In a groundbreaking move, the US Food and Drug Administration (FDA) has authorized the first over-the-counter hearing aid software designed to work with Apple’s AirPods Pro headphones. This innovative software, announced by Apple earlier this week, transforms the AirPods Pro 2 into a personalized hearing aid, amplifying specific sounds in real-time to assist individuals with mild-to-moderate hearing impairment.
The FDA’s approval marks a significant milestone in making hearing support more accessible and affordable for millions of Americans affected by hearing loss. According to the FDA, over 30 million adults in the US report some degree of hearing loss, which can be caused by aging, exposure to loud noises, medical conditions, and other factors.
Apple’s Hearing Aid Feature, authorized on Thursday, is a software-only mobile medical application that can be set up using an iOS device like an iPhone. The user’s hearing levels are accessed from the iOS HealthKit to customize the feature, providing a personalized hearing experience.
This authorization builds upon the FDA’s 2022 approval of over-the-counter hearing aids, which allowed adults with mild-to-moderate hearing impairment to access hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or audiologist consultation.
The new hearing health features will be available this fall for AirPods Pro 2 users in over 100 countries and regions, making it a global solution for hearing support. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, emphasized the significance of this authorization, stating that it advances the availability, accessibility, and acceptability of hearing support.
This breakthrough highlights the potential of technology to address significant public health issues, and Apple’s innovative solution is poised to make a meaningful impact on the lives of individuals with hearing impairments.
