FDA Approves OTC Hearing Aid Software for Apple AirPods Pro: Transforming Hearing Health

Groundbreaking Announcement in Hearing Health

The FDA has officially approved the first-ever over-the-counter (OTC) hearing aid software that integrates seamlessly with Apple’s AirPods Pro.

Enhanced Hearing Solutions

This innovative announcement follows closely behind Apple’s introduction of the new Hearing Aid feature alongside a clinically validated Hearing Test feature for its AirPods Pro earbuds.

• This integrated approach allows users to conduct a quick hearing test in approximately five minutes from home.
• The results create a customized hearing profile directly within the AirPods Pro.

Accessibility and Empowerment

According to Sarah Herrlinger, Apple’s senior director of Global Accessibility Policy and Initiatives, these advancements will significantly impact countless individuals by enhancing awareness about hearing health.

“For decades, Apple has led the way in involving products catering to diverse hearing abilities,” said Herrlinger.

FDA's Perspective on Hearing Loss

Dr. Michelle Tarver, the acting director of the FDA's Center for Devices and Radiological Health, emphasized that hearing loss is a pressing public health concern affecting millions. The FDA's approval represents a major stride towards improving the availability and accessibility of hearing support for adults facing mild to moderate hearing loss.

What’s Next for Apple Users?

Apple users can expect the new Hearing Aid feature, validated through a controlled study, to be available in an upcoming iOS software update.