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Completely ignorant question, but what does it come down to? What if I released this feature but didn't call it "hearing aid", nor positioned it as medical devi
by nixosbestos 2y ago
Completely ignorant question, but what does it come down to? What if I released this feature but didn't call it "hearing aid", nor positioned it as medical device?
Is a phone with optical zoom, a "vision-enhancing device" and regulated like eye wear?
- sneak 2y agoDoes it look like a duck? Does it quack like duck? In-ear devices with speaker and mic that look like hearing aids that perform hearing aid function for those with hearing loss? Hearing aids. Phones, that look nothing like glasses or contacts, and don't serve the same purpose? Obviously not. Don't be silly. Judges aren't.
- nixosbestos 2y agoI really wasn't trying to be silly. I feel like other medical things in the US are regulated differently based purely on how they're marketed. How about an Apple Vision Pro with optical zoom on the exterior cameras?
- kube-system 2y ago> I feel like other medical things in the US are regulated differently based purely on how they're marketed. They aren't. Different classes of medical or medical-adjacent products in the US have to be careful how they market so they aren't making claims that they are not allowed to make, but the absence of those claims alone doesn't make a regulated device unregulated.
- luqtas 2y agowe could all use some civil disobedience for the good of our kind; “The only obligation which I have a right to assume is to do at any time what I think right.”
- userbinator 2y agoIn-ear devices with speaker and mic that look like hearing aids that perform hearing aid function for those with hearing loss? Hearing aids. By that definition every TWS with transparency mode and parametric EQ is a hearing aid.
- NightMKoder 2y agoPresumably depends on the country and the laws. Keep in mind that Apple considers this a new interesting use case - not a killer feature for AirPods. They wouldn’t risk AirPod sales with a gray interpretation of the law.
- K0balt 2y agoRegulated devices have very specific definitions like is represented as O, or does x or z and a and b, or x and b. Things like that. The definition typically hinges on very specific parameters and ALSO what it is called. That way no one can sell an inert plug as a “hearing aid”, and no one can sell a hearing aids as “conversation enhancing devices “ to evade certification requirements if they meet the bar feature-wise to be a hearing aid.
- bongodongobob 2y agoA malfunctioning hearing aid/earbud can potentially cause permanent hearing damage. Unless it explodes, a misbehaving phone can't damage your vision.
- NavinF 2y agoNon sequitur. You could say that about any high quality set of headphones since they're capable of much higher power output than hearing aids.
- bongodongobob 2y agoI'm not saying it makes sense, but that's the idea.
- Retr0id 2y agoIt's still a non-sequitur because regular earphones are not subject to such regulations.
- kube-system 2y agoNo, medical devices are regulated because society demands a certain degree of certainty from those who claim to treat medical issues. Most societies don't want it to be legal to sell snake oil to vulnerable people suffering from a health issue. There are many dangerous unregulated things that can destroy your hearing or vision. But they don't claim to protect them.
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