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Government Medicine United States Technology

FDA Clears Path For Hearing Aids To Be Sold Over the Counter (nytimes.com) 143

An anonymous reader quotes a report from the New York Times: The Food and Drug Administration decided on Tuesday to allow hearing aids to be sold over the counter and without a prescription to adults, a long-sought wish of consumers frustrated by expensive exams and devices. The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans who have hearing loss from buying the devices. Health experts say that untreated hearing loss can contribute to cognitive decline and depression in older people. Under the new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October, without being required to see a doctor for an exam to get a prescription.

The F.D.A. cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. Current costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400at Costco to roughly $4,700elsewhere. The F.D.A.'s final rule takes effect in 60 days. Industry representatives say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or to comply with technical details in the rule.
"This could fundamentally change technology," said Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health. "We don't know what these companies might come up with. We may literally see new ways hearing aids work, how they look."
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FDA Clears Path For Hearing Aids To Be Sold Over the Counter

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  • by Grokew ( 8384065 ) on Tuesday August 16, 2022 @05:04PM (#62794999)
    This is great, up to a point. People might start doing like they do with reading glasses, and keep postponing an actual visit to an audiologist until too late.
    • This is great, up to a point. People might start doing like they do with reading glasses, and keep postponing an actual visit to an audiologist until too late.

      According to the summary, presently 80% of people never seek professional help. So for them, a consumer-grade solution is better than no solution, which is the current state of things.

      • Agree, but I bet that the reason people don't go to an audiologist is the high costs. Not everyone has insurance and even those that do might not be able to afford the co-pay/deductible.
        • by dgatwood ( 11270 ) on Tuesday August 16, 2022 @06:55PM (#62795223) Homepage Journal

          Agree, but I bet that the reason people don't go to an audiologist is the high costs. Not everyone has insurance and even those that do might not be able to afford the co-pay/deductible.

          The thing is, if you're just talking about getting a hearing aid, AFAIK, most of what an audiologist does for those folks could largely be replaced by software. Build a hearing aid with Bluetooth input and provide instructions: click or tap "I hear it" when you hear a tone. Repeat for a different frequency until done. Compute a response curve. Compute a filter bank that roughly compensates for that curve. Store the profile.

          Even better, because it doesn't require an expensive appointment and a huge chunk of time, the software could force you to recalibrate once a month for the first six months, and then once a year after that, using the previous curve as a baseline for compensation, thus making the profile progressively more accurate over time.

          Mind you, tech can't catch everything. It will miss things like ear wax buildup, infections, etc. So if hearing loss is sudden, buying a hearing aid is likely to be a mistake. But for the most part, this seems like it has the potential to massively improve a lot of people's lives, and I'm surprised this didn't happen a decade ago.

          And of course, because they'll be sold over the counter, the potential exists for economies of scale bringing the price down considerably.

          • This is very well explained - almost like you've gone through it personally. This is, in fact, very similar to the "mapping" that we do with a cochlear implant: the response for each band is custom tuned, and, at least at first, is revisited over a period of months to tweak performance.
            • This is very well explained - almost like you've gone through it personally. This is, in fact, very similar to the "mapping" that we do with a cochlear implant: the response for each band is custom tuned, and, at least at first, is revisited over a period of months to tweak performance.

              Although dgatwood's proposed procedure is quite reasonable, it is not revelatory, sorry!

              Other than the re-calibration and historical-averaging, it is essentially the same as many non-tech-averse audiophiles use with audio-analysis software such as the most-excellent REW to create response (and equalization) curves for home audio and home theatre systems. In fact, some even create response and equalization curves for headphones and earbuds/IEMs using specialized acoustic couplers.

              Doesn't invalidate the proc

              • by piojo ( 995934 )

                Speakng of which, if I ever need hearing aids, I want to be able to EQ them to a "Harman Curve" response!

                https://headphonesaddict.com/h... [headphonesaddict.com]

                I've never understood why equalization curves are necessary for making music sound good. Isn't that what the audio engineer should have done during mixing or mastering? Why don't we use equalizers to just correct for weird speakers or weird media? (Alternatively, if it sounds best for the mid-high bands to be louder, why haven't musicians learned to play louder in those bands?)

                It just doesn't make sense that a certain frequency boost sounds good but it hasn't been incorporated into music.

                • Audio engineers use speakers with flat EQ in a dampened room. Headphones play back the same sound but with a flat representation and no echo/absorption. The curve attempts to replicate the effect of speakers in a room and approximate the experience of being in the audio engineer's studio.

                  I never listen to music in silence so it wouldn't do much for me, but it isn't completely crazy either.

            • by dgatwood ( 11270 )

              This is very well explained - almost like you've gone through it personally.

              I went through a routine hearing test as a kid. But no, that's mostly because I did some research into hearing aids for my folks recently, and concluded that the market is utterly insane. You could write some DSP code that runs on commodity hardware that costs $25, and it would produce comparable results, but between the patent minefield and the regulatory minefield (FDA approval requirements — why!?!), a small number of companies have oligopolized the market and charge upwards of $1,000 for these t

          • Great post. I came to post something similar but your explanation was worded better.

            With all the noise-cancelling headphones, noise-cancelling microphones, auto-tune singing aids, and plenty of prior art to emulate, I would be surprised if user-friendly versions aren't in the stores in less than a year. Inexpensive behind-the-ear models shouldn't cost more than a good pair of noise-cancelling headphones. Can't wait to see the Bose and Beats brand hearing aids.

    • My dad had to go through an audiologist and he ended up paying thousands of dollars for something that, at most, was worth a couple hundred

      The reason that he was hard of hearing, was because he was old, there was no other diagnosis, as for most people

      Also, the captured market for hearing aids totally prevents resale, so it is just another bucket of money flushed down the toilet as you enter your golden years

    • Too late for what?

    • This is great, up to a point. People might start doing like they do with reading glasses, and keep postponing an actual visit to an audiologist until too late.

      Too late for what though? I have pretty severe tinnitus. Overall heating loss with severe high frequency loss - I don't hear anything above 3 KHz, and it's been that way since I was 18, almost 50 years now. My weird noggin processes all sounds equally. That's why people with tinnitus can't hear in noisy environments, they cant differentiate between intelligence and background noise. . The only "cure" for my issue is severing the auditory nerve, hardly a cure at all. But some people are driven half crazy by

  • I have heard of many weird things going on in the US, but not selling hearing aids sounds like a most arbitrary and completely non-capitalistic thing to do.
    Are there any other mundane things only available "by prescription" in the US that we should know of...?
    • They made a lot of money by keeping them behind a prescription.
    • They are classified as a medical device so that adds an extra zero or two onto the price. Most people should have a decent hearing test to determine the frequency dropoff and tune the devices appropriately.

    • by PPH ( 736903 )

      I remember when the first tablet computers came out. The medical hardware business had a screeching fit when people stopped buying their clunky, single application text-to-speech boxes and downloaded a cheap app.

    • by MrNJ ( 955045 )
      antibiotics including the most mundane original penicillin.

      The rule of thumb is: anything the government (of any country) touches turns to crap.
    • Are there any other mundane things only available "by prescription" in the US that we should know of...?

      I have two.
      First, Eyeglasses. Excluding simple magnifying glasses, require a prescription and that prescription expires after a period of time.

      Second, medical grade oxygen requires a prescription. This was an obstacle, though not an insurmountable one, when I built my DIY diving rebreather. I was able to get aviation oxygen instead. Still breathable, different certification.

      A wheelchair or power chair

  • It's about time! (Score:5, Insightful)

    by Tony Isaac ( 1301187 ) on Tuesday August 16, 2022 @05:18PM (#62795027) Homepage

    The audiologist racket has gone one long enough. For 90% of people who are hard of hearing, there is no reason a doctor should be required. And there is certainly no reason a pair of earbuds that happen to be called "hearing aids" should cost thousands of dollars!

    • I've got to disagree. Hearing aids don't just make everything louder, they have a frequency response so that they only make louder the frequencies that you have trouble hearing, to avoid damaging your hearing at the frequencies you can still hear okay.

      Still, that's like getting an eyeglass prescription - should be a relatively cheap test the doctor gives you, and then any idiot can configure your hearing aid to match.

      • by dgatwood ( 11270 )

        I've got to disagree. Hearing aids don't just make everything louder, they have a frequency response so that they only make louder the frequencies that you have trouble hearing, to avoid damaging your hearing at the frequencies you can still hear okay.

        Still, that's like getting an eyeglass prescription - should be a relatively cheap test the doctor gives you, and then any idiot can configure your hearing aid to match.

        In one way, it's not at all like an eyeglasses prescription. You need significant hardware to test someone's eyes, including an eye chart at a predefined distance and a set of lenses. Almost nobody can realistically do that test at home.

        But hearing? All you need is a set of earbuds with a well-defined response curve, and the hearing aid itself already provides you with that. From there, the test can be automated in software. Tap the left, right, or both button when you hear a beep. All a human does is

        • by tlhIngan ( 30335 )

          In one way, it's not at all like an eyeglasses prescription. You need significant hardware to test someone's eyes, including an eye chart at a predefined distance and a set of lenses. Almost nobody can realistically do that test at home.

          The eye chart and other things are trivially easy to do at home - you just need them at a certain size and you can easily calibrate printers and screens to do it.

          The expensive part is the equipment - the little rack of lenses and such that they can adjust to figure out your

          • by dgatwood ( 11270 )

            Likewise, an audiologist can examine you for hearing, but the exam should also include an inspection of your ear canal and eardrum to make sure there's nothing of concern, and the exam should be cheap and you end up with a hearing aid prescription, if necessary.

            Sure, but realistically, most people know when they need a hearing aid. And your ear canal gets examined by doctors every time you get a checkup, unlike your eyes. :-) I mean yes, ostensibly your hearing loss could be caused by inflammation or wax buildup, but your GP can tell you that. You don't need an audiologist. Save the specialists for conditions where specialists are actually needed.

            Eyeglasses are expensive purely because of Elissor-Luxxotica monopoly - turning a $2 frame into a $500 frame (it's a piece of injection molded plastic or a piece of metal - it doesn't cost much money).

            No, eyeglasses are expensive largely because they're a profit center for your eye doctor, who charges as much as yo

            • There's also neural problems that can cause hearing loss though, and the last thing you want to do is cause deafness by blasting loud sounds into your ear when the ear is fine, and it's the nerves that have a problem. Then you end up neglecting the real problem until it gets much worse, and now it's barely worth fixing anymore because you've already damaged your ears so badly that they're no longer sending signals anyway.

              A big chunk of of the normal testing for either corrective is ruling out other possibl

              • by dgatwood ( 11270 )

                There's also neural problems that can cause hearing loss though, and the last thing you want to do is cause deafness by blasting loud sounds into your ear when the ear is fine, and it's the nerves that have a problem. Then you end up neglecting the real problem until it gets much worse, and now it's barely worth fixing anymore because you've already damaged your ears so badly that they're no longer sending signals anyway.

                The auditory nerve is entirely inside the skull, so there aren't a lot of opportunities for nerve impingement. So except in the rare cases where there's some obvious physical cause, like a tumor pressing against the auditory nerve, auditory neuropathy is generally not treatable (other than with a hearing aid), AFAIK.

          • Printed eye charts won't tell you anything about astigmatism though - something many/most people have, and which needs additional correction. As I recall it basically comes down to your eye (and lens) being vaguely football-shaped rather than perfectly round, which... I *think* means you essentially need a different correction vertically and horizontally. You can compromise with a basic lens, but you'll never get to 20/20, instead over-correcting on one axis and under-correcting on the other. And I belie

        • An eye doctor wows you with lots of expensive equipment, but most of it isn't truly necessary. What is the actual point of glasses? To enable you to see and read. You can tell when glasses work for you by putting them on and trying to read, just like you can already do at the rack of reading glasses at the big box store. When the glasses are right, you'll know it.

      • Hearing loss follows predictable patterns. It's not like your hearing loss is so unique compared to other people's hearing loss, that you must have a custom solution tailored just for you. Yes, just like eyesight, there are varying degrees. But making safe and effective hearing aids can be done through regulation of the manufacturers. For most, individual customization isn't necessary.

      • by Tablizer ( 95088 )

        > Hearing aids don't just make everything louder, they have a frequency response so that they only make louder the frequencies that you have trouble hearing

        The over-the-counter ones should have a frequency slider or two so you can dial in magnification for your own trouble spot(s). True, a professional examination and hardware is the ideal, but also expensive as hell.

        An over-the-counter one can have knobs/sliders similar to:

        1. Overall volume
        2. Frequency of spike 1*
        2A. Height of spike 1 (spike volume)
        2B.

    • My understanding is that hearing aids are like glasses. For glasses, you have to see a doctor in order to know what lens prescription you need. You can't just buy any random lenses in a store, unless they're basic reading glasses. Similarly for hearing aids, you have to get a hearing aid that is customized for your level of hearing loss.
      • This is true, and you can't just buy either hearing aids or glasses (legally) without a prescription.

        And in both cases, I think people ought to be able to skip the doctor and find their own pair of hearing aids, or glasses, that work for them. When you go to the reading glasses kiosk in any store, you can tell if the glasses work for you, because you can read. All the fine-tuning and visual field mapping that a doctor does, goes on a chart, but doesn't do much else for you.

  • by biggaijin ( 126513 ) on Tuesday August 16, 2022 @05:22PM (#62795033)

    This is a great change. The previous government rules -- lobbied and strongly supported by a small group of manufacturers -- were that the only way to get a hearing aid was to visit one of their "clinics" and pay several thousand dollars for the appliances they sold. There was virtually no competition and no pressure whatsoever to price this stuff competitively.

    There is really no reason for oversight in dispensing these things, as they are not capable of causing any harm to the user and users are more than capable of telling whether it is working or not.

  • Why is this going to change technology suddenly? Does every other country in the world support regulatory capture and near monopolies by hearing aid companies? Isn't there a chance something better already exists?

    • Check it out [nanohearingaids.com]

    • UK's main hearing aid provider will actually ship/program/warranty them pretty well but you have to do your own legwork with your hearing tests.

      What I want to know, based on the four or five people I've known over the years, is how these things get out of whack/require adjustment so frequently. Do people's hearing really swiftly change that much under normal circumstances?
    • > Why is this going to change technology suddenly? Does every other country in the world support regulatory capture and near monopolies by hearing aid companies? Isn't there a chance something better already exists?

      It does (you can get them on eBay) but Americans like to optimize the shit out of everything.

      It's mostly cultural and cultural bias on personality development (little respect for authority).

      China is catching up fast, but they still send their graduate students to the US in large numbers.

      German

  • The great thing about this is now the retail market can take over and make the ones that really serve customers needs, like the ones that have full equalizers on board that we can just adjust in real time.

    The people who suffer from an audiogram gap - aka "cookie bite hearing loss" - have been waiting for this for AGES. The more specialized your hearing loss is, the better this is for access for you to the tools you need to hear again as best as tech can help.

  • Why haven't I heard of this sooner?

  • To extort thousands of Dollars from someone, so they don't have to be yelled at, is too much. I am glad this is changing.
  • The last pair I got were $8000. That was not Bluetooth, and not rechargeable. Just plain, common hearing aids. I have minor to moderate loss in both ears. Hearing loss contributes to the symptoms associated with Alzheimer's and dementia. Waiting quietly for my Apple(tm) Hear appliances...
  • Just as Autozone and RockAuto doesn't negate the existence, necessity, and expense of mechanic shops this will not change much about the existence, necessity, and expense of audiologists. Hearing is incredibly complex and the DIYers will discover quickly that it isn't as simple as "turn up the volume." It just isn't. And the makers of serious HAs - Starkey, et al - will not dispense OTC and will continue to dispense through audiologists only because of the complexity involved.

    The biggest change this will

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