FDA Approves Over-the-Counter Hearing Aid Software for Apple AirPods Pro

The FDA has approved the first over-the-counter hearing aid software to be used with Apple AirPods Pro. This software, which customizes hearing aid functions to individual users, will be available in over 100 countries by fall. It aims to increase accessibility for those with mild-to-moderate hearing impairment.

The U.S. Food and Drug Administration has authorized the first over-the-counter hearing aid software designed for use with compatible Apple AirPods Pro headphones. Announced on Thursday, this software transforms the AirPods Pro 2 into personalized hearing aids through a forthcoming update.

Available this fall in over 100 countries, the software will allow real-time amplification of specific sounds, including parts of speech. This tool caters to users aged 18 and older with mild-to-moderate hearing impairment. '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.

With over 30 million American adults reporting some degree of hearing loss, the FDA's approval aims to enhance the availability and accessibility of hearing aids. The Apple Hearing Aid Feature will be set up using an iOS device like an iPhone and will leverage user hearing levels from iOS HealthKit to customize the experience.

(With inputs from agencies.)