[Karunamon]

I don't think I can accept that, especially with regard to items like hearing aids. There's a fundamental difference between things like implants and surgical tools and relatively simple devices like CPAP machines and hearing aids; things where the harm of a failure scenario is extremely limited.

This is a government at the end of the day. It would be imprudent to not consider the effects of regulatory capture, cronyism, and so forth.

[hprotagonist]

do you have experience in the discipline? It doesn’t sound like you do.

I have some experience, and i can think of about a half dozen ways cpap machines and hearing aids could cause serious harm as a result of design flaws or lack of QA that would be de rigeur if not for regulatory pressure.

[novok]

So can headphones and earbuds, and society seems to do just fine with the normal level of consumer electronics regulation. Is there really value in the medical device regulations for hearing aids beyond that?

[bsder]

> So can headphones and earbuds, and society seems to do just fine with the normal level of consumer electronics regulation.

Do we?

I was under the impression that there has been an uptick in hearing damage in young people due to them increasing the earbud volume above background noise levels (not so much of a problem in earphones that cover the ears as they block out outside noise).

That's a medical problem that will have significant effects downstream over time and the consumer regulation really isn't working.

[novok]

Kids listening to music too loud has been a problem since the invention of the speaker.

[Karunamon]

What are some of those ways that are not addressed by regular old (non-medical-specific) electronics/safety regulation?

Most of the ways I can think of a CPAP failing would be extremely obvious with equally obvious and relatively low-impact effects (I get a crappy night's sleep or wake up in the middle of the night).

[aenis]

Recent case involving very popular Philips Respironics machines: the foam used for internal insulation was degrading and getting into the stream of air, landing those particles in patients lungs. Huge recall, etc. The kind of problem that testing imposed by regulators can detect.

Incorrect use of CPAP can lead to development of central apnea. (Even APAP machines can be programmed to keep the pressure too high which is long term unhealthy).

With that, I am all for liberalization of the laws. My GP did not prescribe me a CPAP machine despite obvious signs of apnea. "Lose some weight instead" (that despite me having apnea even when I had a BMI of 21).

I never felt as much of a positive difference on my life as when I started using the machine and had my first good night of sleep in decades.

I wish my govt would let me buy an insulin measurement device, but nope, those too are regulated and not available for the general public.

[roywiggins]

there's an ongoing CPAP recall, so there's at least one way they can be dangerous

https://www.fda.gov/medical-devices/safety-communications/ce...