FDA Authorizes First Over-the-Counter Hearing Aid Software

Post by sneak » Fri, Sep 13, 2024, 6:05 AM UTC

garyfirestorm wrote: post #25

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…)

Post by [deleted] » Fri, Sep 13, 2024, 6:15 AM UTC

sneak wrote: post #50

sqs wrote: post #47

Earlier quoted context omitted.

Rule of law FTW! Governments can't usually promise timelines, but when the process is well documented and predictable, that is a very good thing.

Literally nobody wants the government telling them what kind of headphones they are allowed to wear. This is a failure of the rule of law.

Post by [deleted] » Fri, Sep 13, 2024, 7:03 AM UTC

ijustlovemath wrote: post #42

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…

Med device startup cofounder here. In terms of difficulty in your path to market, from hardest to easiest (and ignoring some less common pathways): 1. Pre Market Approval: you're addressing a completely unproven technology in a novel and or dangerous space. Usually Class II and above. 2. De Novo: you're adding a new technology to a somewhat well known space. Usually Class II+ 3. 510(k): There's already something in t…

Post by [deleted] » Fri, Sep 13, 2024, 7:05 AM UTC

ijustlovemath wrote: post #42

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…

Med device startup cofounder here. In terms of difficulty in your path to market, from hardest to easiest (and ignoring some less common pathways): 1. Pre Market Approval: you're addressing a completely unproven technology in a novel and or dangerous space. Usually Class II and above. 2. De Novo: you're adding a new technology to a somewhat well known space. Usually Class II+ 3. 510(k): There's already something in t…

Post by viherjuuri » Fri, Sep 13, 2024, 7:22 AM UTC

sneak wrote: post #50

sqs wrote: post #47

Earlier quoted context omitted.

Rule of law FTW! Governments can't usually promise timelines, but when the process is well documented and predictable, that is a very good thing.

Literally nobody wants the government telling them what kind of headphones they are allowed to wear. This is a failure of the rule of law.