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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

#41

Post by ivoflipse »

herpderperator wrote: post #38

It's kinda crazy hearing Apple mention during their event that they expect FDA approval "very soon", and it actually happening 3 days later. I would have thought that governments can't promise timelines to anyone, especially something like FDA approval.

If you've submitted a 510k for your medical device, you can advertise it as "510k pending".

There is a risk that you never receive the clearance or approval, but in this case Apple probably knew they had already addressed any feedback the FDA had so it was very likely there would be no further stumbling blocks

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

#42

Post by ijustlovemath »

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 the market that addresses a similar problem and works using similar technology to your device. FDA understands these things well and have a very clear approval guideline, which usually just takes time to rubber stamp if the submission is of sufficiently high quality.

This is all ignoring Breakthrough Medical Devices, which have a ton of red tape cut (max 30 days to hear back about any submission, and if they run out of time, it's an approval). These kinds of devices are pretty rare, though.

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

#43

Post by thebigman433 »

BOOSTERHIDROGEN wrote: post #31
duskwuff wrote: post #28

Earlier quoted context omitted.

> 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 per…

any recommendations ?

You should go to Costco and try a bunch if you have one near you. Its hard to recommend specific hearing aids to people without knowing what they need. If you dont have a Costco, go to any reputable hearing aid store near you and try from their stock

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

#44

Post by left-struck »

14 wrote: post #40

This is so cool to see. As a health care worker I see lots of people who simply can not afford heating aids as they run for thousands of dollars and then things like they hop into a shower and they stop working happen all the time. What a lot of people don’t realize is that hearing loss is a loss of ability to hear certain frequencies. You can’t simply turn up the volume although that does help to some degree. So wha…

This is a minor point but cranking the volume doesn’t necessarily mean hearing loss.

You could for example have a device that amplifies external sound so that you your hearing is enhanced over all frequencies but has a max volume that it will not exceed. This compresses the dynamic range and makes the quietest sounds easier to detect. It would reduce your ability to distinguish sounds in a noisy environment though I imagine.

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

#45

Post by Nursie »

BOOSTERHIDROGEN wrote: post #31
duskwuff wrote: post #28

Earlier quoted context omitted.

> 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 per…

any recommendations ?

Just to echo what the other poster said - Costco seem to have very good prices and will give you a free hearing test with an audiologist (in Australia anyway)

Their range is fairly limited, but not necessarily in a bad way. Compared to what other audiologists recommend/prescribe, Costco's stuff was about half the price.

OTC hearing aids - no idea.

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

#47

Post by sqs »

herpderperator wrote: post #38

It's kinda crazy hearing Apple mention during their event that they expect FDA approval "very soon", and it actually happening 3 days later. I would have thought that governments can't promise timelines to anyone, especially something like FDA approval.

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.

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

#49

Post by sneak »

Hearing aids are neither food nor drugs. Same goes for glasses and contact lenses, and CPAP machines.

These should never have required approval or prescriptions in the first place. So many people are kept from getting what they need by these arbitrary restrictions.

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

#50

Post by sneak »

sqs wrote: post #47
herpderperator wrote: post #38

It's kinda crazy hearing Apple mention during their event that they expect FDA approval "very soon", and it actually happening 3 days later. I would have thought that governments can't promise timelines to anyone, especially something like FDA approval.

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.
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