Apple's AirPods Pro 2 now let users in France test their hearing and reduce loud noises, but the hearing aid feature is stuck in regulatory limbo.
AirPods Pro
Apple has introduced new health-focused capabilities for the AirPods Pro 2, including a hearing test and loud sound reduction. However, a critical feature -- hearing aid functionality -- remains unavailable in France due to regulatory restrictions.
In September 2024, the company introduced new auditory features for its AirPods Pro series, coinciding with the launch of the iPhone 16. These updates aim to enhance hearing protection and provide corrective support for users with varying auditory needs.
One of the key innovations is Loud Sound Reduction, designed to protect users' ears by automatically dampening loud or intermittent noises. The feature acts like a noise-canceling mechanism, offering relief in environments such as busy subway stations or during large public events.
Another major addition is the Hearing Test, which allows users to evaluate their hearing health directly through the AirPods. The test generates a detailed auditory report by playing low-volume tones and prompting users to confirm when they hear them. Apple claims this tool provides results comparable to professional audiometry exams.
The most advanced feature, Hearing Aid Mode, adjusts ambient sound levels in real time based on the results of the hearing test. By doing so, it mimics the functionality of traditional hearing aids, offering personalized auditory correction.
Government regulations
While Apple has implemented the hearing test and loud sound reduction features in France, the hearing aid mode remains inaccessible. Regulatory approval from health authorities is required, and delays are anticipated until at least 2025, according to Numerama.
France and other European nations have health regulations that limit the implementation of features like hearing aid functionality. Despite being available in over 100 countries since October 2024, the capability is still restricted in several EU regions.
AirPods Pro
Regulatory challenges stem from the device's classification, which overlaps with medical equipment standards. In many countries, including the EU, products designed to diagnose, monitor, or correct hearing impairments must comply with strict medical device standards.
These standards include clinical testing, safety certifications, and approvals from health authorities. For hearing aids or similar devices, the Medical Device Regulation (MDR) in the EU ensures products meet safety, efficacy, and quality benchmarks before marketing.
Apple's hearing aid mode, which adjusts sound levels based on auditory test data, likely falls under these stringent requirements. Until certifications are obtained, features like this may be unavailable in regulated markets like France.
The hearing test is available from iOS 18.1, and October 2024 firmware updates for the AirPods Pro 2. Users can find it in the Health app or through AirPods settings.