FDA Authorizes First Over-the-Counter Hearing Aid Software
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Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#2Consider 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?
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#3Consider 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 your duck doesn't look like the other ducks, you need to create a new animal or make your duck look like other ducks.
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#4Consider 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.
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#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 device”?
How much more onerous is the normal pathway?
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#6Consider 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…
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)?
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#7Earlier quoted context omitted.
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…
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.
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#8Earlier 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.
> "The I in FDA stands for innovation."
LOL. I hadn't seen this before. Quote? Or did you coin it?
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#9> 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…
Sony already has OTC hearing aids on the market
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#10> 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…
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?