car
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 a few years. I'm very glad, that Apple has made this official and even gotten FDA approval.

When I started to loose my hearing a decade ago, for a long time I refused to wear hearing aids, probably due to the perceived stigma. Even though it made life harder and harder -- imagine work meetings with a mumbling boss or me accusing my family to intentionally whisper -- it took years to change my mind. In hindsight I should have gotten hearing aids years sooner.

My 'real' hearing aids are nothing short of a technological marvel. They are tiny and run for a few days on zinc-air batteries (312/Costco but made by Varta), while providing all-day BT streaming. Btw, funny how most hearing aid brands come from Denmark. In contrast, the AirPods run out after a few hours and are also destined to become landfill due to their built in battery.

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...

abtinf
> 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?

_fat_santa
This is huge. Previously if you were hard of hearing, a pair of hearing aids could cost upwards of $2,000. Now Apple just brought that price down to ~$250.

Even if you use them everyday and assume a shelf life of 1.5yrs (which is roughly mine and others' experience with AirPods), you would be replacing your Airpods for 12 years before the cost caught up with a single pair of hearing aids.

Even if you think Airpods are not on the same bar as regular hearing aids, this will certainly help depress market prices. Every manufacturer will probably start releasing sub $1000 hearing aids just to not get destroyed by Apple.

mgerdts
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 trying to shut the world out. If I were wearing them to be able to engage more, I think I would just be sending the opposite message.

herpderperator
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.
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.

pcardoso
One of my kids was born with a slight hearing loss and I think this is huge.

We got from the local health service some basic hearing aids that cost around 1000 euro but we are contemplating buying some high-end Phonak devices that are around 5000 euro as recommended by some experts.

In comparison to this the AirPods (280 euro?) are almost free.

14
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 what happens is you see a doctor who determines what frequency loss you have and the hearing aid when it picks up that frequency shifts it to another frequency that you can hear. So I do see why up until now ya it was regulated. We don’t want some company selling a device that simply cranks the volume and potentially causes more damage. But with today’s technology we are more then ready for this to be a reality. With an app we can offer hearing tests and determine what areas the client needs improved. This I feel will be a game changer for some.

The only thing I wonder about is how well do air pods hold up to waxy ears? With regular hearing aids they need cleaning and often have things like a wax trap which is a tiny plug that catches wax and can be swapped out easily.

dav43
I am surprised the size of their study where they made conclusions was only 118 ppl. I would have thought a much larger study is required.
ChrisArchitect
Related Apple study from May:

Apple Hearing Study shares preliminary insights on tinnitus

https://news.ycombinator.com/item?id=41491121

ChrisArchitect
Related:

AirPods Pro 2 adds 'clinical grade' hearing aid feature

https://news.ycombinator.com/item?id=41491191

coupdejarnac
I made a hearing aid app for the iPhone nearly 10 years ago. It was nearly impossible to get anybody to pay $10 or less for it.Also, there is/was a FDA exception for mobile apps, which kind of obviated the need for the grad school class i was taking at Stanford about getting medical devices FDA approved.
philip1209
Is it possible to spend FSA/HSA funds on medically-necessary Apple products/services?
detourdog
I see this as a major advance for ADA compliance for headphones. This may take a few years but audiogram editing is going to become minimal specification.
hungie
FDA with a reasonable bar - demonstrate that this is equivalent to a professional fitting.

I'll take any opportunities for assistive technology to be a cheaper option.

todotask
How do I deal with itchiness? Having trying to wear for a few seconds, can be annoying after been wearing hearing aid for decade.
ohadpr
Speaking of the AirPods becoming actual hearing aides - how will we reconcile the fact that it is not socially acceptable to wear AirPods when speaking with someone?

Even if you get to explain ‘oh my AirPods are functioning as a hearing aide’ you likely won’t be able to explain that to other people noticing the conversation and thinking to themselves ‘oh that’s douchey, not taking our your AirPods when talking to someone’.

I just really wonder if this will be able to make wearing AirPods while talking to other people socially acceptable because the current presumption is likely that they are not behaving nicely.

amne
cue teenagers with "hearing problems" so they must wear the pods during classes in 3 .. 2 ..
bagels
They need to legalize glasses.
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.

niij
Will this support CROS?
userbinator
The rule enabled consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or seeing an audiologist

Is it just me or does this article sound (pun intended) a bit tone-deaf? All this talk of them "authorizing", when earphones with built-in mics, transparency modes, and adjustable equalisers have existed for years before this, available for everyone to purchase, and can function as a "hearing aid".

mannyv
This also means that the Apple ecosystem is HSA and FSA eligible.
adolph
Do glasses next
neilv
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?