FDA Authorizes First-Ever Over-the-Counter Hearing Aid Software That Works with AirPods

As a long-time advocate for accessible and affordable technology, I can’t help but feel a surge of excitement at this groundbreaking announcement! Growing up with hearing difficulties, I’ve always been on the lookout for solutions that could make life easier without breaking the bank.


Hearing aids are not cheap. At least they haven’t been in recent history. However, that might change soon. For the first-time ever, the Food and Drug Administration has authorized an over-the-counter hearing aid software. The FDA has approved Hearing Aid Feature, a device that will work with versions of the Apple AirPods Pro headphones.

In a statement approving the Hearing Aid Feature (HAF), the FDA explained that the software will boost sounds for adults aged 18 and above who have a perceived mild to moderate hearing loss. This development essentially turns certain Apple AirPods Pro earbuds into functional hearing aids. Once installed, users can personalize the software according to their specific requirements, as HAF employs a self-fitting approach. To clarify, this means that the software will adapt to the unique contours of an individual’s ear canal and listening preferences automatically, making it easier for users to adjust the settings to suit their needs.

The Hearing Assistance Factor (HAF) is configured using an Apple device such as an iPhone or iPad, and it draws data on hearing levels directly from the HealthKit on iOS. This information allows for personalized adjustments to be made on the HAF. Once set up, users have the ability to fine-tune volume, pitch, and balance settings according to their preferences.

Approval was granted following a U.S.-based clinical trial involving 118 participants with varying degrees of mild to moderate hearing loss. HAF’s self-fitting method yielded results similar to those who underwent professional fitting of the same device, demonstrating that it delivers comparable benefits. The study outcomes revealed consistent performance in measurements of ear canal amplification and noise-reducing speech understanding ability, with no device-related adverse events reported during this trial.

As a gamer, I remember back in the day, it seemed like a dream come true when affordable over-the-counter hearing aids were introduced in 2022. Before that, getting prescription and fitting adjustments from an audiologist was the only option, which required a medical exam for those who needed hearing aids. It’s incredible how technology keeps reshaping our world for the better!

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2024-09-17 17:32