[HN Gopher] FDA Finalizes Rule to Deregulate Hearing Aids
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FDA Finalizes Rule to Deregulate Hearing Aids
Author : the88doctor
Score : 63 points
Date : 2023-05-06 15:45 UTC (7 hours ago)
(HTM) web link (www.fda.gov)
(TXT) w3m dump (www.fda.gov)
| Multicomp wrote:
| I use some oticon opn s series hearing aids as open hearing
| headphones. We need this to become cheaper and more ubiquitous as
| hearing aids provide open hearing and quiet sound without people
| necessarily even being aware that you have electronic music going
| on
| civilized wrote:
| I'm seeing this amidst a lot of pundit complaints that the FDA
| and similar regulatory organizations are hopelessly
| restrictionist. Because of their incentives, because they only
| add new regulations and never remove old and ill-suited ones,
| etc.
|
| I'm not saying the pundits are wrong in general, but this seems
| to be an exception. What went right here and why? Is there
| anything to learn?
| elliekelly wrote:
| I feel like there are a lot of similar examples they just don't
| get a lot of press. Naloxone was recently approved for OTC and
| they also recently approved allowing Mifepristone prescriptions
| by mail. They're considering allowing a new birth control to be
| sold over the counter. Maybe a decade or so ago Plan B was
| prescription only but they allow that to be sold over the
| counter now, too.
|
| And a lot of other drugs have made the jump in my adult memory:
| allergy drugs like Claritin and Flonase used to be prescription
| only as did just about every major antacid like Prilosec and
| Nexium. There's a new topical NSAID for arthritis that recently
| made the switch to OTC too, I think.
| armchairhacker wrote:
| Some things need to be over-regulated, like food (making sure
| companies don't put bad things in it or lie about what they're
| selling), or anything common for the matter. Some things
| ehh...like experimental drugs, which some argue need to be
| well-tested, but the alternative for some is dying or living in
| constant pain (personally, I think people should be able to
| sign up for anything as long as its, beyond doubt, under their
| own choice and they're fully aware of potential consequences)
|
| I just don't see the reason to regulate hearing aids. It's not
| like they'll blow up in your ear or translate people's everyday
| conversations into conspiracy theories, and hearing aids which
| don't work well are better than none at all.
| geraldwhen wrote:
| As a counter example, sesame was recently made a major food
| allergen by the FDA, which caused many food makers to add
| sesame to their food.
|
| Adding sesame was easier than following the regulations to
| assert their foods were sesame free, so now food that used to
| be safe is now dangerous for anyone with a sesame allergy.
|
| https://www.fastcompany.com/90830854/sesame-seed-allergen-
| fd...
| janeerie wrote:
| Poorly calibrated hearing aids actually can damage your
| hearing (even worse than it was). It's sending highly
| amplified noise directly into your ear drum.
| Tuna-Fish wrote:
| There has been very significant pushback against such
| restrictionism for more than a decade, and it has steadily won
| over support especially among doctors.
|
| This is FDA starting to go with the flow.
| civilized wrote:
| By this do you mean that doctors are changing their minds,
| and since doctors do things like run advisory boards at the
| FDA, that causes the FDA to behave less restrictively?
|
| In other words, why would the FDA bother to go with any flow?
| On the view of some economists, bureaucrats should never
| deregulate because there's no incentive for them to, and mere
| cultural pressure shouldn't really be an incentive.
| brundolf wrote:
| Cultural pressure means political pressure and eventually
| that works its way through the system. It may be blunt and
| slow, but it gets there eventually.
| cushpush wrote:
| Plans for open-source hearing aids have also been developed and
| released, like happened on HN a few years ago (amazing work by
| the gentleman @zdw)
| https://news.ycombinator.com/item?id=20604566. So, I think like
| someone else said, this is gov't catching up to the fact that
| market alternatives exist and are undercutting an industry that
| has celebrated regulatory shielding for a long time. Really,
| the hardware is less complex as time goes on, right? It makes
| sense that low-cost alternatives will bring quality up for
| consumers and prices down for consumers. Question, Hearing aids
| are considered medical gear and therefore the regulation?
| bigsmiles01 wrote:
| Mr. Beast lobby w
| mperham wrote:
| What are the odds Apple moves the AirPods Pro into this space?
| noipv4 wrote:
| and Bose too. I liked the ambient sound feature of the QC20
| wired earplugs.
| red_trumpet wrote:
| Looks like Bose is already there:
| https://www.soundly.com/product/lexie-b2-powered-by-bose
| slindsey wrote:
| "While Bose is no longer manufacturing and selling
| SoundControl(tm) Hearing Aids, we are continuing to offer
| our complimentary technical support for those who have
| already purchased SoundControl(tm) Hearing Aids."
|
| https://www.bose.com/en_us/products/headphones/earbuds/soun
| d...
| skybrian wrote:
| This is from a year ago.
|
| Here's a website that lets you compare over-the-counter hearing
| aids:
|
| https://www.soundly.com/shop
| rektide wrote:
| Mostly around $5000. Seen a $1000 and a $2000. I wonder how
| long prices will stay up there.
|
| I wonder what mind of hardware is packed in here. Bigger
| battery, bigger microphone, how miniatiruzes are the chips, how
| much DSP processing is there... Interesting times.
| skybrian wrote:
| The website covers all kinds of hearing aids. You can filter
| it to see the OTC hearing aids, which are lower cost.
|
| The reviews on that website don't say much about the mobile
| apps, though. Even for the high-end hearing aids I bought,
| the app was finicky and difficult to even get connected, and
| the controls are dumbed down. If you check the Play Store,
| you'll see lots of bad reviews. Fortunately the app isn't
| needed day-to-day.
|
| I'm a bit surprised Apple hasn't done something; they could
| really clean up here.
| joecool1029 wrote:
| > I'm a bit surprised Apple hasn't done something; they
| could really clean up here.
|
| https://www.cell.com/iscience/fulltext/S2589-0042(22)01708-
| 4 (their current devices are almost there)
|
| My guess is they do enter the OTC space within the next
| year or so or in true Tim Cook fashion just sell a higher
| binned version of airpod with OTC hearing aid capability.
| Their watch series 4 already has FDA medical device
| certifications.
|
| As for the rest of the market, the amount of margin has
| been insane for hearing aids. I say look at IEM market
| which uses same balanced armature technology: They charge
| at a minimum 20x what Knowles charges for the drivers.
| Chinese sellers figured it out and sell IEM's with the same
| drivers and only 3-4x markup. It's killed all but the
| highest custom end of IEM markets (most of the companies
| merged).
|
| Hearing aids once again have the same balanced armature
| drivers and mark up at least 200-500x the driver cost.
| There is of course some cost to the DSP and paying someone
| to customize it but most of it is pure regulatory capture
| to get the FDA approval.
| radicalbyte wrote:
| My small bluetooth DAC/amp with mic cost $120 and I have
| IEMS ranging from $20-$300. With the top combination
| you're looking at $300 for a single ear for the quality
| option.
|
| That is comparable to a pair of glasses.
| s5300 wrote:
| [dead]
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