FDA OKs OTC Hearing Aid Software Using Apple’s AirPods

The U.S. Food and Drug Administration has authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature. It’s designed to be used with compatible versions of Apple’s AirPods Pro headphones.
 
One it’s installed and customized to hearing aid needs, the Hearing Aid Feature allows compatible versions of the AirPods Pro to serve as an OTC hearing aid. This is intended to amplify sounds for adults with perceived mild to moderate hearing impairment.
 
The Hearing Aid Feature (HAF) is a software-only mobile medical application used with compatible AirPod Pro versions. The HAF uses a self-fitting strategy, and users can adjust it to meet hearing needs without the help of a hearing aid professional.
 
THE HAF is set up using an iOS device and hearing levels are accessed from the iOS HealthKit to customize the HAF. Users can refine volume, tone, and balance settings after configuring the HAF.
 
A clinical study with 118 participants with perceived mild to moderate hearing loss at multiple U.S. sites evaluated the HAF. Results showed that those using the HAF self-fitting strategy had similar perceived benefit as those who underwent professional fitting of the same device.
 
Results also demonstrated comparable performance for tests that measured amplification levels in the ear canal, as well as measure of speech understanding in noise.
 
The application was reviewed under the FDA’s de novo premarket review pathway.
 
“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, MD, Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”