FDA Authorizes First Over-the-Counter Hearing Aid Software

https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software

by mgerdts • 2 years ago

438 230 2 years ago

neilv2• 2 years ago

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?

candiddevmike2• 2 years ago

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.

neilv2• 2 years ago

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)?

sureIy2• 2 years ago

I think this event proves you absolutely wrong.

They approved hearing aid “software”, meaning it can run on arbitrary hardware that may or may not have the restrictions you’re talking about… as part of other “software”

mike_d• 2 years ago

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.

StressedDev• 2 years ago

How is Apple violating people’s privacy? They have done a far better job than other companies from what I'm have seen.

zie• 2 years ago

I mean they are the best of the big tech companies, by a country mile, but that's not really saying a lot. If you want the full details, go read the privacy policy with a skeptic's perspective.

kevin_thibedeau• 2 years ago

Scanning for image hashes on everyone's phone is one.

cm2012• 2 years ago

Big tech - including even Meta but definitely including Apple - have an insanely better track record of keeping user data safe than traditional non-tech companies.

olalonde• 2 years ago

If you take away economic incentive from Apple, the plausible scenario is that Apple is simply not going to develop such superior devices.

abtinf• 2 years ago

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?

tootie3• 2 years ago

Sony already has OTC hearing aids on the market

CharlesW• 2 years ago

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?

squidgedcricket• 2 years ago

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”?

Nope, they'd use the 510k process, which is less onerous than de novo. De novo is a quicker alternative to the traditional path for brand new classes of devices. The 510k process is used to develop a new device within an existing class.

ijustlovemath2• 2 years ago

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.

dannyw• 2 years ago

As much as I am in favor of cutting red tape, medical devices should not be received in 30 days max.

xucheng• 2 years ago

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...

bigiain• 2 years ago

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?

FinnKuhn• 2 years ago

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/

galleywest200• 2 years ago

This could also make is more difficult for new administrations to "disappear" documents from government sites by storing them on an archival site.

Nursie3• 2 years ago

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.

duskwuff• 2 years ago

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 periodically.

BOOSTERHIDROGEN• 2 years ago

any recommendations ?

Nursie3• 2 years ago

I guess the big question there is, which market segment will the airpods be comparable to - OTC or prescription?

Because the 'good' hearing aids cost thousands of dollars, and a lot of their added value is in various forms of sound processing. I can see apple doing quite well at that.

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 periodically.

Yeah definitely, though if we are comparing them to 'good' hearing aids then at that price you could buy two pairs and rotate them through the charging case and still come out ahead.

lotsofpulp• 2 years ago

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

jillesvangurp• 2 years ago

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.

dadadad100• 2 years ago

I think I’m the target market. Old enough that my hearing requires some help, but still working in tech from home. The hearing aids I’ve looked at - I have a prescription - have Bluetooth for listening but no microphone for talking. I use my AirPods for teams calls all day long. Switching back and forth to a hearing aid seems too much trouble so I haven’t taken that step. I will get these new AirPods the day the feature ships. I may need two pairs to deal with the battery life but it’s still cheap.

mgerdts2• 2 years ago

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.

garyfirestorm• 2 years ago

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…)

wpollock• 2 years ago

The answer is handicap hang tags, like those used in cars, but worn as earrings. <wink>

hunter2_• 2 years ago

The sticker/paint could change all of the white into a skin tone, the way many hearing aids are. Maybe similar to wrapping a car with vinyl, or nail polish.

sneak4• 2 years ago

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

sureIy2• 2 years ago

Is it? I think that thanks to transparency mode and conversation detection people are keeping them in “full time”. In noisy environments I just keep them on without music and they help me hear people talk.

mgerdts2• 2 years ago

It really depends on the awareness of product features and evolution of the actively used devices. My lived experience is that those with white things in their ears can’t hear you or can barely hear you and have to pull one out to have a conversation.

Those that know you probably understand how you use them. If I were to see you walking in my neighborhood with your AirPods I would probably not bother saying hi unless I already knew you. If you were a new neighbor that always wore AirPods, that means we would probably never become more than strangers to each other unless you initiated conversation.

geoelectric• 2 years ago

I’m pretty pumped about it actually. I have high-frequency hearing loss in one ear (along with replacement tinnitus) that just randomly crept in on me a few years ago, probably after some ENT infection or the other.

The hearing specialist who tested me said it’s fairly significant—eg I can’t hear consonants at the end of words clearly, think he rated it as 75yo hearing and I was ~45, and he asked me if I happened to shoot guns on that side. But he did not recommend going so far as a hearing aid yet.

I personally am skeptical, especially a few years later. What the AirPods solution might do is let me audition the idea. If it turns out whatever it does is beneficial, that will certainly prompt me to get myself retested for the real thing. I should get re-tested anyway, but there’s not much better to motivate you than concrete evidence.

RHSeeger5• 2 years ago

What the AirPods solution might do is let me audition the idea

That's where I stand. Not for AirPods since I don't use an Apple device, but I'm hoping it spurs some Android friendly versions in the near future.

Angostura2• 2 years ago

The fact that Airpods don’t look like hearing aids is a key advantage for some people. it’s especially important to some young people for whom there is a bit of a stigma around wearing them.

ghaff4• 2 years ago

The flip side is you're wearing something that (today) is generally considered an entertainment device or something used to communicate with someone not in the room.

To be clear, I think this is great. My dad bought something off Amazon as a backup for his hearing aid and tried to get remote tech support from me. Who knows what Chinese piece of crap he bought and what he needed to make it work? Fortunately the return was easy.

I'd have a lot more confidence in an Airpod.

talldayo2• 2 years ago

It's a huge double-edged sword. I don't think twice about people wearing hearing aids at the movies or walking down a busy parking lot. If I see someone with Airpods doing the same thing, I'm going to assume they're not using the rare FDA-authorized feature and instead are fully noise-cancelled.

Hell, there's an entire meme of "Oh no, they have their Airpods in!" that certainly won't abate after the release of a rarely-used feature.

AyyEye2• 2 years ago

it’s especially important to some young people for whom there is a bit of a stigma around wearing them.

Anyone who has a stigma about wearing hearing aids around people they are talking to but not a stigma about wearing earbuds while conversing needs to do some deep reflection.

userbinator• 2 years ago

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".

adgjlsfhk1• 2 years ago

Authorization is a big deal. It means it can be payed for by insurance or explicitly prescribed.

herpderperator• 2 years ago

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.

playingalong• 2 years ago

I don't think they can promise. But in a formal process with so many steps involved, you know what else is left to be done. And if there's nothing left, you assume "very soon" completion. Also Apple's announcement was kind of a pressure put on the gov: "hey, enough, unless you want everyone angry at you".

ivoflipse• 2 years ago

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

sqs• 2 years ago

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.

sneak4• 2 years ago

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.

latexr2• 2 years ago

The event was prerecorded. It doesn’t seem farfetched¹ to think they already had the approval but legally couldn’t say it without the FDA making it officially public. But if the FDA had announced it before the event, it would’ve stolen the surprise. Not only of the feature, but that new AirPods would be announced. Apple would’ve hated that so they may have asked for the announcement to be delayed.

¹ Maybe it is. I’m not an expert on the USA’s health and government policies.

robertlagrant• 2 years ago

The approval process requires steps on both sides; Apple could've just delayed sending the last bit of finalising paperwork until they were sure it would drop after the announcement.

alden5• 2 years ago

apple actually didn't release any 'pro' airpods at this event, the feature is for the pro 2's which have been out for over two years now, was glad it wasn't made a feature only for a new version

not_the_fda• 2 years ago

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.

HumblyTossed4• 2 years ago

What in Apple's statement made you think the FDA promised them anything? They were probably all the way through with everything they needed to do for the FDA process and, well, there's a timeline for this process so that's why they knew.

bpodgursky• 2 years ago

They definitely broadcast almost-definite timelines. You see regularly SpaceX prepping launch sites for FAA approval that comes less than a day before launch.

14• 2 years ago

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.

left-struck• 2 years ago

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.

bagels• 2 years ago

They need to legalize glasses.

sneak4• 2 years ago

Zenni has historically been good about shipping without a prescription (not sure about present day), and you can buy contacts in Europe without a prescription and have them shipped, although the shipping is a bit higher.

ewoodrich• 2 years ago

Zenni has historically been good about shipping without a prescription (not sure about present day)

They still are. As long as you don’t confuse them by including a few pairs of glasses with similar but slightly different values in the same order. Then they might demand an actual copy of a prescription. Don’t ask me how I know...

hungie• 2 years ago

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.

sneak4• 2 years ago

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.

wtallis2• 2 years ago

Hearing aids are neither food nor drugs.

Do you really believe that the FDA needs to be renamed before it is reasonable for them to be the agency responsible for regulating medical devices? Is there a different agency you think would be a better fit?

IncreasePosts2• 2 years ago

The NIH?

avianlyric• 2 years ago

While we’re at it, the FDA shouldn’t regulate pacemakers, glucose monitors, artificial hearts, cochlear implants, hip replacement joints, or any other kind of surgical implant.

None of them are either food or drugs, and so many people are prevented from getting what they need thanks to these arbitrary restrictions!

Hmmm, on second thought, I’m not sure allowing ali express implants to be marketed the same as rigourously tested implants, with clear evidence of safety and efficacy, is such a great idea.

bregma• 2 years ago

Same with pacemakers, joint replacements, insulin pumps, glucose test strips, heck even bloodletting razors and leeches. You should be able to just order them online from an Amazon reseller or pick them up down at the Quickie Mart and take the risk entirely on yourself, your dependents, or your co-conspirators without no gov't meddling from so-called experts.

stevesimmons• 2 years ago

So FCA regulation of CPAP machines just gets in the way of people getting what they need?

How about Philips Respironics have to recall something like 15 million CPAP devices in 2021 because they contained foam liable to disintegrate and which the user would then inhale...

autoexec4• 2 years ago

Yeah, if anything that showed we need more regulation and even more importantly a better justice system. They knew their devices were going to cause cancer and kill people, and they not only continued to sell their devices, but they went out of their way to try to hide the facts from the public so that they could continue to kill as many people as possible.

The people at Philips Respironics were/are literal serial killers. Their product has been linked to hundreds of deaths, but not one person spent even a single day in jail.

echoangle5• 2 years ago

Do you think having companies make defibrillators without any approval is a good idea? Those aren't food nor drugs either.

theshackleford• 2 years ago

I’d prefer more oversight of things like CPP, preferably it would been before I spent years inhaling cancerous chemicals.

car6• 2 years ago

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.

spookie• 2 years ago

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.

vitorbaptistaa• 2 years ago

The Sony WH-1000XM4? I'm still on the Bose QC 35, but you got me curious. Could you explain how using it as a hearing aid works? I searched the web but couldn't find good references.

astrange4• 2 years ago

I haven't tried XM4, but the noise cancelling on XM3 had a very uncomfortable "sucking" feeling even though it is very strong, especially on a plane. The AirPods aren't as bad about this and NC is about as good.

AshamedCaptain3• 2 years ago

Note also phonaks are traditionally a couple thousand euros a piece while even the most expensive airpods are still around 300 the pair. Certainly the phonaks are impressively small, lasting, good quality, and imperceptible, but is the almost 10x price markup justified?

The biggest problem with hearing aids (and doctors/calibrators/whatever) is that they are ridiculously expensive... the attitude/stigma much less so. (And in any case airpods are about the opposite of "imperceptible" so I fail to see any appeal other than the price)

alias_neo• 2 years ago

I don't think I've ever seen someone with a hearing aid and though anything negative of it, I get it people can be self-conscious, but for something like a hearing aid I think it's unjustified.

On the other hand, I can't bring myself to keep earbuds (airpods or w/e) in my ears while talking to someone, regardless of if I can hear them properly, I just seems incredibly rude.

My uneducated opinion, is that someone using airpods as hearing aids is more likely to face stigma for that reason, than someone wearing what are clearly hearing aids, unless people actually know they have hearing issues.

josefresco2• 2 years ago

You're certainly not alone in resisting hearing aids. My dad just got some from Costco (most affordable) and really likes them. He probably waited 5-10 years too long.

My father-in-law however doesn't like hearing aids because he feels they amplify things he doesn't want to hear. Granted he's never been fitted to actual hearing aids. I understand his concern, but he's told me multiple times his hearing loss leaves him isolated during conversation. He told me one night that he has a lot to say, but can't hear so he spends a lot of time just smiling. It makes me sad that his pride (and stubbornness?) is causing him this stress.

vel0city4• 2 years ago

he feels they amplify things he doesn't want to hear.

I mean that's kind of the whole point of having them adjusted with an audiologist. They're tuned to your specific needs.

It's too bad so many people think they're just mics and amplifiers. Modern hearing aids do a lot of signal processing.

qup• 2 years ago

My grandmother did that, as well. She was brilliant, but she was reduced to nodding a long, often inappropriately, because she couldn't hear.

RcouF1uZ4gsC• 2 years ago

because he feels they amplify things he doesn't want to hear.

Could that be your mother-in-law telling him things to do?

Is he afraid of losing plausible deniability - "Sorry, honey, I didn't hear that, you know how bad my hearing is."

phkahler• 2 years ago

> he feels they amplify things he doesn't want to hear.

Modern hearing aids can be adjusted to amplify only the things you want to hear, and even reduce the things you don't want to hear.

car6• 2 years ago

Costco is great for this I found out. Free audiogram, and all name brand hearing aids.

I used to be like your father-in-law, pride, vanity, stubborn, not wanting to be told what to do, whatever it was. And my dad was like this too (the hearing loss is heritable), I used to mock him about not wanting hearing aids before my own hearing declined. When I finally got fitted, it was shocking to me how much my hearing had suffered. Suddenly I could hear birds and crickets again, and most importantly speech!

Maybe you can get your father-in-law to first play around with AirPods as hearing aids to win him over to get proper ones. The latest generation hearing aids, like the AP's, have amazing AI signal processing that will suppress noise and enhance speech. It's always cool when my Phonak's detect noise and shut it down.

The important thing about hearing loss in elderly, especially if someone has an elevated risk of cognitive decline, is the resulting social isolation, and the increasing risk of dementia [1]. It should be addressed sooner than later.

To sum it up, the AP's have the potential to provide an affordable on-ramp for more hearing impaired people to experience hearing restoration and warm up to better ones (hopefully covered by insurance). I don't think AP's would a permanent hearing solution, other than for people who are uninsured and can't afford real hearing aids (sadly).

Edit: I could not imagine wearing AP's all day, great as they are, while I don't even notice my receiver-in-ear hearing aids anymore.

Edit: While AP's are not perfect, having any kind of hearing aid is a 100% improvement over having none, which is probably also why the FDA allowed OTC hearing aids.

Edit: [1] https://www.nih.gov/news-events/nih-research-matters/hearing...

hanniabu• 2 years ago

He probably waited 5-10 years too long.

What's the downside of waiting?

astrange4• 2 years ago

My father-in-law however doesn't like hearing aids because he feels they amplify things he doesn't want to hear.

I have this issue with AirPods too, in the "adaptive" mode. It feels natural outdoors, but sometimes indoors and especially in rooms with echo it feels like it makes distant chatter unnaturally loud and closer-sounding.

freedomben3• 2 years ago

In contrast, the AirPods run out after a few hours and are also destined to become landfill due to their built in battery.

Also will entrench the user in a walled garden ecosystem from a very specific giant tech company that isn't big on making their products compatible with other companies.

systemtest3• 2 years ago

I have no issues using my AirPods on Android.

Automatic device switching doesn’t work but that doesn’t work on my Sony headphones either.

Terretta• 2 years ago

will entrench the user in a walled garden ecosystem from a very specific giant tech company that isn't big on making their products compatible with other companies

Are you suggesting AirPods aren't Bluetooth 5.3 and aren't compatible with Bluetooth audio sources? Or that it doesn't play AAC, MP3, and FLAC?

The proprietary capabilities (such as instant smart switching between active devices) are all incremental, taking nothing away from normal Bluetooth usage.

whiterknight• 2 years ago

Is the hearing aid market big on modularity and compatibility?

isn’t it good to have multiple options so consumers can pick what they value?

chipotle_coyote• 2 years ago

That's an argument against buying an iPhone and AirPods Pro together as a combination instead of buying a hearing aid, but

- it's not an argument against using AirPods as an aid with mild hearing loss if you're already an iPhone user

- it's not necessarily a great argument against buying an iPhone and iPods Pro anyway, given that hearing aids can easily run hundreds or even thousands of dollars more than that combination

- the vast majority of smart phone customers, both on and off HN, have either factored "walled garden" into their buying considerations at this point or never will

- let's not pretend Samsung is not already trying to figure out how to cram this into their next Galaxy Buds for Android users anyway, which will somehow work best with Samsung phones, not so well with other Android phones, and not at all with iPhones, but nobody will really complain about it because whatevs, it's not Apple

SoftTalker• 2 years ago

And will put some people off from talking to them. I don't talk to people with AirPods stuck in their ears until they take them out. Too many times I have tried to start a conversation or just say "Hello" but they are oblivious because they are on a call or have music or something else playing.

RobotToaster• 2 years ago

If ever there was an opportunity for apple to earn some easy goodwill, it would be opening accessibility features like this to other platforms. Keeping accessibility features locked to iphones only isn't good optics IMO.

righthand2• 2 years ago

Most people don’t wear hearing aids because they don’t like how it looks and think their hearing isn’t bad enough to warrant social stigma from it. I don’t see how Airpods solve that problem as they are very unsightly, no matter how much pundits say they love them.

In fact you mentioning how they are like hearing aids has made me justify never wanting a pair.

rmccue• 2 years ago

The advantage of AirPods for social stigma is they aren't solely hearing aids, so you have a type of (casual) plausible deniability about why you're wearing them. They won't draw people's attention in the way that hearing aids (because they're different/unique) do.

alnwlsn• 2 years ago

If anything, if someone's wearing Airpods, I'm going to assume they can't hear anything I'm saying. "oh no he's wearing airpods" is a meme for a reason.

ksenzee• 2 years ago

In fact you mentioning how they are like hearing aids has made me justify never wanting a pair.

Why? Because hearing aids are unsightly? Are wheelchairs unsightly? Canes? Prosthetic legs? It looks to me like this idea of what’s “unsightly” is being fed by a cultural bias against the disabled. Interestingly, glasses were “unsightly” a few decades ago, and now they’re in fashion. It would be nice to see the same thing happen for other assistive tech.

tengwar24• 2 years ago

One reason I already use them as hearing aids is because I use Airpods for phone calls, and it's a lot easier to leave them in than change to my hearing aids. So the question of what they look like doesn't arise.

steve1977• 2 years ago

Sonova (Phonak) is Swiss by the way, not Danish.

They also own the consumer of Sennheiser since a couple of years.

car6• 2 years ago

Thanks, I stand corrected.

BeetleB3• 2 years ago

In contrast, the AirPods run out after a few hours and are also destined to become landfill due to their built in battery.

Just looked up AirPod battery run time. Wow - that's short. I have Anker A40 earpods.[1] 10 hours, and the case has enough charge for 50 hours. 10 minutes of charging gives you 4 hours. They're a lot cheaper than Airpods, so you could easily buy a pair (for much cheaper) and be good!

Not sure how accurate they'll be as hearing aids.

[1] https://www.amazon.com/dp/B0B1LPNDGF/?tag=thewire06-20&linkC...

Iulioh• 2 years ago

Depends on the form factor and what functions are active.

I'd say 4-6-8 is low-average-high duration for the standard form factor and ANC will reduce the duration by 25-30%

10 hours is exceptionally high, i don't think i even seen that claim

But year, they don't even have ANC, they are just a good pair of buds, the 10h claim is good.

Pro tip:

You know that a pair of buds is good if they offer Multipoint. It is such a hard feature to find in the mid and low end market

astrange4• 2 years ago

Landfill isn't so bad though. Segregating identical waste into one place is a fine approach, because once it becomes possible to recover it, now you know where it is. Think of it as a mine. (It's a problem if it leaks into the groundwater of course.)

But lithium is not at all rare so it's not going to be hard to make more batteries.

tengwar24• 2 years ago

Is there a way of setting an audiogram? That's basically a frequency response curve for your hearing, so it's the basic requirement for acting as a hearing aid. This is a setting which iPhones have for Airpods (as far as I know, you can't set it without an iPhone).

whatdidyousay• 2 years ago

How have the Phonak's been? I only learned of them recently - I've been wearing Oticons for a few years and have never been super impressed.

I may be ready to drop $$ for my next pair..... do you work with an audiologist or did you do everything at Costco?

car6• 2 years ago

I got them through an in network hospital audiology department, so paid by health insurance. For out of pocket Costco looks good to me. They have special models that are a little less fancy than the top of the line stuff, from name brand manufacturers.

I also checked out earlens.com, a pretty cool concept that’s supposed to be superior in audio quality. But they are pricey, and need to be fitted by a doctor/audiologist with a transducer that sits directly on the eardrums (and stays in your ear canal) and is driven by induction. Ultimately turned off by cost ($12k/pair).

I think the technology in hearing aids has profited from the advances in chip manufacturing [1]. So the latest models may also be on 5nm and thus have more transistors for fancy AI and longer battery life. You may have a better experience nowadays.

[1] https://esg.tsmc.com/en-US/articles/106

car6• 2 years ago

For posterity wanted to add this interesting post [1] by TSMC about their work with Oticon (one of the established hearing aid manufacturers). It's a few years old (2021), so instead of 28nm, more recent models probably use even 5nm.

"Compared to the previous generation of Oticon Opn S™ which is powered by TSMC’s 65nm low-power technology and contains 64 million transistors, the newest model features one of the most advanced chips with AI sound processing and analysis capabilities. The migration to TSMC’s 28nm opened the door for Oticon to utilize DNN, which is trained with 12 million real-life sound scenes. This new feature allows hearing aids to mimic how the brain would hear sounds and aims to respond the same way as the brain. As more functions are added, more compute performance and improved power efficiency will be required to support future generations of hearing solutions."

[1] https://esg.tsmc.com/en-US/articles/106

pcardoso• 2 years ago

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.

tootie3• 2 years ago

OTC hearing aids are now as cheap as $80 USD. I'm sure they're not the best, but it makes the tech incredibly accessible. Sony, Jabra, Eargo ones are more expensive than airpods, less than prescriptions. Not sure how they will stack up to airpods.

https://www.jlab.com/products/hear-otc-hearing-aid-graphite

systemtest3• 2 years ago

Does your nations healthcare system not cover that?

amne• 2 years ago

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

dsr_• 2 years ago

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.

talldayo2• 2 years ago

The "actual complaint" is that Apple made hearing aids indistinguishable from an entertainment device. There's nothing wrong with taking initiative to a good thing, but you can absolutely pave the road to hell with good intentions. People would be rightfully outraged if Tesla drivers could ignore the road to play The Witcher 3 at 50mph on the freeway. Saying something like "either they will crash or they won't" isn't going to assuage the problem or change the design issue. The danger is going to persist as a result of first-party design oversight.

teaearlgraycold2• 2 years ago

Just require a doctor’s note one time?

jimbob45• 2 years ago

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.

You can ignore lectures, not participate in teacher-led activities, generally be a nuisance, and still get an A such that your parents would never catch on to you.

todotask• 2 years ago

How do I deal with itchiness? Having trying to wear for a few seconds, can be annoying after been wearing hearing aid for decade.

dav43• 2 years ago

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.

_fat_santa• 2 years ago

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.

HumblyTossed4• 2 years ago

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.

Woah there fella. Hearing aids last a very long time before needing a new battery. AirPods needs to be charged several times a day. That's a bit of an inconvenience. As is some hearing aids are made to fit one's ear. Where as AirPods are 3 sizes fits all.

jeffhuys• 2 years ago

That’s a much, MUCH lower barrier of entry, though, fella… and that can be celebrated in my opinion

echoangle5• 2 years ago

Just to be pedantic: AirPods Pro 2 come with 4 sizes for tips. Also, I'm sure you can get third-party tips with different shapes if you wanted to.

some_random2• 2 years ago

A condescending reply showing you didn't read the whole comment isn't the best look. The point isn't that they're the bestest hearing aids ever, the point is that they are an option at all at a tiny fraction of the typical price which will force manufacturers to innovate.

wintermutestwin• 2 years ago

Airpods don’t fit in my tiny ear canals. I even bought a smaller aftermarket tip and still no luck.

mitemte• 2 years ago

Existing hearing aid products are still available for purchase for those who want them. I don’t think AirPods are going to replace hearing aids. Hopefully they lower the barrier for entry and perhaps lower the price of existing products.

kstrauser• 2 years ago

You could buy 2 pairs and swap them out. That would still be a 75% discount over the $2000 pair.

This will help more people hear. It might not be the best possible solution, but it surely beats not having it.

insane_dreamer2• 2 years ago

AirPods needs to be charged several times a day. That's a bit of an inconvenience.

that's if you wear them all the time. I have hearing difficulties and know I need aids even without taking a test. But I wouldn't want something in my ear all day long and most of the time I don't need to hear better because I'm working or whatever. But there are situations where it's hard for me to understand what people are saying and that's when I would put them on.

So with that in mind the AirPods would work great. It's unfortunate that it doesn't work with the regular AirPods which are only $100. (I don't have the Pro's).

astrange4• 2 years ago

AirPods Pro have replaceable tips, and there are third parties who sell different tips.

Actually the better the tip fits you, the more I'd think you'd take them out once in a while, because a perfect seal means your ears will get sweaty.

teaearlgraycold2• 2 years ago

My APPs are still going strong after 4 years. I use them daily, but not all day every day. Sure the battery life isn’t as good as before. But they’re still very usable. Am I just really lucky?

ChicagoBoy11• 2 years ago

No, that's my experience as well

cryptoegorophy• 2 years ago

1.5? What happens after 1.5 years? Had mine for 5 years, no issue and sort of the same battery life or not noticeable to me (15% degradation is what I would not notice ) still charge very quick in a case.

CamelCaseName• 2 years ago

You buy a new hearing aid for another $250 that has another 1.5 years worth of technological advancements.

Or maybe you buy multiple instead of just one, so you can hotswap any time.

skybrian• 2 years ago

There are already cheap hearing aids. Airpod Pros will grow the market since they’re good for people getting started and okay for occasional use, but they aren’t good for wearing all day: too distracting for people you’re talking with, not enough battery life.

But now that Apple entered the market, maybe they will come out with wireless headphones that are more suitable?

caeril2• 2 years ago

[edit] Disregard, I forgot that HN has been infested with normies with poor reading comprehension. Further posts will be strictly technical.

rahimnathwani• 2 years ago

Do you need an iPhone to use them, or only for the initial setup/audiogram?

mannyv2• 2 years ago

This also means that the Apple ecosystem is HSA and FSA eligible.

solardev• 2 years ago

Wait, really? You can use your health savings on a iPhone now?

mannyv2• 2 years ago

It's much more justifiable now for sure.

coupdejarnac• 2 years ago

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.

philip12092• 2 years ago

Is it possible to spend FSA/HSA funds on medically-necessary Apple products/services?

ganoushoreilly• 2 years ago

That's a lingering question right now as the software was approved, but not specifically the hardware. I suspect it would be able to be covered, but as with any of those rules, it's kinda murky.

I suspect if it is, we'll see some interesting advertising / marketing from 3rd party resellers.

philip12092• 2 years ago

Makes sense. Would be great to see iPhones / Apple Watches covered for diabetic CGM users, too.

HeyLaughingBoy2• 2 years ago

It's a very good question and Apple may already have an answer.

One of the interesting things I learned in my time building medical devices is the role of insurance reimbursement in the product development process. Before introducing a new device, or a new (blood) test, one of the questions Marketing has to answer is how difficult it will be to get reimbursement from insurance in the US.

It sounds kind of icky, but it's a real concern.

If insurance companies won't reimburse for a particular test or use of a device, then the users are far less likely to buy it, or in the case of a test, the physician may have to warn the patient that their insurance isn't likely to pay for it. This will probably lead the manufacturer to decide that it's too risky to proceed with development.

ohadpr• 2 years ago

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.

ChrisArchitect2• 2 years ago

AirPods Pro 2 adds 'clinical grade' hearing aid feature

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

ChrisArchitect2• 2 years ago

Related Apple study from May:

Apple Hearing Study shares preliminary insights on tinnitus

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

detourdog2• 2 years ago

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.

adolph• 2 years ago

Do glasses next

niij• 2 years ago

Will this support CROS?

FDA Authorizes First Over-the-Counter Hearing Aid Software

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