. They don't have the kind of the fail safes and the technology, the research, but they're definitely getting there. So do you feel in your work that these products improve accessibility? It sounds like you already do feel that they definitely have a place in helping people get help right away.

Reed: Yeah. I mean it's yeah, it's sort of a really interesting thing to me with, with over-the-counter hearing aids and full disclosure, our lab was very involved in the Over-the-Counter Hearing Aid Act, Frank Lin, the director of our center. He testified before Congress about the bill. He was involved with Elizabeth Warren's office and in crafting some of the bill. And my own research contributed to the bill at that time that we shared with them early on. And so to sort of dissect this a little bit, the emerging research in this area, right, right now there technically is not an over-the-counter hearing aid, right? There are personal sound amplification products. The idea of an emerging hearing aid is that the FDA would tell us what qualifies as a device. And then they would go through some sort of FDA process. And this is actually a good thing for the consumer to a certain extent, because when the FDA weaponizes to a certain extent, the word hearing aid and makes an over-the-counter product for it, it means that the current market of all these amplifiers, these things that you see sometimes on the end shelf at CVS, sort of force themselves into a regulated market that the FDA says this meets qualifications and this doesn't. And I think a classic example here would be, there was a $30 device called the MSA30X. And I don't know if it still exists, to be honest, they were sued by the FTC, the Federal Trade Commission for quite a bit of money. They settled for something much smaller, but they were sued for like millions and they started advertising things like hear 50 times better, but they weren't a hearing aid. And you can't say that, because there was no proof in it. In general with our over-the-counter product right now amplifier that's not called a hearing aid, you can't say that you're going to help with hearing necessarily, especially hearing loss. And they made all these insinuations about hearing loss. And anyway, that product was relative junk. We actually did a study that was published in JAMA, where we took a hearing aid that was quite popular at the clinic that we had, that we were affiliated with at the time. And we had ... uh, took four PSAPs four personal sound amplification products that we knew were pretty good. We did some electronic electroacoustic testing as it's called, and that means we're really just looking at like the technologic specifications of the devices. And we were impressed by them. And then we took that MSA30X. We had people come in, we had them sit down in a sound booth and we would play speech-in-noise to them. And we would have them do it without a device, and then with the devices that we had, the seven products, or the six products, sorry, randomized. And we then compared how much do you improve with the different products? And this is a very simplified way of doing this. We're really isolating the devices. It's always key to explain to people this doesn't mean that like over-the-counter necessarily as a holistic approach is what we're studying. We're isolating the devices because each of these devices were, quote unquote, fit by an audiologist. And I do those air quotes because for some of them, the audiologist is basically doing the best they could because they don't all have a lot of customizability. Some of them have a lot of customizability though. As you mentioned, you can use your smartphone app to customize exactly what frequencies are being raised where. And what we found was relative to the comparison with the hearing aid. At least two of the PSAPs basically got us to the same result. I mean, within a percentage point of improvement, a couple of the other PSAPs were also, we saw it wasn't as close. And then with that MSA 30X, the one that we knew going in was relative junk. Let's say it was not a good device. People actually did worse on average because what it was doing was blasting low frequencies with a lot of distortion, which makes it harder for you to hear. We sort of touched on this earlier. If you have a lot of high-frequency loss and you just blast low frequencies, you actually mask out the rest of sound as a user. So for that group, they, they actually, on average did worse. A few people still did better to be honest or the same, but this, this is very much a controlled study. And it was just suggesting that the devices themselves, on a functional outcome, perform similar to a hearing aid. And so that, that study got a lot of attention. Since that study, there's been sort of recreations of that study with different variations. there was a study out of Iowa led by an author with the last name Brody, and I believe she might have been, it might've been like a student thesis, actually. I can't remember. Anyway, it's a phenomenal paper. And they added the twist of not just having the hearing aid versus the PSAPs. Now, the PSAPs were fit by the user themselves, which is more reminiscent of the real world. And I actually really liked their study because statistically, they looked at some things and I think it looks like in their study, the hearing aid is the best, which in our study, it also looks like the hearing aid is the best, but they acknowledged that the range of differential with, with let's say the percentage. So if a hearing aid, you improved by 12% and with a PSAP you improved by 11%, is that really different, right? Like you might statistically say it's different, but clinically is it different? And they found basically the same range of differences that we found with our PSAPs. And I think that's, I personally think it's a really good question to decide, by numbers, it might say that it's different, but clinically like is, it is 5% on a speech and noise test, like out of a 100% correct. Is that really that different? So there's also a study out of Korea where they did something very similar to what we did and they actually, they actually went much further. They did some pupillometry where they're looking at the pupils and how much effort you're putting into the task. And so they went deeper and they added these other two studies, I should put the caveat, only for mild and moderate losses. They added a severe group in Korea and they showed that in the mild and moderate losses. Again, no major differences, really, at least clinically differences between an over-the-counter PSAP and a hearing aid. But then for the severe group, you saw an emerging difference. Like there really, really truly was. And again, most of these studies, I think we have to acknowledge they're isolating the device themselves. And they were showing the effect of that device on these sort of momentary tasks from the self-fitting standpoint, Elizabeth Convey out of NAL in Australia has done so much beautiful work showing that adults can self-fit to a certain extent and they can do it pretty well. And they actually used one of the devices that we used in our study and one of their studies. And it's interesting to see this device performs almost as well as a hearing aid, as the Sound World Solutions products, and it also can be self-fit by the user. So there is this emerging evidence that users, the OTC market has some efficacy, right? Effectiveness is a different story. You could point to Larry Hume's trial, where he shows out of Indiana university comparing people in different fitting paradigms. But in that study they're using a hearing aid. They're not using an OTC product. And it's also sort of, hopefully he doesn't listen to this and get offended, but I sort of think of it as choose your own adventure, the way that they developed the self-fitting process, which I think is realistic, right? It's a very realistic way to think about it. You went in and it was like, here are different options to go with this hearing aid and you sort of do what you want to do. And here are different pre-programmed settings and you choose. And I think things are becoming more sophisticated than that very quickly, where now with a smartphone, you can put the device in your ear, do a test and it self-fits to your test paradigm. And so, that study Dr. Hume's study showed these beautiful findings in a large randomized-control trial, that self-fitting pathway was efficacious. And I think that already, we've seen leaps and bounds since that trial of technology advancements. So it'll be interesting to see as people sort of keep building off that trial, what the next set of findings are. So from a science standpoint, we have emerging evidence. When I think about affordability and accessibility, I think that the engagement of over the counter products create sort of some new market competition. They change the accessibility paradigm from audiology right now is sort of an acute care model for a chronic condition. And what I mean by that is you go to a doctor, they refer you, you come in, you get fit, then you might have some follow-ups and then your sort of annual follow-up, right. And the OTC idea is a little bit more like, okay, you have this product and you have this app and it's constantly like interacting with you. Right. And I actually think that's super important for chronic conditions is that regular engagement that hearables and wearables in general are starting to give us. And I think I sound excited because I am, I think in healthcare in general, we're seeing this convergence of a consumer product that you're wearing all the time and healthcare, true healthcare, right? You wear a smartwatch and it's taking your blood pressure regularly and giving you feedback, right? That biofeedback is important. And the apps that would be linked with some of these OTC products have the same sort of capabilities, a lot of interaction, a lot of feedback. And so you may see affordability, you may see accessibility, but I think, I think that like what's important here is that we're just adding a new class to compliment what we already have. It's not a replacement. It's not like a one, it's not like an either or. It's ... We have ... We will have OTC class of devices designed for mild and moderate hearing loss that are very accessible. And it gives you a new entry point into the hearing care market that you might enter early. And what I mean by that is we sort of use this example with the dementia, populate a discussion ... If you're 60 and you develop hearing loss, and you sort of think about getting a hearing aid, but you're like, ah I have this very, very mild hearing loss. I only notice it in meetings. And even then, not all meetings, it's just the big board ones. And you're just like I'm just going to deal with it. The cost benefit in your mind is not worth it to go through with the ... whether it's the time investment to get a hearing aid as it stands right now, or the monetary investment. I'm not distinguishing any of them, I'm just saying, there's something about the process, but maybe going on Amazon and ordering a product and downloading their app on their phone, we'll get you in early. And I think this is important to think about because as that person progresses over time, I do think that as they get to more moderate and moderate, severe, and severe and profound losses, if their hearing loss progresses that way, then they will engage with the current audiology system. I also see from the audiology perspective, people sort of say like, Oh, OTC is terrible. And they think of it as if it's going to replace the current system. But let's just remember that if you break down hearing loss in the United States and who owns hearing aids, hearing aid penetration among adults with mild losses is incredibly small. When we look at nationally representative data from the NHANES for example, we're looking at like less than 3% or 4% penetration. I mean the vast majority of hearing aid owners have severe or greater, or moderate, severe, or greater, depending on which sort of scale you're using hearing loss. So to a certain extent, we're adding a class for a market that is untapped because we're not tapping it. It's not being engaged right now. So I'm super excited about the prospect of this, and I think it compliments the audiology picture. And I think audiology is in a good position as the experts at the top of this pyramid to sort of control it from top down. And control's not the right word. I more mean that like use it to everyone's benefit. They can take a public health approach actually and say, let's add new ways to get into the system and new ways to benefit people and best practice gold standards is still there. You're not going anywhere. You're still a part of the system. You're still going to be necessary for cochlear implants, for severe losses, for profound losses, and for counseling, you're there.

Host: I completely agree with you. If what we can do is improve accessibility and get more people hearing better, improving their quality of life. And then on top of all of that, reducing the stigmas, so people then even more so approach these other devices, it's just really a win-win for everyone.

Reed: Steve, I think you are spot on with the stigma thing. People say this all the time to me about, they're like, "Well, what about stigma?" And yeah, there is stigma right now, but what about if we create a world where it's so easy to get a product and people are more likely to do it, and everybody starts wearing something on their ears all the time. I mean, in a generation, we may see a complete difference in the way we perceive something on your ear, versus the stigma around hearing aids, right? And I personally, this is very much my personal belief. I think we're already starting to see a pretty big difference in the way people perceive products on the ear and hearing loss, and a lot of that stigma too. Let's just remember, we're not that many generations away from when unfortunately societally, if somebody was, quote unquote, born deaf or born with a profound hearing loss, we treated them as if they had an intellectual disability. We are really not that far away from some extremely ablest, and we are still an ablest society, but from being much more severe about it, and unfortunately the way we viewed hearing loss for a long time was extremely, extremely negative. And I can't think of the right word off the top of my head, but the way we equated it with something that it truly wasn't was so discriminatory, and whereas glasses to the counterfactual of that, glasses tended to be associated with, you lost your sight over time from reading things close up, and that tended to be priests, politicians, educated. And so you're going to associate glasses with education, which is that, that whole like sixties, seventies movies, where they call someone with glasses a nerd, and that's not necessarily a terribly bad thing to have something associated with education, whereas hearing, we never, never had that. We completely associated it with something unfounded and negative. So it's gonna take time to go away from that stigma. But, but I do think that it's happening relatively fast now with the onset of, just Bluetooth products made a huge difference, right? People are walking around all the time with something in their ears.

Host: I know you had mentioned to me before that your work also involves providing aural rehabilitation and hearing loss education to others in your hospital setting. And just as kind of a small example of what those providing those different services can do, maybe on a greater scale. Can you tell me more about that? What types of communication technologies that you helped to find reduce barriers?

Reed: Yeah. So, a lot of my work primarily focuses around studying the effect of let's say the association of hearing loss and health care outcomes. And what I mean by that is, is hearing loss associated with spending more on care or is it associated with delaying care or unmet needs in the healthcare system? And we do see in several studies we took a large claims database and we matched 2,300 people with hearing loss and without hearing loss. And we looked over a 10 year period and we see that adults with hearing loss are spending on average after matching on dozens of variables, meaning they're matched on their geographic location, their current health status, their socioeconomic status, age, people with hearing loss are spending $22,000 more on average than someone without hearing loss, and why? And I think it boils down to ... You can make the case... You can try to make the case to me that well, we're saying people with hearing loss is associated with dementia. So maybe they're just paying up more high costs in the long run. But we controlled for those factors in our models. And I think it has a lot to do with communication in the healthcare setting. And this, this manifests in multiple ways where you go to the hospital and you have trouble communicating with your provider and you end up staying in the hospital a little bit longer, like by a day, let's say, because it took longer to get to a diagnosis and get to a treatment from communication. Or you might've experienced delirium because you couldn't interact with the world around you. And you ended up sort of in a window state of withdrawal and delirium is quite expensive and often misdiagnosed, often underdiagnosed, or you maybe even just had bad experiences because you couldn't communicate with your ... your healthcare providers, the system itself is sort of not built to accommodate people with hearing loss. And we like to think it is. And mostly we like to think it is because we say something like, Oh we'll provide an interpreter. If you need an ASL or we'll, we'll put pocket talkers on all the floors, right. And you put one pocket talker on a floor though, it goes walking. And so what we've sort of started a line of quality initiative work looking at is if we provide a more holistic approach where we provide communication counseling and helping the providers themselves, like the nurses and the physicians outside of audiology, think about hearing, does that make a difference? And then instead of just having one pocket talker, let's say, and I'm using pocket talker, like colloquially, we actually don't use the Pocket Talker that device views a different device by Sonic Ear called the SE9000. It's a little bit more affordable and it does a great job. So we use their product and we put them on the floors and we put them in in bulk. So if somebody has a hearing loss, we can give them one of these products and they can take it home. It even might be the first time anyone has ever said anything about hearing loss to them in the hospital. And we also built in to the healthcare admissions process asking about hearing loss on a meaningful scale. And what I mean by that is if you just ask someone yes or no, do you have hearing loss? you're probably likely to miss a lot of people, but if you ask on a scale and you give them outs of, I have a little, a lot of trouble, I have trouble in noise only. I identify as deaf. Then they're more likely to get closer to accuracy and you can sort of figure out like, can I do something to help this person? And it might mean offering the product... the amplifier ... But it also is ... We use signs to sort of remind our providers about best practice communication. We never label patients. Our signs don't say anything like this patient has hearing loss. Our signs say, remember to speak face to face, remember to turn down the noise when you talk to them, remember little things like that. Don't shout at people with hearing loss, for example. And what we find is that making these basic changes in education on hearing loss makes a big difference. In at least the provider's perceptions of their interactions with patients, they feel like on a large scale, people are experiencing less confusion. They seem to have better rapport with their patients. And, let's just remember that these accommodations for communication that we're talking about also worked for people without hearing loss, right? Speaking slowly, and taking your time to communicate with somebody and speaking face-to-face and turning down background noise. That's not just for hearing loss, that helps everybody. So, thinking about these sort of communication factors about the access to communication is important. We often in the healthcare system, when we think about communication, we focus on the exchange of information. And what I mean by that is we focus on the vocabulary, the lexicon that you're using. And that's not even what I think we're talking about here. We're literally just talking about, do you have access the information, right? Can you hear it? And can you process it? And I think that's an important step in the process. And so, if I had my way, I think I would remove the need. I see a lot of presentations about make sure you advocate for yourself when you go to the hospital. Make sure, especially in the era of COVID we wrote a paper, not that long ago, talking about using clear masks and how noisy COVID units are, but there's, there's this movement to advocate for yourself and advocacy is important and it's, it's vital right now. But what I sort of believe is that the system should be built so that it accommodates with built-in processes. Like, you should not need to walk into a hospital and tell every single person you have hearing loss, because you're worried that you're not going to understand your doctor, right? You, you should not have to do that. I really think it's unfair that we take a segment of the population and basically throw them into a system not built for them. And this is true of disabilities across the board. I think I work very closely with a researcher named Bonnie Sweenor, who studies disabilities in general and in healthcare. And, we, as healthcare systems, we've really sort of failed here. And part of the failure too, is like, when we think of addressing a problem, we often don't think of it as a sustainable solution. Like I said, we throw pocket talkers at every single floor. We put one on the floor and think we've solved the problem, but that's not sustainable. There's implementation science that needs to come into play there. So that's sort of a flavor of what we're doing there and we're doing it in larger and larger numbers now. And now we're starting to study it with bigger outcomes, like preventable hospitalizations and delirium, at Johns Hopkins. And I think it's pretty exciting that, not only can we help with healthcare, but we can just help with the experience of patients. And I think that is extremely valuable.

Host: So you had mentioned from the healthcare provider perspective that they noticed an improvement. Do you notice that from the patient standpoint that it is reducing stay times?

Reed: Yeah. So, when we did a quality initiative, we did see some slight changes. We haven't done it long enough, I think to see the big changes. But what we did see is that patients perceive communication to be better in general. So, they're telling us, even though we've done some very small initiatives, they are telling us that they are appreciative of what's going on. They find that compared to previous stays, communication is better. When we've used sort of large instruments ... to try to measure the statistical differences, it's harder because we just haven't collected enough data... I think yet. I think you need to collect a large amount over a longer period to see these differences. Cause remember we're not talking about like weeks, we're talking about like, we might make a difference of hours or days. And that is a quality of life issue though. I mean, if you can imagine a few extra hours in the hospital, it's worth it to get out earlier a day, one night is worth it to get out earlier. And from the hospital side, remember, it's quite costly, right? So you save a few hours and your bed turnaround makes a big difference to the health care system.

Host: Also curious, I know something a lot of people with hearing loss will struggle with is they will try and self advocate and tell those around them that if you're going to talk to me, get my attention, turn down the TV, reduce background noise, all of the kind of methods and techniques you were mentioning there in aural rehabilitation. Do you find that you need to have regular, like reinstruction for medical providers?

Reed: Our approach has been actually building webinars and building it into what eventually we would like to see it as part of the standard medical education as like a yearly check-in basically, which we do that regularly. There's lots of programs like that. I think that this doesn't take long, especially to complete. So I think it's a good ... I think it's good for people to know that. What's unique about our program and what is truly based sort of in, I mean, this is like behavioral economics now and thinking about like nudging people in the right direction. By using that sign, that doesn't say anything about hearing loss, but the sign directly references what you learned in our webinar or in our education setting, we bring it back to the forefront of people's minds, right? So they get a chance to see that sign. We use sort of standardized colors, standardized branding, and it's quite different from the other colors, to be honest on posters at Johns Hopkins, it's a bright blue color, and they see that and they're like, oh, I remember like the eight foundational things I learned about communication. I need to remember, or it may even trigger in them. And it probably does to think about hearing loss in general. And they might think like, what are the tools in my kit? Do I need to use speech to text app? Like the Google Live Transcribe? Do I need to get a device for this person? Is there anything I could ... We even did some big print written instructions... Like, do I need to get some of that to make sure that this person communicates optimally with me? So I think you're absolutely right. Like, regular training is important, but what's even more powerful is sort of regular reinforcement of that training.

Host: So that wraps things up for this episode. Dr. Nicholas, thank you so much for joining us and giving us all this great information.

Reed: Thank you. Thanks for organizing this.

Host: And thank you to everyone who tuned in, this has been the Hearing Tracker Podcast.