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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

#71

Post by lotsofpulp »

duskwuff wrote: post #28
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 per…

I’ve seen Costco sell AirPod Pros for $170 or $180 a couple times a year.

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

#73

Post by jillesvangurp »

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.

Adam Savage (of Mythbusters fame) discussed his use of very high-end hearing aids on his Youtube Channel. He has hearing loss and he's of course pretty clued in when it comes to hearing aids. He did a review on the specific brand he's using. From what I remember, he was quite critical on the lack of access to good products for most people that need to get these via some insurance coverage. It would be interesting to get his perspective on airpods.

Because of all the legislation, it's actually a hard market to break into and the resulting products aren't necessarily very good or competitive. The focus is on keeping the insurers happy and getting approved; not the end user. The better products can get really expensive too. So the FDA approving consumer grade products could be a big deal.

Apple's airpods probably have quite a lot of non trivial tech on board that probably overlaps significantly what some hearing aids try to do. For example, AI that isolates sound and things like noise suppression that work in a very targeted way are game changers. Instead of just amplifying sound, selectively blocking some sound is probably very helpful.

Thankfully I have no issues but I know some people that do that wear hearing aids. Despite that, talking to them can be challenging and they have all sorts of issues communicating in loud places.

I imagine these could be useful for people that are completely deaf even. They wouldn't hear anything but they might benefit from e.g. live audio transcription; which is something that's probably not that hard anymore for the likes of Apple or Google.

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

#74

Post by ChrisMarshallNY »

sneak wrote: post #51
garyfirestorm wrote: post #25

Earlier quoted context omitted.

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…)

Some RGB LEDs in the airpods that change color depending on the mode could also achieve this.

The issue would be battery use. The batteries in these things are tiny, and using them as hearing aids could mean longer use.

Having a phone lockscreen indicator of status would be a good way to show this.

I think the phone interface for audiograms is ridiculously complex. They need to improve that.

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

#75

Post by spookie »

car wrote: post #66

With the AirPods now officially becoming hearing aids, it will hopefully reduce the stigma and attitude towards hearing aids and allow many more people to realize how bad their hearing actually is. I have been wearing hearing aids for a few years now (Phonak). I've also used the AirPods Pro with the accessibility audiogram feature (basically making them hearing aids), which is really good and has also been around for…

I have got to say it was fantastic seeing my grandmas eyes glow when, for no reason, I thought "wait my xm4's could help her" and put them on her.

She was then able to hear our conversations even though the xm4 are not as good the real thing.

She didnt want hearing aids before that, but afterwards she wanted ones.

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

#76

Post by mikaraento »

viherjuuri wrote: post #59
sneak wrote: post #50

Earlier quoted context omitted.

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.

The government is not telling you which headphones you can wear. They are saying that these particular headphones work well enough as a hearing aid that it is ok that market them as such. This protects you from quacks that claim their device is a hearing aid but that doesn’t actually work.

To be fair, in the case of hearing aids you are both in the right.

Excessive regulation has created oligopolies and kept prices high in the US. The OTC hearing aid category is meant to help. Before that, low-cost devices tended to remain niche.

OTOH the regulation(s) were introduced due to blatant sales of substandard devices, esp in the 1970s. A high-amplification device runs the risk of further damaging your hearing. Many hearing aid users are vulnerable elderly.

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

#78

Post by not_the_fda »

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.

510ks have a 90 day timeline. The FDA can "stop the clock" to ask for more information and clarification. Buts its 90 days from submital to approval or rejection if your paperwork is in order.

Novel devices have a different path.

Once cleared the FDA can and will come by at anytime and do an audit of your processes and if they aren't up to snuff they can shutdown sales.

Its a trust but verify system.

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

#79

Post by dsr_ »

amne wrote: post #72

cue teenagers with "hearing problems" so they must wear the pods during classes in 3 .. 2 ..

What's your actual complaint?

Is it that teenagers sometimes have hearing issues? That's definitely true; many people are born Deaf or with hearing impairments. Some people get injured.

Is it that teenagers might fake having hearing issues in order to wear pods? Either they will be paying attention in class or they won't; this will be obvious from their grades shortly.

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

#80

Post by FinnKuhn »

bigiain wrote: post #30
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?

I don't know how much money the internet archive has received from official US government institutions, but they do receive at least some as you can see from their list of foundations that help with funding them: https://archive.org/about/
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