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FDA Authorizes First Over-the-Counter Hearing Aid Software (fda.gov)
438 points by mgerdts 54 days ago | hide | past | favorite | 240 comments



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.


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.


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...


My hearing is on the border; the doctor told me hearing aids would help, but I don't "need" them. I've been resisting getting them because

- I've always (decades) had issues with distinguishing speech when there's background noise. Even when my hearing was "perfect", my brain just had problems separating the two. This is _especially_ true in a crowded area (mall, restaurant, etc) where the background noise _is_ speech. My father had the same issue, tried many different aids, and _never_ managed to get a pair that worked.

- Cost. I'm not interested in experimenting at thousands of $ per try. With the expectation that I'll wind up at the doctor's office a dozen+ times while they try something new to help me (with the first issue), and a likelihood that they'll never succeed; I'm very hesitant to shell out the money involved.


I have the same issue with noise spaces... If I can't see the person talking, it's impossible for me to distinguish anything but the loudest thing. I may as well be def in a noisy room.


Did LACE not work for you?


I'd never even heard of it before you asked.


>> 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.


How do they accomplish this when the other/background noise is speech, like in a crowded area; where you only want the person near you amplified?


One method is using directional information. My low-end aids have two microphones each, and can share audio information from one aid to the other. I believe there are also some other methods, but I don't know how those work


> 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.


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

This is what I'm still trying to convince my dad of, after he found the pair he was fitted with ~20 years ago absolutely useless. He found that they simply made everything louder which did nothing to help him pick out what he wanted to hear.

But he's always been picky about his soundscapes, wanting the TV muted during ad breaks etc etc.


> But he's always been picky about his soundscapes, wanting the TV muted during ad breaks etc etc.

I'm with him on this one. Commercials always end up being louder than the rest of the content, and are just.. annoying.


I thought I had hearing loss. I don't. I have Audio Processing Disorder. When I found out about APD and read its symptom list, I cried. It's me, all over. Between that and ADHD I now understand how my brain processes (or doesn't process) sound properly and why even a well intentioned (but clueless) audiologist told me I had "selective hearing".


> he found the pair he was fitted with ~20 years ago absolutely useless

IKUK but that's like having bad vision so you put on a pair of your glasses from 20 years ago, still having bad vision, and deciding glasses just don't work well. Hearing and vision change over time. And that's assuming those were good hearing aids 20 years ago compared to what is available today.

I hope your dad ends up taking a chance.


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


It's rough now that I know it bothers him. Late at night, when the house is quiet and it's just you and him, he'll talk your ear off and hear every word you say.


> 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.


> He probably waited 5-10 years too long.

What's the downside of waiting?


Diminished quality of life during the waiting period


> 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."


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.


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.


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.


There is a noise canceling mode that let's you hear what is received by the microphone array and an option to "filter in voices while suppressing noise" (they call that voice passthrough). That section of the app is called "Ambient Sound Control" if that helps your research.


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)


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.


A buddy had a girlfriend who had reduced hearing. I noticed that people would raise their voice and really dumb down when speaking to her, like they were talking to a senile elderly. It'd happen before she'd said a word, so they clearly saw the hearing aid and assumed.

She admitted she disliked wearing the hearing aids, due to such things. But the alternative was not following conversations, which meant she'd get excluded because she missed important information.

Gave me a whole new perspective on hearing loss.


Maybe it's because I have been wearing aids through all my life, but I see things this way. I don't care much what stigma wearing one carries, considering the alternative is being "that guy" who needs everything repeated twice, and that is a stigma I hate.


It does seem to depend on the hearing aids as to whether people can see them. I have NHS hearing aids - made by GN Resound, I think. I really like them, but as they use sound tubes rather than wires to a speaker in the ear canal (the oddly named "receiver in canal"), they are fairly low end. Ok, so that means I have small tubes snaking in to my ears. I still had to tell a cousin four times that yes, I was wearing hearing aids, and no, I hadn't forgotten them. In fact that was how I got my mother to get hearing aids - I told her I'd been wearing them for three years and she had not noticed.

As to being excluded: one of my jobs is funeral officiant. Several times I've found the spouse of the deceased being left out of the funeral conversation because of hearing and I've even been told not to bother talking to them because they won't hear. Every time I've found that we can talk perfectly well - it just needed a bit of effort on my part.


I don’t think the stigma is around hearing loss it’s about age.

And stigma is probably not the right word, it’s an internal acceptance issue.


You are right, I thought about it a bit more, and I think it was more vanity for me, since I was fairly young when the hearing loss started. But hearing aids nowadays are so inconspicuous that most people don't even notice them.


It almost certainly depends how social norms develop.

When Borg bluetooth earpieces first came out, they definitely carried a tech bro/fin bro/VC/etc. vibe that, at any moment, someone more important than you might want to get in touch with me.

I do think Airpods today carry a certain I'm not necessarily giving you my full attention vibe whereas an obvious hearing aid is a medical prosthetic. To the degree that Airpods replace hearing aids for some number of people or just assist people who aren't quite at the prescribed medical device level, that probably changes.


The one thing that I do believe Apple managed with the iPhone is the removal of this "tech bro" vibe from carrying a smartphone overall. So I guess it's not entirely out of the question that Apple will remove the stigma from wearing huge headsets 24h long...


One of the other things that was happening at the time--though not disconnected--is that data charges were getting to the point where normies (or at least reasonably well-paid ones) could at least reasonably consider owning a phone with a data plan even if their company wasn't footing the bill. I bought a Treo a while before the iPhone came out and paid for it on my own after a foot injury that made it difficult to travel with a laptop.


I'm skeptical about big headsets but small earpieces seem headed towards becoming pretty normalized.


> 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.

Neither have I. On the other hand, I have seen people wearing air pods and thought they looked ridiculous, as if they had qtips sticking out of their ears. Especially if they're sticking out at different angles.


> 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...


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


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

Are you talking about the ones I linked to? They clearly have ANC, and Wirecutter claims it's among the better ANCs they've tested.

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

The claim is right there in the product description. Wirecutter also confirmed it with a test:

https://www.nytimes.com/wirecutter/reviews/best-wireless-ear...

They do say it can be reduced depending on how you use it.

Finally, here's a snippet of an Amazon review:

> I just played 7 hours of continous music with the noise canceling activated at high volumes and there's still almost 30 percent battery avaliable.

And another:

> I used the earbuds for 8 hours between ANC & transparency mode, ... Considering how often I use the earbuds after 8-10 hrs per day and 4-5 days of use from a full charge, the battery life is still 2 lights remaining.

One review does state lower life with ANC:

> But, a full charge only lasts me 6 hrs with anc on auto and volume at 50% or less.

A few reviews talk about even lower battery life, but given Wirecutter's tests and the preponderance of those who get long battery lifes, I'll assume the exceptions are defective products.

In any case, is ANC even relevant for hearing aids? I would have thought ANC would be a hindrance.

(In general, several reviews refer to using it continuously for their work shift).

The one thing that may not be particularly good is the mic.

Edit: Here is someone who tested with ANC on. They got 7hr 55 min:

https://www.soundguys.com/anker-soundcore-space-a40-review-8...


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.


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).


Yes. It's called HearID

https://www.soundcore.com/hearid


> 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.


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


I'm looking forward to this going live. I've worn the "we have an app!" BLE enabled hearing aids and am currently wearing a pair of amplifiers I got on Amazon for $200 and they've lasted almost two years. AirPods Pro + this software should make it a lot easier for me to follow conversations and filter out high frequency noise (like you get when there's nothing but bare walls and ceilings and floor space). I mostly ignore the Apple-haters.


> 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.


Seems like a rage bait post but: how do you update the firmware without an apple device?


At an Apple Store[1].

[1]: https://support.apple.com/en-gb/106340


You need to do more than update the firmware. You need to upload your personal audiogram into the device.


As mentioned elsewhere you can't tweak its setting outside Apple's walled garden.

Better wait for more open competition to catch up unless you are already deep in their ecosystem and not intending to move.


Do you need your own iphone, or can you use a friend's iphone to fix the settings once?


It probably should be your own device; the audiogram ends up in the iPhone's health app. It can probably be done by someone else if they don't care and don't need to apply a different audiogram for themselves.


That is some nice integration. Having one’s own up to date audiogram stored in a health record and available to doctors and devices.


I was able to use my partner's iPhone to configure some settings.

It's frustrating that the settings can't be changed on Android, and macOS seems to have a subset of settings compared to iOS.


Can you use them as hearing aids without an iPhone?


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.


The new hearing aid features are gatekept behind an iOS app. You can't tweak the hearing aid settings without an Apple device.


The Samsung Galaxy Buds only have 360 audio and the better audio codec if you use a Samsung Galaxy smartphone. Doesn't even work on other Android devices let alone iOS. And as far as I know you can't tweak the hearing aid features of Galaxy Buds on any device.


If you can't actually tweak audiogram settings, they're not really hearing aids. In fact, Samsung doesn't sell them as hearing aids and from what I can tell never use the term "hearing aid" in any of the marketing, branding, or feature listing of the devices.

They're not FDA approved as hearing aids, so they're not hearing aids.

Either way, pointing to another company being shitty isn't really a good justification of the first company being shitty.


Just trying to understand your argument: Samsung does it so that makes Apple ok? I hear a lot of people argue (when defending Samsung, Google Play, etc) that Apple does it so it's ok, but not usually the other way around. I guess it makes sense that it would devolve into the spiderman meme, but the real losers in that are everyone else that isn't making money from it.

Personally I thinks it's shitty when anybody does it.


+1 on this. I use them with my android phone, steamdeck, windows computer, TV. They work great!


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.


that sounds more like a you problem. i use mine pretty frequently as hearing aids, especially in noisy environments.


> 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.

This is GP's problem? What should GP do to solve this problem? (Seriously asking, even though this probably sounds sarcastic). Should GP tap them on the shoulder or try to wave them down or something to get their attention? What if they don't want to be bothered? What about the sibling comment ( https://news.ycombinator.com/item?id=41533796 ) about it being a feature not a bug? If GP were to tap that person or get their attention someway, it seems that it would be unwanted.


Sounds like a feature and not a bug.


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.


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?


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


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

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


Thanks, I stand corrected.


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.


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.


But a lot of people don’t wear Airpods because they look dorky and look like something is growing out of your ears. This is what I’m saying, coolness doesn’t trump looks even if pundits say “I love my Airpods”. A lot of people do not like wearing headphones for a similar reason.

If i see someone wearing AirPods or headphones my initial reaction is they don’t want to be talked to or interacted with. Even if that’s not true and they have passive throughput.


I think that's more of a negative though. I always remove Airpods/earbuds if I'm in a situation when I may be interacting with others because otherwise I come across as rude, uninterested or unsocial, like having a "do not disturb" sign on.

Whereas I can see myself wearing a hearing aid (and probably need one) because people will recognize that I'm not trying to shut them out but I may have difficulty hearing.


Having earpods in while talking is an entirely new and worse social stigma than wearing hearing aids.

> you have a type of (casual) plausible deniability about why you're wearing them

"He doesnt even give enough of a shit about talking to me to remove his earbuds" isn't a good thing.

> They won't draw people's attention in the way that hearing aids (because they're different/unique) do.

They won't draw peoples attention in the same way because normal humans only begrudgingly interact with people wearing earbuds in conversations and only for a bare minimum.

I really can't stand this website sometimes. But at least you all got the AirPods™ branding right instead of just calling them earbuds.


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.


> 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.


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.


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?


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


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/


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


> 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?


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.


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


"Breakthrough" devices have to be devices which show a significant improvement to quality of life over existing treatments for "life threatening or irreversably debilitating" conditions, using breakthrough technology in a space where an existing device doesn't exist yet.

So it's less "we made a better pacemaker that uses ChatGPT" and more "this new ventilator can keep people alive even when their lungs are filling with fluid and they're going to die otherwise".


Really what happens is your application is given a higher priority level and dedicated reviewers. They're still going through the full review process, its just they're focusing on your submission.


Why? I do this sort of technique all the time at work to keep things moving. “I’m gonna ship this code on Friday and if I don’t hear anything before then I’ll assume no news is good news and do it!”.

There should always be an upper bound to how long somebody can block your progress. If something was so important that they want to block me, why didn’t they tell me before Friday? That was ample time to raise objections.

It’s just an SLA and holds people accountable.


> 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.


Sony already has OTC hearing aids on the market


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?


It seems like it's software to conduct a hearing evaluation to tune the airpods.

There's actually loads of OTC hearing aids on the market already although most seem fairly pricey.


It does some tuning based on a hearing test.


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.


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.


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.


> 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.


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.


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.


> 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.


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…)


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


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.


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.


How would a phone lockscreen indicator work? If someone walks up to you in a store with AirPods in, how are you seeing the indicator on the phone in their pocket? The situations where I can look at the lock screen of the phone of the person I'm speaking to are pretty limited.


Good point.

But LEDs would probably take too much battery power.

Not sure if the new color eInk would be useful.


Quick maths on the LED thing:

According to Wikipedia, AirPods Pro Gen 1 have 0.16 Wh of battery per AirPod (There's no data on Gen 2). With 5 hours listening time, that gives a power draw of 0.032 watts or 32 milliwatts. This answer https://electronics.stackexchange.com/a/640179 (I know, not the best source, but I'm just guesstimating anyways) gives a current of 1 mA at 5 V for an indicator LED. So the LED would need 5 mW. That increases power draw to 37 milliwatts and gives a new battery life of about 4 hours and 20 minutes. If using 5 mA, which the answer calls "blindingly bright for some clear LEDs, even from 10 feet away", the LED would draw 25 mW and reduce listening time to only 2 hours and 50 minutes. The answer is also about non-diffuse LEDs so the indicator would only be visible from a narrow angle, but since it would point forward, that's probably fine. Making it diffuse would reduce perceived brightness again.

Brightness could be fine indoors, but outside with direct sun is probably harder. Since you would have the LED on both AirPods, you could probably expect that at least one of them is in the shadow at any time though.


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.


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.


> 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.

You can still do a slight but friendly wave or nod. That would open the door for them to verbalise a “hi” or “good morning” and strike up a conversation. And it only needs to happen once for you to know.

Also, anecdotally, over a decade ago I used to wear non-white headphones or earphones in public frequently. Yet I was still accosted by strangers all the time, asking for directions or other information, when there were plenty of other people around with nothing in their ears. Still I tried to always be helpful and friendly, even if it could get tiresome: I was always listening to a book, not music, so interruptions were meaningful distractions.


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.


> 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.


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.


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


It's helpful, sure, but it's not the same thing.


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.


> 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).


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.


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.


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.


Condescending or not, saying "Now Apple just brought that price down to ~$250." is grossly overstating it.

But Apple always gets a pass, so...


"You can now buy hearing aids (as defined by the FDA) for $250" is an objectively true statement, so unless you think the FDA is filled with Apple fanboys I have no idea what "pass" you think Apple is getting.


To be fair, it is a little misleading. "You can buy hearing aids with considerably lower functionality for $250" is more accurate. But there's absolutely nothing wrong with that. There's a LOT of people who can't afford high quality hearing aids (and the doctor assisted tuning) costing thousands of dollars. And if this getting _something_ into their hands, it has the potential to be a very big win.

Also, since it is an alternative (even if lower functionality), it has the potential to bring down the cost of other options, because that's a common outcome from competition.


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


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?


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


Until wearing Airpods during conversation is normalized, this will be a problem. Why?

I tried conversing with somebody recently, and they were completely ignoring me. Then I saw the Airpods. Of course. They have music or something else going on.

For now, Airpods = "I am listening to something other than you right now." So yes, if somebody were wearing Airpods as a hearing device, I'd probably not talk to them because of that expectation.


> you're better off with them not in your life.

Offer not valid if it's your in-laws, nurse, kid's teacher, your teacher, civil servant who you need to convince, and overall anyone in a position of authority or otherwise capable of gatekeeping you. You can't always just opt out of dealing with people without consequence.


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


> We've homeschooled before, and it would be trivial to pull them (and a small portion of the district's funding with them) and do it again, and they know it.

You'd homeschool your kids because their teachers find it odd that you're wearing AirPods during a conversation? To each his own, I guess.

> Nurse? If they commit intentional malpractice, my attorney is ready to go.

In what world does subtly judging you for wearing AirPods during a conversation qualify as malpractice?


Being summarily pulled out of school isn't without consequence, especially to your kid!


I have bad news for you. Everyone judges people for these sorts of fashion choices (though perhaps not that specific one). Though some will do so more harshly than others, of course, and some enlightened folks will manage never, or rarely, to manifest or act on these judgments. And you'll absolutely never convince me that you don't make the same kinds of snap judgments about people based on things like what they're wearing.

It's healthy not to care too much about the fashion judgments of others, as you're suggesting. Is I agree with your first line. But you're otherwise bringing too black-and-white an approach to what is, in my view, an unavoidable part of social life.

Edit:

> Disregard, I forgot that HN has been infested with normies with poor reading comprehension.

OK. You object strenuously to anyone making any sort of judgment about a person wearing AirPods, all of whom should be completely cut out of your life, but are happy to throw out baseless insults at people who disagree with you in the mildest of terms on the internet. Got it.


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?


No, that's my experience as well


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


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.


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.


[flagged]


If iPhone owners can improve their hearing for $250, that’s a win for a large number of people. Sure, it doesn’t solve the problem for everyone, but neither does a $2000 pair of hearing aids.


Great. But it doesn’t mean Apple Airpod hearing aids are only $250.


Many people already have an iPhone, so that's a sunk cost.

Even not looking at the used market, a new iPhone SE is $430 (and likely to be substantially updated soon)


So we agree, not just $250.


Good thing most people carry those around for other purposes. That $1000 tiny computer in their pocket just swallowed yet another thing that was once discrete.


By definition and per every observable statistic, most people do not carry iPhones around.


Except it’s a separate device, so it didn’t swallow it. It’s just an abstraction on an already existing thing. Digital wallets is something that swallowed wallets, for example.


I don't carry around any Apple device, neither do most of people (including various IT folks in various banks) I know. You can't tweak its settings without one.


Fair. I was more referring to smart phones in general. The argument was “you need a $1000 device for this $200 thing”. But if other manufacturers come out with similar hearing aids, I’d expect most to work with either iOS or android and would require one of the two $1000 devices to work.


Used iPhone 7 for $51, iPhone 11 for $154, 12 for $226, 13 for $262...

https://swappa.com/buy/iphones

I mean, I'm all-Android all-the-way, but I think the used market is viable for this.


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.


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.


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.


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


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".


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.


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.


Nobody is telling anyone what kind of headphones they're allowed to wear. They do, however, tell _companies_ that they can't claim their product has medical benefits without proving (to some kind of standard) that the product is safe to use, and does what it claims to do. This system was put in place after businesses spent decades scamming the public with "medicine" that didn't do what it claimed to do and, in many cases, was also poisonous.


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


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.


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.


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


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.


> 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.


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.


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


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.


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


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.


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.


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


Does your nations healthcare system not cover that?


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.


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.


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.


Related Apple study from May:

Apple Hearing Study shares preliminary insights on tinnitus

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


Related:

AirPods Pro 2 adds 'clinical grade' hearing aid feature

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


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.


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


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.


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.


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


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.


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.


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


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.


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.


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.


Playing video games when you’re supposed to be piloting a half ton death trap isn’t the same as teenagers lying to authority.


The problem isn't really the lying though is it. It's the fact that they're not being educated if they aren't paying attention.


Worse. It's probably a bit over 2 tons.


Just require a doctor’s note one time?


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.


They need to legalize glasses.


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.


> 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...


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.


> 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?


The NIH?


That's purely a research organization, with no existing regulatory role.


Sure. But it would work if you're just looking at names, as it seemed OP was doing.


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...


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.


Eh, we need better regulation. Regulation proponents should distinguish between bullshit hoops that only the big boys can jump through vs targeted regulations that prevent this kind of thing from happening.


You're right. Regulations are critically important, but they're just tools and they can be used for evil or good depending on what they're doing and whose interests they serve.


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.


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


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


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.


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".


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


Will this support CROS?


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


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


It's much more justifiable now for sure.


Do glasses next


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?


> 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.


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.


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)?


The opposite, they're going to be ridiculously stubborn and require all of these high tech gadgets to be "less". The I in FDA stands for innovation.


Especially here. Expecting good faith in hearing aid regulation - from the FDA?! Remember, Congress authorized OTC hearing aids back in the Trump administration, in August 2017 (https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...). For perspective, GPT-1 didn't even exist yet. But the FDA slow-walked it so long that the Biden administration had to intervene (and is now trying to claim credit for it all, of course), which is part of why the OTC hearing aid explosion has taken so long, been so tentative and slow, and you're only seeing it really taking off the past 2 years or so.


If they hadn't intervened, would it have happened?


Hard to say. They could have fiddled with the rules to make it really unappetizing and kill the market, or slowwalk every last thing (how many vaping products have been approved?). It could have taken many more years and been a lot worse, which is a tragedy for the many, many old people who seriously need it.

(Like my grandfather. I also appreciate it, because while OTC hearing aids are - for now - too weak for my hearing loss, it's providing much more competition for the prescription hearing aid oligopoly and I'm benefiting indirectly. The jump between my hearing aids from 2017 to the pair I bought this year is the largest jump in quality I've heard in my hearing aids in like 20+ years.)


> "The I in FDA stands for innovation."

LOL. I hadn't seen this before. Quote? Or did you coin it?


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”


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


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.


Everything in there seems fine to me, not sure what you’re talking about


“Do your own research “


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


They aren't doing that currently though, right? The only thing I remember is the NeuralHash thing which was delayed and then never came.


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.


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




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