FDA Approves Over-the-Counter Hearing Aid Software for Apple AirPods Pro

FDA Approval:
The U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter (OTC) hearing aid software device, specifically designed for Apple AirPods Pro, marking a significant advancement in hearing support accessibility.

Hearing Aid Feature (HAF):
The HAF is a software-only mobile medical application intended for use with compatible AirPods Pro versions. It allows users to conduct a personalized hearing test on their iOS device, which then customizes audio settings to amplify sounds for individuals with perceived mild to moderate hearing impairment.

Clinical Study:
The HAF was evaluated in a clinical study involving 118 participants with mild to moderate hearing loss across multiple U.S. sites. The study demonstrated that users who employed the HAF self-fitting method reported benefits comparable to those who received professional fitting of the same device, with no adverse effects reported.

Regulatory Context:
This approval aligns with the FDA's 2022 regulations that enable individuals with perceived mild to moderate hearing difficulties to acquire hearing aids without needing a medical examination, prescription, or audiologist's approval.

Availability:
The Hearing Aid feature will be available through an upcoming software update for compatible AirPods Pro, expected to be released in conjunction with iOS 18.

Impact:
This authorization represents a significant step in advancing the availability, accessibility, and acceptability of hearing support for adults with mild to moderate hearing loss, addressing a significant public health issue affecting millions of Americans.