Sept 12 (Askume) – The U.S. Food and Drug Administration on Thursday authorized the first over-the-counter hearing aid software for use with a compatible version of Apple’s (AAPL.O) AirPods Pro headphones.
Earlier this week, Apple said its AirPods Pro 2 can now “transform” into personal hearing aids through an upcoming software update that will instantly amplify specific sounds, including parts of the user’s speech or elements in the environment.
Apple said the new hearing health features will be available to AirPods Pro 2 users in more than 100 countries and regions this year.
The health watchdog said that once installed and customized to a user’s hearing needs, the software allows the AirPods Pro version to function as an OTC hearing aid for people over the age of 18 with mild to moderate hearing loss by turning down or increasing the volume.
“Hearing loss is a significant public health issue that affects millions of Americans,” said Michelle Tarver, acting 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 noise, certain medical conditions and other factors.
Licensing of over-the-counter hearing aid software increases the availability, accessibility and acceptance of hearing aids, Tarver said.
In 2022, health regulators approved the sale of over-the-counter hearing aids , allowing adults with mild to moderate hearing loss to obtain hearing aids directly from stores or online retailers without a medical exam, prescription, or visit to a clinic. License.
Apple’s hearing aid feature, which was authorized on Thursday, is a software-only mobile health app that can be installed using iOS devices such as the iPhone and accessed through iOS HealthKit to customize the feature based on the user’s hearing level.
