FDA Approves First Hearing Aid Software for Apple’s AirPods Pro
FDA approves hearing aid software for AirPods Pro, offering a new solution for mild hearing loss.
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.
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