You know for a fact Apple will get fda clearance? Why would they jump into a market they have no experience with? Hearing aid manufacturing is very different than cranking out mediocre earbuds. There's alot more to hearing aids then I think you realize. I have had hearing aids since 2019. Now sonos and a few others can pipe audio directly into their hearing aids if you have an iPhone.
You being very cynical, I’m not sure why?
If you read up on it, they are expecting clearance around November being they are Apple. They will not release the product until it is cleared. I’m not sure why your statement.
They did the same thing with their electrocardiogram app years back as they waited for FDA clearance
This goes far beyond, way far beyond many other of these electronic manufacturers who market products like this and seek no government evaluations.
I certainly don’t need a lesson in hearing aids. The FDA knows that as well too, and that is why they now allow over-the-counter hearing aids. Just do a search almost every major electronics manufacturer now makes them.
It’s called a hearing aid, it aids somebody to hear better. The FDA realizes not everybody has to spend thousands of dollars and people of all income levels can go out and spend a couple hundred dollars instead and actually be able to hear better.
Not exactly rocket science to have a speaker close to your ear.
I supplied you with a number of links in a previous post, did you not check them out?
This isn’t just Apple. It’s dozens of companies, however Apple being who they are takes things a step further and does things the right way and the FDA evaluate it. In the meantime, they’re not going to release it until the FDA does evaluate it and that is not a requirement, but it is something that Apple does.
To directly answer your question, you asked me how I know if they will get FDA clearance. Well, the company stated they will release the product when they get FDA clearance, which is expected around November. I doubt very much that Apple is going to make that statement for a product that they’re promoting what it will do if there was any doubt that the FDA would not approve it.. I don’t think approve are correct words though, I would tend to use the word evaluate for its advertised purpose.
Which would be similar to what they did with their electrocardiogram app on the Apple Watch, which by the way, greatly helped two cardio specialists, evaluate my condition and correct a heart rhythm issue before any heart damage took place.