The US Food and Drug Administration (FDA) has approved a software update that allows Apple's AirPods Pro 2 to function as over-the-counter hearing aids.

The FDA authorization follows Apple's announcement of a new hearing aid feature for the second-generation AirPods Pro, describing it as "the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature." The feature was evaluated in a clinical study with 118 subjects with mild to moderate hearing loss, demonstrating similar perceived benefits as professional fitting of the same device.

This development is part of Apple's focus on hearing health, including a new Hearing Protection mode and a Hearing Test feature for AirPods Pro owners.

Analyst QuickTake: In November 2023 , Soundwave Hearing obtained FDA 510k clearance for Sontro, its OTC hearing aids. While Soundwave’s hearing aids are designed specifically to be hearing aids, Apple’s AirPods are considered the first wireless earbuds that have also been cleared as FDA-approved hearing aids.