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How is Apple violating people’s privacy? They have done a far better job than other companies from what I'm have seen.
I mean they are the best of the big tech companies, by a country mile, but that's not really saying a lot. If you want the full details, go read the privacy policy with a skeptic's perspective.
It's kinda crazy hearing Apple mention during their event that they expect FDA approval "very soon", and it actually happening 3 days later. I would have thought that governments can't promise timelines to anyone, especially something like FDA approval.
¹ Maybe it is. I’m not an expert on the USA’s health and government policies.
It's kinda crazy hearing Apple mention during their event that they expect FDA approval "very soon", and it actually happening 3 days later. I would have thought that governments can't promise timelines to anyone, especially something like FDA approval.
The event was prerecorded. It doesn’t seem farfetched¹ to think they already had the approval but legally couldn’t say it without the FDA making it officially public. But if the FDA had announced it before the event, it would’ve stolen the surprise. Not only of the feature, but that new AirPods would be announced. Apple would’ve hated that so they may have asked for the announcement to be delayed. ¹ Maybe it is. I’m…
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This problem could be solved easily. One could put some kind of tiny sticker on their AirPods - it would take sometime for it to become mainstream - like an orange color ring - indicating the user is using the AirPods as hearing aids. (This is a people problem…)
The answer is handicap hang tags, like those used in cars, but worn as earrings.
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Is it? I think that thanks to transparency mode and conversation detection people are keeping them in “full time”. In noisy environments I just keep them on without music and they help me hear people talk.
It really depends on the awareness of product features and evolution of the actively used devices. My lived experience is that those with white things in their ears can’t hear you or can barely hear you and have to pull one out to have a conversation. Those that know you probably understand how you use them. If I were to see you walking in my neighborhood with your AirPods I would probably not bother saying hi unless…
You can still do a slight but friendly wave or nod. That would open the door for them to verbalise a “hi” or “good morning” and strike up a conversation. And it only needs to happen once for you to know.
Also, anecdotally, over a decade ago I used to wear non-white headphones or earphones in public frequently. Yet I was still accosted by strangers all the time, asking for directions or other information, when there were plenty of other people around with nothing in their ears. Still I tried to always be helpful and friendly, even if it could get tiresome: I was always listening to a book, not music, so interruptions were meaningful distractions.
I have been wearing hearing aids for a few years now (Phonak). I've also used the AirPods Pro with the accessibility audiogram feature (basically making them hearing aids), which is really good and has also been around for a few years. I'm very glad, that Apple has made this official and even gotten FDA approval.
When I started to loose my hearing a decade ago, for a long time I refused to wear hearing aids, probably due to the perceived stigma. Even though it made life harder and harder -- imagine work meetings with a mumbling boss or me accusing my family to intentionally whisper -- it took years to change my mind. In hindsight I should have gotten hearing aids years sooner.
My 'real' hearing aids are nothing short of a technological marvel. They are tiny and run for a few days on zinc-air batteries (312/Costco but made by Varta), while providing all-day BT streaming. Btw, funny how most hearing aid brands come from Denmark. In contrast, the AirPods run out after a few hours and are also destined to become landfill due to their built in battery.
We got from the local health service some basic hearing aids that cost around 1000 euro but we are contemplating buying some high-end Phonak devices that are around 5000 euro as recommended by some experts.
In comparison to this the AirPods (280 euro?) are almost free.
Hearing aids are neither food nor drugs. Same goes for glasses and contact lenses, and CPAP machines. These should never have required approval or prescriptions in the first place. So many people are kept from getting what they need by these arbitrary restrictions.
None of them are either food or drugs, and so many people are prevented from getting what they need thanks to these arbitrary restrictions!
Hmmm, on second thought, I’m not sure allowing ali express implants to be marketed the same as rigourously tested implants, with clear evidence of safety and efficacy, is such a great idea.
Hearing aids are neither food nor drugs. Same goes for glasses and contact lenses, and CPAP machines. These should never have required approval or prescriptions in the first place. So many people are kept from getting what they need by these arbitrary restrictions.
> This application was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device. Does that mean that if Android/Bose/Sony/etc were to develop a comparable solution, they would not be able to use the “De Novo premarket review pathway” because AirPods Pro is now a “prior legally marketed…
Med device startup cofounder here. In terms of difficulty in your path to market, from hardest to easiest (and ignoring some less common pathways): 1. Pre Market Approval: you're addressing a completely unproven technology in a novel and or dangerous space. Usually Class II and above. 2. De Novo: you're adding a new technology to a somewhat well known space. Usually Class II+ 3. 510(k): There's already something in t…