Hearing test not available in Australia after iOS update this morning

Thank you for your enquiry to the TGA.

Hearing aids that meet the definition of a medical device as set out in the Therapeutic goods legislation, require approval by the Therapeutic Goods Administration (TGA) prior to legal supply in Australia.

Generally the TGA does not disclose if an application has been submitted as this is potentially commercially sensitive information. You will need to contact Apple, the manufacturer of the device directly to obtain this information.

To date, the TGA can confirm that a clinical grade hearing aid manufactured by Apple has not been approved.

Kind regards

I have been following this for sometime now and must say it is another form of Australian government protectionism. The only reason they have not let Apple implement this software upgrade presumably is to protect some local interest in regular hearing aids which cost upwards of $6000 in Australia. Hardly surprised that they won’t allow this simple upgrade to the Apple air buds which cost < $400!

I have bought a pair and fully expect Australia to agree to allow Apple to market the product

Re: Why was Australia not included in the release?

We are all Apple users like yourself in the community, so no-one here knows for sure. Seems only some countries marketing and health authorities have given their approval, as the FDA has done in America.

Re: When Australian’s be given access.

As Apple users, like yourself, we have no way of knowing for sure.

Various health products can not be shipped to Australia from US because of Australia's regulations.

If needed: AirPods support website: (info / resources / support / contact etc.)

AirPods Support - Official Apple Support

You kidding me, they were so fast that, australia was one of the first places to have the vaccine available.

TGA is doing more harm than good to be honest. Just let more people take advantage of the new features, if it doesnt work, people will stop using it !!!! simple as that

The $5000 hearing Aid my father got, it's RUBBISH ! It so frustrating that we cant even have a normal conversation with him!!!

IOS 18.2 update has:

• Support for the Hearing Test feature on AirPods Pro 2 in Cyprus, Czechia, France, Italy, Luxembourg, Romania, Spain, United Arab Emirates and the United Kingdom
• Support for the Hearing Aid feature on AirPods Pro 2 in the United Arab Emirates

But not Australia

I have written to Choice magazine about this issue asking them to look into it asap.

If I buy the AirPods Pro 2 in the USA, will the hearing features work, or are they linked to the country of your Apple ID?

I did exactly the same thing this morning. over an hour on the phone to Apple support only to find out myself on google it is not avaliable in Australia. I did not need to spend $400 on "just another set of ear buds".

They could not even give an ETA.

I subsquently put in a complaint on the TGA website after calling them and being advised "no eta". The more squeeking we make might strike oil. :-)

While we wait for full hearing assistance tech to be made available in Australia, there's an article on the use of the 'Headphone Accommodations' feature which does seem to work (I just tried it) - a Feb 2023 article on techradar about how to use it search for How to use your Apple AirPods Pro as hearing aids

also an interesting v recent article on hackaday website

I saw the multiple YouTube videos talking about this feature. I bought the pro2 and looked forward to setting up with this.

when I got them there was no feature in the 18.1.1 update. I rang Apple and they tried for an hour to figure out the problem. Finally we figured it out. The software is not available in Australia.

so like $400 later I am back to zero. Thanks for the heads up when I purchased these Apple. NOT

Has Apple submitted to the TGA in Australia?

Waited ages for ECG and it’s been incredibly useful.

The TGA indicated to me that Apple hasn’t applied for the approval yet !! That was three weeks ago.

i believe you can still add your own audiogram by going into the Health App and select Browse, then Hearing, then Hearing Test results and add the numbers manually (unless this feature was only left over from prior to 18.1 when I had added my audiogram).

then you go to Settings and select Audio & Visual, then Headphone Accommodations and tick tune for Audiogram.

i think this puts your profile into the AirpPods but it is not the hearing aid feature.

This was what I got from the TGA today

“Thank you for your enquiry of 14/11/2024 to theTherapeutic Goods Administration (TGA).

Due to confidentiality the TGA does not disclose information about current applications and cannot advise whether an application has been received or is in progress. The information that the TGAcan lawfully provide about a product is publicly available on the TGA website.

You may wish to contact the sponsor or manufacturer for further information about their intentions to submit an application to the TGA for registration of this product.”

So even less helpful than your reply