Is it possible to spend FSA/HSA funds on medically-necessary Apple products/services?
FDA Authorizes First Over-the-Counter Hearing Aid Software
151–160 of 258 posts
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#152cue teenagers with "hearing problems" so they must wear the pods during classes in 3 .. 2 ..
What's your actual complaint? Is it that teenagers sometimes have hearing issues? That's definitely true; many people are born Deaf or with hearing impairments. Some people get injured. Is it that teenagers might fake having hearing issues in order to wear pods? Either they will be paying attention in class or they won't; this will be obvious from their grades shortly.
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 going to assuage the problem or change the design issue. The danger is going to persist as a result of first-party design oversight.
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#153Is 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.
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#154Earlier quoted context omitted.
I don't carry around any Apple device, neither do most of people (including various IT folks in various banks) I know. You can't tweak its settings without one.
Fair. I was more referring to smart phones in general. The argument was “you need a $1000 device for this $200 thing”. But if other manufacturers come out with similar hearing aids, I’d expect most to work with either iOS or android and would require one of the two $1000 devices to work.
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Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#155It'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.
They definitely broadcast almost-definite timelines. You see regularly SpaceX prepping launch sites for FAA approval that comes less than a day before launch.
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#156Earlier quoted context omitted.
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…
As much as I am in favor of cutting red tape, medical devices should not be received in 30 days max.
Really what happens is your application is given a higher priority level and dedicated reviewers. They're still going through the full review process, its just they're focusing on your submission.
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#157Hearing 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.
> Hearing aids are neither food nor drugs. Do you really believe that the FDA needs to be renamed before it is reasonable for them to be the agency responsible for regulating medical devices? Is there a different agency you think would be a better fit?
The NIH?
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#158Earlier quoted context omitted.
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…
As much as I am in favor of cutting red tape, medical devices should not be received in 30 days max.
"Breakthrough" devices have to be devices which show a significant improvement to quality of life over existing treatments for "life threatening or irreversably debilitating" conditions, using breakthrough technology in a space where an existing device doesn't exist yet.
So it's less "we made a better pacemaker that uses ChatGPT" and more "this new ventilator can keep people alive even when their lungs are filling with fluid and they're going to die otherwise".
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#159With 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…
> In contrast, the AirPods run out after a few hours and are also destined to become landfill due to their built in battery. Also 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.
And will put some people off from talking to them. I don't talk to people with AirPods stuck in their ears until they take them out. Too many times I have tried to start a conversation or just say "Hello" but they are oblivious because they are on a call or have music or something else playing.
Re: FDA Authorizes First Over-the-Counter Hearing Aid Software
#160Is 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.
Makes sense. Would be great to see iPhones / Apple Watches covered for diabetic CGM users, too.