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Medicine United States

The FDA Wants You To Be Able To Buy a Hearing Aid Without a Prescription (npr.org) 76

Posted by msmash from the moving-forward dept.
People with mild or moderate hearing loss could soon be able to buy hearing aids without a medical exam or special fitting, under a new rule being proposed by the Food and Drug Administration. The agency says 37.5 million American adults have difficulties hearing. From a report: "Today's move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss," Health and Human Services Secretary Xavier Becerra said as he announced the proposed rule on Tuesday. There is no timeline yet for when consumers might be able to buy an FDA-regulated over-the-counter hearing aid. The proposed rule is now up for 90 days of public comment. The Hearing Loss Association of America, a consumer advocacy group, welcomed the proposal. "This is one step closer to seeing OTC hearing devices on the market," Barbara Kelley, HLAA's executive director said in an email to NPR. "We hope adults will be encouraged to take that important first step toward good hearing health."
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The FDA Wants You To Be Able To Buy a Hearing Aid Without a Prescription More

The FDA Wants You To Be Able To Buy a Hearing Aid Without a Prescription

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  • Concern (Score:2, Insightful)

    by Joey Vegetables ( 686525 )

    As a libertarian I understand that governments do not have lawful authority over what people put in their ears.

    However, I would still very strongly recommend the appropriate auditory and/or neurological exams, because, without them, it is very likely that some folks will further damage their hearing by these kinds of devices.

    • Re:Concern (Score:4, Insightful)

      by fahrbot-bot ( 874524 ) on Tuesday October 19, 2021 @03:03PM (#61907395)

      As a libertarian I understand that governments do not have lawful authority over what people put in their ears.

      Pretty sure "believe" would be more a more appropriate word than "understand".

      • Power over someone is, to some extend, based on anothers yielding to that authority. Civil disobedience occurs when people decide they simply do not recognize the authority to enforce something. To the OP, they understand, and should they want one, they buy them elsewhere. I do not recognize the governments authority to require a prescription for contacts when glasses do not require them. I am quite capable of buying whats marked on the box and if they dont work as well, I go get a new eye exam. Im not payi

    • As a libertarian I understand that governments do not have lawful authority over what people put in their ears.

      However, I would still very strongly recommend the appropriate auditory and/or neurological exams, because, without them, it is very likely that some folks will further damage their hearing by these kinds of devices.

      The end goal here is to not find hearing aids priced at the ridiculously unaffordable levels they are currently at, which is likely feeding a good percentage of the population who need hearing aids but don't have them.

      If your recommendations support that, then fine. Otherwise, the statistics will not change.

    • Re:Concern (Score:5, Informative)

      by gurps_npc ( 621217 ) on Tuesday October 19, 2021 @03:12PM (#61907425) Homepage

      Bull. Hearing aids are the biggest scam and the doctor's approval to get one is part of it.

      One of the worst things is that the insurance companies negotiate HIGHER prices for them, and then do not cover them.

      If you go to get a hearing aid, most of the time you will pay less for the same or better equipment if you do not use insurance or show a doctor's prescription (which often locks you into one brand).

      Analog ones just act as amplifiers. The digital ones can do any of the following, but only #1 really needs any doctors help:

      1) Amplify specific frequencies that you have problems with.
      2) Amplify ONLY the frequencies used for human speech
      3) Not amplify noises above a certain volume/reduce them (preventing additional hearing loss)
      4) Not amplify certain easily detectable artificial noises, such as hiss, whistles, or lower level background noises.

      Only issue #1 needs a doctor to identify which frequencies you have problems with. The rest is helpful to all.

      • Even odder, you can get shooting ear buds that can also act as amplifiers off the shelf.

        https://heavy.com/outdoors/sho... [heavy.com]

        https://www.etymotic.com/produ... [etymotic.com]

        So why do official hearing aids require a prescription and the above do not?

        Yet another medical scam.

        • Comparing shooting noise suppressors to hearing aids is way off target.

          Shooting ear protectors are designed to suppress any sound above about 85dbm. Some provide amplification -- both in-ear and ear muff style -- to compensate for the blocking of all sounds they cause. But this amplification is for all frequencies equally.

          Hearing aids are designed to compensate for the specific frequencies that a user is having problems hearing, with emphasis on the frequencies used for speech. Custom hearing aids will u

    • Re: (Score:2)

      by gtall ( 79522 )

      The libertarian philosophy (ack!) is what promoted the current current situation whereby the industry is run by a cabal. Ayn Rand would approve, but no sane person would.

    • Re:Concern (Score:4, Insightful)

      by dgatwood ( 11270 ) on Tuesday October 19, 2021 @04:26PM (#61907751) Homepage Journal

      As a libertarian I understand that governments do not have lawful authority over what people put in their ears.

      However, I would still very strongly recommend the appropriate auditory and/or neurological exams, because, without them, it is very likely that some folks will further damage their hearing by these kinds of devices.

      Not really. The best hearing aids use beamforming to reduce unwanted sound, rather than just amplifying sound. Unfortunately, the huge cost of the approval process and the near total lack of competition drives up the price of hearing aids so much that the only hearing aids most people can afford are the crappy ones that just amplify the sound, or at best, amplify sounds in specific frequency bands. So the huge cost overhead resulting from these regulations actually makes it MORE likely for people to get a hearing aid that will damage their hearing, not less.

      Besides, there's nothing preventing someone from designing an app that will do a hearing test that's every bit as good as what an audiologist would do. Companies that manufacture these devices could just provide an app that connects to the hearing aid and plays a bunch of frequencies, ramping slowly from a low volume, and saying "tap the button as soon as you hear the sound". Then it would take that frequency response profile compute the optimal gain for each frequency band on top of any beamforming. It could even force you to update that profile once a month so that it can detect any deterioration and warn you. That's something a traditional, FDA-approved hearing aid really can't realistically do.

      So even as a left-leaning non-libertarian, I think regulating hearing aids in the way that they currently do is stupid. The archaic set of regulations no longer makes sense in the age of smartphones. It actively hinders the capabilities of the technology, drives up the costs, and results in significantly worse outcomes medically. We should just get rid of hearing aid regulations altogether, or at best, create a set of lightweight functionality rules (e.g. limits on volume at certain frequencies) while eliminating the approval process entirely. Then introduce new regulatory processes if and when it becomes obvious that they are needed, and only to the minimum extent required to achieve the desired outcome.

      • In fact both Apple & Samsung have these apps for use with normal wired or wireless earphones where they run the diagnostic sounds of various frequencies and different volumes, ask to to tap here n there and then output graphs for both your ears and adjust the sound frequencies accordingly.

        Used with apple earpods or samsung earbuds there are even better ccustomizations and much higher amplification plus ambient mode where music / calls plus amplified outside sound is combined.

        I have used these for some m

    • As a libertarian I understand that governments do not have lawful authority over what people put in their ears.

      However, I would still very strongly recommend the appropriate auditory and/or neurological exams, because, without them, it is very likely that some folks will further damage their hearing by these kinds of devices.

      If this was like going to get an eye exam, then glasses, I'd agree.

      But the hearing aid/testing industry is a full fledged scam. The cost of a hearing aid is often in the thousands, while using a couple dollars worth of components.

      It's also a little odd that in the USA, we can't get eyeglass hearing aids. I'd give some thought to those. What is more, the "professional: hearing aids tend to be rather uncomfortable.

      As an almost deaf person with raging tinnitus, (caused by mumps, and worsened by mono ye

    • As a libertarian I understand that governments do not have lawful authority over what people put in their ears.

      As a libertarian do you understand they regulate the sales of these things not the you sticking it in your ear part?

      • Re: (Score:2)

        by sjames ( 1099 )

        If you can't buy it without special permission then you can't stick it in your ear without special permission.

        • Is that argument going to convince a judge that the government doesn't have the authority to regulate the sale of those things, because you have a harder time getting and using them, which is completely within your rights? I'm not buying it.

          I think we're well off into wishful thinking land now, there are probably dozens of *rhymes with amortion* laws passed in the last few years that would be shot down a lot quicker if it were that easy.

          I hope the FDA changes the rules for hearing aids, but to the libertar

          • Re: (Score:2)

            by sjames ( 1099 )

            I made no claims that the argument DOES anything, only that it does effectively regulate what you can stick in your ear.

            As for the AHEM *amortion* laws, it is not unknown for courts to bend the law into a pretzel in order to "justify" a desired ruling.

    • Re: (Score:2)

      by ElVee ( 208723 )

      I'm a hearing aid user with upper range hearing loss, partially genetic, mostly caused by being in band and by dancing in front of the speakers at too many concerts during the 80's.

      I originally went the medical/audiologist route. Those hearing aids set me back a cool $4k and required constant adjustments/maintenance. Insurance covered absolutely nothing.

      When the $4k ones stopped working, I got fed up and bought some $200 "digital hearing amplifiers" off Amazon that can be set to amplify high-end sound. T

      • You already knew you had high-frequency hearing loss, as opposed to several other kinds. You knew what the "correct" kind of hearing aid was supposed to sound like. So you also knew what a "digital hearing amplifier" should sound like.

        All I'm saying is that I recommend that same approach for others: that they figure out what kind of frequency response their unaided ears have - which usually requires an audiologist - and then purchase and/or configure their new hearing aid or "programmable amplifier" or wh

  • People have been asking for this for years (Score:5, Funny)

    by Aighearach ( 97333 ) on Tuesday October 19, 2021 @02:04PM (#61907371)

    but the FDA couldn't hear them.

    • Re:People have been asking for this for years (Score:4, Insightful)

      by dgatwood ( 11270 ) on Tuesday October 19, 2021 @04:12PM (#61907677) Homepage Journal

      The biggest problem is that the FDA is claiming approval authority over something that is neither a food nor a drug. Were it not for the huge regulatory burden, beamforming microphones would have been built into $60 noise canceling headsets for your phone, giving you the best hearing aids possible for $1,940 less, and they would probably have been available a decade earlier.

      The best hearing aids cost thousands of dollars, but contain maybe double-digit dollars worth of parts. Why are they so insanely expensive? Because a small number of companies have cornered the market, and nobody else is willing to even try to enter that market because the approval process is so expensive and slow that it will take a decade to make a profit.

      And because any improvements to the technology have to go through the same lengthy approval process, there's minimal incentive for the existing manufacturers to improve things quickly, which means that improvements are years (or even decades) late compared with what you'd expect in a healthy tech market.

      In short, this is a classic case of regulations being overly burdensome and hindering innovation. If we were talking about medication, the need for caution would be warranted, but we're talking about a hearing aid. Nothing that a hearing aid can do is any worse than listening to music at high volume through similar earbuds on your phone, and the FDA doesn't regulate your cell phone. So why the h*** does the FDA regulate hearing aids?

      Regulating hearing aids as though they were a drug is just plain stupid no matter how you look at it. Maybe it made some sense prior to the invention of the Walkman, but ever since then, it has made progressively less sense with every passing year.

      The FDA should absolutely not be involved in regulating hearing aids at all. This proposed change is one small step in the right direction, but it is nowhere near adequate. It's time to just pull the plug on this outdated and unnecessary regulatory approval process once and for all.

      • Re: People have been asking for this for years (Score:5, Informative)

        by chill ( 34294 ) on Tuesday October 19, 2021 @04:25PM (#61907745) Journal

        The FDA regulates medical devices. Arguing that isn't in their agency name and this out of scope is childish.

        • Re: People have been asking for this for years (Score:4, Insightful)

          by dgatwood ( 11270 ) on Tuesday October 19, 2021 @04:39PM (#61907851) Homepage Journal

          The FDA regulates medical devices. Arguing that isn't in their agency name and this out of scope is childish.

          I would argue that a hearing aid is not actually a medical device. A medical device is a device used in the delivery of medical care. The only thing that makes getting a hearing aid qualify as getting medical care is the fact that it requires a prescription from a doctor. It's quite literally medical care only in a purely tautological sense.

          If we extend the term "medical device" to broadly include anything that can help you see or hear better, then it becomes comical. Is a cell phone a medical device? I can enable play-through in a voice recorder app, and that's a crude hearing aid. I can use the camera to see small printing that is too small for my eyes to make out, so that makes it a crude pair of eyeglasses. I can use it to look up information about drug interactions and then question my doctor about why he or she prescribed erythromycin while on a statin or whatever. So why doesn't the FDA require every cell phone to be approved?

          Maybe — maybe — you could argue that software intended for creating a frequency profile for hearing aids should be regulated. But even that's a stretch. And for hearing aids that just do pure beamforming without any specific frequency boosts, it's literally no different than using a zoom microphone, an amplifier, and a pair of headphones, none of which are regulated as medical devices. Yet put them together in a single package with a battery and call it a hearing aid, and suddenly it requires a prescription, which suddenly makes it a medical device.

          This is nonsensical.

          • Re: (Score:3)

            by chill ( 34294 )

            Hearing Aids have an official definition in law as they are intended for people with hearing loss and thus, used to treat a medical condition. What you're describing is legally called a "personal sound amplification product". The FDA site [fda.gov] has a lot of good information.

            Remember, it is Congress that defines things like "medical device" and the what is regulated or not. The FDA was created by Congress in 1906, and the Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices

            • Re: (Score:2)

              by dgatwood ( 11270 )

              Hearing Aids have an official definition in law as they are intended for people with hearing loss and thus, used to treat a medical condition.

              But that's the thing. Everybody over the age of 12 has some hearing loss. And literally everybody would benefit from assistive hearing devices of some sort in some circumstances (e.g. in a party with lots of people and ambient noise). The only difference between people with significant hearing loss and people without significant hearing loss is the extent to which they benefit from it.

              What you're describing is legally called a "personal sound amplification product". The FDA site [fda.gov] has a lot of good information.

              Yes, those are the cheap ones that people can afford. They blow out people's hearing further to the point where they req

              • Re: (Score:2)

                by chill ( 34294 )

                I think much of this has to do with advertising as treating a medical condition. I'm not interested in going back to the days of patent medicine [wikipedia.org], caveat emptor, and people permanently damaging or worsening their hearing because some greedy jackass wants to advertise as a "certified medical device".

                I agree there should be less regulation now that technology has advanced, but for every new DTC hearing aid [bose.com], there's going to be a cheap Chinese knockoff that looks just the same, costs 1/10th, and does tons of da

                • Re: (Score:2)

                  by dgatwood ( 11270 )

                  I agree there should be less regulation now that technology has advanced, but for every new DTC hearing aid [bose.com], there's going to be a cheap Chinese knockoff that looks just the same, costs 1/10th, and does tons of damage.

                  Maybe, but chances are those knockoffs would still be better than cranking up PSAPs. :-)

                  Also, the need to configure them would require a level of software sophistication that is at least currently probably out of reach for the knockoff goods market. And anything that doesn't require that level of sophistication is probably a PSAP and is already on the market and hurting people today.

                  Besides, removing the need for FDA approval would not preclude banning products that cause harm, once identified. It would j

                • Re: (Score:2)

                  by sjames ( 1099 )

                  Fraudulently claiming certification is another matter entirely. That should be prosecuted in any case, not just for things that resemble medical devices.

      • They have authority over the ones that are approved, but you can also go on amazon and buy a cheaper "hearing aid alternative" that looks an awful lot like a hearing aide.

        They don't actually have authority over amplification. Just things advertised as medical devices. Hilariously, you only need to say it is an alternative to the medical device to have it not be regulated.

        The real problem is that if you're a parent, you want to make sure you're buying the right thing, so you might want your child's doctor to

      • The biggest problem is that the FDA is claiming approval authority over something that is neither a food nor a drug.

        The FDA isn't claiming authority over anything. They were explicitly given authority over medical devices by Congress via the same Act that grants them nearly all of their authority [wikipedia.org]. The reason their name doesn't reflect that authority is in part because the authority to regulate medical devices [wikipedia.org] wasn't theirs from the start; it was added in a 1976 amendment.

        But a name is just a name. It doesn't always accurately describe the thing to which it refers. What does "Secret Service" even mean? Are you upset that

    • WHAT?

  • I hate when my prescription medicine goes "Over the Counter". Yes - don't need to see a doctor once a year to renew the prescription, and the cost of the actual medication actually goes down

    BUT

    The actual cost to my pocket goes way up. So my allergy medicine was 20 bucks for a 3 month supply - delivered automatically to my house. Easy Peasy. Now it is 20 bucks for a month, and I have to remember to pick it up at the grocery store before I run out.

    Dang it, just ran out today.

    • True. Now, insurance won't cover it, unless you are a Medicare advantage customer/beneficiary.

    • The only reason you're paying more for your allergy meds is because you are shopping in the wrong place. Sam's Club, for example, has Flonase (generic) at $25 for 6 bottles, about an 18-month supply. https://www.samsclub.com/p/mem... [samsclub.com] If you prefer the brand name, you can get 3 bottles for $50, about 9 months. Without prescriptions, you can still get taken for a ride, but you do have other options. When prescriptions are required, you have fewer options.

      • Re: (Score:2)

        by wwphx ( 225607 )
        Just wait for it to run out: apparently Flonase is trending as the next miracle Covid-killer. After all, who needs proven vaccines for free when you can by OTC nasal sprays!
  • If I take a drug and it has bad side effects I can't easily get rid of that drug outside of quit taking it and hoping the effects aren't long lasting.

    If I stick something in my ear and it has bad side effects, I can just drop the damned thing in the trash and be back to normal.

    Why is the FDA regulating these things?

    • I think the real issue is that it is overwhelmingly clear that the medical devices in this field no longer have any sort of perceivable functional or safety benefit over commodity hardware, and old people are even starting to notice and speak up about it now.

    • Are you telling me that dropping headphones in the trash is a cure for tinnitus? The problem isn't that the things are regulated, the problem is they system for regulating them is sufferings from serious industry capture. Same issue with the need for a prescription/hearing test if Doctor's didn't try and take responsibility for every single thing when Nurses, Pharmacists and Allied Health can offer a cheaper and often better solution it would bring cost and availability down significantly.

    • ME ME ME

      ...

      Why is the FDA regulating these things?

      Because when a parent goes to buy a hearing aid for their child, they can't guarantee useful, accurate feedback on if the device is working right. How is the kid supposed to know what sounds are supposed to sound like??
      Same for anybody who was born with serious hearing problems, really. Some people do need a device that has undergone the right testing, and has specific features to support particular conditions, and doctors need to be able to direct patients to those devices.

      That's why. What change will d

  • what about Single-payer healthcare?

  • I have always hated the idea of monopolists being able to sell a hundred dollars worth of electroniccs for $4,000 just because they have a legally endowed monopoly - and then providing a product that most patients hate to use. Now that hearing aid manufacturers will have to compete for the first time, let's see testing apps that can configure a hearing aid as it evaluates a person's hearing. Finally we will be able to move beyond just amplifying background noise.

    • It might only be a few dollars of electronics, even using top shelf op amps.

      The case is the hard/expensive part, since it has to fit into a small space and be comfortable against the skin for long periods of time.

      • The case is the hard/expensive part, since it has to fit into a small space and be comfortable against the skin for long periods of time.

        If that's the problem - and I'm not sure it is - then that's a solved problem, for years. I wore a conventional hearing aid for a few years in the '80s and '90s and never had any comfort issues with it. The bigger difficulty was the silicone ear piece wearing out and becoming hard / less flexible, degrading the fit in the ear canal and leading to feedback.

        The cochlear implant I now wear for hours on a daily basis was designed and built in the mid-90s. I have newer models, but the sound quality sucks,

  • I've read that hearing aids need to be customized to the individual, similar to how people get a very specific eyeglass prescription. I know there are generic hearing aids that supposedly work for anyone without adjustment, but those apparently aren't very good.

    • In both categories, the customization is frequently "gold plating." Most people can do just fine picking their own reading glasses from a store rack, and they could do just fine with corrective lenses. Of course, there are people with unusual situations that need a doctor, but why force the 80% who don't, to pay all that extra money?

      I say, let people pay less for "good enough" rather than cut poor people out of improved hearing or eyesight because they can't afford it.

      • Reading glasses is different. Millions of people need corrective lenses. How on earth would they know if they should get a -1.00 or -10.00 lenses, and what other parameters for astigmatism, etc. without seeing a doctor?

        • How would they know if they need -1 or -10 lenses? By trying various options and choosing the ones that help them see best. That is something most ordinary people can do just fine. Will they be able to use this method to correct astigmatism? No. But is that really a requirement? What bad thing happens if a person chooses lenses that enable them to see well enough to read and function, but doesn't correct their astigmatism? This is a very first-world problem, that only those with money really care about. Tho

  • Ignoring libertarian idiots (I know, I'm repeating myself), the point is that only "approved" hearing aids are legally allowed to be sold as hearing aids... and they run $4000-$6000.

    Meanwhile, bluetooth earphones, good ones, are well under $400.

    They could no longer justify this ripoff, and I think I've seen ads calling themselves everything *but* "hearing aids" at $200 and under

  • Can we also do glasses too? ... and then work on our drug policies?

  • There is a place out of the HK that sells hearing aids direct to people in the US. IIRC, they were essentially (either the or one of) manufacturer or distributor for the UK's version of medicaid.

    The prices were good.
    Customer service was excellent
    You could give them a hearing test or get them stock

    I got a pair for my grandmother and my girlfriend's mom. We went through some fitment issues and confirmed they were working well . . . .

    Then they never used them. Same as everyone else with hearing aid

  • Also, without implants? Mine won't pay for external only BAHA/BAHS. :(

  • "If it moves tax it. If it keeps moving regulate it. And if it stops moving subsidize it" --Ronald Reagan (b. 1911)

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