After years of dabbling in hearing health, Apple earlier this week went all-in, announcing that AirPods Pro, the tech giant’s top wireless earbuds, will soon double as hearing aids for people with milder forms of hearing loss.
Apple’s redoubled effort on hearing also includes software to test a person’s hearing and to customize the output of the hearing aid. This hearing aid feature, which boosts sound around users to make it more audible, is intended for people with mild to moderate hearing loss of the kind that can make it difficult to hear conversation in a noisy restaurant or other quiet sounds in everyday life — not for severe or profound hearing loss that requires professional treatment. Both the hearing aid and hearing test tools will be available in the United States this fall. Apple plans to launch the features worldwide.
On Thursday, the Food and Drug Administration announced that it had cleared the hearing aid feature via the De Novo pathway, calling it the “first over-the-counter hearing aid software device.” Clearance for the hearing test, which will be classified as an over-the-counter audiometer, is still pending.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily market-moving biopharma analysis — by subscribing to STAT+.
Already have an account? Log in
