In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has approved AirPods Pro 2 for use as hearing aids. This approval marks a significant milestone, as it’s the first time the FDA has authorized an over-the-counter (OTC) hearing aid feature within a widely available consumer product. This new functionality is expected to provide a valuable solution for millions of people dealing with mild to moderate hearing loss, offering both convenience and affordability.
A Game-Changer for Hearing Accessibility
The approval, granted in September 2024, enables the AirPods Pro 2 to function as hearing aids, making it possible for users to amplify sounds based on their specific hearing needs. This feature is available for individuals aged 18 and older who experience hearing impairments. The approval is part of the FDA’s broader effort to make hearing aids more accessible to the public, allowing users to obtain support without the need for professional fittings.
Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, emphasized the importance of this decision, stating, “Hearing loss affects millions, and this approval is an important step to make hearing aids more accessible.”
Self-Fitting Technology and Clinical-Grade Results
The AirPods Pro 2’s hearing aid feature allows users to adjust their hearing experience themselves using Apple’s HealthKit. Through their iPhone or iPad, users can modify settings such as volume, tone, and balance to cater to their unique hearing preferences.
A study involving 118 participants with hearing loss demonstrated the effectiveness of this self-fitting option. The results revealed that the self-adjustment feature provided benefits similar to those of professional fittings. Users reported improvements in speech clarity and amplification levels comparable to those found in clinical settings.
Expanding Access to Hearing Health
This development is a significant step forward in making hearing aids more accessible, especially for individuals with mild hearing loss. With no prescription required, users can now enjoy hearing support through a device they already use daily, eliminating the need for expensive, specialized hearing aids.
The FDA’s approval reflects a growing trend of healthcare innovations driven by consumer technology. Apple’s integration of hearing health features into its products signals a shift in how consumer tech is contributing to healthcare solutions.