Apple’s AirPods Pro hearing aid software gets FDA approval

Just days after Apple unveiled a new hearing aid feature for its second-generation AirPods Pro, the US Food and Drug Administration (FDA) has granted authorization for the software that enables this function.

The FDA's press release highlights Apple's solution as “the first over-the-counter (OTC) hearing aid software device.”

According to the FDA, the feature was tested in a clinical study involving 118 participants with mild to moderate hearing loss.

The study found that users of Apple's self-fitting hearing aid strategy experienced benefits comparable to those who had professional fittings with the same device.

This fall, Apple is enhancing its second-generation AirPods Pro with new features focused on hearing health.

In addition to introducing clinical-grade hearing aid capabilities, the earbuds will also offer a Hearing Protection mode. This feature, which will be enabled by default, is designed to protect users' ears in noisy settings such as concerts while maintaining "natural and vibrant" sound quality.

AirPods Pro users will also gain access to a new Hearing Test, which prompts them to tap the screen when they hear different tones through the earbuds. Results from this test will be displayed in Apple’s Health app and used to customize the hearing aid feature.

By integrating hearing aid functionality, Apple aims to reduce costs for users seeking to protect their hearing. The World Health Organization estimates that 1.5 billion people worldwide experience some degree of hearing loss.

The FDA indicates that Apple’s application for the hearing aid feature was reviewed under the De Novo classification, which is used for "low- to moderate-risk devices that are novel and do not have a prior legally marketed counterpart."