The Therapeutics Goods Administration (TGA) has approved Apple’s AirPods Pro 2 for use as hearing aids in Australia but its Hearing Aid Feature is not yet available here until Apple updates software.
The Australian Government Department of Health and Aged Care classified the product’s Hearing Aid Feature (HAF) as a medical device class IIa on the Australian Register of Therapeutic Goods (ARTG) on 17 December 2024.
But an Apple spokesperson confirmed that the feature cannot be used in Australia until Apple updates software for the region.
“Receiving product approval from the TGA on our Hearing Test and Hearing Aid features on AirPods Pro 2 is an important first step toward making these features available in Australia,” Apple told HPA on 14 January 2024.
“We are working through the other necessary steps to make these experiences available as soon as possible; feature availability will be via a software update.”
Apple said it was “looking forward to making these features available in many regions around the world as soon as possible and was currently navigating the local medical device guidelines in each region, which can be associated with different timelines and requirements”.
A public summary of the Australian Register of Therapeutic Goods entry stated the intended purpose of the HAF was a software-only mobile medical application that is intended to be used with compatible wearable electronic products.
“The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment,” the ARTG summary stated.
“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 professional. The device is intended for over-the-counter use.”
Apple unveiled the hearing health tools in the US in September 2024, stating they were a scientifically validated Hearing Test feature and a clinical grade Hearing Aid Feature. It claimed the HAF could be used, in in-the-ear earbuds, as a ‘clinical-grade over-the-counter hearing aid’ for adults with perceived mild to moderate hearing loss.
On 12 September 2024, America’s Food and Drug Administration (FDA) authorised Apple’s HAF as the first over-the-counter (OTC) hearing aid software device.
Apple said that meanwhile Australians could gain hearing health support across devices including Loud Sound Reduction on AirPods Pro 2, Noise app notifications with Apple Watch, and Headphone Audio Level notifications with iPhone.
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