The U.S. Food and Drug Administration (FDA) has granted marketing authorization for Apple's AirPods Pro 2 to function as over-the-counter (OTC) hearing aids, marking a significant step in accessible hearing support for adults with mild to moderate hearing loss. This authorization allows Apple to roll out a software update that transforms the popular wireless earbuds into clinical-grade hearing aids.
FDA Approval and Clinical Validation
The FDA's decision follows a clinical study involving 118 participants with self-reported mild to moderate hearing loss. The study demonstrated that users of the new AirPods Pro 2 feature experienced similar benefits compared to those who received professional fittings for traditional hearing aids. No adverse events were observed during the study, reinforcing the safety and efficacy of the self-fitting strategy.
Michelle Tarver, M.D., Ph.D., acting director of the FDA's Center for Devices and Radiological Health, stated, "Hearing loss is a significant public health issue impacting millions of Americans. Today's marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss."
How AirPods Pro 2 Will Function as Hearing Aids
With the upcoming software update, AirPods Pro 2 users will be able to conduct a hearing test via the Apple Health app. This test, which takes approximately five minutes, utilizes a standard clinical approach called pure-tone audiometry. The results generate a personalized hearing profile that boosts specific sounds in real-time, like parts of speech or environmental elements, tailored to the user's needs.
Users can customize the Hearing Aid Feature (HAF) to meet their hearing needs without professional assistance. Set-up occurs via an iOS device, utilizing the iOS HealthKit to access users’ hearing levels for personalization, allowing users to adjust volume, tone, and balance settings based on their preferences.
Impact on Accessibility and Stigma
More than 30 million American adults have some degree of hearing loss, but only a fraction use hearing aids due to high costs, lack of accessibility, and social stigma. The FDA's approval of OTC hearing aids in 2022 aimed to address these barriers, and Apple's new feature is expected to further expand access to hearing support.
Meredith Resnick, a spokesperson for the Hearing Loss Association of America, hopes Apple's new hearing aid feature will help spread awareness and reduce stigma around hearing loss. She added that most over-the-counter (OTC) devices mainly serve people with mild to moderate hearing loss.
Future Implications
The integration of hearing aid technology into mainstream consumer products like AirPods Pro 2 could normalize the use of assistive devices and encourage earlier intervention for hearing loss. Experts emphasize that while this technology offers a convenient entry point, it may not be suitable for everyone, and individuals with more severe hearing loss should still consult with audiologists or healthcare professionals.
Apple's move is part of a broader trend of incorporating digital health features into its products. The company continues to innovate in the health space, offering users tools for prevention, awareness, and assistance related to various health conditions.
