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FDA Authorizes First Over-the-Counter Hearing Aid Software

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131–140 of 258 posts

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

#131

Earlier quoted context omitted.

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Good thing most people carry those around for other purposes. That $1000 tiny computer in their pocket just swallowed yet another thing that was once discrete.

Except it’s a separate device, so it didn’t swallow it. It’s just an abstraction on an already existing thing. Digital wallets is something that swallowed wallets, for example.

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

#133

Earlier quoted context omitted.

> 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.

> 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.

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

#134
post #128

Earlier quoted context omitted.

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Many people already have an iPhone, so that's a sunk cost. Even not looking at the used market, a new iPhone SE is $430 (and likely to be substantially updated soon)

So we agree, not just $250.

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

#135
I made a hearing aid app for the iPhone nearly 10 years ago. It was nearly impossible to get anybody to pay $10 or less for it.Also, there is/was a FDA exception for mobile apps, which kind of obviated the need for the grad school class i was taking at Stanford about getting medical devices FDA approved.

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

#136

Earlier quoted context omitted.

[flagged]

Good thing most people carry those around for other purposes. That $1000 tiny computer in their pocket just swallowed yet another thing that was once discrete.

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.

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

#137

Earlier quoted context omitted.

I don't think I've ever seen someone with a hearing aid and though anything negative of it, I get it people can be self-conscious, but for something like a hearing aid I think it's unjustified. On the other hand, I can't bring myself to keep earbuds (airpods or w/e) in my ears while talking to someone, regardless of if I can hear them properly, I just seems incredibly rude. My uneducated opinion, is that someone usin…

A buddy had a girlfriend who had reduced hearing. I noticed that people would raise their voice and really dumb down when speaking to her, like they were talking to a senile elderly. It'd happen before she'd said a word, so they clearly saw the hearing aid and assumed. She admitted she disliked wearing the hearing aids, due to such things. But the alternative was not following conversations, which meant she'd get exc…

Maybe it's because I have been wearing aids through all my life, but I see things this way. I don't care much what stigma wearing one carries, considering the alternative is being "that guy" who needs everything repeated twice, and that is a stigma I hate.

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

#138
post #70

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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.

Why? I do this sort of technique all the time at work to keep things moving. “I’m gonna ship this code on Friday and if I don’t hear anything before then I’ll assume no news is good news and do it!”.

There should always be an upper bound to how long somebody can block your progress. If something was so important that they want to block me, why didn’t they tell me before Friday? That was ample time to raise objections.

It’s just an SLA and holds people accountable.

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

#139

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…

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Used iPhone 7 for $51, iPhone 11 for $154, 12 for $226, 13 for $262...

https://swappa.com/buy/iphones

I mean, I'm all-Android all-the-way, but I think the used market is viable for this.

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

#140

Earlier quoted context omitted.

[flagged]

Used iPhone 7 for $51, iPhone 11 for $154, 12 for $226, 13 for $262... https://swappa.com/buy/iphones I mean, I'm all-Android all-the-way, but I think the used market is viable for this.

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