The US Food and Drug Administration (FDA) has announced the approval of the first over-the-counter hearing aid software designed to be used with compatible versions of Apple’s AirPods Pro headphones.
This marks a step forward in making hearing aids more accessible and affordable for millions of Americans. Earlier this week, Apple revealed that its AirPods Pro 2 would soon be “transformed” into personalised hearing aids through a software update. This update will enhance specific sounds in real time, including speech and environmental elements, providing users with a more tailored hearing experience.
The new hearing health features will be available this fall for AirPods Pro 2 users in over 100 countries and regions. Once installed and customised to the user’s individual hearing needs, the software enables compatible AirPods Pro models to function as over-the-counter hearing aids, designed to amplify sounds for adults aged 18 and older with mild-to-moderate hearing impairment.
“Hearing loss is a widespread public health issue affecting millions of Americans,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health. “The authorization of this over-the-counter hearing aid software advances the availability, accessibility, and acceptability of hearing support.”
More than 30 million American adults report some degree of hearing loss, which can be caused by various factors such as aging, exposure to loud noises, medical conditions, and other factors. The FDA’s approval of this software-based hearing aid solution aims to address this growing need by providing a convenient and affordable option for individuals with mild-to-moderate hearing impairment.
In 2022, the FDA approved the sale of over-the-counter hearing aids, allowing adults with mild-to-moderate hearing loss to purchase hearing aids directly from stores or online retailers without a medical exam, prescription, or audiologist visit. Apple’s Hearing Aid Feature, authorised on 12th September, 2024, is a software-only mobile medical application that is set up using an iOS device like an iPhone. The user’s hearing levels are accessed from the iOS HealthKit to customise the feature.
