Hearing test not available in Australia after iOS update this morning

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.

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).

They also appear to have removed the ability to select your clinical audiogram stored in the Health App in headphones accommodations.

Such a loss. This feature was the best!

My money is on a traditional hearing aid provider telling some offical Australian government department to force Apple to block the feature until Apple ticks of the offical boxes in some form (I bet on paper) from the 1980s.

There was a similar delay in the ECG feature on Watch.

The question is why is the TGA taking so much time to approve the hearing aid capability of the Air Pro 2? Surely it can’t be too hard to make such a decision just as so many other countries have. Is it due to lobbying from those in the audiology industry or just bureaucratic indecisiveness?

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.

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.

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.

So cranky about this. It’s the ONLY reason I bought them.

The reason is to protect other hearing Aids companies. Simple as that. Imagine the impact it could have.

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

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.

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