Sept 12 (Reuters) - The U.S. Food and Drug

Administration on Thursday authorized the first over-the-counter

hearing aid software that is intended to be used with compatible

versions of the Apple AirPods Pro headphones.

Earlier this week, Apple ( AAPL ) said its AirPods Pro 2 could now be

"transformed" into a personalized hearing aid via an upcoming

software update that would boost specific sounds in real time,

including parts of speech or elements within a 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 ( AAPL ) had said.

Once installed and customized to the user's hearing needs,

the software enables versions of the AirPods Pro to serve as an

OTC hearing aid, that is intended to amplify sounds for 18 years

or older people with perceived mild-to-moderate hearing

impairment, the health regulator said.

"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.

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.

The authorization of an over-the-counter hearing aid

software advances the availability, accessibility and

acceptability of hearing support, Tarver added.

In 2022, the health regulator

approved

the sale of over-the-counter hearing aids that allowed

adults with mild-to-moderate hearing impairment to access

hearing aids directly from stores or online retailers without

the need for a medical exam, prescription or seeing an

audiologist.

Apple's ( AAPL ) Hearing Aid Feature, authorized on Thursday, is

a software-only mobile medical application and is set up using

an iOS device like an iPhone and the user's hearing levels are

accessed from the iOS HealthKit to customize the feature.