FDA Approves first OTC hearing aid software device for Apple AirPods Pro

TapTechNews September 12th news, the US Food and Drug Administration (FDA) today approved the first over-the-counter (OTC) hearing aid software device - Hearing Aid Feature, which can be used for compatible versions of Apple AirPods Pro headphones.

The FDA stated that after installation and customization according to the user's hearing needs, the Hearing Aid Feature can make the compatible AirPods Pro function as a OTC hearing aid to amplify sound for users aged 18 and above with mild to moderate hearing loss.

The Hearing Aid Feature (HAF) is a software-only mobile medical application that is applicable to compatible versions of AirPods Pro. HAF adopts an adaptive strategy, and users without the need for the assistance of a hearing professional can adjust it according to their own hearing needs. HAF is set up through iOS devices (such as iPhone, iPad), and the user's hearing level is accessed through iOS HealthKit to customize HAF. After the setup is completed, users can adjust the volume, tone, and balance settings.

According to TapTechNews' earlier report today, an upcoming firmware update from Apple will enable AirPods Pro 2 to be used as a hearing aid, which will put it in direct competition with existing over-the-counter (OTC) hearing aid products.

According to TapTechNews' understanding, most OTC hearing aids offer Bluetooth headphone functions, so whether using AirPods or OTC hearing aids, both hearing assistance and headphone functions can be achieved simultaneously, but AirPods will offer two significant advantages.

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