The Food and Drug Administration (FDA) gives approval for Apple's AirPods Pro to function as personal hearing aids.

The Food and Drug Administration (FDA) gives approval for Apple's AirPods Pro to function as personal hearing aids.

Apple's recent event saw the company demonstrating its AirPods Pro earbuds functioning as hearing aids, much to everyone's excitement. The missing piece of the puzzle was regulatory approval, which was swiftly provided by the U.S. Food and Drug Administration (FDA) on Thursday. The FDA gave the green light for AirPods Pro to function as a "hearing aid software device," making it the first OTC hearing aid solution implemented as a software feature for an existing product.

The new feature includes several enhancements for iPhones and the Apple Health App. The standout capability is an assistance mode for earbud wearers, boosting sounds such as speech or music in real-time. Users need to take a series of tests with an iPhone to create their unique listening profile. Alternatively, they can set it up with an audiogram crafted by a doctor.

The FDA conducted a clinical study involving 118 subjects with mild to moderate hearing loss, showcasing that the feature provided similar benefits as professionally fitted devices. There were no reported adverse effects from participants who trialed the new software. The hearing aid feature will be rolled out in an update for the AirPods Pro 2 later this fall.

This move comes in the wake of President Joe Biden's executive order and FDA approval of OTC hearing aids without the need for a prescription. The goal was to provide more options for the 30 million U.S. citizens suffering from hearing issues without the exorbitant costs associated with prescription medical devices.

Rumors of Apple transforming its AirPods into OTC hearing aids have been circulating for years. Apple has been building upon its accessibility features, such as Live Listen, which allows an iPhone or iPad to access a sound-boosting microphone, and previous studies showing AirPods' potential as a low-cost sound amplification device.

While this new feature is a significant step forward, it's important to note that the AirPods Pro 2 with the hearing aid feature is not FDA-approved as a medical-grade hearing aid. Nonetheless, it offers a clinical-grade hearing aid feature that can enhance sound amplification and noise reduction for individuals with perceived mild to moderate hearing loss.

In comparison to other OTC hearing aids like ELEHEAR Beyond, the AirPods Pro 2 is a more affordable option, priced at $170. The ELEHEAR Beyond, on the other hand, is designed for people with mild to moderate hearing loss and offers more targeted features like volume amplification and noise reduction. The choice between these devices depends on the specific needs of the user.

The new AirPods Pro feature, approved by the FDA, categorizes AirPods as a "hearing aid software device," making it the first OTC solution in this category for an existing product. The tech giant is leveraging its existing technology, like Live Listen, to provide real-time sound amplification, showcasing its commitment to tech innovation in the healthcare field. The projected cost of the AirPods Pro 2 with this feature is considerably lower than many OTC hearing aids, potentially making high-quality hearing solutions more accessible to a wider audience.

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