FDA Authorizes Apple's OTC Hearing Aid Software

(RTTNews) - The U.S. Food and Drug Administration authorized Apple Inc.'s over-the-counter or OTC hearing aid software device, Hearing Aid Feature, a first of its kind. The tech major intends to use the new software with compatible versions of the Apple AirPods Pro headphones.

The Hearing Aid Feature or HAF, once installed and customized to the user's hearing needs, enables compatible versions of the AirPods Pro to serve as an OTC hearing aid. It amplifies sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.

HAF is a software-only mobile medical application, and utilizes a self-fitting strategy. Users may adjust it to meet their hearing needs without the assistance of a hearing professional. The HAF is set up using an iOS device, such as iPhone and iPad, and the user's hearing levels are accessed from the iOS HealthKit to customize the HAF. Users can refine the volume, tone and balance settings after setting up the HAF.

The marketing authorization for HAF was based on a clinical study with 118 subjects with perceived mild to moderate hearing loss, at multiple U.S. sites. As per the trial results, subjects who used the HAF self-fitting strategy achieved similar perceived benefit as those who received professional fitting of the same device.

The application was reviewed under the FDA's De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

While launching the software upgrade for its latest AirPods Pro 2 earbuds, Apple had expressed optimism that those features would soon receive marketing authorization from global health authorities, with availability scheduled for this fall in over 100 countries, including the United States, Germany, and Japan.

Apple then added that the new health features would be compatible not only with the latest hardware but also with previously sold Apple devices.

It's important to note that the hearing aid feature will not be available for individuals without hearing loss or those with severe to profound hearing impairment. In such cases, the app will recommend that these users consult a hearing specialist.

In the United States, more than 30 million adults report some degree of hearing loss, and hearing aids reduces the frequency or severity of cognitive decline, depression and other health problems in older adults.

In August 2022, the FDA had issued a final rule to improve access to hearing aids, establishing a new category of OTC hearing aids, with a view to lowering costs for millions of adults with mild to moderate hearing loss.

As per the agency's OTC hearing aid regulations established in October 2022, it is ensured that adults with mild to moderate hearing loss have improved access to more safe and effective product options.

The rule followed President Biden's Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter.

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