New Over-the-Counter Hearing Aid Category

21-51 New Hearing Aid Category

Nancy Benson: This is Radio Health Journal. I'm Nancy Benson. This week coming soon to a store near you over the counter hearing aids.

Barbara Kelley: I'm not going to say that it's not going to be really confusing for consumers, but I really do think think that it is positive how hearing aids are getting a shake up.

Nancy Benson: When Radio Health Journal returns…

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Nancy Benson: Many people discount hearing loss is a major problem, yet about 15% of American adults have some trouble hearing. By the time they're age 65, about a quarter of people have disabling hearing loss. And it can contribute to a whole host of other health problems, according to Barbara Kelley, executive director of the Hearing Loss Association of America.

Barbara Kelley: Hearing loss, especially in treated hearing loss, is linked to increased falls. It's also the number one thing that sends older people to the emergency room. It's increased isolation because when it becomes hard to communicate, people pull themselves away from social situations, from family situations. It's much easier, less exhausting, easier to stay at home than go out and try to fight to hear, and walk into a room where you can't hear. It's also, when you have isolation that leads to depression or anxiety. And now there's research being done with the cognitive link between untreated hearing loss and cognitive decline.

Nancy Benson: Despite that, most people who have a significant hearing loss don't do anything about it, even when they're well aware they have a problem.

Barbara Kelley: When people find out they have a hearing loss to the time they do something about it, believe it or not, it's five to ten years. And that is a really long time to have communication breakdowns. And people can start noticing that they have a hearing loss. For example, if they are having trouble hearing on the phone or if they're turning the volume up on the TV or the radio, or their families are complaining that they're doing that, or having trouble with background noise, or when people start to say, ‘Hey, you're mumbling.’ It's often the other people aren't mumbling. They're having trouble hearing.

Nancy Benson: The failure to get needed hearing aids has long been the basis for insensitive comedy routines and cartoons. But why are people so resistant in real life?

Barbara Kelley: Sometimes it's stigma. People think that having hearing loss means you're getting old and they don't want to wear hearing aids. And physicians really don't help that… because I've had so many anecdotal stories where people go to their general physician and they say, I'm having trouble hearing. And if they're over 50, the physician will say, oh, don't worry about it. There's nothing you can do. It's just part of aging. So that doesn't help the situation right there.

Nancy Benson: Access to care is another hurdle. Getting a hearing aid isn't easy. They're considered medical devices, so you can get one only through an audiologist or hearing aid specialist. You need to get your hearing tested and get a prescription. And a lot of the time, insurance doesn't cover any of it.

Barbara Kelley: People have the impression that hearing aids cost a lot of money. And while there are many price points, there are certainly hearing aids that cost up in the five and six thousand because they have artificial intelligence and they can measure your blood pressure, and when you fall. There's also hearing aids that are very good that have Bluetooth streaming, rechargeable batteries, telecoils, and repair for $13.99. But people often don't realize that the cost of a hearing aid is about a third of the device, and the services are bundled into that. So even if somebody has a need for a hearing aid and goes for the lower cost ones, sometimes it could be out of their budget, especially if they have a young family. And Medicare does not cover the cost of her aids. So sometimes the cost could be not reachable for a senior.

Nancy Benson: That's why Kelley is excited that the FDA has started the wheels rolling for a new category of hearing aid that could be in stores within a year or so. They'll be from mild to moderate hearing loss, and you'll be able to get them over-the-counter yourself, without seeing an audiologist.

Barbara Kelley: Over-the-counter hearing aids will be self-fitted. A person will also have to determine: do they have a mild to moderate hearing loss? And there will be no help of a professional in this process. They will go to a store, they will be over-the-counter products on the shelves. They might be in your pharmacy, they might be in big box stores, and there will not be a help of a professional, so they will be 100% self-fitting. Now, a hearing healthcare professional could carry some over the counter devices, and they could help people with these devices… for a fee, of course. But mainly they will be over the counter self-fitting.

Nancy Benson: The new over the counter hearing aids won't be customized the way they are now, but they'll still likely pack a lot of technological punch. Even so, Kelley admits, some consumers may completely mess up their purchase and get a device that's completely wrong for them.

Barbara Kelley: This is all new. I'm not going to say that it's not going to be really confusing for consumers. Or I'm not going to say it could start out as the Wild West. But I really do think that it is positive. There will be some very good products on the market, and we're going to have to do a lot of consumer education. Now a person could buy the wrong thing. But this is where I want the FDA to make sure that there are return policies and that people have recourse… And that people have education to know that if this over-the-counter products doesn't work, maybe you should find the help of a hearing healthcare professional.

Nancy Benson: The new category of hearing aids is a continuation of the trend, giving patients more involvement in their own care. It greatly lessens the cost objection, keeping so many people from getting needed hearing aids. So Kelley says, even if some people start off on the wrong foot, at least they'll be getting started.

Barbara Kelley: We know that 80% of people who could benefit from a hearing aid don't get one, for whatever reason or another. And this could, first of all, make hearing health care more mainstream, more easily accessible. Instead of talking thousands of dollars, we're talking hundreds of dollars. And my hope is that people who wouldn't normally take that step will take that first step into good hearing health care. So I am very excited about it, but I do think it's going to be a bit confusing.

Nancy Benson: The FDA should wrap up the process of collecting comments on the plan in the next month or two, then formulate details. New devices could hit the shelves by the end of next year. But Kelley says people shouldn't wait if they know they've got a hearing loss. They're likely already missing far more than they know.

You can find out more about all our guests through links on our website, radiohealthjournal.org. Our production manager is Jason Dickey. I'm Nancy Benson.