How the FDA’s new rule expands access to hearing aids for millions

Editor's note: Barbara Kelley reached out to PBS News Weekend after this piece was published to say she misspoke about the return policy her organization was supporting. She intended to say that her organization pushed for a 45-day return policy. We've updated the transcript to reflect this.

Nearly 48 million Americans have some level of hearing loss, but the high costs of hearing devices is prohibitive for many people. This week, the FDA cleared the way for hearing aids to be sold over the counter — a new rule that could expand access for millions across the country. Barbara Kelley, executive director of the Hearing Loss Association of America, joins Geoff Bennett to discuss.

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  • Geoff Bennett:

    Nearly 48 million Americans have some level of hearing loss. But because of the high costs of hearing aids, many people who need them go without, but that could soon change. This past week, the FDA cleared the way for hearing aids to be sold over the counter, a new rule that could expand access to hearing devices for millions across the country.

    Joining us now is Barbara Kelly, Executive Director of the Hearing Loss Association of America. It's great to have you with us.

    Barbara Kelly, Executive Director, Hearing Loss Association of America: Thank you, Geoff.

  • Geoff Bennett:

    And as I understand it, only about 30% of people who need hearing aids are getting them right now. And the biggest limitation has been cost. So how significant is this move by the FDA?

  • Barbara Kelly:

    It's a huge move. In fact, 80% of people who could benefit from hearing aids don't get them. And it's not only cost that stops people's, another is the barrier to care, where did they go? It's really a murky process and also their stigma. Some people just don't want to take that step to treat their hearing loss because they associate it with older people. So we are really excited about this new avenue or this new pathway opening up as adding to the traditional pathway to care.

  • Geoff Bennett:

    Does this pathway as you put it, is it apply to everybody with hearing loss, what groups would be most affected?

  • Barbara Kelly:

    That's a great question. It specifically is for adults with self-perceived mild to moderate hearing loss.

  • Geoff Bennett:

    So this would be — I've heard people compare this to going to a CVS or Walgreens and buying a pair of reader glasses is that sort of a fair comparison?

  • Barbara Kelly:

    I think it's a good analogy because before you couldn't get glasses in the — in your main door, and so hearing aids will also be available, like the way readers are. However, it's really important to not make that comparison to literally, because if you put on a pair of glasses, they generally will correct your vision. But when you put on hearing aids, they don't necessarily correct your hearing.

  • Geoff Bennett:

    So what are some of the other important questions that people should be asking, if they're in the market for one of these over the counter hearing aids?

  • Barbara Kelly:

    Well, first of all, they should definitely read the box. We don't know what kind of products that are going to be on the market now. I mean, we have an idea. But it takes time to get used to hearing aid. I mean, your brain has to adjust, your auditory system has to adjust. So people should look about return policies. And one of the things that our organization pushed for with the FDA were $45 return policies. Well, the FDA doesn't have this jurisdiction, it's really left up to the States or the manufacturers. So if there is a return policy, the manufacturer has to put on the box saying so, if they don't have a return policy, there won't be anything in the box. So I think consumers should definitely look for that. And if that product doesn't work for them, they should try another and if need be, they may be walking down the path to see a hearing health care provider, which is an audiologist or a hearing instrument specialist.

  • Geoff Bennett:

    You know, I was struck in preparing to speak with you, in learning that hearing loss can affect other aspects of health, if you have hearing loss, there's a greater chance of developing dementia. Hearing loss also makes it harder for the brain — makes the brain work harder, because it forces you to hear and sort of fill in the gaps of what you're not hearing, give us a sense of the sort of overall impact of hearing loss on oneself?

  • Barbara Kelly:

    Well, through hearing is how we connect with all our relationships on the job in our family life. And when that starts to break down, it interrupts everything. I mean, we like to say there's no such thing as a small hearing loss. But now we know that untreated hearing loss is associated with falls, and falls are the number one reason that older people go to the emergency room, with isolation if you start having problem communicating, because you can't hear and because you can't participate, you start to withdraw. And we know during COVID that isolation leads to depression and anxiety. And there's also a link with dementia. So it's really important that people start considering hearing health as part of overall health.

  • Geoff Bennett:

    Barbara Kelly is Executive Director of the Hearing Loss Association of America. Thanks again for your time.

  • Barbara Kelly:

    Thank you, Geoff, I appreciate it.

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