8 ms·
The FDA has to certify the devices for use as hearing aids in the U.S Other countries have similar regulatory bodies the certify the use of a medical device.
by resonanttoe 2y ago
The FDA has to certify the devices for use as hearing aids in the U.S
Other countries have similar regulatory bodies the certify the use of a medical device.
Hearing aids (and things sold as it) are medical devices.
- Krasnol 2y agoSo what? You file the paperwork, pay for it and you get the certification. They decided that they won't do that in India. This is all. They even did that in Germany and the whole world know how much of a hassle it had to be...but Germany has a more significant market share and potential than India so....we all know it's just about the money.
- elzbardico 2y agoIt is all just about the money. Or India's government could have given a special waive. But Apple is a private company, private companies usually do things for money.
- Krasnol 2y agoOh yeah, please give the poor fruit company an SPECIAL waive so they don't have to be treated like all the peasant companies.
- capitainenemo 2y agoFair 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 agoThat 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 agoMedical 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 agoNo 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 agoHearing 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
- seany 2y agoWho cares? Call the feature something else, enable it everywhere and move on.
- 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?