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.
Interesting. Do you think the FDA will be more proactive and sharper, than regulatory authorities that got confused in the past by tech companies (Airbnb, Uber, RealPage (YieldStar), and others)?
Especially here. Expecting good faith in hearing aid regulation - from the FDA?! Remember, Congress authorized OTC hearing aids back in the Trump administration, in August 2017 (https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...). For perspective, GPT-1 didn't even exist yet. But the FDA slow-walked it so long that the Biden administration had to intervene (and is now trying to claim credit for it all, of course), which is part of why the OTC hearing aid explosion has taken so long, been so tentative and slow, and you're only seeing it really taking off the past 2 years or so.
Hard to say. They could have fiddled with the rules to make it really unappetizing and kill the market, or slowwalk every last thing (how many vaping products have been approved?). It could have taken many more years and been a lot worse, which is a tragedy for the many, many old people who seriously need it.
(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.)
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”
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.