The Food and Drug Administration has approved Apple’s over-the-counter Hearing Aid feature, designed for people with mild to moderate hearing loss. It transforms the second-gen AirPods Pro into OTC hearing aids, following the FDA’s decision to allow adults with less-than-severe impairment to use corrective consumer hearing devices without a professional test, prescription, or fitting. Apple’s software-based Hearing Test for AirPods Pro showed similar benefits to professional fittings, with the FDA reporting no adverse events from using the device as an OTC hearing aid. The feature begins with a hearing test on a paired iPhone or iPad, activating active noise cancellation and testing tones in the left and right ears. Results can be monitored in the iOS Health app, downloadable for audiologist review if needed. Engadget’s Billy Steele got an early preview of the feature after Apple’s big iPhone 16 event, describing the process as quick and easy. Apple developed the feature using real-world audiograms and simulations, with FDA approval under the De Novo premarket pathway. The Hearing Aid and Hearing Test features will launch when iOS 18 goes public on September 16, requiring the second-gen AirPods Pro for use.
