麻豆传媒

The FDA authorized the first over-the-counter software that can convert compatible versions of Apple AirPods Pro earphones into a hearing aid, the Thursday.

Customizable to individual hearing needs, the Hearing Aid Feature (HAF) amplifies sound for adults with mild or moderate hearing impairment. According to the FDA, an estimated 30 million Americans have some degree of hearing impairment.

"Hearing loss is a significant public health issue impacting millions of Americans," said Michelle Tarver, MD, PhD, of the FDA Center for Devices and Radiological Health. "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."

The HAF software is available as a for current owners of compatible versions of Apple AirPods Pro and is included at no additional cost with the purchase of Apple AirPods Pro 2.

Users can adjust the HAF software to meet their individual hearing needs without the assistance of a hearing professional, the FDA said. The software can be installed on an Apple iPhone or iPad, which can be used to set up hearing parameters on compatible Apple AirPods Pro earphones, including volume, tone, and balance settings.

The FDA evaluated the HAF in a clinical study of 118 people with mild or moderate hearing impairment who were enrolled at multiple U.S. sites. The HAF achieved similar perceived benefit as people who received a professional fitting of the same device, the agency 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.

No adverse events were observed during the study.

The application was reviewed under the FDA's pathway, a regulatory pathway for some novel low- to moderate-risk devices.

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