Yeah it’s concerning if the EU is going to classify OTC as a MD which we know it’s not, it certainly shouldn’t fall under MD class II.
This from the interwebs (Aria)
The EU MDR was implemented in May 2021, replacing the previous Medical Device Directive (MDD). It aims to improve patient safety and ensure that medical devices are properly regulated throughout their lifecycle. The regulation covers a wide range of medical devices, from simple bandages to complex implantable devices.
How is it possible that the EU is deciding country hearing aid approvals when Germany, Greece, Portugal, Austria, Ireland and Denmark have been approved for the use of the AirPods Pro 2s as hearing aids?
France, Spain, Italy and Belgium are all in the EU and they don’t.
Enquiring minds want to know.
Just did the current update from Apple(iOS 18.1.1) and the hearing aid test from Apple dropped(shows up as Hearing Assistance). I am in the USA. The audio-gram from the test matched to what I received from Costco. I let it setup the Air-pods as it saw fit and noticed that the Amplification setting was reduced to 50 percent(I had it set at 80 percent) and the Ambient Noise Reduction was reduced from 20 percent to zero.
Mr. Tankan, you have given me advice on using Widex P2R to replace my broken M2R (medium)
I am tempting to try Apple ipod with my moderate-severe loss
Get any smart advice given
Thanks
I have a moderate severe loss on my right.
Do you think replacing my Widex Evoke 330 with Apple Ipods for which it is out of their capbablity ?
Thanks
Hi there, I’m no expert with electronics, but you shouldn’t try anything that is outside the limits, as you’ll only end up disappointed, again without seeing your audogram it’s hard to give advice.
I tried to get the 3 years old audio-gram from the hospital archive.
Hopefully I will upload it to you for advice if it arrives.
For your info, out of 6 hearing clinic, I can only get an appointment on May 6,2025. Wow, it may be the ready why so many Americans
turn their “deaf ears” to do things right…
Yeah that’s unacceptable, far too long to wait, just out of curiousity have you tried your local Costco wholesale, you can’t beat the price or service options.
For comparison- with my type of hearing loss I found Apple’s Airpods wholly inadequate as HAs (as the company acknowledges) even when pushing them to the limit. But I was disappointed they have very low volume output even when used as music earbuds- there are competitors out there that are far better in this respect.
I’m not sure how the OTC HA classification works under FDA regulations, but why would you say that OTC HA are not MD?
From what I’ve understood so far, OTC HA are very similar to prescription HA, main difference being in the way the HA are tuned where with OTC the end user (patient) can tune them theirselves
Hello Richard,
where did you read about the Airpods Pro 2 HA capabilities being allowed in some europe countries? I’ve searched online but havent found anything
Here:
The AirPod Pro 2s have been available as hearing aids since they were launched since September 2022. Apple simply didn’t publicise them as such and the FDA in the US would have stopped them if they had.
They will work in all countries if your iPhone (or iPad) is running an IOS older than 18.1. You set them up via Hearing Accommodations in Settings.
You can only try them. Buy them from the Apple Store on Amazon for a 30 day free trial.
My left ear borders on severe but they work incredibly well for me.
I know of many with people with severe hearing loss who use Airpods as a backup to their hearing aids and for listening to music and watching TV prefer them.
If you are running IOS 18.1 or newer on your iPhone you may and return a severe hearing test which will prevent the Airpods working as hearing aids at all and you can thank the FDA for that. Enter your Audiogram manually and tweak the numbers to show a moderate loss.
Even better, if you are still on an older IOS, set them up in Setting/Headphone Accommodations and you will have no restrictions.
And the firmware updates keep coming… which is good. the Airpods are not a bad solution for me. I use them especially for conversations, but also for loud music at concerts. I see no reason to spend thousands on another hearing solution when I could purchase these for $189. Comfortable, functional, reliable. They work!
You can always return the AirPods if they don’t work for you. I was planning on doing that if it didn’t work out. However I am so pleased with them that I bought a second set so I can wear them the entire day. The sound is so much better (pleasant) than my Costco Jabra hearing aids. I also have multiple Apple devices and the AirPods switch between them seamlessly.
Thanks really so much.
I will have a new audio-gram after the visit to the medical center
on February. In fact, I will try to use the Apple Ipods if suitable.
However, another coming task too early to be discussed, the need of an Iphone with IOS 17.1 and the right apps
Again, thank you so much
You can use an app like mimi or the built in to the new ios version hearing test to get your audiogram now. It might not be quite as accurate as what a professionally administered test would show, but it is better than a sharp stick in the eye.
WH
Dear WhiteHat,
Thanks for the advice. Currently I am wearing a 3 years mold Widex 330 with 2 broken receivers of which I have ordered a new set to replace them. Likewise, i think I need a check-up(doctor says once a year, Phew) to see how bad the loss progresses.
i do plan to use Ipods for future use if it fits. If you don’t mind
tell me what apps I should download to finish the job. Shame to tell you, I gave up a cheapy cell-phone for almost 6 years at the advice of my kids. Normal phone converation is done sometimes thru my
family members. What a drag.
Again thank you so much
Mimi comes to mind although there is also a test is built into iOS since 18.1. You’ll need an iPhone or iPad as well. The app pushes your audiogram into the accessibility settings which then program the iPods.
WH
Based on my anecdotal experience, I see no reason that Transparency Mode and Headphone Accommodations would work for anyone in iOS 18.1+ (it did nothing in my APP2, whereas it worked fairly well for me in iOS 17). I think Apple is bowing to the regulators and stealthily withdrawing a user-controlled feature (Headphone Accommodations). Those are rare in the Apple ecosystem.
If you’re not in the supported regions and care about this feature in Transparency Mode, stay on iOS 17 if you can. The same applies for all regions for iPadOS and iOS if you’ve crossed the moderate-to-severe threshold on your audiogram.
I do notice that some (perhaps FDA?) mild-to-moderate-limit of 60 dBHL seems to have been enforced, as I’m getting less high-frequency amplification with Hearing Assistance with my audiogram (which hits 60 dBHL and rising, starting at 4 KHz on the left side) than I was with Hearing Accommodations.
I haven’t done Apple’s hearing test yet, so I can’t comment knowledgeably on that. It tells some users that the feature will not be activated (probably because their loss is “too severe,” perhaps exceeding the aforementioned limit). Perhaps there’s a way to force this.
If you’re already in iOS 18+, it’s a pain going back. You may still have to wait. That said, my experience so far is that the audiogram compensation is now portable (resides in the APP2), as I’ve found it works in watchOS, tvOS, and Windows, where it didn’t in previous APP2 firmware versions. I’m on 7B21. That’s a big leap forward for APP2 utility, as I had to use other TWS devices that were equalization-embedded with those OSs. That may work if you configure your APP2 (and its firmware) in a supported device/region.
So, overall — iOS 18 is a win for me for non-iPhone/iPad Media and Phone sources and a mild-to-moderate step down for Transparency Mode.