Topline
The Food and Drug Administration on Thursday allowed the first over-the-counter hearing aid software device to hit the market, a feature Apple announced earlier this week would be compatible with its latest earbuds to assist consumers they say may be unaware they have hearing loss.
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Key Facts
The FDA approved the software device, “Hearing Aid Feature,” which the agency said could be installed on Apple’s AirPods Pro headphones to amplify sounds for anyone 18 or older with mild to moderate hearing impairment.
Apple announced Monday its upcoming Apple AirPods Pro 2 could “transform” into over-the-counter hearing aids through an upcoming software update that would increase some sounds in real-time, including voices or other sounds in a user’s environment.
Apple said it expects to include the hearing aid software in an update in the fall.
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Big Number
More than 30 million. That’s how many American adults have reported some degree of hearing loss, which can be caused by aging, exposure to loud noises and certain medical conditions, among other factors, the FDA said.
Key Background
The Hearing Aid Feature is new software intended to expand access to hearing support, the FDA said. Access was previously much more limited, the FDA noted, before the agency announced new regulations in 2022 allowing consumers with hearing impairments to purchase hearing aids directly from stores or online retailers without a medical exam or prescription. Apple has advertised the software as a benefit for “millions of people” unaware they are living with hearing loss, adding users can receive hearing tests through their iPhones. The software was evaluated in a study involving 118 participants with mild to moderate hearing loss, indicating patients who used the software received similar benefits to those who used traditional hearing aids, the FDA said.
Crucial Quote
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said in a statement the software’s authorization “advances the availability, accessibility and acceptability” of hearing support for adults.