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Hearing test not available in Australia after iOS update this morning

Updated to 18.1 this morning. I read the fine print—Australia is *not* in the list of countries where Hearing Test is available. Very disappointing. I was looking forward to using iPods Pro 2 for hearing assistance.

AirPods Pro (2nd generation)

Posted on Oct 28, 2024 1:59 PM

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Question marked as Top-ranking reply

Posted on Oct 30, 2024 11:25 PM

Just bought my airpods pro this morning for just this feature. Get home and find it’s not available in Australia. Guess how I feel about this issue. Not happy.


79 replies

Nov 6, 2024 6:17 PM in response to kit laughlin

Hi. Found this article:



Heavily marketed hearing health features for Apple’s AirPods Pro 2 earphones are now the latest innovations from the technology giant which have launched in the United States but remain unavailable in Australia due to a lack of regulatory approval.

Announced in September and released on 28 October, the hearing health features on Apple’s $399 AirPods Pro 2 — including a hearing test and a clinical-grade hearing aid capability — are available in dozens of countries, including New Zealand.

The features, which Apple has touted as “groundbreaking”, are yet to receive regulatory approval from Australia’s Therapeutic Goods Administration (TGA).

Nov 9, 2024 12:58 PM in response to kit laughlin

It’s not Apple’s fault. They made it clear in promo that approval was required by health authorities in each country as this is a “medical” device. Best you all can do is to contact your local federal member of parliament and cc the federal Health Minister. They will respond to you. It’s the only way to move what is a slow process for items not deemed life threatening and that are likely reviewed by a TGA panel that includes Audiologists ( no prize for guessing their recommendation ). There are literally over a hundred countries inc New Zealand that have already approved. Point that out to your MP.

Nov 8, 2024 6:55 AM in response to mypyjamas

Spot on.

It's all about money. How do you sell the rest of your stockpile if a $300 earphone can do 80% if not better than some of the hearing Aid that cost almost 20x the cost?


Hearing Aid on the market today are waaaaayyyy OVER PRICED !!!!!


I am not sure if we should call the ACCC to take a look at this, I am not even sure if there is any foul play. Surely there are a lot of incentive to.


Why would you even need TGA approval to sell something that has other uses.... like... we can have such feature even if TGA dont approve it. Unless..... TGA block it from having its feature as they can argue that it will hinder some people to get the "RIGHT" hearing aid and it would be detrimental in long term.





Nov 8, 2024 6:25 AM in response to frewy

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.

Nov 6, 2024 10:14 PM in response to kit laughlin

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

Nov 8, 2024 2:56 AM in response to kit laughlin

My sister and I pooled our resources to purchase the AirPods Pro 2 for our father. He has been unable to afford a hearing aid. We had hoped this would help him to be more involved in conversations without the frustration of misunderstanding people. Particularly his grandchildren. I feel that withholding a devices feature that has no potential to cause harm is quite absurd. My frustration is more with the TGA dragging its feet than with any other party involved. That is presuming Apple has made a submission for approval by the TGA. It has not been a problem in NZ.

Nov 18, 2024 7:10 PM in response to kit laughlin

I received a sort-of reply from the Department of Health and Aged Care a few moments ago; full text here:


Dear Mr Laughlin


Thank you for your correspondence of 10 November 2024 to the Minister for Health and


Aged Care, the Hon Mark Butler MP regarding Apple AirPods Pro 2 approval as a hearing aid.


The Minister has asked me to reply.


The Australian Government is committed to supporting Australians with hearing loss


through the Hearing Services Program, which provides subsidised high-quality hearing


services and devices to eligible Australians with hearing loss.


We are aware of the Apple AirPods Pro 2 and its hearing test and hearing aid features. The


timing of the launch and sale of the Apple AirPods Pro 2 in Australia is a business decision


for Apple, and the Australian Government is not involved in this decision.


For the Apple AirPods Pro 2 to be supplied in Australia with these new features, the


Therapeutic Goods Administration (TGA) need to check that the product meets the


standards for hearing aid products. The TGA cannot disclose commercially confidential


information about products being assessed. However, we can only assess products after we


have an application and I assure you that we assess every application as quickly as possible,


so Australians can access new technology sooner.


Thank you for writing on this matter.


I asked the author to clarify whether the Department has received an application—and it is not clear where this application needs to come from, but it looks as though this has to come from the manufacturer. Still pursuing this.



Nov 1, 2024 5:49 PM in response to Wowee22

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

Hearing test not available in Australia after iOS update this morning

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