FDA announcements and news reports

FDA Approves First OTC Hearing Aid Software for Apple AirPods Pro, Including AirPods Pro 2

Sep 12, 2024, 05:10 PM

The U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter hearing aid software device, intended to be used with compatible versions of Apple’s AirPods Pro headphones, including the AirPods Pro 2. This new feature, called the Hearing Aid Feature, allows the AirPods Pro to function as hearing aids by boosting sounds in real-time. The approval marks a significant advancement in health-related technologies for consumer electronics, allowing users to access hearing aid capabilities without a prescription. The software was reviewed under the De Novo pathway.