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FDA Authorizes First Over-the-Counter Hearing Aid Software

fda.gov

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Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#21

Post by gwern »

candiddevmike wrote: post #7
neilv wrote: post #6

Earlier quoted context omitted.

Interesting. Do you think the FDA will be more proactive and sharper, than regulatory authorities that got confused in the past by tech companies (Airbnb, Uber, RealPage (YieldStar), and others)?

The opposite, they're going to be ridiculously stubborn and require all of these high tech gadgets to be "less". The I in FDA stands for innovation.

Especially here. Expecting good faith in hearing aid regulation - from the FDA?! Remember, Congress authorized OTC hearing aids back in the Trump administration, in August 2017 (https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...). For perspective, GPT-1 didn't even exist yet. But the FDA slow-walked it so long that the Biden administration had to intervene (and is now trying to claim credit for it all, of course), which is part of why the OTC hearing aid explosion has taken so long, been so tentative and slow, and you're only seeing it really taking off the past 2 years or so.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#22

Post by mgerdts »

I’m conflicted on use of AirPods as hearing aids. I use one hearing aid and have normal hearing in the other ear. I often listen to things on my phone over the one hearing aid. It would be nice to have stereo. For this reason, AirPods for both listening to stuff and hearing assistance would be great.

On the other hand, when I see someone wearing AirPods I assume they are listening to something else or are otherwise trying to shut the world out. If I were wearing them to be able to engage more, I think I would just be sending the opposite message.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#23

Post by tomrod »

gwern wrote: post #21
candiddevmike wrote: post #7

Earlier quoted context omitted.

The opposite, they're going to be ridiculously stubborn and require all of these high tech gadgets to be "less". The I in FDA stands for innovation.

Especially here. Expecting good faith in hearing aid regulation - from the FDA ?! Remember, Congress authorized OTC hearing aids back in the Trump administration, in August 2017 ( https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A... ). For perspective, GPT-1 didn't even exist yet. But the FDA slow-walked it so long that the Biden administration had to intervene (and is now trying to claim credit for it all…

If they hadn't intervened, would it have happened?

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#24

Post by zie »

StressedDev wrote: post #13
neilv wrote: post #2

Consider the plausible scenario of Apple developing a superior hearing aid -- a medical device. If that happens, will people be able to use best medical device without being subject to the various liberties that tech companies take with users -- violating privacy, and exercising leverage to other purposes? We've become acclimated to expect violation from the "tech" industry, but what about the medical field?

How is Apple violating people’s privacy? They have done a far better job than other companies from what I'm have seen.

I mean they are the best of the big tech companies, by a country mile, but that's not really saying a lot. If you want the full details, go read the privacy policy with a skeptic's perspective.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#25

Post by garyfirestorm »

mgerdts wrote: post #22

I’m conflicted on use of AirPods as hearing aids. I use one hearing aid and have normal hearing in the other ear. I often listen to things on my phone over the one hearing aid. It would be nice to have stereo. For this reason, AirPods for both listening to stuff and hearing assistance would be great. On the other hand, when I see someone wearing AirPods I assume they are listening to something else or are otherwise t…

This problem could be solved easily. One could put some kind of tiny sticker on their AirPods - it would take sometime for it to become mainstream - like an orange color ring - indicating the user is using the AirPods as hearing aids. (This is a people problem…)

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#26

Post by sureIy »

mgerdts wrote: post #22

I’m conflicted on use of AirPods as hearing aids. I use one hearing aid and have normal hearing in the other ear. I often listen to things on my phone over the one hearing aid. It would be nice to have stereo. For this reason, AirPods for both listening to stuff and hearing assistance would be great. On the other hand, when I see someone wearing AirPods I assume they are listening to something else or are otherwise t…

Is it? I think that thanks to transparency mode and conversation detection people are keeping them in “full time”. In noisy environments I just keep them on without music and they help me hear people talk.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#27

Post by sureIy »

candiddevmike wrote: post #3
neilv wrote: post #2

Consider the plausible scenario of Apple developing a superior hearing aid -- a medical device. If that happens, will people be able to use best medical device without being subject to the various liberties that tech companies take with users -- violating privacy, and exercising leverage to other purposes? We've become acclimated to expect violation from the "tech" industry, but what about the medical field?

The FDA, for all of its warts, is pretty good at curbing bad behavior like this. All medical devices are pretty rigorously controlled, to the point where you can't really add anything to it that isn't absolutely necessary for the device to function. And if you do, there's an encyclopedia worth of paperwork you're going to have to write to defend why the functionality is needed. FDA likes to "duck type" things, and if…

I think this event proves you absolutely wrong.

They approved hearing aid “software”, meaning it can run on arbitrary hardware that may or may not have the restrictions you’re talking about… as part of other “software”

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#28

Post by duskwuff »

Nursie wrote: post #18

I’m very positive about this development. I don’t personally need hearing aids (yet) but I know people that do, and dear god are they expensive pieces of equipment. Even if the AirPods aren’t perfect for everyone (not everyone wants in-ear devices) a big name like this getting in at that price-point might shake up the market.

> I don’t personally need hearing aids (yet) but I know people that do, and dear god are they expensive pieces of equipment.

They aren't as bad as they used to be. You can get over-the-counter hearing aids in the $200-500 range nowadays.

Even so, at $250, AirPods Pro are in a pretty good spot. The main drawback I see is that the earbuds don't have all-day battery life; users will need to recharge them in the case periodically.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#29

Post by userbinator »

The rule enabled consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or seeing an audiologist

Is it just me or does this article sound (pun intended) a bit tone-deaf? All this talk of them "authorizing", when earphones with built-in mics, transparency modes, and adjustable equalisers have existed for years before this, available for everyone to purchase, and can function as a "hearing aid".

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#30

Post by bigiain »

xucheng wrote: post #15

Interestingly, in the end of the article, the FDA links to an old article hosted on web.archive.org[1] even though the linked article was originally published by FDA themselves. Considering the linked article was only published at 2022, a merely 2 years ago, maybe the FDA should do more to prevent dead links. [1]: https://web.archive.org/web/20221028042729/https:/www.fda.go...

> maybe the FDA should do more to prevent dead links

Perhaps government departments (and companies) taking advantage of archive.org storing their old docs should be appropriately supporting them?

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