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FDA Authorizes First Over-the-Counter Hearing Aid Software

fda.gov

171–180 of 258 posts

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#171
post #52
post #46

They need to legalize glasses.

Zenni has historically been good about shipping without a prescription (not sure about present day), and you can buy contacts in Europe without a prescription and have them shipped, although the shipping is a bit higher.

> Zenni has historically been good about shipping without a prescription (not sure about present day)

They still are. As long as you don’t confuse them by including a few pairs of glasses with similar but slightly different values in the same order. Then they might demand an actual copy of a prescription. Don’t ask me how I know...

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#172
post #88

Earlier quoted context omitted.

It almost certainly depends how social norms develop. When Borg bluetooth earpieces first came out, they definitely carried a tech bro/fin bro/VC/etc. vibe that, at any moment, someone more important than you might want to get in touch with me. I do think Airpods today carry a certain I'm not necessarily giving you my full attention vibe whereas an obvious hearing aid is a medical prosthetic. To the degree that Airpo…

The one thing that I do believe Apple managed with the iPhone is the removal of this "tech bro" vibe from carrying a smartphone overall. So I guess it's not entirely out of the question that Apple will remove the stigma from wearing huge headsets 24h long...

I'm skeptical about big headsets but small earpieces seem headed towards becoming pretty normalized.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#173
post #66

With the AirPods now officially becoming hearing aids, it will hopefully reduce the stigma and attitude towards hearing aids and allow many more people to realize how bad their hearing actually is. 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…

Most people don’t wear hearing aids because they don’t like how it looks and think their hearing isn’t bad enough to warrant social stigma from it. I don’t see how Airpods solve that problem as they are very unsightly, no matter how much pundits say they love them. In fact you mentioning how they are like hearing aids has made me justify never wanting a pair.

If anything, if someone's wearing Airpods, I'm going to assume they can't hear anything I'm saying. "oh no he's wearing airpods" is a meme for a reason.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#174
post #133

Earlier quoted context omitted.

> will entrench the user in a walled garden ecosystem from a very specific giant tech company that isn't big on making their products compatible with other companies Are you suggesting AirPods aren't Bluetooth 5.3 and aren't compatible with Bluetooth audio sources? Or that it doesn't play AAC, MP3, and FLAC? The proprietary capabilities (such as instant smart switching between active devices) are all incremental, tak…

As mentioned elsewhere you can't tweak its setting outside Apple's walled garden. Better wait for more open competition to catch up unless you are already deep in their ecosystem and not intending to move.

Do you need your own iphone, or can you use a friend's iphone to fix the settings once?

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#175
post #22

I’m conflicted on use of AirPods as hearing aids. I use one hearing aid and have normal hearing in the other ear. I often listen to things on my phone over the one hearing aid. It would be nice to have stereo. For this reason, AirPods for both listening to stuff and hearing assistance would be great. On the other hand, when I see someone wearing AirPods I assume they are listening to something else or are otherwise t…

The fact that Airpods don’t look like hearing aids is a key advantage for some people. it’s especially important to some young people for whom there is a bit of a stigma around wearing them.

> it’s especially important to some young people for whom there is a bit of a stigma around wearing them.

Anyone who has a stigma about wearing hearing aids around people they are talking to but not a stigma about wearing earbuds while conversing needs to do some deep reflection.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#176

Earlier quoted context omitted.

The "actual complaint" is that Apple made hearing aids indistinguishable from an entertainment device. There's nothing wrong with taking initiative to a good thing, but you can absolutely pave the road to hell with good intentions. People would be rightfully outraged if Tesla drivers could ignore the road to play The Witcher 3 at 50mph on the freeway. Saying something like "either they will crash or they won't" isn't…

Playing video games when you’re supposed to be piloting a half ton death trap isn’t the same as teenagers lying to authority.

The problem isn't really the lying though is it. It's the fact that they're not being educated if they aren't paying attention.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#177
post #111

Earlier quoted context omitted.

Most people don’t wear hearing aids because they don’t like how it looks and think their hearing isn’t bad enough to warrant social stigma from it. I don’t see how Airpods solve that problem as they are very unsightly, no matter how much pundits say they love them. In fact you mentioning how they are like hearing aids has made me justify never wanting a pair.

The advantage of AirPods for social stigma is they aren't solely hearing aids, so you have a type of (casual) plausible deniability about why you're wearing them. They won't draw people's attention in the way that hearing aids (because they're different/unique) do.

Having earpods in while talking is an entirely new and worse social stigma than wearing hearing aids.

> you have a type of (casual) plausible deniability about why you're wearing them

"He doesnt even give enough of a shit about talking to me to remove his earbuds" isn't a good thing.

> They won't draw people's attention in the way that hearing aids (because they're different/unique) do.

They won't draw peoples attention in the same way because normal humans only begrudgingly interact with people wearing earbuds in conversations and only for a bare minimum.

I really can't stand this website sometimes. But at least you all got the AirPods™ branding right instead of just calling them earbuds.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#178
post #49

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.

So FCA regulation of CPAP machines just gets in the way of people getting what they need? How about Philips Respironics have to recall something like 15 million CPAP devices in 2021 because they contained foam liable to disintegrate and which the user would then inhale...

Yeah, if anything that showed we need more regulation and even more importantly a better justice system. They knew their devices were going to cause cancer and kill people, and they not only continued to sell their devices, but they went out of their way to try to hide the facts from the public so that they could continue to kill as many people as possible.

The people at Philips Respironics were/are literal serial killers. Their product has been linked to hundreds of deaths, but not one person spent even a single day in jail.

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#179

This is huge. Previously if you were hard of hearing, a pair of hearing aids could cost upwards of $2,000. Now Apple just brought that price down to ~$250. 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 ar…

My APPs are still going strong after 4 years. I use them daily, but not all day every day. Sure the battery life isn’t as good as before. But they’re still very usable. Am I just really lucky?

No, that's my experience as well

Re: FDA Authorizes First Over-the-Counter Hearing Aid Software

#180

Is it possible to spend FSA/HSA funds on medically-necessary Apple products/services?

That's a lingering question right now as the software was approved, but not specifically the hardware. I suspect it would be able to be covered, but as with any of those rules, it's kinda murky. I suspect if it is, we'll see some interesting advertising / marketing from 3rd party resellers.

It's a very good question and Apple may already have an answer.

One of the interesting things I learned in my time building medical devices is the role of insurance reimbursement in the product development process. Before introducing a new device, or a new (blood) test, one of the questions Marketing has to answer is how difficult it will be to get reimbursement from insurance in the US.

It sounds kind of icky, but it's a real concern.

If insurance companies won't reimburse for a particular test or use of a device, then the users are far less likely to buy it, or in the case of a test, the physician may have to warn the patient that their insurance isn't likely to pay for it. This will probably lead the manufacturer to decide that it's too risky to proceed with development.

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