Hearing test not available in Australia after iOS update this morning

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?

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

You can do a hearing test as before but cannot activate Hearing mode. Apple was not clear in its announcements and would be useful if they provided an update. Is it approval by regulators or something else?

Two questions: Why was Australia not included in the release? When Australian’s be given access.

It is extremely disappointing when you look at the list of ‘haves’ when near neighbours such as New Zealand have the software let alone so many unfriendly countries to the USA.

Hi

There is a list of TGA applications but Apple Hearing is not on it. Don’t think it is a complete list. Can lodge a freedom of information application but states there is a delay in these. Historically e.g. Covid vaccines the TGA has not been very fast on its feet……and is not it appears an efficient process - approvals by a number of major countries is not it seems a driver.

mypyjamas wrote:

Bought my new AirPods Pro 2, and sat here trying to get the new firmware to download. No avail, then I found online it's not available in Australia. So I got a quote for so called hearing aids my Health Fund would stump up some money for, that were not obvious when on, close to the size of the Apple AirPods . . not as cool though. They sent me a quote for Signia Active Pro X, they were $5,220. . . Advertised as 'singles' only so 50% online. I suspect your theory could be on the money. Traditional providers have a lot to lose from customers like me. . .with mild loss, I just can't afford or justify that much money . . . when Apple Air Pods Pro 2 are going to help at a significantly more affordable price. So annoyed with Australia's regulatory system. Even NZ is ahead of us.

It was only recently in the U.S. that people became eligible to buy hearing aids "over the counter", meaning without going through an audiologist. I suspect the change in that regulation made it a lot easier for Apple to get approval here in the U.S. And yes, I also suspect that audiologists and possibly the traditional hearing aid companies resisted that change as long as possible.

Of course, the change has also probably been a goldmine for hearing aid companies who were able to adapt. Although they now have to compete on price in the open market, that market is much, much bigger.

Not that it is much help, but the TGA did respond to my message.

From TGA;

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. Approvals require submissions to be made by the manufacturuer or their Australian representative.

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.

Agreed, not Apples fault, but they should have a big red notice on the Airpod Pro page on their web site stating the hearing aid function won't work in Australia. I mean it's not like they don't have an Australian focused web site. :-)

kit laughlin wrote: "...Does anyone know where one can post to convey our wishes to Apple?"

Here:

Feedback - AirPods - Apple

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Seems Apple Support's article dated September 2024 (link below) explains step-by-step how to prepare, and then "Use your audiogram data from the Health app"

Customize headphone audio levels on your iPhone or iPad - Apple Support

If Apple's method isn't working for you, you might want to send feedback to Apple, They will likely not reply, yet your feedback will reach those who can make changes if others are also having a similar issue: Feedback - iPhone - Apple

Alancito wrote:

kit laughlin wrote: "...Does anyone know where one can post to convey our wishes to Apple?

"

Here:

Feedback - AirPods - Apple

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It will do no good to contact Apple. As I mentioned before, It's not Apple who approves where the hearing aid feature will be allowed. It is up to each country. Contact the government agency that approves medical devices.