All right. So for this initial sort of phase of research, basically what we relied on is doing epidemiologic studies. So taking a large cohort or large groups of older adults who have been followed in the community just cross-sectionally at one time point or followed for many, many years. And basically asking these large cohorts of older adults recruited from the community who have their hearing measured, have their cognition measured, have their blood pressure measured, all these things. In these cohorts, do we see on average, is greater hearing loss, again measured by the better ears, pure-tone average or some pure-tone audiometry, is that a social poor cognitive scores even after controlling or adjusting or accounting for things like age, diabetes, smoking, hypertension.

So some of the first analysis we did many years ago was looking just first at cross-sectional sites, one snapshot at one time point. And so on the first data we looked at was from NHANES, again the National Health Nutritional Examinations Surveys, basically a sample of the whole US population several thousand people at a time who have a whole bunch of things measured. All right, so this first analysis we did several years ago now looking only at adults. They’re 60s. This is– the range for hearing and cognition was both done, right. There are 600 adults on their 60s who had their hearing measured, had their cognition measured, and also where we adjusted for sort of everything on the bottom, their age, sex, race, education, diabetes, et cetera, et cetera, right. And what you see on average in these analyses is that for every difference in age of one year, you see that on average the DSS score has a lower score of about half a point. And that makes sense. The age goes up, your digit score should go down a little bit, the cognitive scores go down. If you look now at a shift in 25 decibels in the pure-tone now, basically for a normal to a mild hearing loss roughly, you see that’s associated about a 3.9 point score difference.

So what does that mean, how do you interpret that? In sort of the last column, if you look at the difference in age and years, that’s approximately equivalent to a 25-decibel difference with hearing and is associated with the cognition. It’s about seven years of aging, so it’s actually a very, very clinically meaningful fact as far as we can tell. Now importantly this is just one study, so the response that we got back then, well, Frank, this is interesting. But this is just one cross-sectional study, one exam, one test– I mean maybe, just a fluke, right.

So we did the same analysis now in a completely independent dataset. This is something called the BLSA or the Baltimore Longitudinal Study of Aging. It’s a longstanding, longitudinal cohort of older adults followed at the National Institute on Aging, which is based in Baltimore, for this one center, where they’ve been following many, many hundred people for literally decades. And then we just have initial cross-sectional sample again, so 347 adults all older than 60, none of whom who have baseline in our analysis had dementia. We do the same analysis, but now we use two other cognitive tests. We use something called a Stroop Mixed, you saw before and the Trail Making test part B. This is the same analysis. We see that the association with difference in age in one year is this, with a 25 decibel hearing loss is this. And amazingly in many ways, across two completely independent datasets, three completely independent cognitive tests, is we’re roughly seeing the same magnitude of association here.

Here at this point several years ago, the response we still got was– Well, this is interesting. I mean, there’s been some previous works to adjusting this but this is just– This is cross-sectional data, right. You’re averaging across people. You’re measuring like a one time point, that’s it. You’re averaging assuming one person with a hearing loss would be behave like this if they had a hearing loss, et cetera. And the more convincing aspect is well, they’ll say, well, show me some more convincing data, by more convincing, I mean show me longitudinal data. Show me some data now where you’ve been following people for many, many years and you say within a given person, those with the greater hearing loss, did they actually have faster rates of decline over time.

Now if you do the same analysis now looking at the digit symbol test which is completely, again, no auditory stimuli as I showed you before, we see basically the same results. This is just one summary figure. The reason I say that because you can break down hearing loss, don’t keep it as just, you know, yes or no. You can treat it like continuous variable. You have some, mild, moderate, severe. And what you clearly see then is you do see this dose dependent effect — that the greater the severity of hearing loss up to a certain degree, the faster it declines. It’s just hard to show on the figure here so I’m not presenting those.

All right, so, you remember though I began this portion of talk talking about how– yes, cognition is important, but the bigger issue is dementia. It’s what you’ll more about today and just– There are many ways to define dementia. I’m just going to tell you in terms of from my perspective globally. I mean just a very useful pragmatic definition of dementia is that we– it’s not that you wake up one day and all of a sudden you have dementia. There’s a degree, the prodrome where you have cognitive impairment for many, many years possibly. The key thing is when you tip over dementia per se, many rules would say that’s roughly when it begins interfering with your daily activities. So that’s when you sort of are defined as having dementia. There are many, many different classification criteria for how you define dementia.

Importantly then, if we think hearing loss is associated with a faster rate of cognitive decline. Is it actually associated in a faster rate or a greater risk then of being diagnosed with dementia over time. So this is what we looked at. So this is data again from the BLSA, the Baltimore Longitudinal Study of Aging. About 640 adults in their early to mid 90s who all had their hearing tested and were basically followed every year to two years thereafter up potentially until 2010 when we did the study basically. And importantly in the BLSA, when you diagnose with someone with dementia, it’s based on a very, very, adjudicated definition of dementia. It was based on the — it was called the NINCDS criteria back then, but this is based on a very adjudicated consensus basis definition of dementia back then. It wasn’t based on just one cognitive test for instance. It was based on a consensus definition of when someone developed dementia.

So, if we look at this raw data, this is just called a Kaplan-Meier plot. The y-axis is the percentage of people who remain dementia free. And the x-axis is basically a time from baseline. So obviously, at time zero, when people join the study per se as analytic cohort, no one had dementia. I mean, that’s why we include it in the study. And what you do, what you observe is you’re far more for the next 15, 16 years though, is that we see that progression or the progression to developing dementia being clearly related to the severity of your hearing loss at baseline. Now this is unadjusted though. We cannot– we haven’t adjusted yet for things like age, sex, diabetes and things like that. So when you apply these models now where you begin adjusting for those possible correlational factors, the possible confounding factors, we see a very, very similar relationship. That compared to people with normal hearing, the risk of developing incident, developing dementia all cause dementia is basically this called the hazard ratio or called risk ratio. For people with a mild, a moderate and severe hearing loss are roughly about twofold greater, threefold greater and almost about fivefold greater. I mean these are substantial risk ratios. We’re not talking a 5% increase in risk, like that. We’re talking theoretically, at least this one study at least, the 89% increased risk, the 200% increase, with a 400% increase of risk and I’m not going to show you– this study has been replicated now in another cohort based in the UK, only on men, though. That’s how the study was designed back then, but roughly showing exactly the same risk ratios as well. So very, very substantial risk ratios that we’re observing, not a small clinical effect per se.

Now, importantly here though, when we published it several years ago though, the response that we got back then from many people was that yes, there clearly appears to be something there, that hearing loss does appear to be making a difference here. But what many people asked us still was well, “Do you have more objective evidence? Namely, if you think that hearing loss possibly affects diagnoses of cognition and a cognitive impairment, dementia, do you actually see hearing loss actually affecting the brain as well?” I mean a lot of times brain function follows with brain structure, not perfectly but to some degree. Do you actually see that hearing loss actually affects the brain. So our hypothesis back then when we did the study, again with the BLSA data, is that we a priori hypothesized that hearing loss is associated specifically with accelerated atrophy, brain tissue loss over the superior, the middle and the inferior temporal gyri, the lateral parts of the temporal lobe, which are not class of the parts of the brain which implicated in dementia. Those are more of the mesio or the more of the medial temporal lobe structures. But the reason why we hypothesize a priori is if you look at the literature as a whole, those parts of the lateral temporal lobe are the– they’re probably arguably, the very, very important areas for auditory association for how we process sound. So if we’re going to see atrophy anywhere, it should be namely in those areas, so the lateral temporal lobe.

In particular, what we did was we used data again from the BLSA. So from Susan Resnick, who’s at the BLSA, beginning in the early to mid 90s, this is remarkable back then and still remarkable to this day. They initiated a neuroimaging substudy. So they took about 130 people who are all the healthiest of the healthy. Basically, I think only a couple of them had diabetes. Some had hypertension but a very, very healthy subcohort. And enrolled them back in the mid 90s into a neuroimaging study where they basically came back every one to two years for a brain MRI. And this is fundamentally unique almost to this day still in terms of the degree to which they have longitudinal data. Most neuroimaging studies you see nowadays in the literature are still based on cross-sectional data. You have MRIs at one time, where you’ll have hearing at one time point at best and that’s it. What the BLSA is– has done, and still doing to this day, is a longitudinal cohort. So we had about 126 people back then who had their hearing measured who had MRI scans and basically had average follow-up at least 6 years of MRI scans done almost every one to two years basically up to about 12 or about 8 MRI scans. So offers tremendous sort of power in looking at individual change over time.

And importantly, if you look at this cohort of people, which I break out as the normal hearing and having hearing loss just make it easier because there weren’t that many people, is that what you see is that the audiograms of people are what you expect. I mean normal hearing up there and then this is the people with hearing loss. We’re not talking like profound hearing loss. We’re talking what we typically see in people who are 60, 70, 80, all right.

When we look at this data, I’m not going to summarize, only just neiroimaging data is a little boring to look at this tabular form. I’m just going to summarize this for one figure. Is that if we look at this– these are what we– we call region of interest analysis. We’re going to look region by region. We also do voxel-based analysis. We look at voxel by pixel of the brain per se, is that exactly sort of hash out the way we thought it would for the most part. Is that we saw that hearing loss is very, very specifically associated with faster rates of atrophy over the lateral temporal lobe, again, the superior, the middle, inferior temporal gyri and not the middle, the mesial temporal lobe structures. And specifically– and this is what we didn’t expect though. It’s primarily almost exclusively in the right temporal lobe and not the left. And I’ve no idea why and I don’t think that any of us do yet at this point. It still needs to be replicated but this is a very, very clear specificity in association of hearing loss with faster rates of temporal lobe atrophy specifically with the right lateral temporal lobe. And again, in terms of lateral, we’re honestly not sure and this needs to be replicated. But we’re seeing a very, very clear effect there.

All right, so it gets on this model too which I told about briefly before, the idea that hearing loss independent of amyloid or another class of pathologies, may be acting as sort of an independent hit on the brain in addition to these other pathways as well.

Now, so far, I’ve only talked per se about cognition and what Margaret alluded to is that over the last couple of years, a lot of people from my group now have begun also exploring other domains or aspects of healthy aging, namely, the same mechanism of pathways that we invoke for affecting cognition namely, cognitive load, brain structure or social isolation could also clearly possibly influence other things as well. Namely, for example, things like falls, so falls being taken for granted actually, but maintaining a bipedal stance and gait is actually very, very cognitively demanding. And you know this. If you’re having a serious conversation on the phone or something like that, and you’re walking, you actually slow your gait or you’re trying mental arithmetic, you’ll slow your gait speed, right. These are actually cognitively demanding process.

 

There’s a cognitive load itself affect on things like falls per se and the one addition to having– This is interesting actually. We take it for granted but when you are just walking along on a hallway. You’re actually registering auditory cues, right. So literally, you could walk blindfolded down a hallway and you can tell when you’re passing a door way. You don’t think you can but you actually can. So, registering auditory stimuli and how that affects your gait and your balance is actually really hard to study. We think it makes a difference but it’s hard to study mainly because you could put earmuffs on someone and– but you still have the bone conduction. So you can’t completely mask hearing in many ways. But yet our understanding now is that those very subtle auditory cues though are probably actually incredibly important for our gait and balance. So, if you look at a variety of studies now, some longitudinal, some cross-sectional, showing a very, very nice, clear association now between hearing loss, severity of your hearing loss, and your risk of developing falls over time, even after adjusting for all the confounding variables.

 

If you look at broader aspects of mobility and physical functioning, your gait speed for instance, your progression to disability based on established criteria. We’re seeing very, very strong associations there as well. And if we even look at some broader health economic proxy measures namely, odds of hospitalization actually even risk of hospitalization we’ve done a longitudinal study now as well, as well as mortality, as well as healthcare cost, we’re seeing associations there as well.

So, importantly though, I think it comes down to this though. So if I put on my hat now as epidemiologist. I’ll say, “These results are fascinating.” This is where it takes some areas of research in different directions where it hasn’t gone before in terms of studying hearing loss as a “modifiable risk factor”. It opens up some new areas of research. But then, it’s like I’m excited as an epidemiologist. But if I put now my hat now as in more specifically as a surgeon, all right, I’ll say, “I don’t care. Because show me that I can make a difference. Show me that I can address this and that makes a difference and that’s all I care about.” All right, regardless whichever mechanistic pathway we’re going through. That’s all it matters in the very end.

Audience Question

Just a quick question about the earlier work that you presented. So you presented three studies, all large groups, and you didn’t indicate there if they– if those folks were ever aided or if you were just assuming the less than 25%, and also just thinking about it’s likely the people with more hearing loss would be the people more likely to adopt to hearing aids.

Great question. So, key question. So, based on all these other previous cohorts now as I’ve shown you, on average, about 20% of people who have had a hearing loss have actually used hearing aid. So when you do this analysis, I never emphasize, I never actually show it for this reason, is that if you actually tease out hearing aid use, you look at people who have hearing loss who use a hearing aid versus those who don’t. Do those people who just report of using hearing aid, do they do better? And they actually do, right. But I never show the data because you can’t– from my perspective, you can’t believe it. Because you can imagine among people of hearing loss, those who choose to get hearing aids versus those who don’t are fundamentally different.

And there are two cross competing biases, right. The one bias is clear, that people who choose to get hearing aids are the ones who are more affluent, the ones who are more health conscious, the ones who are more socially engaged to begin with. And that would all bias towards being a positive effect of hearing aids regardless of whether or not the hearing aids work or not. At the same time, with the cross-cutting bias though, that usual people with a more severe hearing loss are the ones who got treated, which was sort of biased, sort of against seeing that effect. You can tease that all you want in the way I still won’t believe it though. So I think there’s so many factors there that affected that I think it’s going to be very, very hard. You can tease out epidemiological, what we call propensity score analysis like that. And it’s being done right now. We’re trying to do it. But the fundamental question, and I think it will never be answered with observational data, because that’s these epidemiologic datasets. All they’re asking is that one question, do you use a hearing aid. Has nothing to do about whether it was properly fit, how many years you were wearing it? Are you using in one ear or two ears? Are you using it for most of the day or not in a day? Do you have overall good communicative strategies? So there’s so many other little nuances there that’ll never be teased apart from observational data though. So that’s why I said this has not been answered. And I think the thing that’s really needed to definitively answer this is a clinical trial. Where you randomize that baseline, people get treated versus don’t treated. Yeah.

Audience Question

This question is somewhat related, but it’s addressing what you said here with the randomized clinical trial. I know that randomized clinical trial is really important in this sense, but it is extremely difficult to do– also in public health, it has to be population-based. And randomized clinical trial tends to be more clinically centered. This is the same problem on the other end of the spectrum, the universal newborn hearing screening. When the US Preventative Task Force actually judged whether newborn hearing screening is worthwhile to do, and they actually downgrade to grade B. Because there’s no randomized clinical trial. Even until now, it is extremely difficult to pull off a randomized clinical trial in the other spectrum. So in a sense of that, how do you get around this for the adult population?

So, give me two slides.

I think what she was getting at fundamentally is sometimes clinical trials are really, really hard to do. Even beyond, I think what you touched on briefly too is that, clinical trials show efficacy — if you did everything perfectly in a clinic-based setting. But we’re still not been getting it at effectiveness in terms of broad-based real populations, audiologists and the field, things like that. Two different questions, usually they start with efficacy and they go to effectiveness hopefully, but all right.

What is the impact of treating ARHL on older adults?

So that gets at this question. What is the evidence? What happens if you treat hearing loss? Does that actually make a difference?

Unfortunately though, this is the state of the science. The very, very fundamental basic question of whether, if you address hearing loss — I mean, address it well, can you possibly delay the onset of cognitive decline or dementia? It remains completely totally unanswered.

To your– and to [the point of the prior question] — First of all, the reason why I even care about this, I think why many people begin to care about this many ways is that if we think about these mechanistic pathways that could possibly link hearing loss with cognition dementia, is an increasing our understanding that at least as far as we’re concerned is that as we think about our interventions, best practice, sensory management, counseling, rehabilitation, sensory management with amplification, things like that, is that as far as we can tell now based on what we know about our field in the field of science per se on what hearing aids can do, is that they could plausibly actually impact these pathways, and that’s the key. We clearly hope with a good hearing loss intervention that we can reduce the cognitive load of processing degraded sound. If we can send a clear signal on average. We hope that we reduce the cognitive load of that.

 

Secondly, we clearly hope providing increased auditory brain stimulation for what it’s worth. And finally, clearly the sine qua non for a lot of us is can we hopefully improve social engagement communication. So, the idea of treating hearing loss could theoretically impact these mechanistic pathways. That’s very, very important, right.

 

So important to that end though, I think the reason why this– just overall idea of hearing loss in cognition dementia has gotten some attention is because the important thing about hearing loss here is that understanding it now theoretically though, is that it’s potentially a modifiable late life risk factor for cognitive decline dementia.

 

What I mean by that, if you look at some of the most important, arguably modifiable risk factors for cognitive decline dementia right now, they are probably things like early– I would say midlife, probably midlife vascular disease. Things like diabetes, hypertension control in midlife. Namely, if you wait until someone is 70 before you treat their diabetes and hypertension, it’s sort of too little too late. But if you can treat it in midlife, when they’re 50s and they’re early 60s, it makes a big difference.

 

And that’s actually interestingly why there’s one theory at least that, if you actually look at the absolute risk of dementia nowadays, it actually maybe going down a little bit. The number is still going up with people getting older, but the absolute risk of individual adult may be going down a little bit now compared to a couple of decades ago. And one thought process behind that, is that we maybe catching up now to the cardiovascular interventions we started 20 years ago to have better control in hypertension and cardiovascular disease. So anyway, but the problem with those, though, I should say the problem with that, is that you have to intervene upon those in midlife. You got an average of 20 and a half.

 

I understand about hearing loss right now, I guess on the theoretical basis though, is that it may be potentially modifiable in late life, which makes it a very, very attractive target then for public health interventions because you could still intervene, it’s not too late per se. And more importantly, you can’t against the fact that any type of hearing loss intervention, I guess sort of the cochlear implant, it’s fundamentally no risk. I mean if there’s absolutely no risk with treating someone’s hearing loss, there’s only a possible upside for the most part many people would argue.

ACHIEVE Healthy Aging Clinical Trial

So with that in mind, to your point, well, what about clinical trial? So this is where we’re going right now. So we have the initial phase of funding from the National Institute on Aging to develop this exact clinical trial. So, conceptually it’s called the ACHIEVE Trial, that Aging, Cognition, and Hearing Evaluation in Elders or the ACIEVE Healthy Aging Trial. And it’s being done in collaboration with a lot of people across the US.

The design of the study, it looks like this, is that at baseline we’re taking 70 to 84-year-old adults with mild to moderate hearing loss with no cognitive impairment, randomizing at baseline to basically best practices hearing rehabilitation as defined, and being manualized by Terry Chisolm’s groups at University of South Florida. So basically hearing treatment as it should be done, counseling, sensory management, fitting of devices, education, not really auditory training but ACE therapy, so Louise Hickson’s work looking at just communicative strategies, things like that. We randomize at baseline versus a successful agent control, which is basically an established program at the University of Pittsburgh, which is basically these individual instructor or clinician one-on-one interactions with– It’s been going over healthy agent topics, nutrition, diet, exercise, things like that. Which has been shown to– seniors, older adults actually like this a lot. So, randomized at baseline to one of these interventions.

Proximal outcomes looking at things like audibility speech, environmental sounds obviously, as well as communication, social engagement, but really being powered over a three to five year period looking at rates of cognitive decline, can we actually reduce the rate of cognitive decline, possibly reduce the risk of dementia, really powering up cognitive decline in this cohort though. As well as looking at a host of secondary outcome measures, looking at things like mobility, daily functioning, brain MRI hopefully as well if we can get funded, as well as social activities.

Now, importantly this trial, much to your point: how do you operationalize in such a trial like this? So this is where efficient science is key and collaboration is key. So there is a study called the ARIC study, the Atherosclerosis Risk in Communities studies. A 16,000 person cohort study, began in 1987 at four different centers across the United States. So people back then were 40 to 60-years-old. And now– they’ve been followed now on average about five visits over the last 25 years, right. Where every year, every five years on average they have been coming back for neurocognitive batteries and measure vascular blood pressure, a whole bunch of things. The initial phase of the study was being powered to really look at midlife vascular disease and how it is associated with later life cardiovascular events. And they have — I think have been 1300 papers published as a cohort already. So what we’ve been doing over the last few years now is teaming up with the ARIC cohort, is our clinical trial will be nested within the existing ARIC cohort. So we’re taking a sub-sample of their– Because that there are about 6000 people who are still surviving, taking a sub-sample of those and doing a clinical trial in these folks. So, operationalize across these four community-based cohorts across the United States going forward.

Now, the reason why this is important and this is key, is because if you’d recruited a complete de novo cohort, you could, but then you have four measures, right. You have their baseline measure of cognition, and hearing obviously, too. And then you have annually, their measure of cognition at years one, two and three. So can you look at these individual trajectories over time, and what you hope to see obviously, the people with treated hearing loss, it’s flatter than people who have– don’t get treated maybe it’s a little more steep. That’s where you hypothesize. But you’re fundamentally basing that change though in basically essentially four data points, the baseline and years one, two and three. In ARIC, the beautiful thing about ARIC though, is people have been followed for 25 years. So we know their preceding 25-year trajectory of cognitive function to begin with. So it makes it far more powerful looking for an inflection point. So basically looking at, 25 years goes like this, do we change the inflection point for what they’re doing now, once we began addressing hearing loss. So it makes for a very, very efficient science here. Not only in terms of logistically in terms of operationalizing the study across four different sites and like things like that, but more importantly from a scientific perspective too, it makes it far more efficient and far more powerful as well.

So just a brief overall view of what this RCT is doing right now. For the last year and a half now– or, last year I guess. We’ve been funded under, it’s a weird grant. It’s called– It’s a Clinical Trial Planning Grant process from NIA, which basically just allows us to do the development of protocols, operational manuals, the pilots have to be funded actually by another grant though. But just operationalizing the whole process takes about literally about a year and a half, two years. Next year, we’ll submit for the complete trial grant, which is a bit of a monster. From there about two years recruitment and from there about three to four years of follow-up.

Right now, it’s being powered about 766 people, 70 to 84 years old. Again, healthy cognitive and normal community-based sample. Intervention, again, is the best practice here in rehab versus a successful agent control group. And finally, we’re being powered to about a 0.25 effect size in rates of cognitive decline over time.

So this, I get very excited about this in many ways, but it’s for me it’s also a little bit daunting in a way, right. Because what you’re fundamentally doing is a primary prevention trial for cognitive decline. Which means the earliest, well, results from a study like this assuming it gets funded in the first round next year, which is hopeful but you never know at NIH. The earliest of results is about 2021. So this takes a long, long time actually. And the reason for that again is because it’s not so much when we treat someone’s hearing loss we’re going to improve their cognition, I think. But it’s not looking for improvement, we’re looking for whether stem the decline. By definition, you have got to follow everyone for several years then. All right.

How can ARHL be effectively addressed in the community?

So I’m going to move on to the last part of my talk right now. And this is sort of where I’m spending more of my– more and more of my time nowadays for various reasons but it’s a– getting at this fundamental idea that if 2/3 of older adults have a hearing loss, and we think that hearing loss important now, we hope that treating hearing loss will make a difference. Well, I mean, what do we possibly do about this thing? Am I going to wait until 2021 to do something about it? You know, hopefully not.

Barriers to Hearing Health Care

But, importantly from that perspective though, you realize that we have some challenges ahead of our field. So– I mentioned before the overall rate of hearing aid use is about 15 and 20%, and this hasn’t changed in decades. And a lot of people always want to assume right off the bat, and this is true though. Don’t get me wrong. Is that it’s all about cost. It’s just because we need to pay out of pocket for, it’s expensive, and because of that, that’s why it’s so low. That’s true but I’ll tell you it’s not the only reason, that’s important.

And the reason why I say that is because you can look for our data is about 15% of older adults have– treat their hearing loss. If you go to the national health system, England and Wales, and you look at the rate of use under completely funded systems of bilateral digital hearing aids are completely covered. It is about sort of maybe sometimes an 8 to 10, 8 to 12 week wait sometimes, but don’t get me wrong. But it’s still completely free though. Their rate of use is, you know, marginally a little higher at best. So, don’t get me wrong, cost is important. I’m telling you it’s not the only thing. And what I mean by that is that I think there are sort of fundamentally four barriers to broader adoption or integration of hearing health care with sort of society right now.

So one is clearly cost, but I’m telling you it may not be the biggest one.

I’ll tell you, fundamentally a bigger issue is access, accessibility of services, accessibility of technology. And what I mean by this is, as probably many of you realize right now, across the world, almost anywhere you go around the world right now, there is essentially only one model of hearing health care. And it’s the gold standard. It’s a clinic-based model of medical care where a patient comes to see an audiologist or possibly dispenser for repeat visits for evaluation, needs assessment, counseling, sensory management, fitting, back and forth, back and forth, back and forth. In the United States right now, FDA as well as state regulations limit direct access to obtaining a hearing aid, let’s say over-the-counter per se. That’s a fundamental issue right now too.

 

So basically what this means then is for say the average adult, is that if you’re lucky, they start with a primary care provider and they say, you know, I think I have a hearing loss. And private provider, if you’re lucky, will say, well, you should get a hearing test. They refer you to an audiologist. So that is a referral right there. You get– So they see you guys and you get a hearing test. And you know, as you know now, technically by FDA criteria, you need medical clearance though before you can fit a hearing aid. So then they may come see me about a month later. They get an appointment with me, finally. I say, yeah, age related hearing loss. You’re fine. Go back to the audiologist, right. You go back to the audiologist and audiologist says, yeah it’s not funded though and it’s a bundled model so it will cost you about $4000 to $5000, and I can help you. Assuming they can pony that up. They pay that and you ordered the hearing aids, you fit, counsel, et cetera, et cetera.

 

So what I’m trying to say is this whole process for the average American, of which 2/3 have hearing loss over 70. This whole process can take five to six months and cost $4000 to $5000. So, to put that in perspective, that basically means then for the average American, getting “a pair of hearing aids” can be the third largest purchase in their life after a house and a car. So there is something fundamentally wrong with this entire system to begin with. So the accessibility here over and above cost is a big, big issue.

But that’s just another issue. Another big one is probably many recognize in this room, is fundamental issues of awareness, understanding, stigma.

So I think many people assume in the medical community still even because this research is still just evolving anew. Is that there still is understanding that hearing loss, it’s just something as you get older, who cares, it’s like a natural– as you get older, it’s got to be inconsequential then. And not many people realize now that we’re establishing these very, very clear links though between hearing loss and these broader outcomes. I think one big issue is we don’t have the definitive clinical trial yet. And the same time, this awareness, poor awareness of what the impact of public health importance of hearing loss is, but there’s– fundamentally there’s a fundamental complete lack of understanding of what even hearing health care is. I mean how many people in this room think the average person in the street will know the difference between a hearing instrument specialist versus an audiologist. That’s a huge failing of the field and we can’t even distinguish what you guys do versus someone who is just a technician trained with a correspondence course, that is a big, big issue. I mean how many of you guys thing a given a primary provider would know the difference? I mean maybe a few. These are big, big issues. Over and above cost, these are big root issues that if we can’t go over this, we’ve gone nowhere.

And fundamentally, I’ll say to the– I think the fourth big barrier is fundamental issues of technology, design and utility. And I’ll say this from a couple– I’ll give myself soapbox, I can’t help it. But I think there are couple of things here. One is the way devices are designed right now is they are designed by the big 6 for you guys. They’re not designed with the end user in mind because their customer on the end is not the end user, it’s the audiologist and those who buy the devices from them.

 

What I’m trying to say by that though, is because usually the people who can afford hearing aids are people who are more affluent to begin with. There’s no incentive to make ones with bigger batteries or rechargeable batteries, why? They don’t sell. And finally, that’s a perversion to the marketplace that since you guys were the– are the consumers per se, they’re not designed for the true end user. And that’s a big, big issue. Along with that, that’s just one thing I’ll mention though and that’s what you– if you go into a senior home people always complain, why are the batteries so small, why don’t they get rechargeable batteries? This is why. They weren’t designed for those people to begin with.

Another big issue I’ll tell you this is this, and this gets more of a theoretical issue per se. But if we think about this– the situation when hearing really matters, right in auditorium, in a meeting room, TV, electronics. You realize that hearing aids always have fundamental limitations in these sort of larger rooms with reverberations, things like that. So if you want to hear well the situations, we can. And what we rely on a system that looks like this. So yeah, you can get an FM receiver in a loop or maybe there’s a hearing induction loop, you can get a remote mic that goes to the streamer, I mean. So this looks complex is because it is. So how many on average, how difficult is this, why not say average patient, who cares of these situations explained that these are the solutions that I need. It’s incredibly complex. And yet these all lot of times are the most important situations for a lot of people.

All right. So, what I’m trying to get to the end, I think there are– There are not just one barrier, there are four I would say major, major barriers to sort of broader adoption of hearing healthcare. And importantly, I think it’s one of those things you just can’t pull one lever and everything gets better. You just can’t make hearing aids free without changing the system of care and awareness to understanding this thing. And all of a sudden expect everyone to care. Right, you got to sort of pull all four levers at the same time to advance the field in tandem. I think that’s a key thing. That’s why it makes it very, very hard.

Future Trends

So on a more positive note though, I think this is beginning to happen. And importantly, I think there are some very rapidly– I would say future sort of current trends right now that are rapidly evolving. And probably one of the most important ones is actually, if you ask me is that it’s we’re increasingly understanding and approaching hearing loss within this context of healthy aging public health. And what I mean by that is that hearing loss in and of itself, by itself is not interesting. It’s a usual process of aging. It’s like hidden disability, yada, yada, yada, it’s not interesting. But if you understand hearing loss in the context of why it matters for the big important things is when it becomes really, really interesting. And fortunately, I think this is beginning to be recognized at the national level, right.

So, one of the biggest one, this just came out three weeks ago now. The White House Conference on Aging and the President’s Council of Advisors on Science and Technology, PCAST report, how many of you guys have heard of this? That’s it. All right. So– right so we’ll give a– oh we get this– There’s something, if you have anything remotely to do with hearing loss in adults, this is something you have to know about this. This is– this is fundamentally at the national level about as top-down as you can get. So basically what happened in– in July of 2015, just four months ago now is the White House had their– who’s heard of the Conference on Aging? Few of you guys, all right, that’s not bad. All right. So the White House has a Conference on Aging about every decade, roughly on average.

I think this is the fifth conference on aging they’ve had since the 1950s, and these are big deals, I mean this is a– President Obama attends, this is a big conference on aging, which fundamentally address what are the issues, barriers to older Americans. What can we do to reduce cost, help them integrate, et cetera, et cetera. These for the last 50 years, and we have them every decade, they lead to big things. They have led to the social security. They have led to Medicare. These have a major policy which have come directly from White House Conference on Aging. So one of the sub-themes that came out of the White House Conference on Aging this past July was around the theme of technology and aging. What can we do to harness technology to allow older adults to age in place, to increase our productivity, to increase their participation in society? It’s a very, very broad topic for technology as a whole.

Now interestingly what came out of that, that first sub-theme though was straight from the White House. The first topic that the White House wanted taken up was the issue of hearing loss and access technology in older adults. So this got– This is just four months ago, by the way, right. This got immediately tasked then to PCAST. So PCAST is the President’s Council of Advisors on Science and Technology. Basically, President Obama’s personal scientific council, about 20 senior scientists from around the country in a variety of disciplines, but all very, very, very senior scientists who got tasked for looking at this just three months ago saying, the White House wants, take up this issue. What are the issues with access technology for adults? So over the last two and a half months, they’ve held a variety of open and closed meetings, have interviewed people in this room actually, right. And their report was officially adopted with their letter sent to President Obama three weeks ago, right. So, there are four major — I won’t touch them all in here. I just want to highlight a couple and you can read the report so that– I actually highly encourage you to read but this is fundamentally a big, big deal.

Is the first recommendation is this, is that the FDA should designate as a distinct category “basic hearing needs, non-surgical air conduction hearing aids, intended to address for a basically mild to moderate hearing loss and approve this class of hearing aids for direct over-the-counter sales not subject to state regulations.” So, providing direct over-the-counter access to hearing technologies. This is fundamentally ground shaking in terms of how the whole hearing industry now are being developed right now.

 

So the second one — there are three more. We’ll look at all of them. The second one asked FDA to withdraw their guidance cycle on PSAP, so basically personal amplifiers to make it less restrictive as well. And this– I won’t get into this too much right now though– But the big thing here though is that this report go straight for administrative executive action. So, there are certain things that the White House can do unilaterally without Congress and things like this are one of it. That’s why this report was basically as commissioned by the White House. So it’s still too early say what’s going to happen? Probably many of you seen ADA, Academy of Doctors of Audiology came up with a position same on this just yesterday which then you read is incredibly supportive. They support essentially all four of the recommendations. The American Academy of Otolaryngology came out with this statement essentially supporting all four as well. I think AAA hasn’t done anything yet. I’m not sure ASHA has either. But many, many group are weighing and very, very quickly at this, and usually, what we’ve seen so far is one door or coming out frankly against it are the hearing– The Hearing Industries Association America which is very, very threatening to the business model, obviously. So that that– this is big.

In parallel to this, I’ll say almost equally as big, or maybe bigger in many ways, is fundamentally what’s going at the Institute of Medicine right now. So, probably many of you have heard of Institute of Medicine. Institute of Medicine is an independent body from the government. But it’s often charged by Congress to the government with producing position statements, consensus summaries, recommendations for topics ranging from vaccines to national security issue — though that’s more than National Academy of Sciences, things like that.

 

So what’s happened with Institute of Medicine now over the last two years? They’ve also gotten tremendously interested in this topic of hearing loss and particularly hearing loss and things like healthy aging. And because it’s seen now as potentially a modifiable risk factor for big, big important things. So, the start of last year, January 2014, they had a– They hosted a formal two-day workshop to explore all the issues related to hearing loss, healthy aging. And inviting a variety of stakeholders and they published report on that just last year. A nonbinding report, just basically just a summary statement about the whole issue. But immediately, what that was done is that’s been taken up by various funding agencies now to immediately fund now for the IOM to do a formal consensus study. So when a consensus study takes place over about a year, we have about a series of meetings over about the last– should be the last meeting just, just yesterday actually. And what we’re charged now with– what the IOM consensus committee is charged with now is coming out with by next year a formal set of consensus recommendations now to all of government about what needs to be done to broaden accessibility and affordability. Of which something like the PCAST, which narrowly focused only on access to devices and industry is just one component what the broader IOM report would do. So this report is sort of very much sort of complementary. Probably what PCAST has been trying to do as well and this report is due out next year.

 

So these are two major, major that if you’re anywhere in the field that you’re addressing hearing loss in adults, that these are things you have to read. I mean, this is about– This is not a bottom-up process. This is about as top-down as you get from major, major changes that’s going to affect all of us in this room and hopefully affects society as well. All right, so I think that’s– very positive. That’s what’s happening there.

I think a second big– I won’t say future trend is, the current trend — I should change the slide — is fundamental innovations in hearing healthcare technology.

And what I mean here is broadly the issue of accessible services and affordable technology. And probably all of us in the room here have heard of PSAPs. Who’s heard of PSAPs? Good, right. So, PSAPs, personal sound amplifiers, non-regulated by the FDA. Over-the-counter. You can’t claim to treat hearing loss. You can’t claim to help impaired hearing. But as maybe some of you realize though, some of these can be completely indistinguishable down to the micro circuitry level than hearing aid. I mean, you could take an Oticon Agil Pro, call it a hearing aid for sensory hearing loss and it’s a hearing aid. Just strip that labeling off and just say, it just, you know, it’s a boost hearing and for people normal hearing, right. And you can sell the PSAP. There’s no magic there, right.

 

The final issue there to understand about PSAPs, so PSAPs also encompass things like hunter’s ears. So you go into the woods and you want to hear the deer, you put this– and those– It’s just a broad, broad category, right. So, what that functionally means then is that if you’re trying to use “a PSAP” usually as you have impaired hearing, about 98% of them are just junk. I mean, those are ones you see at the CVS store, those are the ones you see in the back of magazines that say 39 miracle– $39 miracle that we’ve all seen this before. Ninety– I’ll say 99% of those are just garbage, complete garbage, right.

 

But a few of them are really, really good. In particular, those are the ones which usually I’ll tell you were designed by people who knew what they’re doing. So the cost here are dramatically lower. Maybe you cut out a lot of middlemen in terms of how this devices can be market and sold.

 

One device I’ll just mention, I have no personal affiliation with the company at all. I do know that these people though, because actually I use a– I use a device in my research, is a company called Sound World Solutions. The reason why this company is interesting, it was founded by two people. As you– have any of you heard of Sound World Solutions? You have, good.

 

So Sound World Solutions was founded by two people. This guy here is called David Green. So David Green won the MacArthur Genius Grant– MacArthur fellowship about five years ago for being a social entrepreneur. What David has done, about 15 years ago after getting his public health degree, he went to India and in India the leading cause of preventable blindness is cataracts. Right, same actually, same around the whole world. And back then, if you want to get intraocular lens replacement, cataract surgery, the surgery could be relatively cheap. Essentially labor is cheap per se. But the actual lens was about $400. And that is very cost prohibitive for a developing nation. So, what would happen every now and then is Johnson & Johnson, they donate some device or donate some lenses to India. They all getting, you know, everyone stretch your hand, you know, says, “Hallelujah.” But it wasn’t sustainable.

 

So what David Green went in and he’s like, why is a little piece of plastic $400? I mean, it doesn’t make sense. So back then, he found his own company called Aurolabs and without violating any patents they started manufacturing their own intraocular lenses and they started selling them for $3. To this day, I think they are still the third largest manufacturer around the world now of intraocular lenses. About five years after this– so we– by the way the reasons they want to do that is David is a really, really bright guy. He understands the whole supply chain side of things. He understands where everybody is getting their cut, where they probably should be getting cut and why it is so inefficient, right. So that five years after that Aurolabs took on the issue of surgical sutures. Sounds so esoteric. But surgical sutures also made by Johnson & Johnson were, usually I think about $25 a box. He goes like, why is a piece of string $25 for like 6 a pack basically? He’s like, that’s ridiculous. So Aurolabs, David Green hired on a person who used to have a small suture company in Germany and they start a suture– they start making– manufacturing sutures for Aurolabs and they brought the cost down to $2. Now, what’s interesting here though is that around this time period they bid for this, essentially this million dollar contract from the government, Indian government to provide surgical sutures and actually won the contract as you can imagine. But then they promptly got sued by Johnson & Johnson for a variety of reasons. And that lawsuit actually went all the way to the Indian Supreme Court and they eventually won the law suit. But by then Johnson & Johnson had dropped there price to $2.

 

So, David Green himself has a mild to moderate hearing loss, and you can imagine the person he is, he’s like, why are hearing aid so bloody expensive, right. So, about six years ago now, he paired with a guy called Stavros Basseas. Anyone know the name? Yeah, so Stavros is– Stavros Basseas used to be the chief technological engineer for GN Resound. So he knows what he’s doing in other words. So they paired up and they found a company called Sound World Solutions nowadays which makes “PSAPs” per se, right. Which are pretty good. And the way they do this– their device usually unique though because they do actually in situ fitting and verification per se. And what I mean by that, it’s not a real– our classic verification. But what happens is, in order to plug in your auditory threshold or pick how much gain you want, right. It pairs to your phone, right. It plays tones at different frequencies. Your port whether or not you can hear it based on your iPhone or you smart phone. So to the same concept it plays a sound and you record if you hear it. And based on your responses in situ, it programs your amplification based on it. So, basically imagine as close you can get to like a verified fit per se and a self do method, right. But that’s what they do though.

 

Now, they’re not the only company that’s really, really good. Another company which is much more of– looks more like a piece and not your old hearing aid. Have you ever heard of Soundhawk? So Soundhawk founded by Rodney Perkins’ group formerly the reason for– several Resound execs as well. So basically it comes with a– it comes with a mic you wear on your ear of the– amplify you wear on your ear which looks like more like a Bluetooth if they want to look like that. It also comes with a remote mike as well, you program with the phone. And actually use– actually works really, really nicely. It’s quite good actually.

 

At the same time, what’s interesting is you have companies like this. How many of you heard of Bragi? So, the reason for this is because Bragi is not developing a device “for hearing loss”. Bragi last year at the Consumer Electronics Show in Las Vegas, and there’s more and more of these sort of devices that– at the CES. They won the CES innovation award. And what they have a small startup company in Germany. You can actually go to the website and order now. I think it’s being delivered this fall. It’s a little pair of, you know, neon earbuds. And these things are wireless. They have headphones, they have mp3 player, microphone, Bluetooth, headset, it tracks your distance and your heart rate. And, oh yeah, it could also just not only do a simple pass through, it can also amplify sounds.

So, the fundamental question here then — is that a hearing aid or is that just a consumer electronic? And I think what’s rapidly emerging as probably many of us realize, it is not unique to our field. This is across essentially all of medicine now — is that there’s increasing convergence between what is a consumer electronic versus what is a medical device. And this blurring is happening incredibly quickly.

All right, so at the end though and my postdocs in the room actually presented a poster on this a couple of days ago is, well, what objective evidence do we have that some of these “PSAPs”, are they good or are they bad? How do we do it. So, what Nick’s been doing over the last few months is he’s been doing some electroacoustic real ear analysis of some of these devices. And as you can imagine, we will probably find that some are really lousy and some are good. So for example, this is basically, this is the CS50– the Sound World Solutions device. So the black line here is what will be prescriptive NAL, NAL2 targets. The gray hashed area is basically what will be with intended as a hitting target per se. The red, purple, and blue are basically different presentation of the stimuli, right. So we can say the CS50, it can actually pretty decently hit what we consider to be target, all right.

 

The Soundhawk device, sort of the same thing. And I’ll tell you, this is not coincidental. These people when they design these devices, these are designed by usually former sound engineers, they did this on purpose. So that’s why they’re actually not bad. But they have other devices, I think it’s called– something called the Tweak which is just it’s boomy in the base so it sounds loud but it’s actually terrible. So I think what all comes you can’t just broadly say, oh, PSAPs are all bad, these are all good. There’s not. There is a lot of tremendous amount of heterogeneity in terms of how they’re designed, the pedigree of those devices and what they’re designed for and who design them, all right. But these type of basic questions, analysis studies looking at these things are not really being done, and yet such a basic, basic question.

All right, so that’s just one issue. I think there’s fundamentally a innovation that’s going on very quickly with more affordable technology whether you’ve calling it over-the-counter hearing aid or a PSAP, what have you. But this is rapidly emerging, so outside the big 6, rapidly emerging, very, very affordable technology.

 

Probably many of you guys heard– how many of you guys heard the ADA-IntriCon venture? The ADA and IntriCon venture, the earVenture? Oh man. All right, so I should know more of those than you guys. But listen, so what ADA, part of IntriCon now is if you’re an ADA member, IntriCon will manufacture a– basically a pretty basic digital hearing aid and sell it essentially at $450 wholesale cost to the audiologist. So, what’s happening really rapidly outside of the traditional big 6 is the rapid emergence of innovations for more affordable technologies.

 

Beyond that though, technology is great. Technology is one piece of the pie, technology can help many people but maybe not all people. What about services? And what I mean by this is that let’s face it. There are quite– There are 11,850 audiologists in the whole country I think right now. I think it’s the latest I heard. So there are about 12,000 audiologists in the whole country, maybe about 6000 dispensers. There are not enough people quite simply if you’re going to really serve everyone who possibly could benefit. There is never will be. It just won’t be. So what else do we do?

 

So what’s emerged now from a researcher called Nicole Marrone at the University of Arizona as well as for my group now is they’re going to test now the idea of using community heathcare workers to provide primary front level care for some basic hearing rehabilitation. So community healthcare workers have long been used in other sort of very, very common chronic conditions in older adults, hypertension management, diabetes management, even depression management. So basically train a lay health person to provide a very specific set of service in the community, in that person’s home, like literally going out to where they normally live. So not bring them in a clinic. And train them with a various specific set of skills, but under a supervision of a broader care team, a clinical team.

So what’s happening right now is one of my previous postdocs called Carrie Nieman and I, we founded a nonprofit. It’s called Access HEARS, which stands for Hearing care Equality through Accessible Research & Solutions, where we develop a CHW model which we begin to disseminate and test now through various nonprofit, as well as NIH grants. But what Carrie did a couple years ago is– maybe three years ago now is she began manualizing the HEARS intervention. An intervention designed to be delivered by a lay health person in the community, which would do three things. It’ll provide basic hearing loss screening with a portable audiometer on basically essentially iPhone now. Provide essentially immediate provision of a self-fit amplification device namely a PSAP, right. Can’t do a hearing aid, has to be called a PSAP. As well as helping then learn how to use it, and then mainly providing sort of expectation management, communication strategies to that person as well as his or her communication partner. So, essentially a two hour intervention designed to be given by a CHW at average cost about $120, so $80 for the device when you buy it wholesale and $20 per hour for the CHW’s time.

 

So far we piloted this now in three different populations, a site called Weinberg Senior Living, which is basically senior housing towers throughout Baltimore City which are basically affordable housing for low to moderate income older adults. Sarah Mamo my other postdoc has been doing this now specifically in people with cognitive impairment and with dementia in group homes for instance. So basically people with existing dementia, can we lessen some of their communicative burden and hopefully help some of their neuropsychiatric symptoms, not reversing dementia obviously but can we help reduce some neuropsychiatric symptoms of agitation and things like that.

 

And finally, Janet Choi, another of my pre-doctoral students has been developing this and has developed this and has implemented a a Korean version. There’s a large Korean American population in Baltimore. Many of whom are first generation who don’t speak anything besides Korean for the most part who have no access now as, you know, probably all those realize there’s very little diversity in audiologists, but bringing some type of more community-based intervention with them as well. Looking at some short-term outcomes over three to six months, again, social engagement, communication and things like that.

 

And we are right now is from 2013 till now, intervention development. We’ve been doing policies for the last couple of years and we’re rapidly moving toward now is through the nonprofit, we are doing dissemination with various state agencies, as well as even some international interest in licensing and what we’re doing, as well as with the NIH grant, be more official in testing and refinement. So that’s all ongoing right now. And to give you idea what this looks like.

This is sort of the draft materials are still being refined. But I mean it’s very, very conceptual. There are no numbers, there are no audiograms. We explain, you know, normal hearing, signal that goes in is what goes through brain it is very clear. We have some hearing loss. I think it’s a little fuzzier, right. So no numbers here, no audiograms put over the care. But these conceptually explain what hearing loss is.

We go to some communication tips and tricks. If someone didn’t understand you, repeat it once. If that does not work, reword it. So it may be for the communication partner, saying you know, what do you think of the meal, what do you think of the meal, tell me about the food. So very, very basic concepts around oral rehabilitation and communication repair strategies.

And finally, with the devices– There’s a first generation CS50 device we’re using now they’ve gone on to next generation. But just really going with basic stuff I mean how you– it’s big rechargeable battery, by the way, which makes it very nice. How you connect the battery, having a checklist to make sure they know how to use the device properly. So, again, this all takes about two hours for this first intervention.

Now, this is small but I like to read it though. So I think quantitative today is all good and that’s wonderful. Right now I’m not going to bother showing you that. But I could but I am not. I think what’s more interesting a lot of times though is on the qualitative data we’ve been collecting. So this is a project that Sarah Mamo has been doing, which she adapted here for implementation in the memory clinic at Johns Hopkins. So basically patients with existing dementia implementing in when they come to clinic for other clinical visits, immediately intervening with them as well as him or her and his or her caregiver.

 

So this is just a– we track some quantitative data, neuropsychiatrics and other things like that. But we also ask them first that every week, we asked them to keep a little guidebook and just log what they’re noticing, right. So this is a feedback from the son-in-law of a 91-year-old woman with an MMSE or something, so basically she was– she actually had dementia.

 

And what he reported at week one– I’ll read it out loud since it’s hard to read. His handwriting is a little messy too. “This week there was trouble adjusting the volume, different TV stations had different levels of volumes. People came into a room with different ways of expressing themselves. She would holler the device is too loud.” All right, that’s week one.

 

Week two, “The huh, stopped right away. Her asking to repeat a statement has almost disappeared. The speed of conversation has quickly picked up. She helped me to adjust the hearing device and make things more comfortable.” That’s week two.

 

Week three, “she began telling her historical stories more accurately. She asked me questions in smoother sentences. Her patience was extended. There are less hurry ups,” right.

 

Week four, “she’s seem to be less interested in having her way and imparting restrictions on the second party when she do not get her way.”

 

And finally week five, which is the end of our follow-up period, he wrote, “her willingness to make decisions is stronger. Such decisions had made more sense. Note dementia is still there but it seems to take more of a backseat in her life.”

So this is $120 intervention delivered at the point of care which is– it has to make incredibly low hanging fruit for making a difference before they even get into see an audiologist and fitting a $4000 device. I mean this is a stuff where there’s so much low hanging fruit here where our field– and we think about probably in the big picture can make a huge difference, yet I feel that very few people are moving in this direction yet.

 

So, to this end– I’m getting close to the end of my time — I think right now in the US, around the world, there is one gold standard model of hearing healthcare right which is– and it should be the gold standard, audiologist directed care, clinic-based care, takes three to– two or three months. It takes a lot of time. It takes a lot of expertise and it takes a lot of expense. And there’s nothing in between. So I think what’s raptly emerging now is that there is diverse– There needs to be diversification in terms of delivery models, where you can imagine at the lowest level would be the wide availability, hopefully based on the PCAST report, of over-the-counter technologies, some of which, because they were going to be regulated will be very, very good. And that may be enough for some people.

 

The next level, some people– listen, they still aren’t going to figure out the device themselves. They need a little help but they can’t, they’re not going to make the commitment to come back and forth and they don’t want that level of service. And I think there’s a role– clearly a role there for CHWs, community health workers providing initial frontline level of care.

 

Then above that, hearing specialists, technicians who were trained to precisely fit the device but don’t necessarily do the whole oral rehabilitation, accounts for things like that, right.

 

So I think this is what needs to happen. If you look at almost any of the chronic medical condition or whatever you have you, these things happen. There’s a– There’s evolution, there’s a progression, there is different levels of care. And yet hearing healthcare right now there isn’t. And that’s a big, big problem.

 

And finally what I think happened here and these are just two of my postdoctoral audiology work right now is where I’ve been thinking about is how the audiologist can be essentially the leader of this team. This– It shouldn’t be directed by me, shouldn’t be directed by hearing specialist, it needs to be directed from you guys. I mean so you should be practicing the scope– at the top of your scope of practice in other words to do this. And I think this hopefully evolve over time.

All right, so this is just– that’s one big thing. A second one which I won’t go on too much about but I do feel strong about I just had this slipped in here but I think it is important, is the issue of open wireless standards. And usually the response that I hear is like, what are you talking about. But this is important though.

So if we’re going to look at the fundamental limitation of all hearing aids, I think probably many of us agree, it’s how to increase signal noise ratio. The speaker is here and I’m all the way back there. There is no amplification. So how do I boost the signal noise ratio. Hearing aids with a microphone at ear level can only do so much. So clearly the way to really do enhancement approach is typically as industries approached it, has been a lot of post-microphone algorithmic processing of sound, beam formers and things like that. I mean, you get a boost of what, I don’t– I mean, Harvey could tell you more than I. Maybe like plus one, plus two, and a plus three gain SNR, boost in SNR. But it’s not like– It’s not sort of hit out of the ballpark sort of thing. And I think probably many of us would probably agree is that we are probably rapidly reaching the point where we won’t put a boost anymore, just purely based on the size of devices and the battery power to go, with a supercomputer I could. But not in real time of little half ounce device with a little miniature little battery.

 

And yet some of the most promising things are if you can go pre-microphone. If you can move that microphone closer to the speaker, I mean your boost in SNR is what? Twenty, 30 minimally? I mean, they’re exponential, I guess, I mean as much as you wanted to. And the way we go on about now is, you know, hearing loops when they’re installed they work great. Also proprietary wireless which manufacture use, they come with different types of wireless mics, some are 2.4 gigahertz or 100 megahertz. I mean, it runs a whole gamut as you all know.

And fortunately then– unfortunately, I should say, what it looks like is this, is that every single manufacturers of different device, it’s not they’re not cross compatible, they’re– some of them is FM system, some have loop system, some infrared. It’s just a mess. We all know it’s a mess.

So why can’t it be a system like this?

 

Why can’t there be a universal frequency for a near field sound transmission which is approachable, Bluetooth LE as you guys know with the latest resounds there is some Bluetooth LE or Bluetooth Smart they integrate into it, but still not universal. But it’s still only is primarily used for near field where you sort of– it comes on a handshake protocol, you can’t broadcast. What about far field? So rather than having to have a loop installed, what if you go one common wireless band that send out a signal with any compatible device, you hit a button, you pick it up in the abnormal hearing from the back and you’re going to hear better. So you can’t basically do a Bluetooth right now, but with something called Wi-Fi Direct you possibly could. So Wi-Fi Direct allows peer to peer. So you can broadcast, right. And there’s thoughts now that we needed about a sub-protocol now for audit– for sound transmission but I’m pretty sure this impetus will not be coming from the big 6, this is going to be coming from the consumer electronic side.

 

And yet, you can imagine if this evolved, universal frequency, universal transmission, this changes everything. Because when you convince me as a 39-year-old person with essentially normal hearing I think, that I want to wear a device like this, you’ve won the game. And to be honest– Actually a caveat, I’ve actually ordered that Bragi device before I showed you, the little one because I actually go running a lot. but I haven’t got them yet. But if that also have this little wireless band, you pick whatever, I will love it. Because I can sit in the back of the theater and hear everything– I mean that’s where it’s a big game changer. But this stuff usually probably should come from the consumer electronic side. I think that’s why with the PCAST report, what the CE– the consumer electronic research is doing, I think this is what’s going to emerge. I don’t know how long it’s going to take them. I think it’s almost inevitable in terms of how we approach it.

Right, the last thing I’ll mention here is clearly as you all know, this is essentially a travesty. The 1965 CMS Medicare Act, this is all of you guys as diagnosticians, and diagnosticians only, I mean what gives. So there clearly needs to be coverage of the services you guys provide beyond diagnostics services and– I mean these are all things that are being discussed at a higher level with CMS, and I mean they’re all looking at this issue. So, whether it will change, I don’t know. But this is where I want to start talking about it. I think what could happen here very, very quickly though, is that there is going to have to be a fundamental process on bundling. You can’t bundle things together, it does not make sense. Where conceived a model in the future where there is coverage for audiologic services somehow, through insurance companies, but there’s actually no coverage for devices. And to be honest, I don’t think it’s a bad thing. I mean the pace of device nowadays in terms of once you get the consumer electronics industry involved in things like this, you’re dropping to less than $100 for a device nowadays, why should that be covered? I mean, if anything, they go pay for a little more but your services will never be that way, your service can never be commoditized. So the fact that still most audiologists and hearing — most audiologist don’t bundle, just it just– it’s absolutely bizarre to me. It just doesn’t make any sense on how the field is heading. Especially with this PCAST report coming, I think everyone is going to have to change to some degree.

All right, so this is my last slide, and the reason why I show the slide at the very end is because I think no matter what you do in this room, whether you’re a researcher or a clinician or a policymaker, what have you, it always comes down to the people we care about and the people we want to help. So this is actually my 92-year-old grandmother who for the last 20, 30 years has had a mild to moderate hearing loss. And she’s hearing us for the last, you know, 25 years to at least– and the– This was about three years ago now. I’m sitting down with her at lunch and she’s asking me how work is going on in Chinese. And I’m going on, but oh, this is– which was going fine, and I’m doing– I’m saying this research and these three questions, et cetera, et cetera, and go on and on and on. And after five minutes, she’s looking just a little more like just little disconcerted and she stops me and she says, it’s like are you telling me that I’m going to develop dementia. And she was not happy actually about this.

 

So you know I paused and I said, grandma, and I said no, no, no, of course not. For example you have high blood pressure because that, you know, you just really get more risk of heart attack and stroke. Which wasn’t probably the best way to explain it, but she knew what I meant though, right. Because on a population base level, if you have high blood pressure, more like you have a heart attack and a stroke. I said, with hearing loss it’s the same way. At a population based epidemiologic level, we’re understanding that hearing loss likely increases our risk for dementia and things like that, but it’s on a population based level. It’s a lot of obviously tremendous amount of individual heterogeneity. And I said, you know, with hearing loss we’re understanding it’s sort of the same pattern. And obviously what we’re missing here though is a definitive clinical trial, and see what– whether treating her makes a difference.

 

Now the reason why I like to mention the example at the very end is that we take it for granted now as society that high blood pressure. If you’re a 65-year-old person with high blood pressure, you treat it. It’s just– it is almost like God-given, it’s just a done deal. Of course treat it. Yet the amazing thing about if you ask any primary care physician who’s over 50 years old and you ask them just 25 years in the early 1990s, if you had isolated systolic hypertension, that higher number, if you had isolated systolic hypertension, and it was less than 140 plus your age. That was a rule of thumb. If it was less than 140 plus your age, not treated. Right. So you could be a 70-year-old man and if your blood pressure is let’s say 200 over 70, not treated. Because the attitude back then, understanding back then, was that hypertension is very much often a usual process of aging. Your arteries get a little stiff over time, your blood pressure goes up. You get more blood to your brain, it’s a good thing. So that was the accepted thinking for literally decades until 19– I think it was 1993 something called the SHEP study came out, the Systolic Hypertension Elderly Program trial came out. A definitive randomized clinical trial took several thousand adults randomized to a diuretic therapy I believe versus no therapy. And dramatically dropped rates of heart attacks and strokes. And literally– I won’t say overnight, but over a year period, that changed the entire worldwide management of hypertension. And many people would probably even say, you’re seeing a sequela of that nowadays with possibly an absolute lower risk of dementia because of the attention now paid to midlife vascular disease back then.

 

So I think there are a lot of parallels between that and hearing loss. Hearing loss like hypertension can be very much a usual process of aging but we’re increasingly understanding though is that it might not be without consequence. But what we’re still missing though is what is the definitive evidence though that if you treat it, how much of a difference can you possibly make? So I’ll finish up there. I think we saw some questions and just thank you for everyone’s attention.

Questions and Discussion

Audience Question

Hi. My name is Fatima. That was a great talk. I have two questions actually. The first one is, what is the best practice for including or excluding people with dementia who also have hearing loss when we do research related to communication. I was wondering, like, whether we should include those who only wear hearing aids or some kind of hearing amplification, or we can actually include those with mild, moderate hearing loss who are not being treated?

I think– that’s a tough one. I think it all depends on a scientific question you’re trying to answer, right. So for example for our clinical trial for instance there’s no dementia, even cognitive impairment, because the question there is can hearing loss delay cognitive decline. So I think it all comes down to what the scientific question is. Does that make sense? I mean I guess maybe one question is that if you have intervention, can it help reduce neuropsychiatric symptoms for let’s say some type of behavioral therapy or something like that. I would hope you wanted some people with hearing loss and dementia when it makes sense. I’m not sure I’m getting what you’re asking but I think it all depends on a scientific question you want to ask for how you define your inclusion/exclusion criteria.

Audience Question

So secondly with your ACHIEVE project, you were saying that one group is getting the best treatment for hearing aids, and the other one is getting successful aging which might not be related to fitting hearing aids and so forth. So in the after you collect all the data, will both groups receive both kinds of treatment?

Great question. Yeah, I know I think right now is currently conceived, the trial is at the end of the study. If you want to receive the other intervention, whether it’s successful aging healthy aging counseling and/or the treatment of hearing loss, you can receive it at the end of the trial.

Audience Question

My name is Aaron Roman. You talked about changes in brain density and neural changes. So you said in your study you looked at changes to superior, inferior, medial, temporal gyri. Do you notice any larger scale changes such as associations with the prefrontal cortex and pre-motor cortex?

So, great question. So we didn’t. So don’t forget though, this type of analysis we’re doing purely are structural measures of volume, volumetric measures. So we didn’t actually. Not to say they’re not there, just with a 126 of people, it’s relatively small. We didn’t see any change of prefrontal cortex. I mean, in terms of structural. But you know one thing we are moving toward now though is begin to look at diffusion tensor imaging. So, tractography in the brain, whether the tracks are changed. That’s going to be a little– if you are as hard. The bigger thing we’re looking at more importantly now is we’re beginning to look at something called default mode network in terms of functional MRIs. It looks at patterns of how the brain in the resting state how it works and whether we see changes there, right. Because– I mean based on the functionor imaging in terms of past activation, we see that on either fMRI or something called high density EEG, [inaudible] is doing that work in actually in Colorado. But we will begin to start– We’ll soon begin studying that looking at resting state fMRI which looks at patterns activation. So I think there are many ways to sort of get at the brain, this is one of them. Actually we haven’t looked at cortical thickness either yet either, so there– but we didn’t see at least on that initial set of analysis now.

Audience Question

Hi, I’m Julie Dalmasso. For the cognitive assessments, you mentioned that they don’t need the verbal audibility to complete the tasks, but how are the participants given the instruction, when those still have to come from a verbal nature?

This comes up all the time and– I mean you can imagine too there’s hearing loss so how do you standardize or not on these compounds. I’ll tell you for the study like ARIC, the way they do it is instruction is printed– written and verbally, right. And that’s a big thing right there. And also, again, for the most part, these instructions are being given face to face quiet room, so it’s obvious. But usually there are written instructions as well though.

Audience Comment

Barbara Cone, VP for Academic Affairs and Audiology. Thanks, Frank. I have a comment first and then a question. And my first comment is about the gold standard for treatment, which you defined as: audiologist, $3000 or $4000 hearing aids. I would just like to say that I think that as a result of the FDA regulations and some of the decisions made by the medical community over the last 30 years, we have been hamstrung by that to only provide that kind of care. So I think with this call for a decrease in regulation, we as audiologists can come up with better models. But we have been hamstrung by these regulations.

Yeah. No, I completely agree.

Barbara Cone:

But I do have a question for you. I’m so glad that you brought up the the example of cardiovascular intervention that is now the norm. And that is with the complex condition like cardiovascular disease or even diabetes, would you recommend over-the-counter treatment for that? Because it seems to me that hearing loss is also a very complex disease or condition, and we’re recommending over-the-counter treatments now? Would you recommend over-the-counter treatments for other health care conditions that do impact dementia like cardiovascular disease or dementia?

Frank Lin:

I mean, a lot of the cardiovascular– I mean these medicines are great. But even beyond that though, exercise, things like that are I guess over-the-counter as far as you can say it. I mean I think it– it all depends on the system you’re talking about. I mean, the analogy that PCAST used was issue of readers, for vision and things like that, you get prescription spectacles where you get magnifying spectacles.

Barbara Cone:

Yes. But would you manage cardiovascular disease completely in the hands of a person who could buy an over-the-counter medication and not be– and not have the opportunity to consult with a qualified health care provider?

I think that we have to temper some of what we’re saying about over-the-counter treatments with the realization, this is a complex health condition and there will be a considerable need for a person with such a complex condition to be able to be seen by an appropriate healthcare provider which I think is the audiologist.

Frank Lin:

I’ll qualify that though. It can be complex. It doesn’t always have to be complex. So I think the key thing there is that there are multiple different components of what we call hearing healthcare screening, diagnosis, counseling, training use of the device, ALDs and there are always different components of it. And I would argue for any given person, they may only need one or two, or they may need all but I think it varies from individual, individual. And yet, we don’t give that option right now, more importantly, yeah.

Audience Question

[Margaret Rogers] I had a question, and that concerns, will this work for kids as well as adults?

.

Oh no, no– No, no, I think that’s a whole different ball of wax. No, completely. I mean the PCAST report is only written for adults– actually older adults even. IOM report were limiting purely to adults too. Pediatric hearing loss is a whole another beast where that has to be medically evaluated. That’s completely different though. Yeah. No, I agree. Yeah.

Margaret Rogers:

And of course there are many of us that are worried that parents in the future will just slap whatever they get at CVS or Walgreens onto their kids. And do you have any sense of how these governmental and the IOM agencies are going to manage that risk, just how to manage that risk?

Frank Lin:

Can’t fully probably comment at this point, but it is something that’s come up obviously, the topic, yeah. But this– Let me say, that’s not unique to hearing devices. You could apply almost any type of over-the-counter where you could do the same thing, let us put it this way. Yeah.

Audience Question

My name is Jan [unsure], I’m from Nebraska, and I’m interested in this model looking at farmers and actually even starting with teenage children who are exposed to noise and so they are developing noise and just hearing loss over their life span. And seeing if maybe these cognitive defects or that deficits start earlier in patients like that. Do you think that’s something interesting to pursue?

Yeah, no I think it’s– No, I think it’s a great question. I mean, you know, always epidemiologic data have been done, you know, broadly 60s, 70s, 80s. Probably the vast majority per age they’ve lost begin at 40s, 50s but I– none of these studies have enough power to distinguish an early onset. I mean we’ve actually– you know early, I mean pediatric congenital onset obviously. But in terms of when onset begins, it’s– I think it’s a great question, it’s just hard to study, because you need a lot of data on a long term cohort people, so it’s tough though, yeah.

Audience Question

I’m Evy Webbing and I am a North Carolina Central graduate student. Going off of that question, do you know if there are any studies that have been done studying early onset hearing loss, and then later developing or cognitive decline?

So I don’t. And I think– Let’s take it to extreme. I mean let’s say children who are born congenitally deaf, who grew up in deaf culture. I would argue these– all these pathways will talk about cognitive load, brain structural changes, socialization, don’t really apply anymore. I think hearing loss, the way the brain adapts to hearing loss when you’re born with it is really different than what happens for the rest of us who were all hearing. So I think it’s very, very different. But as far as I know, no one’s really studied. It’s jus hard to come with a study that follows, I mean, people though. I think it’s very, very different– congenital concept hearing lose versus adult onset hearing loss. Yeah.

Audience Comment

Harvey Dillon. Just a comment on a comment that came up earlier about there not being any evidence about early intervention in kids. There actually is. In Australia we had the opportunity, when had some states had newborn screening and others didn’t. But no matter what age they found it, they all got treated the same way by the national organization, so we jumped in and started a longitudinal study. Those kids are now 9 to 12 years old. We recruited them when they were babies or up to age 2, and there’s a huge difference between the ones who got the early intervention and those who did not. I just wanted to correct that record. There’s a special issue of the International Journal of Audiology from earlier this year. It’s got a bunch of papers that’s the age 3 data. And the age 5 data we’re working on at the moment. But Teresa Ching is the person leading the study.

Audience Question

I was interested, over a 40-year period or whatever, these increases with age of hearing loss have remained about the same. But now we have a generation of people who grew up on rock music and, you know, iPods in their ears and so forth. And they are now becoming the aging group. Do you have any hint that that may change the profile of hearing loss increases?

I don’t. I mean at the best– the most theoretical thing I would go on a limb and say though was more like — Charlie Liberman’s work with Sharon Kujawa at Harvard, basically showing that with a lot of noise exposure, you can get actually glutamate excitotoxicity where you preserve relatively normal thresholds but you actually lose spiral ganglion. So you actually– You hear far worse than your thresholds look. That’s the big picture there. In terms of how that would extend to people who’ve had a long history of noise exposure from rock and roll, iPods, I mean, I don’t think anyone knows.

Audience Question

I’m Rosemary McKnight from CU Boulder. Do you think there’ll be any recommendations forthcoming about a hearing screening program? At what age to start offering routine screenings as part of primary healthcare?

I don’t know. I honestly don’t. I mean the USPSTF, I mean, the United States Preventive Services Task Force, they came out with their report three years ago now on hearing screen for adults who were 50, where they do a comprehensive review of the literature, et cetera, et cetera, and they found no evidence suggest it, to do hearing screen. And not because there was– They shouldn’t do, it’s just that there was no evidence, right. So I think I don’t see a new report changing anything because there have been no new studies since then, unfortunately.

Audience Comment

Hi, I’m Nancy Nelson from Indiana University, and I just have a comment about you just referenced Sharon Kujawa’s work. And just thinking about this public health model and how it might work, and how consumers might get more direct access either through telepractice or through the telephone hearing tests or a variety of ways that they can be tested. That work makes me think as an audiologist that the pure-tone audiogram probably isn’t going to continue to be the end all and be all. And so I would just caution that as we move forward with these really large scale kinds of initiatives that we think carefully about adding some additional kinds of testing, maybe speech and noise testing might be the easiest to implement.

Audience Question

I work for Centers for Disease Control and Prevention. So I’m rare in a sense the audiologist working in a public health agency. My question is, I think this is the broad question, are you also going towards the direction of policy study in whatever you’re doing? Are you going to integrate a policy angle into it?

So– I can’t do everything. But I would say, the closest I guess personally for me that I have been very interested in this is, yes the– You can do all the research in the world, let’s face it, and you can make– if you’ll make a little difference. So I mean that’s been a lot of my work through IOM, so I was– I co-chair the panel last year of IOM on that, that’s why that led to this consensus study.

So I think policy will hopefully evolve very quickly from PCAST and when the IOM come out next year, we don’t know what they’re going to say yet, obviously, or we’re going to say yet. But that I think will be where policy evolves from, very quickly, hopefully. Those are the– those are only initiatives I know– the big initiatives going on right now. Within the VA, obviously, VA is a whole another– and, you know, Lucille Beck and I mean, there– they have been long aware of these issues too. But, I mean that’s– I can say personally is what I’m doing at least. But beyond that, the policy piece looking at I would say broader questions of demonstration projects within CMS, within Medicare for different types of therapies for treating hearing loss and what are the long-term benefits. I mean those, I guess, were policy issues, more research which no one is really doing yet unfortunately.

Audience Question

Then my next question is somewhat related with the hearing aid legislation. Now in the newborn hearing population, this is what CDC is charged to at the other spectrum of the world. All right, in the sense of what we have been noticing in the newborn hearing screening with regarding hearing aid use is that legislation to actually cover hearing aid — it seems to us you have to be fighting a state by state, beginning at the state law. It is extremely hard from the federal level to fight that war. It’s been very successful in the newborn population to fight state by state, lots of states have passed coverage for hearing aids and some of them actually extended to adults. So do you foresee that this may be replicated in the adult population fighting it from the state to state level? And how much of the PCAST is you think that it’s going to influence the state legislation and politics?

I don’t know.

Margaret Rogers:

Well, you have really shared so much with us today and it is wonderful to get this data and to get this look at where we’re going with the future. I know that all of us have been thinking a lot about our roles in the future healthcare system. This is very helpful and I think very clear and well thought out. So, thank you, Dr. Lin.