This device is developed for adults with mild to moderate hearing loss, according to the U.S. Food and Drug Administration (FDA) in a statement announcing its authorization.
Users will be able to test their hearing themselves in just a few minutes by downloading the latest software update for free on their Apple phone or tablet (iPhone or iPad).
The earbuds will then be able to “amplify sounds” based on the results, and the user can fine-tune the “volume and tone settings,” the FDA said.
“Hearing loss is a significant public health issue affecting millions of Americans,” noted Michelle Tarver, a senior official at the health agency.
The authorization of this over-the-counter device “on a widely-used audio product is a new step in advancing the availability, accessibility, and acceptability of hearing aids,” she added.
The product was tested in a clinical trial involving 118 people.
The results showed that those who set up the adjustments themselves “achieved a perceived benefit similar to those who had the device adjusted by a professional,” the FDA wrote.
The compatible earbuds will be the AirPods Pro 2, priced at $249 excluding taxes, Apple had announced on Monday.
The tech giant explained that the device works by “boosting frequencies to make sounds clearer.”
Apple expects this feature to be – subject to local health authority approval – available starting “this fall in over 100 countries and regions,” including Germany and Japan, in addition to the United States.
Step Forward:
Apple benefits in the U.S. from a 2022 FDA decision. At that time, the agency authorized the purchase of certain hearing aids directly from stores, without a medical prescription or adjustment by an audiologist, in order to lower prices and improve accessibility.
The cost of hearing aids in the United States can reach several thousand dollars.
“We are very pleased with Apple’s announcement,” said Barbara Kelley, executive director of the Hearing Loss Association of America (HLAA). “The fact that a product millions of people already own can offer hearing help and protection is a big step forward.”
The self-administered hearing test consists of a series of sounds the user listens to and responds to by tapping on their screen, Apple explains on its website.
The feature can also be used by people not necessarily diagnosed with hearing loss, but who want to increase certain sounds to better hear conversations, for example.
Hearing loss can be caused by various factors, such as aging or exposure to loud noises.
It can have consequences on the well-being of affected individuals and their relationships with others. Wearing hearing aids has been shown to slow cognitive decline or even depression in older adults, according to the FDA.
Dr. Apple?
More broadly, “Apple continues to push into the health sector,” noted independent analyst Carolina Milanesi for AFP, highlighting the financial benefits of this strategy for the company.
Apple also unveiled a new feature for its smartwatch, which will be able to detect if the wearer is suffering from sleep apnea.
“We are hoping for FDA approval and other regulators’ green lights very soon,” said Sumbul Desai, Apple’s vice president of health.
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