FDA Approves First Hearing Aid Software for Apple’s AirPods Pro

The US Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) hearing aid software for Apple’s AirPods Pro, enabling people with mild to moderate hearing loss to use the popular headphones as hearing aids. The software, known as the Hearing Aid Feature (HAF), can be accessed via a simple software update, making it easy for users to customise their AirPods Pro without professional assistance.

Designed for individuals 18 and older, the HAF is self-fitted using an iPhone or iPad through the iOS HealthKit, which gathers the user’s hearing data. This allows users to adjust volume, tone, and balance to match their preferences. In a study involving 118 participants, the HAF was shown to provide similar benefits to professionally fitted hearing aids, with no adverse events reported.

Approved under the FDA’s De Novo premarket review pathway, the HAF offers a new, accessible solution for hearing support. Michelle Tarver, Acting Director of the FDA Center for Devices and Radiological Health, stated that this approval marks a significant advancement in hearing aid accessibility.

Apple recently introduced additional features for its Apple Watch Series 10 and AirPods Pro 2 to enhance sleep and hearing health, further cementing its role in personal wellness.