Apple has taken the next step in integrating its users' health into its products. On Thursday, the company received approval in the United States to turn some of its wireless earphones, the AirPods, into hearing aids.
Apple's AirPods Pro 2 can now function as customized hearing aids, thanks to a software update. This FDA-approved feature allows specific sounds, such as speech or environmental elements, to be amplified in real-time.
According to the FDA, the device is designed for adults with mild to moderate hearing loss. Users can test their hearing in just a few minutes by downloading the latest software update to their iPhone or iPad for free. Based on the test results, the headphones will automatically adjust volume and tone to suit individual needs.
"Hearing loss is a significant public health issue affecting millions of Americans," said Michelle Tarver from the FDA. She noted that approving this feature for a widely available audio product without a prescription marks a major step toward making hearing aids more accessible.
A clinical trial involving 118 participants demonstrated that users who adjusted the settings themselves achieved outcomes comparable to those set by professionals.
Source : Apple
The AirPods Pro 2, priced at $249 excluding tax ($279 in France), will support this new hearing aid feature. Apple plans to roll it out in over 100 countries and regions, including Germany and Japan, starting this autumn, pending local approvals. This move aligns with a 2022 FDA ruling that allows the sale of hearing aids without a doctor’s prescription, aiming to lower costs and enhance accessibility.
Barbara Kelley, executive director of the Hearing Loss Association of America (HLAA), praised the development: "The fact that a product millions already own can now serve as a hearing aid is a significant step forward."
The stand-alone hearing test consists of a series of sounds that the user listens to and responds to by tapping the screen. This feature can also benefit people without identified hearing issues who want to enhance their listening experience in specific situations.
Hearing loss, often caused by aging or exposure to loud noises, can impact well-being and social interactions. According to the FDA, wearing hearing aids has been shown to slow cognitive decline and reduce depression in the elderly.
With this update, Apple continues to expand its presence in healthcare—a strategy that boosts both societal impact and revenue. On Monday, the company also introduced a new feature for its smartwatch, designed to detect sleep apnea.
Shares in European hearing aid manufacturers fell after Apple's announcement, but recovered quickly. Companies such as Amplifon, Sonova, Demant and GN Store could be affected by Apple's entry into this market.
Source : MarketScreener.com
However, Jefferies analysts argue that over-the-counter (OTC) hearing aids are aimed at a different demographic and still fall short of prescription devices in terms of technology and service.
Vontobel analysts further note that, unlike dedicated hearing aids, AirPods are not customized and do not require professional installation at a hearing center. They believe this initiative could raise awareness about hearing loss and expand the hearing aid market, particularly for those with mild conditions.
The transformation of AirPods into hearing aids represents a significant advancement for both Apple and the hearing aid industry, providing an accessible solution to a widespread public health issue.
Apple Inc. specializes in the design, manufacture and marketing of computer hardware and music supports. Net sales break down by family of products and services as follows:
- telephone products (52.1%): iPhone brand;
- peripheral devices (10.5%): screens, storage systems, printers, video camera, memory cards, server, switches, etc.;
- computers (10.2%): laptops (MacBook, MacBook Air and MacBook Pro brands) and PCs (iMac, Mac mini, Mac Pro and Xserve);
- music support (7.4%): music readers iPod and iPad and accessories;
- other (19.8%): software, maintenance service and Internet access service, etc.
Net sales are distributed geographically as follows: Americas (42.4%), China/Hong Kong/Taiwan (18.9%), Japan (6.3%), Asia/Pacific (7.7%) and Europe/India/Middle East/Africa (24.7%).