US: FDA approves first over-the-counter hearing aid software

It essentially allows compatible AirPods Pro to function as a hearing aid

Image by Gerd Altmann from Pixabay (with added purple filter and cat face courtesy of Canva)

The United States Food and Drug Administration (FDA) has authorized the first over-the-counter (OTC) hearing aid software device, called the Hearing Aid Feature (HAF), for use with Apple AirPods Pro.

Here are a few key points:

• This software allows compatible AirPods Pro to function as a hearing aid for individuals 18 years or older with mild to moderate hearing loss.

• Users can customize the device through an iPhone or iPad using their hearing data from iOS HealthKit.

• This authorization follows the FDA's 2022 regulations that made it easier for adults to buy OTC hearing aids without a prescription or audiologist visit. In a clinical study, the HAF showed results comparable to professionally fitted hearing aids, with no adverse events.

• The FDA granted Apple Inc. marketing authorization for the device under its De Novo premarket review pathway, which supports innovative health technologies and aims to improve access to care.