FDA authorizes first OTC hearing aid software for Apple's AirPods Pro
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The U.S. Food and Drug Administration on Thursday authorized the Hearing Aid Feature, its first over-the-counter hearing aid software device that is intended to be used with the Apple AirPods Pro.
Why it matters: A hearing aid that's built into a relatively inexpensive and easily accessible product that many people already own could help far more people get the hearing help they need.
How it works: The Hearing Aid Feature is set up using an iOS device, such as the iPhone, and the user's hearing levels are accessed from the iOS HealthKit to customize it. Users can refine the volume, tone and balance settings after setting up the feature.
- The Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid. It can be customizable to an user's needs and boost sounds for individuals over the age of 18 with mild-to-moderate issues.
Between the lines: The Hearing Aid Feature will allow consumers to try out a hearing aid before buying a separate product and also to do so in a way that doesn't reveal that they are wearing hearing aids.
What they're saying: "Hearing loss is a significant public health issue impacting millions of Americans," said Michelle Tarver, 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," Tarver added.
Zoom in: More than 30 million American adults report some degree of hearing loss, which can be caused by aging, exposure to loud noises, certain medical conditions, and other factors.
