FDA Approves Apple AirPods Pro 2 as Over-the-Counter Hearing Aid

Key Insights

• The FDA has authorized Apple's AirPods Pro 2 as an over-the-counter (OTC) hearing aid, marking the first approval of its kind for a software-driven consumer product.
• The new hearing aid feature is designed for adults 18 and older with mild to moderate hearing impairment, offering a clinical-grade solution.
• Users can conduct a hearing test via the AirPods Pro 2 and a paired iPhone to create a personalized sound profile based on detected hearing loss.

Apple's AirPods Pro 2 have received FDA approval as an over-the-counter (OTC) hearing aid, a first-of-its-kind authorization for a clinical-grade software device integrated into a consumer product. This approval allows Apple to introduce a new firmware update that transforms the existing AirPods Pro 2 into hearing devices for individuals aged 18 and older experiencing mild to moderate hearing deterioration.

Hearing Aid Feature Details

The hearing aid functionality requires users to perform a brief hearing test using the AirPods Pro 2 paired with an iPhone. This test assesses for any hearing loss, and upon detection, generates a customized sound profile. Sound and volume adjustments are then tailored to this profile, with test results accessible via the Health app on the iPhone.

Accessibility and Hearing Protection

While some AirPods models support Active Noise Cancellation (ANC), the hearing aid feature is currently exclusive to the AirPods Pro 2. Apple may extend this functionality to future AirPods models, such as the rumored AirPods Pro 3 expected by 2025.

In addition to the hearing aid feature, Apple is introducing a hearing protection mode, enabled by default, to safeguard users' hearing in loud environments. This mode utilizes passive noise isolation to reduce the impact of high-decibel sounds, such as those experienced at concerts or in industrial settings.