The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the first over-the-counter hearing aid software. AirPods Pro will now function as a hearing aid for anyone with perceived mild to moderate hearing impairment.
The newly authorized software, known as the Hearing Aid Feature, is a mobile medical application designed for compatible AirPods Pro. It lets users customize the device to their hearing needs without professional assistance through a self-fitting strategy. The setup involves using an iOS device to access hearing levels from the iOS HealthKit. Once done, users can make personalized adjustments to volume, tone, and balance settings. On top of this, the FDA granted marketing authorization for the Hearing Aid Feature to Apple, so it can now market its earbuds as the only earbuds that are FDA-approved for hearing loss.
The FDA’s decision follows its October 2022 move to allow over-the-counter sales of hearing aids without a prescription. This will help address the widespread issue of hearing loss affecting over 30 million American adults. Hearing loss can stem from various factors, including aging, noise exposure, and medical conditions, and it can significantly impact communication, relationships, and day-to-day life. This development will likely expand access to hearing support for those with mild to moderate hearing impairment because these earbuds are already popular as premium earbuds.
After installing and customizing the Hearing Aid Feature software, Apple’s AirPods Pro will offer an additional function as an over-the-counter hearing aid. The software’s efficacy was evaluated in a clinical study involving 118 subjects with perceived mild to moderate hearing loss. The results showed that users who employed the self-fitting strategy had a comparable experience to those who received a professional fitting. However, this is not recommended for those with major hearing loss, just those who have mild to moderate hearing loss.
Source: FDA
