During the huge It's Glowtime event, Apple announced that its AirPods Pro 2 earbuds would get a game-changing new feature allowing people to use them as an over-the-counter hearing aid — a first of its kind.
Following that announcement, the U.S. Food and Drug Administration (FDA) announced that it granted Apple authorization for "the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature (HAF), intended to be used with compatible versions of the Apple AirPods Pro headphones."
According to the FDA, once customized to a user's hearing needs, the AirPods Pro 2, already one of the best wireless earbuds you can get, can amplify sounds for individuals with mild to moderate hearing impairment. The government agency also noted that the feature is intended for users 18 and older.
"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."
Dr. Michelle Tarver, FDA
A vital portion of the FDA's release mentions that users can adjust the AirPods Pro 2 to meet their hearing needs without the assistance of a hearing professional. For those who don't want — or can't afford — to go to a doctor, being able to adjust the volume, tone and balance settings on their own is a great option to have.
@tomsguide ♬ original sound - Tom’s Guide
The FDA says they tested the Hearing Aid Feature with 118 adults with mild to moderate hearing loss at multiple sites around the U.S. It found that Apple's AirPods Pro 2 had similar benefits to professionally-fitted hearing aids. "HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device," reads the FDA's report. It continues, "No adverse events related to the device were observed in this study."
Speaking about how significant a publicly-available OTC hearing aid is, Michelle Tarver, M.D., Ph.D., acting director of the FDA's Center for Devices and Radiological Health, said, "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."
More than 30 million American adults have some degree of hearing loss, whether caused by natural aging, loud noise exposure, medical conditions or other factors. Having a device like the AirPods Pro 2 readily available, as noted by the FDA, can lead to reductions in the frequency or severity of mental decline, depression and health problems in older adults.
More from Tom's Guide
