Apple's recently unveiled hearing aid feature has become the first over-the-counter (OTC) hearing aid software to receive FDA approval, and it is expected to be available on devices soon. The FDA officially introduced the company's new "Hearing Aid Feature" (HAF) shortly after Apple's "Glowtime" event, which highlighted several new health-related functions. The HAF enables AirPods Pro users to take a personalized hearing test on their device, which then adjusts the audio settings within the hearing assistance software, effectively transforming the earbuds into a hearing aid.
Apple first announced the Hearing Aid mode on September 10, anticipating swift federal approval, and the FDA acted faster than anticipated.
"Today's authorization of an over-the-counter hearing aid software for a widely used consumer audio product is a significant step forward in enhancing the availability, accessibility, and acceptance of hearing support for adults with perceived mild to moderate hearing loss," stated Michelle Tarver, FDA Director of the Center for Devices and Radiological Health.
The FDA also provided details about the clinical trials for the feature. Apple's HAF was tested in a study involving 118 individuals with mild to moderate hearing loss across various U.S. locations. According to the FDA, the results showed that participants who used the HAF's self-fitting method experienced a similar perceived benefit as those who had the same device professionally fitted.
Tests indicated comparable performance in terms of ear canal amplification and speech understanding in noisy environments, with no adverse effects reported during the study.