Apple has secured FDA approval to offer its software update that can turn the Apple AirPods Pro 2 into over-the-counter hearing aids.
During Monday’s “Glowtime” event, the company talked about the hearing aid capability, which has been designed to help people with mild to moderate hearing loss. But at the time, Apple said the hearing aid feature still needed FDA approval.
On Thursday, the FDA then announced it had cleared the software-based hearing aid tech, calling it a win for consumers since hearing aids can often cost up to $2,000 or more. In contrast, the AirPods Pro 2 currently retail for $249.
“Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss,” said Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health.
(Apple)The FDA cleared Apple’s hearing aid feature following a clinical study involving 118 subjects in the US with mild to moderate hearing loss. The results showed that users experienced similar benefits from the hearing aid software when they "self-fitted" the AirPods, compared to those who received a professional fitting.
“Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study,” the FDA added.
Apple didn’t immediately respond to a request for comment. But the company has so far said it plans on rolling out the hearing aid capability to the AirPods Pro 2 this fall to users in more than 100 markets, including the US. The feature promises to personalize AirPods into clinical-grade hearing aids that can boost specific sounds in real-time after the user takes a hearing test.