FDA Approves First Over-the-Counter Hearing Aid Software Compatible with Apple AirPods Pro

FDA approves first over-the-counter hearing aid software for use with compatible versions Apple Inc. (NASDAQ:AAPL) AirPods Pro headphones.

The software, known as Hearing Aid Feature (HAF), was designed to increase accessibility for people aged 18 and older with perceived mild to moderate hearing impairments. This approval marks a significant milestone in the expansion of consumer hearing solutions.

With HAF, users can transform their AirPods Pro into an over-the-counter hearing aid by installing and customizing software to suit their hearing needs.

According to the FDA, the device is intended to improve access to affordable hearing correction solutions, especially for people who would otherwise avoid seeking professional care.

Michelle TarverThe director of the FDA’s Center for Devices and Radiological Health emphasized that this step increases the availability, affordability and acceptability of hearing aids for adults.

The hearing aid feature uses a self-fitting strategy, allowing users to adjust volume, tone, and balance settings using an iOS device such as an iPhone or iPad.

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

The software is the first of its kind to receive marketing approval under the FDA’s De Novo process, which allows for the introduction of innovative devices with low or medium risk to the market.

The approval is part of a broader regulatory shift that began with the FDA’s October 2022 rule for OTC hearing aids, which allowed consumers to purchase hearing aids without a medical exam or consultation with an audiologist. The rule aims to improve access to safe and effective hearing aids for millions of Americans with mild to moderate hearing loss.

Studies have linked hearing aid use to cognitive decline, depression and other health problems, making affordable hearing solutions a vital public health issue.

Price action: AAPL shares were up 0.32% at $223.38 as of last check on Thursday.

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Photo via Apple

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This article FDA Approves First Over-the-Counter Hearing Aid Software Compatible with Apple’s AirPods Pro originally appeared on Benzinga.com