The U.S. Food and Drug Administration (FDA) on Thursday approved the first over-the-counter hearing aid software, intended for use with compatible versions of Apple 's AirPods Pro headphones .
See also: What features make the AirPods Pro 2 stand out?
Earlier this week, Apple said its AirPods Pro 2 could now be "transformed" into a personalized hearing aid via an upcoming software update that would amplify specific sounds in real time, including segments of speech or elements in the user's environment
New hearing health features will be available this fall for AirPods Pro 2 users in more than 100 countries and regions, Apple said.
Once installed and adjusted to a user's hearing needs , the software allows AirPods Pro to serve as an OTC hearing aid, which is intended to amplify sounds for people 18 years of age or older with mild to moderate hearing loss, the FDA said.
See also: New AirPods Pro beta feature optimizes noise cancellation
"Hearing loss is a significant public health issue that affects millions of Americans," said Michelle Tarver, deputy director of the FDA's Center for Devices and Radiological Health.
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.
Authorizing an over-the-counter hearing aid software promotes the availability, accessibility and acceptance of hearing aids, Tarver added.
In 2022, the health regulator approved the sale of over-the-counter hearing aids, allowing adults with mild to moderate hearing loss to access hearing aids directly from stores or online retailers without requiring a medical exam, prescription, or visit to a specialist.
See also: How to properly clean AirPods?
Apple's Hearing Aid feature , which was approved Thursday, is a mobile-only medical app that will be set up using an iOS device like an iPhone, and will access iOS HealthKit to adjust the hearing aids to the user's hearing levels .
Source: Reuters
