The Food and Drug Administration (FDA) has approved Apple’s new AirPods Pro to double as an over-the-counter hearing aid.
The approval includes a software-only mobile medical application that functions as a hearing aid feature for consumers.
Driving the news: This new feature aims to enhance the accessibility, availability, and acceptability of hearing support for adults with mild to moderate hearing loss.
- Users can customize the device with a self-fitting strategy to adjust their hearing needs without requiring assistance from a professional.
- Since October 2022, consumers have been allowed to purchase hearing aid products without the need for a medical exam, prescription, or visit to an audiologist.
- Apple’s AirPods Pro 2 will offer a clinical-grade hearing test and a professional-grade hearing aid feature for iPhone and iPad users, claiming it to be the world’s first software-enabled hearing aid feature.
What they’re saying: “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,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.
