Posted by - For Consumers, Regulation.

The President’s Council of Advisors on Science and Technology met on September 18th to discuss hearing aids and hearing technology. The discussion was led by Dr. Christine Cassel, MD, a leading expert in geriatric medicine, who suggested that “technology-based changes in Federal regulations … could make this [Personal Sound Amplification Product] technology more available and begin to promote more innovation in the market.” Here is a short snippet from Dr. Cassel’s professional bio, over at the National Quality Forum.

Christine K. Cassel, MD, President and CEO of the National Quality Forum, is a leading expert in geriatric medicine, medical ethics and quality of care. Previously, Dr. Cassel served as President and CEO of the American Board of Internal Medicine (ABIM) and the ABIM Foundation.

Dr. Cassel is one of 20 scientists chosen by President Obama to serve on the President’s Council of Advisors on Science and Technology (PCAST), which advises the President in areas where an understanding of science, technology, and innovation is key to forming responsible and effective policy.

For those interested in hearing the entire talk, here is a link to the video and powerpoint used by Dr. Cassel. For your convenience, we have compiled the entire discussion in text, below.

DR. ERIC LANDER: Another update is from Chris Cassel on work that PCAST has been doing asking about how technologies can help Americans age in place, age with independence, age with productivity, and that’s a broad topic that Chris has been leading a study group through. And then within the course of that it’s been identified a very specific topic where there seems to be tremendous opportunities for, I think short-term progress. And that has to do with the question of the normal mild to moderate hearing loss that’s associated with aging. And the question of hearing aids to help with that. So Chris is going to give us a bit of an update on the broad work that she’s been leading on aging. And then particularly on hearing technologies.

CHRIS CASSEL: Thank you, Eric. Well, first let me just say that in terms of the broader study, the group is focusing on ways that technology can help people as they age with issues of cognitive function and cognitive impairment. With issues of mobility enhancement. With issues of social connectedness and engagement as well as with this important area of hearing. So PCAST will hear more about the broader focus in subsequent meetings. So I’m not going to spend a lot of time since our time is limited today. I did want to update the group on our findings to date and the direction of our thinking with the hearing report. So let’s see if we can . . .

So as Mark did, I want to thank and be very grateful to, what you see here is a very hard-working list of Working Group members for the whole report, many of the PCAST members from many different disciplines and perspectives have joined this group, as well as experts in all of the other fields that I mentioned. You see their names up there. I particularly want to thank Ashley Predith and Diana Pankevich who really worked very hard to staff all of the subcommittees and various groups that are working in this area, and also our science writer, Robert Saunders.

So let me just give a little background about why this has taken sort of the forefront of our work over the recent last couple of months. The first is that there’s not only an urgent need to improve hearing, but a great opportunity right now. This is a major health and social problem, if you think about it, if you have trouble hearing, it leads to social isolation, it leads to an inability to keep working if that’s what you want or need to do. It can lead to depression. There’s some demonstrated association with higher risk of falls, falls with injury. And even dementia. And of course all of this is made more important by the good news that people are living longer in our country and that a vast majority of people with hearing impairment have hearing impairment because of age related hearing loss or what’s called presbycusis. So our focus is on that group.

There’s a lot of people in this country who have hearing loss from congenital problems, who have serious hearing impairment from injuries and other kinds of disorders that are much less common, so I do want to emphasize that our report is really only focusing on the presbycusis related hearing loss. But if you think about how many people actually use hearing aids. There is technology that can be extremely helpful for this problem, and yet of the people who suffer from these problems, so let me give you some numbers. 1 out of 4 of people between the ages of 65 to 69, One-half, 50% of people between the ages of 70 and 79, and almost 80% of people over the age of 80 have some degree of hearing impairment. So that’s huge. Roughly we think 30 million people now. And that number is likely to grow, and yet very few of them actually seek help and get hearing aids. It’s hard to know because a lot of this is self reported. But somewhere between probably 15 to 30% of people actually use available technologies.

This is a big problem, and as I’m going to say in a moment, the Institute of Medicine is just launched a big study in this area of the whole broad area of hearing loss, both age related and other kinds, but as we look at the data to what the barriers are on the adoption of available technology, the No. 1 issue that people report over and over again is the cost of technology. Averaging about $2400 per hearing aid, and since with presbycusis it’s mostly a bilateral condition, most people need two of these. And it’s not uncommon to have them cost even more, 4,000 to $8,000 is not an uncommon cost. Added to that insurance, Medicare does not cover the cost of hearing aids. And most other insurance doesn’t. It doesn’t consider it a medical condition, interestingly enough.

In addition to that, the access is very complex. Often you have to seek out an audiologist in a specific kind of arrangement with one or more hearing aid companies. The choices are somewhat limited. By and large these are not available online or in other kinds of consumer venues the way people are increasingly accessing many aspects of health care. There is a requirement that people see a physician to rule out other medical causes of hearing loss. And so while a large majority of people actually waive that requirement it’s somehow also seen as a barrier because you also have to get a doctor’s appointment with a doctor who knows something about this. There are some innovators in the market in terms of marketing organizations like Costco and others who have begun to find ways to make the cost a little bit lower and make access a little bit easier.

There’s also a market in devices that are not hearing aids, called personal sound amplification products, that can amplify sounds. But that aren’t marketed to people who are hard of hearing. So they have not been widely used for that purpose. There’s also kind of a social stigma. It’s kind of interesting to me as a geriatrician that people are wearing eyeglasses for example, and we have age-related condition of people needing reading glasses it’s called presbyopia, and you know people nowadays think that there are different fashionable glasses that they wear, and certainly don’t hide the fact that you need eyeglasses. And yet, I think because it’s so difficult and because the large number of people who need them don’t actually use them that we just haven’t gotten to that tipping point in terms of social attitude. So there’s still a reluctance to admit that people need help. And this is important. Because there are risks to waiting too long. And this is very well demonstrated that if you begin to notice you’re having trouble hearing, and you say well I don’t need this quite yet and you wait six or eight years until it gets worse, then when you do seek help it’s harder to get back to baseline. Sometimes impossible. Because changes to how the brain processes auditory signals decline, and so here is another situation as in many places in health care where it’s better to seek help early rather than wait.

And then another factor that I mentioned earlier is that by and large, most primary care physicians don’t consider this part of their business. They rarely include it in a review of systems with a patient. And if a patient is hard of hearing, it may be tough to communicate with them. But they don’t consider that they should try to get you help for that as part of your medical workup.

So all of this creates a kind of a situation that we think is actually ripe for a technology solution that could be helped along by Federal action. Now, there is this big study that the National Academies of Medicine has just launched and we have talked to many of the same people. We have attended their public meetings. They are not likely to issue a report before probably a year from now. So we are thinking, and what they are looking at is a much broader scope of this whole problem. Our focus is people who have age mild to moderate hearing loss associated with age and what technology could do. And what Federal actions might make that technology both more available and more widely used.

So the goals of our report are the following. To reduce the costs number one. And we think that the market forces are quite ripe for doing that. And also if the cost went down significantly, the likelihood of insurance coverage would be increased so we could have a salutary effect in both of those ways and would increase the number of people who use this technology I mentioned the 30 million figure. There will be more people, as more of us are living longer and as the baby boomers are now beginning to enter in greater numbers, that cohort. So this benefits people in terms of their own lives. But it also benefits families. So if you think about it, it’s a lot more than 30 million people who would benefit from a spouse or a parent or a grandparent being able to hear better.

And then finally, there is enormous productivity and innovation in acoustic technology and signal processing. People are wearing noise canceling headphones on the airplanes, and there’s all kinds of interesting things that people in the music industry and in the sports arena use. And we live in a new world where there’s much more rapid advances in that kind of technology. Also aging baby boomers are much more comfortable with things like trying things out at home, ordering things on the Internet, programming devices on their cell phone, things need to be interoperable with other devices, all of your tablets and music devices with loop technologies in theaters and other public places. So the technology is out there. And innovation I think is happening. But it hasn’t really been made available to this important market I think.

So if you look at a couple of observations, one is that in every other aspect of electronics, technical advances in general reduce costs. Not increase costs. And actually reduce costs quite dramatically. And that in the traditional hearing aid market, it’s actually the opposite. If you add features like programmable to your cell phone and other kinds of things, it costs more, not less. So we think there needs to be a way to open the market up to more competition in that area. Secondly, the technologies itself is not that costly. And several groups are actually selling the very same hearing aids at lower costs. I mentioned the Costco example. but the Veterans Administration covers first dollar coverage for hearing aids for Veterans who need it and have told us that it costs them about $500 per patient. or that’s what they spend on that condition. Lots of European countries cover hearing aids as part of their health insurance programs. And buy them from the same companies and spend much, much less. So we think that there is a disconnect between the cost of these things and what’s available in the market.

And these electronic solutions consumer products, these electronic sound amplification products. are available at a much, much lower cost and some of those companies actually make traditional hearing aids as well as the PSAPs. They have many of the same features. And could in fact be very helpful in people who don’t need a lot of fancy features. who have a simple need for amplification and perhaps some personalization that could be accomplished in a much easier way. So what we really need is consumer shopping. That’s the challenge here. We need to allow consumers to shop for the best value to maybe take a test online that evaluates their hearing. and have a much more wide availability of trying things out and finding what works for them at a price point that works for them. So that includes Internet shopping. and would allow more new entrants into the field.

So let me then turn to this one concern that keeps coming up over and over again about well, what if you had some other medical condition that was causing your hearing loss that went without treatment. And we have examined this in some detail and find that there’s the actual risk of this is actually quite small. Especially if you focus on this issue of age related mild to moderate hearing loss. The main concern in most of the literature is acoustic neuroma, which is a quite rare condition, .001% according to NIH data. It’s a benign tumor, it’s not a malignant tumor. Very slow growing. Most common in people between the ages of 30 to 60. So not really in the demographic that we’re talking about here. And you know, there can be very unusual conditions that would lead to a sudden hearing loss or a hearing loss just on one ear. But think about the way that eyeglasses are treated. Glaucoma for example, is much, much more common than acoustic neuroma, 3.5% of the population. People have disorders of their retinal arteries or veins. And if you have a sudden problem with your eye or it’s painful, you go to the doctor. And we trust consumers to make those decisions. So I think we need some comparison here about the risk of, the relative risk of millions of people going without treating their hearing loss with the relatively smaller risk of missing a serious treatable condition. We have heard from many people about this comparison with the reading glass situation. I think there are some lessons there. And I think we also have ways of alerting people to seek help if they have certain red flag conditions. And those lists are out there. They are available.

So in conclusion, I think our path forward is that we think there are some technology-based changes in Federal regulations that could make this technology more available and begin to promote more innovation in the market. And that as these consumer products became more acceptable, we think it could also lower the barriers and increase access and acceptance among a much broader number of people. So let me stop there and see if we have any questions.

DR. ERIC LANDER: Wow, that’s great overview of the entire situation. Let’s me throw it open to PCAST for questions. Mario?

MARIO MOLINO: I think one of the common problems with this age related hearing loss is noisy environments. So my question is are there any technology advances there, or is it something that only the human brain can do, mainly, discriminate human voice from background noise.

CHRIS CASSEL: There are actually advances Mario in that area where there’s selective amplification of certain kinds of sounds like human voices as well as dampening of ambient noise of various kinds. And some of the products in this PSAP market will do that, too, where you can put microphones, selective microphones on the restaurant table in a noisy restaurant for example and then wear a special kind of gadget in your ear that helps to get both of those things. One of the concerns we have is that in general the current regulatory framework doesn’t allow those kinds of things to be easily available to people. You know if you have a mild hearing loss, you may not need to wear a hearing aid in normal places where it’s reasonably quiet like this room for example, with good amplification. But I think probably everyone in this room has been to a noisy restaurant where it’s hard to hear a conversation. And that kind of technology ought to be available and more widely.

DR. ERIC LANDER: Great, Michael McQuaid.

MICHAEL MCQUAID: This was a really fascinating overview and presentation. Really good work. You mentioned in passing a number of places outside the U.S. where these things are more uniformly covered under insurance. Do we know about where the model you’re talking about is being implemented outside of the U.S., the more commercial driven easy access model? Do we have any evidence of success one way or the other?

CHRIS CASSEL: By and large, the answer is I don’t know in great detail about whether this kind of open consumer market, if there’s examples of that. I do know that the barriers are much lower in many of those countries. But also there’s an issue of what — in any insurance situation, what the insurance will cover versus what consumers might want to buy. They might want to buy up to a different model, or might want to try a different model. But it’s a good question. We should probably look into that more.

WILLIAM PRESS: I was interested in your mentioning that Medicare in the original legislation today doesn’t consider hearing loss a medical condition in the other things that it handles I wonder if you have any thoughts on how do we decide what kinds of things we consider medicalized. For example, I can’t run as far as I could when I was ten years younger, but we don’t have a Latin word for inability to run as far. We haven’t medicalized that. So is that completely a question of social policy, or is there a medical basis for deciding when something is a condition.

CHRIS CASSEL: Well, Bill, that’s a really big almost philosophical question. There was a time for example, when we used to think senility was a normal part of aging, then we began diagnosing Alzheimer’s disease and other causes of dementing illness and we have created a National Institute on Aging that has led the study of that. It was interesting similarly there was a lot of stigma associated with that in previous decades. Similarly things like osteoarthritis which, is an age-related condition is treatable. It isn’t reversible or curable in the same sense that a lot of other conditions are. So I think we are evolving in our understanding of the biology of aging and where things are treatable or not. Whether they are considered medical conditions to my mind as a physician is if something has a medical treatment, then that treatment ought to be available. And so I don’t find that terminology, I think it’s becoming less useful as we look at ways to enhance functions with aging. And so you know that Medicare legislation dates from 1966.

ERIC LANDER: Interesting.

CHRIS CASSEL: Yeah. That was a long time ago.

DR. ERIC LANDER: So I was struck by your numbers. I’ll just, I know we’re a trifle over but we’ll stop in second but if I’ve got your numbers right, buying hearing aids for both ears is like 10 times more than buying a sophisticated smart phone or iPad or something like that. And yet the technology is dramatically less sophisticated. So a factor of 10 more than consumer electronics. Then the other number I was struck by was 30 million people who have mild to moderate age related hearing loss, versus maybe the couple of cases we’re worrying about about rare conditions of acoustic neuroma and such that if I counted correctly might be out of those 30 million people 150 cases. And balancing the possibility that 150 cases might not be picked up for what you said was a benign tumor anyway, versus 30 million people either not having access at all or having vastly expensive devices available. So I think those two numbers were really striking to me. was the cost relative to any other consumer device. And the balancing of risks one way, that is under-treating the age related hearing loss, versus the very handful of conditions that might be missed in a medical inspection, especially when people can waive and often do waive any medical examination when they buy a hearing device.

CHRIS CASSEL: I don’t want to under appreciate that acoustic neuroma is a real condition and people who have it, if you require a surgery, sometimes it’s so slow growing, particularly in older people, that the doctor advises usually just watching it and if it grows more quickly so that it can impair your hearing, then recommends either radiation or surgery. But the surgery often ends up damaging the hearing in that ear anyway. So it is an important condition to recognize. So two points about that. One is that if you have hearing loss in only one ear, then you should go to the doctor. I mean

DR. ERIC LANDER: If it’s not bilateral, so that’s an easy rule.

CHRIS CASSEL: Right. And the second is that the numbers of people that are affected, well, let me put it this way, since so few people are seeking help for their hearing anyway, picking up people with acoustic neuroma isn’t working anyway if only 1 out of 5 people are seven seeking help.

DR. ERIC LANDER: I should be quiet, I don’t mean in any way to understate the importance of those cases. I’m just balancing numbers here and thinking about leaving 30 million people under treated in some way is also a very serious thing given the comments you’ve made.

CHRIS CASSEL: It’s a major public health issue.

DR. ERIC LANDER: It’s a major public health issue. And all regulatory decisions are about balances. But it’s great. I think you have assembled a gr, and that could be in a situation that we can better serve Americans and we look forward very much to getting your report with recommendations. My understanding is you’re hoping to be able to produce such a report relatively soon. And it may even be perhaps before the next PCAST meeting in which case we’ll schedule a public phone call or whatever, but we’re very eager to hear the recommendations.

CHRIS CASSEL: I wanted to signal to my colleagues that I hope you’ll be hearing from us within the next few weeks to set up a phone call.

DR. ERIC LANDER: That would be great. Excellent and I would also like to thank Ed Penhoet for his leadership on this general aging and specifically the hearing technology, as well. So we’re now going to go to a break until 11:00 o’clock when we are going to hear from Willie May, the Director of the National Institute of Standards and Technology and the Under Secretary of Commerce for Standards and Technology. During the break, members of PCAST will be free to try to develop a Latin name for Bill’s age-related inability to run as fast as he used to. We’re on break.

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