Affordable Hearing Aids Just Got a Giant Step Closer

Decision Could Make Hearing Aids Available Over-the-Counter
– Getty Images

Buying hearing aids could soon become as easy as buying reading glasses.

In a surprise announcement yesterday, the Food and Drug Administration (FDA) said that, effective immediately, it would no longer require adults to get a medical evaluation before buying most hearing aids.

The agency  is also considering creating a category of over-the-counter hearing aids to encourage more “new, innovative, lower-cost products to millions of consumers,” the agency said in a prepared statement.

The announcement was made at a meeting of the National Academies of Sciences, Engineering and Medicine on hearing health care. Previous recommendations from this group, as well as from a White House advisory panel on science and technology, and consumer and some audiologist groups, had urged easing this restriction to make hearing aids more affordable and accessible.

The decision does not apply to those ages 18 and under, who still must have a medical evaluation before purchasing hearing aids. It also does not apply to bone-conduction hearing aids or to prescription-use hearing aids that are inserted deep in the ear canal.

Age-related hearing loss affects some 30 million Americans, affecting not only their work and social interactions but also their overall health and quality of life. For most, the hearing loss begins before the age of 60. The isolation and loneliness that can result from serious hearing loss have been linked to a higher risk of cognitive decline and dementia.

Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from wearing a hearing aid actually use one, the FDA noted. The high price of the devices — about $4,600 a set — has been a major barrier. Medicare and many private insurance plans don’t cover the cost of hearing aids, so most consumers are stuck paying for them out of pocket.

In addition, six companies manufacture nearly all the hearing aids sold, and only one is based in the U.S., a White House blog post about the FDA decision said.

The impact of the FDA’s move could open the hearing aid market to new companies and more competition.

The ruling was one of several recommended by the Hearing Loss Association of America and other consumer groups. HLAA Executive Director Barbara Kelley commented, “We applaud the FDA’s decision to remove this requirement and believe it is a step forward to remove barriers and make hearing health care for consumers more affordable and accessible.”

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf, M.D.


This post was first published on AARP Heath on December 8, 2016.

For more on hearing loss and hearing health:

shoutingwonthelpLiving Better jpegKatherine Bouton is the author of “Living Better With Hearing Loss: A Guide to Health, Happiness, Love, Sex, Work, Friends … and Hearing Aids,” and a memoir, “Shouting Won’t Help: Why I — and 50 Million Other Americans — Can’t Hear You”. Both available on

10 thoughts on “Affordable Hearing Aids Just Got a Giant Step Closer

  1. It’s sure a step in the right direction – but – I’m concerned about self diagnosis and more serious hearing issues. I would hope people would consider having a hearing check somewhere before taking the step to buying hearing aids. I’m also hoping that something is better than nothing.


  2. Excellent point.
    By far the majority of people have routine noise or age related hearing loss. This comes on gradually and affects both ears.
    But if you have any of the so-called red flag symptoms you should see a doctor, preferably an ENT, immediately.
    Those symptoms are sudden hearing loss that lasts more than 24 hours, single-sided hearing loss, pain, or any kind of oozing or disfigurement of the ear. Those are indications of serious conditions and should be treated as quickly as possible.


    • Katherine,

      Getting assistance for hearing loss is more than (over-the-counter) hearing aids. Having worked in a program with both a large mail-order delivery system, and an in-person approach, I can tell you that guiding a person with hearing loss is much better when the encounter is face-to-face. I know there are many very happy with these proposed changes, I also hope this will be recognized as an avenue for the well-connected and more affluent to get appropriate audiological care. For the others, I suppose “Let them eat cake” is appropriate.

      The newer companies will not want the professionals standing in their way of selling products. In-person support will be a luxury item. I have been in that position, and know firsthand how distorted it can get. This is not taking hearing loss seriously.


      • I agree with you that a professional hearing test and an in-person consultation is by far the best way to go. But I also think that the majority of people do not need a $3000 hearing aid (usually two of them, so $6000). They need a basic $1000 hearing aid, which is what the FDA is considering. That’s still $2000 per pair, and most people aren’t going to be buying them on line. They’ll still need professional guidance.
        As it is now, if you have normal age-related hearing loss and you buy a $3000 hearing and make one or two follow-up visits with an audiologist you’re paying a LOT for those two visits. People like me with severe hearing loss will always need the $3000 hearing aid — and along with it many follow up visits and instruction in assistive devices and auditory rehab. I get a lot for my $3000. But someone else is subsidizing me by paying $3000 for services they aren’t using.
        So I think it’s good news for consumers that good, FDA approved hearing aids seem to be becoming not only more accessible but more affordable.


  3. I disagree. It is not the expense of getting a hearing evaluation but the inflated costs of hearing aids and lack of insurance coverage. I got a cheap exam at a grocery store ten years ago, but could not afford a hearing aid. I had severe one-sided hearing loss. When I did get insurance, I found out I had a meningioma. If I had merely gotten a hearing instrument without that crucial knowledge, the tumor could have grown much bigger without my knowledge.

    I believe we need to have hearing exams and hearing sides as part of routine health coverage and properly trained professionals doing the examinations because hearing loss may not just be age-related but a dangerous underlying condition.


    • Sudden, severe or single-sided loss is always a medical emergency. No one would ever suggest self-diagnosing or buying an over the counter hearing aid under those conditions. If anyone reading this has this kind of hearing loss, or knows someone with it, urge them to get to a doctor, preferably an ENT immediately.
      But most people have garden-variety age or noise related hearing loss, and most of it is mild to moderate. These people could benefit from bilateral hearing aids, but they aren’t going to get them if they have to jump through hoops and pay $6000. That’s what’s happening now, and a very small percentage of people who could benefit from hearing aids has them.


  4. Katherine, the difficulty is finding a way for consumers to reliably detect the red flags themselves. Fortunately, work is being done right now to help consumers with this challenge. Please Google the research article “Identifying and Prioritizing Diseases Important for Detection in Adult Hearing Health Care” for more information.


    • These red flags are mentioned in every discussion of over the counter hearing aids or hearing devices. I neglected to mention it because my editor deleted it and I didn’t notice until I read these comments. That was very bad, and I immediately corrected it.
      If OTC hearing aids do come to be, those red flag conditions will be prominently described on any labeling and advertising. Those conditions are being missed now, because people ignore the loss because they can’t afford hearing aids.
      Read the comment by Rev. Mary Dyer. She wrote in favor of medical clearance for hearing aids but her own example shows that after she found out she had hearing loss (in a drugstore) she didn’t get them because they were too expensive. If they hadn’t been so expensive, she might have gone to an audiologist and that meningioma would have been found sooner.
      The requirement for a physician’s advice is routinely been ignored. All the FDA is doing is removing a non-obstacle. The important part of their statement is that they’re considering an OTC hearing aid.


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