Apple AirPods Pro 2 Gain FDA Approval as Over-the-Counter Hearing Aids
The FDA grants Apple permission to turn AirPods Pro 2 into clinical-grade hearing aids through a simple software update. This milestone makes the earbuds the first over-the-counter hearing aid software device approved in the United States.
The FDA officially grants Apple approval to turn the AirPods Pro 2 into over-the-counter hearing aids through a software update. This landmark decision marks the first time a widely used consumer audio product receives authorization to function as a medical hearing device. The new feature specifically targets adults with perceived mild to moderate hearing loss.
Users access this capability directly through the iOS 18 settings menu when their AirPods Pro 2 are connected. To unlock the hearing aid functionality, users must either take an Apple-provided hearing test built into the software or upload existing test results from a doctor. Once activated, the system adjusts different frequency levels to amplify key sounds like the human voice.
This development stems from a 2022 FDA rule that allows the sale of hearing aids without a prescription. That regulatory shift opens the door for tech companies to introduce more accessible and affordable hearing solutions to millions of Americans. Apple's integration of this medical feature into existing hardware signals a major step in blending consumer electronics with personal healthcare.