[capitainenemo]

Fair enough - that certainly explains the situation in the US, where they were allowed. It just seemed surprising to me that every country in the world has medical device certification for anything that calls itself a hearing aid, forcing apple to restrict it to just 2 or 3 countries. You'd think in some it would be linked to what's covered by state medical care, or sold with a particular emblem or... Actually, couldn't find the rules for india at all, but probably 'cause I was searching in english.

But maybe it was just easier for them to block everyone by default pending lawyer review of each country, one at a time.

... I wonder also why they couldn't sell it as a non medical "hearing enhancement" with a disclaimer that it had no medical certification in your country, but perhaps that would also invite lawsuits.

[observationist]

In the US, and nearly everywhere else this type of hearing assist tech is sold, the Hearing Aid cartel is responsible for lobbying and influencing and bribing officials to maintain a stranglehold on their cash cow. Retired, elderly people with extra cash get screwed over with markup rates of 40,000% or more (yes, that's the right number of zeros.) Hearing aid technology, along with DSPs and specialized high quality, miniaturized sound technology, has received full benefits of economies of scale. These devices cost $5 or less per unit mass produced, but because of the "medical device" classification and the overreach of the FDA, people who need these devices cannot afford them.

Insurance won't cover it. Until you're completely disabled or retired, you're stuck paying for hearing aids out of pocket. $2500 or more, apiece.

The patent situation around hearing aid features in airpods and other headsets is the responsibility of the hearing cartel - the 5 largest hearing aid companies that collude to maintain this status quo, prevent meaningful competition, innovation, or alleviation of the plight of the hearing disabled.

These people are preying on some of the most vulnerable people worldwide and the US government is complicit in it. There is no valid, rational basis in fact for the medical device classification or the rationalizations used to justify it. People "might" damage their hearing? Liability disclaimers work for literally every other possible product. Maybe, just maybe, people are capable of adjusting an equalizer on their own, and those who can't or don't want to, can go to an audiologist. Dialing in hearing aids isn't particularly difficult, and the dangers are obvious and easy to avoid.

This is a world where people go to concerts and make other decisions injurious to their hearing health, and most of the time, the bands aren't required to disclaim liability or even notify of the potential danger, but if you want to correct your hearing, you're shit outta luck unless you pay through the nose.

[mschuster91]

> There is no valid, rational basis in fact for the medical device classification or the rationalizations used to justify it.

I wouldn't be that certain. The situation with stuff like fakes and knock-offs is already bad enough as it is - at least for anything classified as "medical devices", be it condoms or hearing aids, the threat of the law is keeping bad actors reasonably at bay. You go and buy a hearing aid, you can at least rely on the thing and its delivery chain having been through multiple very experienced hands checking everything on it.

Additionally, it's about stability. People's lives can matter with hearing aids - of course, users are responsible for keeping their batteries charged, but at least a hearing aid should be reasonably well enough made to not randomly lock up and leave someone without adequate hearing in a situation where they're operating some machinery.

I agree that the price margins on medical products are ridiculous and even the additional certification and paperwork doesn't warrant even a tenth of the price tag. But dismantling the regulatory framework around medical stuff comes with serious side issues.

[observationist]

Fake hearing aids, or dangerous ones, would get rooted out quick. The function is the test of quality. There are laws that hold companies liable for material and actual harms caused by their products. There's no need for the FDA to be standing in the middle of this industry - there is no value add. Zero. Zip. Zilch. Nada. I have looked. I have tried to steelman its presence in the regulation of hearing devices for more than a decade. Nothing holds up to scrutiny. The closest you get to a plausibly legitimate reason for regulation is when it comes to children, but even then, it's flimsy as hell.

There are zero legitimate reasons among the swathes of paperwork put forth by this cartel. They are irredeemably corrupt and morally bankrupt exploiters of the elderly and disabled, and the method by which they accomplished that was regulatory capture via the FDA medical device classification. Given that as a platform, they perform a series of manipulative maneuvers and establish a bureaucratic framework, self sustaining, given the color and flavor of legitimacy with the government's stamp of authenticity.

They've been presenting Audiology programs as a legitimate medical field, when these are effectively sound system equalizer knob twiddlers in doctor costumes. Yes, there are legitimate medical professionals who go into ENT and such, but a large majority of audiologists are essentially salespeople for one of the 5 HA cartel members, whether they realize it or not.

They're getting away with a gross and vicious exploitation of some of the most vulnerable people among us; so no, there is no valid, rational basis for the medical device categorization and regulation by the FDA of hearing aids. The disability can absolutely destroy someone's quality of life, and this is an insidious and evil market. But hey, it's Starkey and Oticon, they do good things and charity for kids, right?

[mschuster91]

> Fake hearing aids, or dangerous ones, would get rooted out quick.

Ah and here I think we disagree the most - because in everything else you say, I think we are in agreement.

IMHO, the only thing keeping Alibaba and their dropshipper "friends" on Amazon and eBay scamming off elderly people with worthless junk is the legal protection. The scam problem is massive enough that it's gotten really annoying to shop on Amazon, and I say that as a "digital native" - remove the paperwork and you'll get the digital equivalent of ambulance chaser lawyers in less than a month. Scam "hearing aids" would not get rooted out - they'd infest the world.

[alistairSH]

I don’t disagree, but it’s not like the cartel products are necessarily any good. My wife and father both wear HAs and both have had all sorts of issues, predominantly set-up tunings, absolute shit UX in the apps, and so-so hardware quality. It would be one thing if the devices were a joy to use, but they aren’t even close.

[miki123211]

Is the certification required for things labeled as hearing aids, or for things that perform hearing-aid-like functions?

Could you sell a "heering eyd" or an "in-ear sound amplifier that lets ornithology enthusiasts hear faraway birds better", which incidentally functions as a (non-insurance-covered) hearing aid, at least for those who can Reddit?

[alistairSH]

In the US, it's a bit of a mix.

There are ~3 categories of hearing devices in the US... 1. Prescription hearing aids - go to audiologist, pay $$$$$$ for devices 2. OTC hearing aids - AirPod Pro etc - less money 3. PSAP - Personal Sound Amplification Product

In theory, from top to bottom, you loose features and complexity. But, I haven't been able to find a good summary of technical requirements for each tier of device, just vague language.

Very generally, PSAP is a "dumb" amplifier - all frequencies get amplified - often used by hunters and bird watchers to hear animals.

What I can't figure out is the difference in requirements between OTC and prescpription - is there some feature that Apple CANNOT deliver OTC that a prescription device may?

[observationist]

The only real constraint now is volume - there's still a hard db limit of 111 db because of the technicalities of medical device categorization. Software and hardware patents are entwined with the medical device nonsense and the hearing cartel is incredibly litigious. They make FAANG look like playground bullies if they feel their territory is being infringed on, and have an absurd breadth and depth of patents covering every possible iteration and permutation of audio technology they can possibly get away with.

[NavinF]

That would definitely invite lawsuits. Do you think competitors who sell hearing aids for $2500 today would allow Apple to sell their $200 device without medical device certification?

[observationist]

Medical Device certification is regulatory capture. There's no good reason for it except to exploit a source of cash. Hearing Aid companies are among the most evil on the planet.

[kristofferR]

No good reasons for medical device certification?

That's absurd, be glad that machines like that are tested to work as described. The certification process is often flawed and should be improved, but letting random people build medical devices for sale in their garages and sell them without certification is way more flawed than the current solution.

[observationist]

Hearing aids should not be qualified as medical devices. There are devices that should be. You are capable of following sensible instruction and operating an audio equalizer. Audiologists are capable of existing in a world where interaction with them is voluntary and it's not going to lead to terrible mishaps. Hearing Aids can be dangerous, especially at the severe to profound levels of amplification, but that can be trivially handled in software and manuals.

[kristofferR]

> There are devices that should be.

Ah, I thought you were arguing for the opposite.

[rodgerd]

> It just seemed surprising to me that every country in the world has medical device certification for anything that calls itself a hearing aid,

"Trusting the FDA" instead of having your own evaluation seems a lot less foolish now that Americans have decided to put a guy in charge of the FDA who wants to get rid of vaccines.