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
embarrassing Since they are so heavily used by people in multiple
demographics, hearing aids could conceivably become a more socially
acceptable accessory again. Apple may also give otolaryngologists reasons to
hope that more people with hearing loss will seek help since the new devices
represent a stylish, socially acceptable alternative (“How Apple and Google
changed the world — even after Jobs and Page were gone”). A more accessible
price point for AirPods Pro 2, likely set at $249 compared to few thousand
dollars for other over-the-counter hearing aids, might help in its
adoption.
