FDA Approves Apple AirPods Pro 2 As First OTC Hearing Aids

Photo Credit: Apple

The U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter hearing aid software for the Apple AirPods 2 Pro.Apple advertised its AirPods Pro 2 as a personalized hearing aid that would be “available in an upcoming software update.” These earbuds are capable of boosting specific sounds in real-time, including parts of speech or elements within a users’ environment. The hearing aid feature will be available this fall for the AirPods Pro 2 model across more than 100 different countries.

“Hearing health is an essential part of our overall wellbeing, yet it can often be overlooked,” says Sumbul Desai, M.D. “According to the Apple Hearing Study, a staggering 75% of people diagnosed with hearing loss go untreated. We’re thrilled to provide breakthrough software features with AirPods Pro that put users’ hearing health forefront and center, bringing new ways to help test for an receive assistance for hearing loss.”

The AirPods Pro 2 can assist people with mild to moderate hearing loss. Using the personalized hearing profile from Hearing Test, this new feature seamlessly transforms AirPods Pro 2 into a clinical-grade hearing aid. After setup, the feature enables personalized dynamic adjustments so users have the sounds around them boosted in real-time.It helps users better engage in conversation and keeps them connected to the people and environment around them. “This first-of-its-kind software-based Hearing Aid feature brings users the ability to fine-tune their experience at any time, making access to hearing assistance easier than ever at an approachable price point.”

Users can set up the Hearing Aid feature with an audiogram created by a hearing health professional. Both the Hearing Test and Hearing Aid features are grounded in science and were validated through rigorous scientific studies. More than 30 million American adults report some degree of hearing loss—which can be caused by aging, exposure to loud noises, certain medical conditions, and other external factors.

With the FDA authorization of Apple’s Hearing Aid feature, this is the first software-driven hearing aid solution. Users set up their hearing profile using an iPhone, while hearing levels can be accessed from the iOS HealthKit app to customize.