Apple's AirPods Pro 2 have received FDA approval that allows them to be classified as over-the-counter hearing aids, marking one of the latest milestones for those with mild to moderate hearing loss.
FDA Approval for AirPods
The Hearing Aid Feature (HAF) software was approved by the FDA and cleared for marketing on September 13, 2024, which allowed AirPods Pro 2 to double as over-the-counter hearing aids when connected to compatible devices running iOS 18. At the time (and indeed still — this is until today all but vaporware), this was a new frontier for the FDA in authorizing OTC hearing aid software..., essentially as an aspect of a consumer audio product. The action is intended to help meet the needs of the more than 30 million people in the US with hearing loss — often a mild or moderate variety stemming from aging, noise exposure, and diseases such as diabetes or multiple sclerosis.
Hearing Aid Feature Software
The Hearing Aid Feature (HAF) software will enable AirPods Pro 2, which may allow an undetermined level of personalized dynamic adjustments to amplify surrounding sounds in real-time up to clinical-grade hearing aids. This cutting-edge technology functions to automatically apply the user's personal hearing profile over a range of sound experiences — including music, movies and phone calls. The eventual software update will be available in more than 100 countries and regions, which suggests it's aimed at people with what Apple deems to be mild-to-moderate hearing loss.
AirPods Pro 2 Accessibility
AirPods Pro 2 provide end-to-end hearing health, featuring professional active Hearing Protection, an NHS scientific validated Hearing Test and a medical-grade Hearing Aid feature. Its app enables users to get a quick hearing test in just five minutes from the comfort of your own home, giving them an easy and concise verdict complemented by audiograms that can be shared with health service providers. This new model can help tackle the problem of unaided hearing loss — the Apple Hearing Study found 75% of those studied with hearing loss had never used assistive support.
Reducing Hearing Aid Stigma
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