Tech giant Apple, which introduced AirPods Pro earbuds at its ‘It’s Glowtime’ event, has received US Food and Drug Administration (FDA) approval to serve as “hearing aids”.
The company had said that the AirPods Pro add an innovative, over-the-counter Hearing Aid capability for users with mild to moderate hearing loss. The earbuds were expected to receive FDA approval.
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Now, the FDA on Thursday authorised the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature (HAF), intended to be used with compatible versions of the Apple AirPods Pro headphones.
“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health.
“Today’s marketing authorisation 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,” she added.
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Once installed and customised to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment, the FDA said.
The FDA further mentioned that the HAF utilises a self-fitting strategy, and users may adjust it to meet their hearing needs without the assistance of a hearing professional. The HAF can be set up using an iOS device (e.g., iPhone, iPad), and the user’s hearing levels can be accessed from the iOS HealthKit to customise the HAF. Users can refine the volume, tone and balance settings after setting up the HAF.
A clinical study at multiple U.S. sites evaluated the HAF on 118 subjects with mild to moderate hearing loss.