4 ms·

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 med

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.

NavinF 2y ago
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 2y ago
  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 2y ago
    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 2y ago
      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 2y ago
        > There are devices that should be. Ah, I thought you were arguing for the opposite.
observationist 2y ago
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 2y ago
  > 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.
rodgerd 2y ago
> 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.

NavinF 2y ago

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 2y ago
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 2y ago
  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 2y ago
    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 2y ago
      > There are devices that should be. Ah, I thought you were arguing for the opposite.

observationist 2y ago

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 2y ago
> 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.

rodgerd 2y ago

> 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.