The U.S. Food and Drug Administration (FDA) has authorized the hearing aid features for AirPods Pro 2, a move that will benefit millions with mild to moderate hearing loss. This is the first time the FDA has approved an over-the-counter (OTC) hearing aid feature in a mainstream consumer product. It offers both accessibility and convenience to users in need.
A Milestone for Hearing Accessibility
Approved in September 2024, the AirPods Pro 2 update lets the earbuds function as hearing aids. The update allows users to amplify sounds for those 18 and older with hearing impairments. This step aligns with the FDA’s efforts to make hearing aids more accessible through OTC solutions. Now, people can get affordable hearing support without needing professional fittings.
“Hearing loss affects millions, and this approval is an important step to make hearing aids more accessible,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.
Self-Fitting and Clinical Results
The new feature allows users to self-fit their AirPods Pro 2 using Apple’s HealthKit. This lets users adjust volume, tone, and balance to suit their hearing needs, all from their iPhone or iPad.
In a study, 118 people with hearing loss tested the feature. The results showed that self-installing the software gave users similar benefits to professional fittings. The tests found that speech clarity and amplification levels were comparable to those in clinical settings.
Broader Implications for Hearing Health
This approval is a huge step in making hearing aids accessible, especially for adults with mild hearing loss. With no need for a prescription, users can now enjoy hearing support through a device they already own and use daily.
The FDA’s decision signals its support for innovation in healthcare. As Apple continues to blend health features into its products, this update shows how consumer tech is playing a growing role in healthcare solutions.
