FDA approves Apple AirPods as hearing aids

Sept. 13 (UPI) -- The U.S. Food and Drug Administration has authorized software that can transform the latest version of Apple's AirPods Pro earbuds into hearing aids.

The Thursday announcement from the federal agency came just four days after the U.S. tech giant on Monday unveiled its redesigned AirPods lineup, including AirPods Pro 2 with its clinical-grade over-the-counter hearing aid feature and a clinical hearing test that users can access on their iPhones.

According to Apple , users will be able to use their iPhone in conjunction with their new AirPods Pro to create a personalized hearing profile that "seamlessly transforms AirPods Pro into a clinical-grade hearing aid."

The FDA on Thursday said its marketing authorization of the product was its first ever for a over-the-counter hearing aid software device.

"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." Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, said in a statement .

According to the FDA, the hearing aid feature of the AirPods Pro is intended for those 18 years of age or older with mild to moderate hearing impairment.

The device's software-enabled hearing aid feature uses a "self-fitting strategy" that allows users to adjust the AirPods Pro to their hearing needs without professional assistance, the administration said. The adjusting is done via an iPhone or iPad with the user's hearing levels accessed by the device's operating system's HealthKit application.

A clinical study of 118 people across the United States found that the self-fitting strategy achieved similar results to the same device being fitted by a professional, the federal administration said.

"Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise," the FDA said. "No adverse events related to the device were observed in this study."

Some 30 million adults report some form of hearing loss, according to the FDA, which said the impairment could negatively affect one's communication, relationships, performance and well-being.

The AirPods Pro 2 sell for $249 on Apple's website and at its physical stores.