The FDA greenlights Apple’s Hearing Aid feature for AirPods Pro

The FDA has approved Apple's over-the-counter Hearing Aid feature for second-gen AirPods Pro, designed for individuals with mild to moderate hearing loss. The feature includes a self-administered hearing test that has shown similar benefits to professional fittings. The software-based test starts by ensuring a good earbud seal, then plays tones and asks users to indicate when they hear them. The results are stored in the Health app and can be shared with audiologists. If the test indicates severe hearing loss, professional assessment is recommended. Apple developed the feature using extensive data and simulations. The FDA reviewed the application under its De Novo premarket pathway for novel devices with low risk. The Hearing Aid and Hearing Test features will become available with the iOS 18 launch on September 16th, and require second-gen AirPods Pro. The feature is expected to be quick and easy to use, based on early previews.