[kristofferR]

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]

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]

> There are devices that should be.

Ah, I thought you were arguing for the opposite.