Apple last week unveiled new health features for some of its technologies, including the “Hearing Aid Feature” for its AirPods Pro headphones. Once installed and customized to the user’s needs, the feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid. The headphones can amplify sounds for individuals aged 18 years or older with perceived mild to moderate hearing impairment.
FDA said the software-only mobile medical application utilizes a self-fitting strategy. Users may adjust it to meet their hearing needs without the assistance of a hearing professional. Using an iOS device, they can access the iOS HealthKit to customize the Hearing Aid Feature. There, they can refine the volume, tone and balance settings once set up.
Apple evaluated the feature in a clinical study of 118 subjects across multiple U.S. sites. Results demonstrated that subjects achieved similar perceived benefit as subjects who received professional fitting of the same device. Outcomes also included comparable performance for tests measuring levels of amplification in the ear canal and a measure of speech understanding in noise. Apple reported no adverse events related to the device.
The company plans to roll out the feature in more than 150 countries and regions — including the U.S., Europe and Japan — this month.
“Hearing loss is a significant public health issue impacting millions of Americans,” said Dr. Michelle Tarver, acting director of the FDA’s CDRH. “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.”
