FDA Approves First OTC Hearing Aid Software Compatible With Apple's AirPods Pro

The FDA has approved the first over-the-counter (OTC) hearing aid software device for use with compatible versions of Apple Inc.’s AAPL AirPods Pro headphones.

Known as the Hearing Aid Feature (HAF), the software is designed to enhance accessibility for individuals 18 and older with perceived mild to moderate hearing impairment. This approval marks a significant milestone in the expansion of consumer hearing solutions.

The HAF allows users to transform their AirPods Pro into an OTC hearing aid by installing and customizing the software to their hearing needs.

According to the FDA, this device is expected to improve access to affordable hearing solutions, especially for those who might otherwise avoid seeking professional care.

Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, emphasized that this move enhances the availability, accessibility, and acceptability of hearing support for adults.

The Hearing Aid Feature leverages a self-fitting strategy, enabling users to adjust volume, tone, and balance settings using an iOS device like an iPhone or iPad.

The software also integrates with iOS HealthKit, tailoring the hearing experience to the user’s needs. In a clinical study involving 118 participants, the HAF demonstrated results comparable to those of professionally fitted hearing aids, showing similar levels of sound amplification and speech understanding in noisy environments.

This software is the first of its kind to be cleared under the FDA’s De Novo premarket review pathway, which allows for the introduction of novel low-to-moderate-risk devices.

The approval is part of a broader regulatory change that started with the FDA’s October 2022 OTC hearing aid rules, which allowed consumers to purchase hearing aids without a medical exam or audiologist consultation. These regulations aim to improve access to safe and effective hearing aids for millions of Americans with mild to moderate hearing loss.

Research has linked the use of hearing aids to reduced cognitive decline, depression, and other health issues, making affordable hearing solutions a crucial public health concern.

Price Action: AAPL stock is up 0.32% at $223.38 at the last check on Thursday.

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