The Food and Drug Administration (FDA) made a significant announcement on Thursday, revealing that it has granted authorization for Apple’s upcoming hearing aid functionality in the AirPods Pro 2.
The FDA referred to this development as the “first over-the-counter (OTC) hearing aid software device.” This news comes just days after Apple introduced the feature at its annual September event.
The FDA emphasized that the new hearing aid feature is specifically designed to “amplify sounds for individuals 18 years or older with perceived mild-to-moderate hearing impairment.”
“Hearing loss is a major public health issue affecting millions of Americans,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in the agency’s press release.
She added, “Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step toward increasing the availability, accessibility, and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
While I’ll delve deeper into the AirPods’ hearing aid functionality in a forthcoming article, it’s worth reiterating the significance of Apple’s move.
As I mentioned earlier, not only is Apple providing a clinically sound hearing test with clear and user-friendly results, but the fact that AirPods—already a cultural staple—are being transformed into legitimate hearing aids could change how society views hearing aids altogether.
Historically, traditional hearing aids have been utilitarian, often unattractive beige devices that improve hearing but lack style. To borrow a term from Alton Brown, they are “unitaskers”—functional but far from fashionable.
In contrast, AirPods are considered stylish and multifunctional. They serve as everyday listening devices for music, podcasts, audiobooks, and more, with features like active noise cancellation and transparency mode for conversations.
They also integrate seamlessly with Apple’s assistive technologies like the VoiceOver screen reader.
The bottom line is clear: for someone experiencing hearing loss who is already immersed in the Apple ecosystem, the AirPods Pro will soon be the best earbuds—and hearing aids—available. Full stop.
Of course, there are important caveats. First, the FDA clearly states that the AirPods hearing aid feature is intended for those with mild-to-moderate hearing loss. For individuals with more severe hearing impairment, prescription hearing aids remain the better option.
Additionally, it remains to be seen how effective Apple’s software will be in practice. As monumental as this news is, Apple is entering this space for the first time, and some issues may arise in its initial implementation.
This isn’t a criticism of Apple’s capability or ambition but simply an acknowledgment that no first attempt is ever perfect.
Furthermore, while Apple’s AirPods are groundbreaking in their versatility and performance, they aren’t the only players in the OTC hearing aid market.
For instance, Okra—a company founded by former Apple engineer Ben Sun—offers hearing aids that can also stream music and have a form factor similar to AirPods.
Okra has been featured in this column before, most recently in November when I interviewed Sun about the second-generation Okra One device.
Apple’s and the FDA’s announcements have also brought increased attention to accessibility, particularly in mainstream tech media.
Outlets have picked up on the story, highlighting its accessibility focus. At its core, the addition of hearing aid functionality to AirPods is about improving accessibility for individuals with hearing impairments.
While coverage of disability issues often trails behind other social justice topics like race and gender in both technology and journalism, the spotlight on AirPods’ hearing aid feature is a positive development.
In many ways, Apple’s decision to enhance AirPods with hearing aid capabilities is a smart continuation of its focus on health monitoring, much like what it has done with the Apple Watch.
From a journalistic perspective, Apple is a company that garners attention with nearly every move it makes.
The enthusiasm surrounding the AirPods and hearing aids in the media over the past few days reflects how impactful this development is.
It’s particularly noteworthy considering that coverage of accessibility in technology has historically lacked depth and breadth. This shift in focus is encouraging and marks a step forward for both tech and accessibility reporting.