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.