[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.