Why is Apple's Hearing Aid feature not available in the UK?

Do we know how to find out how far along this process is for UK. (Even if it has started?)

Who could we even ask (that would actually answer)?

Really looking forward to seeing this feature. The cost of Air Pod Pro 2 compared to Prescription hearing aids, it’s just a no brainier.

Apple wasn't able to release it in the U.S. until after it had gained U.S. FDA (Food and Drug Administration) approval.

It is currently available in the U.S and Canada. I suspect that they are still waiting on approval from other countries.

See the following from Apple introduces groundbreaking health features - Apple (UK)

The Hearing Test and Hearing Aid features are expected to receive marketing authorisation from global health authorities soon, and will be available this fall in more than 100 countries and regions, including the US, Germany, and Japan.3

footnote 3 - The Hearing Test and Hearing Aid features are expected to be available fall 2024. The Hearing Aid feature is pending marketing authorisation from the FDA and other global health authorities. The Hearing Test and Hearing Aid features will be supported on AirPods Pro 2 with the latest firmware paired with a compatible iPhone or iPad with iOS 18 or iPadOS 18 and later, and is intended for people 18 years or older. The Hearing Aid feature is intended for people with perceived mild to moderate hearing loss.

This is primarily a user-to-user support forum; other Apple users like you.

The UK has its own organisation for protecting consumers of medical products, called the MHRA. They just haven’t ratified this feature yet. In fact other notable European countries to miss out on Hearing Health are France, Spain and Belgium. This is presumably because their own respective national health authorities also haven’t ratified this product yet.

[Edited by Moderator]

This question has been asked over and over and answered many, many times since IOS 18.1 was released.

The Hearing Test has now been approved for use in the UK. Why they didn’t wait until the hearing aid feature was approved too I have no idea as hearing test apps have been available for a long time. I used the Mimi app.

What most don't realise is that the hearing aid feature has been working on the AirPod Pro 2s since September 2022 when they were first launched. If you have an iPad or older iPhone running an older IOS you can set your AirPod Pro 2s up as hearing aids, add your audiogram and set them up in Headphone Accommodations which is in Settings/Accessibility/Audio & Visual/ .

They work really well as hearing aids for people with mild to moderate hearing loss. IOS 17.7.1 works really well on my 15 Pro Max and I've been using them since September. An iPhone 12 will work and my wife's 2018 iPad running IOS 17.7.1 does too.

If you have updated to IOS 18.1 or newer you will not get them to work in any of the countries where they have not been approved. It includes Canada, the UK, France, Spain, India, Italy and India.

Here’s what the UK MHRA has to say. It’s Apples fault!

Airpods Pro 2 have been marketed by Apple Inc. in the United States with a Hearing Aid Feature (Hearing Test and Hearing Aid). The Hearing Aid feature has received FDA authorisation (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230081) for use in the United States. 

The Hearing Aid Feature has indications for use as a software-only medical application intended to be used with compatible wearable electronic products intended to amplify sound for individuals 18+ years old with perceived mild to moderate hearing impairment. The Hearing Aid Feature utilises a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. 

Should the AirPods Pro 2 product have a medical intended purpose with the Hearing Aid Feature to be placed on the UK market, Apple Inc may register the product with the MHRA. The necessary conformity assessment or declarations will need to be submitted with the device registration.

As of 18 Nov 2024, Apple Inc has not registered the AirPods Pro 2 or Hearing Aid Feature as a medical device with the MHRA. Details on what Apple has registered with the MHRA are available to search on the Public Access Registrations Database (PARD) at the following link: https://pard.mhra.gov.uk/manufacturer-details/40950

Registration of devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA.

In accordance with the above, medical device manufacturers must ensure that all information registered with the MHRA is accurate and up to date.

You may wish to contact Apple UK (see details below) to learn of plans to introduce the Hearing Aid Feature in the UK.

Telephone: 0800 107 6285

Contact – Contact – Official Apple Support (UK)

Get technical support for Apple’s Accessibility features - How to contact Apple for accessibility support – Apple Support (UK)

Connect with British Sign Language support - https://www.signtime.apple/en-GB/applecare/bsl

Should you require any further advice or assistance on this matter please feel free to call us on 020 3080 6000 or reply to this email.

Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)

Kind Regards,

Teillia

MHRA Customer Experience Centre

Communications and Engagement

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000 gov.uk/mhra Stay connected

I’m so disappointed that the Hearing Aid feature hasn’t been released in the UK yet. I also think it’s non-sensical to release the Hearing Test feature but not the Hearing Aid feature.

I think for most customers who are just wanting to use the hearing aid feature, the two go hand in hand.

These features got announced months ago and they’re still not fully rolled out. I know some people will likely say this is down the UK not approving it yet, but my main gripe is the fact the test and aid functions have been released separately. I feel like you have to really look to discover the two are separate and it’s probably caused a lot of confusion amongst customers. I called Apple today and i suspect they’re getting a lot of calls about it

Just to clarify, the hearing aid features are currently available in 104 countries AirPods Pro 2 - Hearing Health Feature Availability - Apple

Thanks -- the Apple article that currently states U.S. & Canada was about the Hearing Protection feature rather than the Hearing Test and Hearing Aid features.

The hearing protection feature is available in Canada but the hearing health feature (with the hearing aid and hearing testis) not yet available as of 28.x.2024. That second feature is currently available in the US and many other countries even in tiny countries ouch as Cape Verde islands.

I do see this. The problem appears to be a ‘hearing aid’ is classified as a class 2 medical device that requires authority by the UK to be used that way. It has not been approved yet (in the UK) for an unknown reason. The FDA in America have approved it though. This is what my original reply was asking, as to whom is this approval waiting for now? Have Apple applied or is the UK approval system clogged up?

Same issue for Costa Rica. Any way to find out when it will become available or to sign up to be notified when it does?

In the UK It’s the MHRA who have to approve it

Thank you