FDA Authorizes First Over-the-Counter Hearing Aid Software
fda.gov
fda.gov
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.
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.
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...
- 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.
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.
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.
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.
I'm with him on this one. Commercials always end up being louder than the rest of the content, and are just.. annoying.
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.
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.
What's the downside of waiting?
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."
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.
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)
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.
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.
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.
And stigma is probably not the right word, it’s an internal acceptance issue.
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.
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.
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...
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
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...
But lithium is not at all rare so it's not going to be hard to make more batteries.
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.
- 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
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.
Better wait for more open competition to catch up unless you are already deep in their ecosystem and not intending to move.
It's frustrating that the settings can't be changed on Android, and macOS seems to have a subset of settings compared to iOS.
Automatic device switching doesn’t work but that doesn’t work on my Sony headphones either.
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.
Personally I thinks it's shitty when anybody does it.
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.
isn’t it good to have multiple options so consumers can pick what they value?
"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."
They also own the consumer of Sennheiser since a couple of years.
In fact you mentioning how they are like hearing aids has made me justify never wanting a pair.
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.
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.
> 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.
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.
I may be ready to drop $$ for my next pair..... do you work with an audiologist or did you do everything at Costco?
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://web.archive.org/web/20221028042729/https:/www.fda.go...
Perhaps government departments (and companies) taking advantage of archive.org storing their old docs should be appropriately supporting them?
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?
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.
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".
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.
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.
So what does "first OTC Hearing Aid Software" mean, given that both are hardware/software systems?
There's actually loads of OTC hearing aids on the market already although most seem fairly pricey.
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.
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.
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.
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.
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.
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.
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.
But LEDs would probably take too much battery power.
Not sure if the new color eInk would be useful.
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.
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.
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.
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.
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.
This will help more people hear. It might not be the best possible solution, but it surely beats not having it.
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).
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.
But Apple always gets a pass, so...
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.
But now that Apple entered the market, maybe they will come out with wireless headphones that are more suitable?
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.
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.
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?
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.
Or maybe you buy multiple instead of just one, so you can hotswap any time.
¹ Maybe it is. I’m not an expert on the USA’s health and government policies.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Apple Hearing Study shares preliminary insights on tinnitus
AirPods Pro 2 adds 'clinical grade' hearing aid feature
I suspect if it is, we'll see some interesting advertising / marketing from 3rd party resellers.
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.
I'll take any opportunities for assistive technology to be a cheaper option.
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.
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.
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 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...
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.
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?
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...
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.
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.
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".
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?
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.
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.
(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.)
LOL. I hadn't seen this before. Quote? Or did you coin it?
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”