FDA Authorizes First Over-the-Counter Hearing Aid Software

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.

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.

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)

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.

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

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

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.

What stigma? I think you're assuming something about society that doesn't actually exist. My father wears hearing aids. Nobody cares.

Maybe stop caring about imagined judgement that doesn't actually happen and live your life?

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.

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?

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?

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.

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.

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

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

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.

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.

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 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.

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.

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.

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.

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.

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".

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.

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

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

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.

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?

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...

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

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

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.

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.

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.

Sony already has OTC hearing aids on the market

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.

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.

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 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.

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.

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.

Probably not, but it's a reasonable risk to take. There is a 95% chance the IRS won't bother looking into your claim. If the IRS disputes your claim, your maximum exposure is 50% penalty plus a bit of interest, depending on how long it takes for them to catch up.

The statistical EV of your penalty is 0.05 * ((249 * 1.5 ) + ( 249 * 1.5 * 0.04 * 3 )) == $20.92, assuming the IRS takes 3 years to catch up with you (don't ask me how I know).

The IRS act like they're God, but they're just evil, horrible, soulless people pretending to be God. They still have rules to follow, and limited resources with which to do so.

Most people here on HN can afford $20.92.

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?

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

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?

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

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.

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

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.