Apple AirPods Pro 2 receive FDA authorization as hearing aid software

Apple has introduced a hearing aid feature for the AirPods Pro 2, designed to assist adults with mild to moderate hearing loss. This development marks a significant shift as consumer audio hardware integrates medical-grade amplification capabilities.

On September 12, 2024, the United States Food and Drug Administration (FDA) granted marketing authorization for the Hearing Aid Feature (HAF) via the De Novo premarket review pathway. This makes it the first over-the-counter (OTC) hearing aid software device. Clinical trials involving 118 adults demonstrated that the autonomous self-fitting interface provided speech intelligibility and functional benefits statistically equivalent to professional audiologist fittings, with no recorded adverse events.

While standard earbuds use transparency modes to amplify ambient noise, this specialized feature adjusts specific frequencies to address individual hearing difficulties, such as trouble perceiving certain consonants. Following the US rollout, the technology is expected to reach the United Kingdom in early 2025 under MHRA registration, with further European Union availability pending CE marking.