[1]: https://web.archive.org/web/20221028042729/https:/www.fda.go...
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 device”?
How much more onerous is the normal pathway?
On the other hand, when I see someone wearing AirPods I assume they are listening to something else or are otherwise trying to shut the world out. If I were wearing them to be able to engage more, I think I would just be sending the opposite message.
Even if you use them everyday and assume a shelf life of 1.5yrs (which is roughly mine and others' experience with AirPods), you would be replacing your Airpods for 12 years before the cost caught up with a single pair of hearing aids.
Even if you think Airpods are not on the same bar as regular hearing aids, this will certainly help depress market prices. Every manufacturer will probably start releasing sub $1000 hearing aids just to not get destroyed by Apple.
I don’t personally need hearing aids (yet) but I know people that do, and dear god are they expensive pieces of equipment.
Even if the AirPods aren’t perfect for everyone (not everyone wants in-ear devices) a big name like this getting in at that price-point might shake up the market.
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.
What a lot of people don’t realize is that hearing loss is a loss of ability to hear certain frequencies. You can’t simply turn up the volume although that does help to some degree. So what happens is you see a doctor who determines what frequency loss you have and the hearing aid when it picks up that frequency shifts it to another frequency that you can hear. So I do see why up until now ya it was regulated. We don’t want some company selling a device that simply cranks the volume and potentially causes more damage. But with today’s technology we are more then ready for this to be a reality. With an app we can offer hearing tests and determine what areas the client needs improved. This I feel will be a game changer for some.
The only thing I wonder about is how well do air pods hold up to waxy ears? With regular hearing aids they need cleaning and often have things like a wax trap which is a tiny plug that catches wax and can be swapped out easily.
Apple Hearing Study shares preliminary insights on tinnitus
AirPods Pro 2 adds 'clinical grade' hearing aid feature
I'll take any opportunities for assistive technology to be a cheaper option.
Even if you get to explain ‘oh my AirPods are functioning as a hearing aide’ you likely won’t be able to explain that to other people noticing the conversation and thinking to themselves ‘oh that’s douchey, not taking our your AirPods when talking to someone’.
I just really wonder if this will be able to make wearing AirPods while talking to other people socially acceptable because the current presumption is likely that they are not behaving nicely.
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.
Is it just me or does this article sound (pun intended) a bit tone-deaf? All this talk of them "authorizing", when earphones with built-in mics, transparency modes, and adjustable equalisers have existed for years before this, available for everyone to purchase, and can function as a "hearing aid".
If that happens, will people be able to use best medical device without being subject to the various liberties that tech companies take with users -- violating privacy, and exercising leverage to other purposes?
We've become acclimated to expect violation from the "tech" industry, but what about the medical field?
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.