ASA Monitor November 2024, Vol. 88, 29.
FDA authorizes first over-the-counter hearing aid software
The U.S. Food and Drug Administration (FDA) authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.
The FDA’s OTC hearing aid regulation, established in October 2022, represented a significant step toward enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or seeing an audiologist.
The Hearing Aid Feature (HAF) is a software-only mobile medical application that is intended to be used with compatible versions of the AirPods Pro. The HAF utilizes a self-fitting strategy, and users may adjust it to meet their hearing needs without the assistance of a hearing professional. The HAF is set up using an iOS device (e.g., iPhone, iPad), and the user’s hearing levels are accessed from the iOS HealthKit to customize the HAF. Users can refine the volume, tone and balance settings after setting up the HAF.
The HAF evaluation results demonstrated that subjects who used its self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device.
The FDA granted marketing authorization of the HAF to Apple Inc.
Source: asamonitor.pub/47wqTDi