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Apple AirPods Pro 2 Approved as Over-the-Counter Hearing Aids by FDA

Apple AirPods Pro 2 can soon be used as hearing aids after receiving Food and Drug Administration (FDA) clearance. This development is considered a game changer for the hearing aid market.

FDA Authorization

The FDA authorized a software called Hearing Aid Feature (HAF) that allows Apple AirPods Pro 2 and other compatible Apple AirPods Pro devices to function as hearing aids when paired with an iOS 18-compatible iPhone or iPad. This marks the first time the FDA has authorized an over-the-counter hearing aid software.

Release of iOS 18

iOS 18, the software through which HAF will be available, is set to arrive by October. The new HAF is designed for the estimated 30 million Americans who suffer from mild to moderate hearing loss due to aging, exposure to loud noises, certain medical conditions, and other factors.

Features of HAF

The application will include a hearing test, the results of which are used to customize volume, tone, and balance settings built into the hearing aid. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, stated that today’s marketing authorization advances the availability, accessibility, and acceptability of hearing support for adults with mild to moderate hearing loss.

Over-the-Counter Hearing Aid Regulations

In October 2022, the FDA established over-the-counter hearing aid regulations, allowing consumers to purchase these devices in stores rather than at a physician’s office. This change makes it easier for many to access assistive devices at a lower price point. Apple AirPods Pro 2 retail for $249, which is significantly less than the cost of other models of OTC hearing aids.

Impact on the Hearing Aid Market

Experts believe Apple’s entry into the hearing aid market will encourage more people with hearing loss to seek assistance. The ubiquity of ear buds like Apple AirPods among all populations could also help reduce the stigma associated with hearing aids. Barbara Kelley, executive director of the Hearing Loss Association of America, noted that Apple’s mainstream appeal and attention to hearing health could significantly impact overall health.

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