I’ve just updated my AirPods Pro 2 with version 7A294 and tested them. I think the hearing aid features are pretty good. I have Oticon Intent 1’s which I’m very happy with. I don’t think AirPods will replace proper hearing aids anytime soon but I’m pleasantly surprised by how well they work as “hearing aids”. If you put on “Conversation Awareness” and “Transparency Mode” and you put your audiogram into “Headphone Accommodations” with the Accessibility options then they behave like hearing aids. I’ve only just got the update and busy testing but so far I think they are not bad. I have moderate to severe hearing loss in the high frequencies.
I’d love to hear other real world experiences and I will update this thread in a few days when I have more experience with them.
At the Apple event a couple of weeks ago, Cook said it would need “regulatory approval” first and most commentary I have seen says a few months yet. I don’t think we know what firmware may be required but likely another AirPods firmware release at least.
I am interested in these things as true, standalone HAs that (after configuration) work untethered to any iPad, iPhone or Mac right out of their charger. Please keep us posted…
Apple can sell in the US once they have regulatory approval from the FDA but they won’t be able to sell elsewhere (eg in the EU or the UK) until the relevant regulator approves for their territory.
I don’t believe there is automatic recognition of FDA approval in the EU or in the UK, but the regulators could decide to recognise the US approval I think.
“The Hearing Test and Hearing Aid features are expected to receive marketing authorization from global health authorities soon, and will be available this fall in more than 100 countries and regions, including the United States, Germany, and Japan.”
Which sounds like the firmware(?) update is to be rolled out globally, except I don’t understand the “global health authorities” part. There is the WHO, but it provides guidelines, not marketing authorizations, like the local FDA, the EMA and others.
It means those authorities in each of the countries of the world who control the sale of regulated products in their country. That’s the FDA in the US I suppose. But anyway it’s nothing to do with the WHO. And as I said before, some countries may accept the FDA’s authorisation but some will not.
Based solely on what I’ve seen posted here and elsewhere, it seems many countries don’t allow OTC hearing aids at all. I’m curious to see how a firmware update that converts earbuds to hearing aids will be handled in those countries. As far as I know, this issue has never come up before.
Yes- given that Apple is leaving out AI features in its latest iOS updates in Europe out of fears over recent EU legislation in this area its apparent handwaving here surprises me a bit.
They already behave as hearing aids. They have not implemented it formally for regulatory reasons but if you do what I suggest in my original post (i.e. put in your audiogram and enable transparency mode) then they behave like hearing aids. I have tested them with sounds that I know I can’t hear (eg. the beep my fridge makes when I leave it open) and in conversations with my family and it works almost as well as my Oticons.
This was all possible with the previous version but it’s definitely improved with the iOS18 update.
Glad to hear that! I’ve been using the custom transparency mode for a couple of years now, and while it works, it definitely has some limitations (there are a few threads on this forum discussing the issues). My hope is that Apple will introduce an updated, improved hearing aid feature with the next release.
You’re source for this information, I haven’t seen anything that bans OTC or any other hearing amplifier, only “medical devices” are regulated etc, but I can say the resellers (Jabra,Sony) refuses to offer in other countries, but that’s most likely because of the their suppliers(the manufacturers) refusing to allow them to do so.
I haven’t done a deep dive into it, but when discussing or recommending OTC options, I’ve been told several times that the only way to get XYZ thing in their country would be to basically smuggle it in, because not only is it not sold there, it’s not legal to sell it there. The US didn’t allow them until recently (late 2022, IIRC), and I remember seeing some statements from European organizations expressing concern that consumers importing them directly from the US would effectively negate the existing regulatory ban. I guess it might have changed in the meantime.
I think that’s likely to be the reason OTC manufacturers generally refuse to ship outside the US. I haven’t looked at every single one, but I’m not aware of any that ship internationally. And that includes companies like Sennheiser/Sonova and Jabra that are based in Europe. If they could lawfully ship to their home countries, I think they’d do so. They do it with all their other products.
r/hearingaids has an automod warning that hearing aids aren’t available OTC in most countries. The saga behind that was kind of funny, actually. They used to ban discussion of OTC aids outright, but users revolted once they became widely available in the US. First they tried to make everyone declare their country and have a little flag next to their name, but a lot of people didn’t like that because it’s a privacy violation (particularly for those who live in smaller countries). Finally they settled on allowing it, but autoposting a mod warning about why people shouldn’t use OTC aids as a reply to every post that uses the word “OTC.”
Why tho, there not “medical devices” you can buy on eBay and ship to you country, there’s nothing to say you can’t, only “medical devices” are regulated.
Can I see the regulations that are stating this and in which countries?
But what ban is this referring to, only on “medical devices”?
Your right, they won’t do it, but my guess it’s because of the manufacturer status, not because Jabra,Sony, Sennheiser don’t won’t to, I’m sure they can see the $$ to be made selling world wide.
Ha, to believe anything from that site is not recommended! it was just scaremongering from someone who hasn’t a clue what their on about, a quick look around you can see a lot of incorrect nonsense being thrown around there, but yeah they shouldn’t be trying to “control” what people want to discuss in that regard.
I really think these need to be available anywhere prescription “medical devices” are available, it’s about choice for the people, hopefully in the coming years we’ll see a turn around.
The EU has laws that restrict the output of earbuds at 85 db. I believe that all Apple’s Airpods are capped at that output level- beyond this, the EU probably doesn’t care how the buds work (as HAs or to play music). That may be the reason Apple is so confident it can roll out its software update globally this Fall.
Unlike medicines, I am not aware of EMA-approved HA models (can’t find any data on this) and the only relevant list for HAs here in Switzerland appears not to be released by Swissmedic (our local FDA), but by state health insurance, which says what models are reimbursed.
Yes that’s my point, there just doesn’t seem to be much in the way of regulations on this, so one is “capping” the MPO to 85dB, well this “sounds” reasonable,a few OTC models would fit into this then, I just think there’s a bit of scaremongering going on, the UK and Spain have some pretty strict requirements for “medical devices” tho about who can import and sell them, possiblity people are just putting OTC in the same basket?