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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

#11

Post by squidgedcricket »

abtinf wrote: post #5

> This application was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device. Does that mean that if Android/Bose/Sony/etc were to develop a comparable solution, they would not be able to use the “De Novo premarket review pathway” because AirPods Pro is now a “prior legally marketed…

> Does that mean that if Android/Bose/Sony/etc were to develop a comparable solution, they would not be able to use the “De Novo premarket review pathway” because AirPods Pro is now a “prior legally marketed device”?

Nope, they'd use the 510k process, which is less onerous than de novo. De novo is a quicker alternative to the traditional path for brand new classes of devices. The 510k process is used to develop a new device within an existing class.

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

#12

Post by Spooky23 »

CharlesW wrote: post #10
tootie wrote: post #9

Earlier quoted context omitted.

Sony already has OTC hearing aids on the market

Neat: https://electronics.sony.com/more/otc-hearing-aid/c/all-otc-... So what does "first OTC Hearing Aid Software" mean, given that both are hardware/software systems?

It does some tuning based on a hearing test.

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

#13

Post by StressedDev »

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.

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

#14

Post by cm2012 »

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?

Big tech - including even Meta but definitely including Apple - have an insanely better track record of keeping user data safe than traditional non-tech companies.

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

#15

Post by xucheng »

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...

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

#16

Post by [deleted] »

mike_d wrote: post #4
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?

> We've become acclimated to expect violation from the "tech" industry, but what about the medical field? Oh, you sweet innocent child. Look at price gouging on EpiPens, J&J "lifelong" hip implants needing replacement every few years, insulin pumps with proprietary batteries, glucose monitors that actively prevent you from reading data, etc. Big bad tech companies don't hold a candle to the medical industry.

[deleted]

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

#17

Post by tootie »

CharlesW wrote: post #10
tootie wrote: post #9

Earlier quoted context omitted.

Sony already has OTC hearing aids on the market

Neat: https://electronics.sony.com/more/otc-hearing-aid/c/all-otc-... So what does "first OTC Hearing Aid Software" mean, given that both are hardware/software systems?

It seems like it's software to conduct a hearing evaluation to tune the airpods.

There's actually loads of OTC hearing aids on the market already although most seem fairly pricey.

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

#18

Post by Nursie »

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.

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

#19

Post by olalonde »

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?

If you take away economic incentive from Apple, the plausible scenario is that Apple is simply not going to develop such superior devices.

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

#20

Post by [deleted] »

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…

[deleted]
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