FDA Authorizes First-Ever Over-the-Counter Hearing Aid Software That Works with AirPods

Hearing aids are not cheap. At least they haven’t been in recent history. However, that might change soon. For the first-time ever, the Food and Drug Administration has authorized an over-the-counter hearing aid software. The FDA has approved Hearing Aid Feature, a device that will work with versions of the Apple AirPods Pro headphones.

White Apple AirPods against a black screen
Apple

In an announcement giving Hearing Aid Feature (HAF) a greenlight, the FDA wrote that the software will “amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.” That will mean some Apple AirPods Pro headphones will now double as actual hearing aids. Users who install the software will then customize the the software for their own needs, as HAF “utilizes a self-fitting strategy.” How will that work? From the announcement:

The HAF is set up using an iOS device (e.g., iPhone, iPad), and the user’s hearing levels are accessed from the iOS HealthKit to customize the HAF. Users can refine the volume, tone and balance settings after setting up the HAF.

The approval came after a clinical study with 118 subjects in the US who are perceived to have mild to moderate hearing loss. HAF’s “self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device.” The study’s results also showed “comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study.”

This type of product, which should prove far more economical than traditional hearing aids, once seemed impossible. It was only in 2022 when the FDA created an entirely new category of over-the-counter hearing aids for adults. Before that, those who needed hearing aids had to undergo a medical exam so they could get prescription and fitting adjustment by an audiologist. We love when technology changes the world for the better.

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