Apple AirPods Pro 2 Approved as Over-the-Counter Hearing Aid by FDA

Apple’s new AirPods Pro 2 have been approved by the Food and Drug Administration (FDA) as an over-the-counter hearing aid, marking a significant milestone in the company’s efforts to improve accessibility and availability of hearing assistance for adults with mild to moderate hearing loss.

According to Michelle Tarver, M.D., acting director of the FDA’s Center for Devices and Radiological Health, “Today’s marketing authorization of over-the-counter hearing aid software for widely used consumer audio products is another step toward improving the availability, accessibility, and acceptability of hearing assistance for adults with mild to moderate hearing loss.”

The FDA reports that more than 30 million Americans experience some degree of hearing loss. Apple’s new mobile feature allows users to customize their devices with self-tailored strategies that can help them adjust their hearing needs without the help of a hearing professional.

Consumers can purchase products in stores or online retailers without a health screening, prescription, or visit to an audiologist, thanks to new FDA regulations introduced in October 2022.

AirPods Pro 2 will offer “clinical-grade” hearing testing and professional-grade hearing aids for iPhone and iPad users, which Apple claims are the world’s first software-based hearing aid features.