Apple obtains FDA nod for hearing aid software for selected Airpods

The FDA has authorized a hearing aid feature for select Apple AirPods Pro models, making Apple the first company to gain approval for over-the-counter (OTC) hearing aid software. This follows Apple's de novo premarket application and comes two years after FDA regulations allowed hearing aids to be sold without prescriptions.

Apple validated the technology through a study of 118 people with mild to moderate hearing loss, finding that self-fitted AirPods provided similar results to professional fittings. The FDA identified risks such as physical discomfort and insufficient amplification but outlined mitigation measures for these issues.

Apple plans to launch the feature in the fall, allowing AirPods Pro 2 users to perform a hearing test and adjust their devices based on the results. This development positions Apple to compete in the OTC hearing aid market, alongside other companies like Sony and Lexie.