Apple's New OTC Hearing Aid Mode for AirPods Pro Earbuds Gains Approval from FDA
Only three days after Apple made its announcement introducing an OTC hearing aid feature mode for Apple AirPods Pro 2 earbuds, the FDA approved the software)
The US Food and Drug Administration announced that it has authorized the first over-the-counter (OTC) hearing aid software, Apple's Hearing Aid Feature (HAF), for use with the Apple AirPods Pro 2. As described in HearingTracker's article published on Monday, the new HAF mode gives users the option to convert all Apple AirPods Pro 2 earbuds and other compatible headphone versions into a set of OTC hearing aids. With some 100 million AirPods users worldwide—and the earbuds' wide availability for about $250—Apple's new hearing aid mode is arguably the biggest leap ever in the global accessibility of amplification.
HearingTracker Audiologist Matthew Allsop provides his perspective on Apple's new hearing health features in AirPods Pro 2.
The time span between Apple's unveiling of the new Hearing Aid Feature at its Glowtime launch event on Monday and today's FDA marketing authorization was surprisingly short. The FDA says the application was reviewed under its De Novo premarket review pathway, a regulatory pathway for some low—to moderate-risk devices that are novel and for which there is no prior legally marketed device. The first official OTC hearing aid, Bose SoundControl (now Lexie Powered by Bose), was also granted approval via the De Novo process.
The HAF was evaluated in a clinical study with 118 subjects who had perceived mild to moderate hearing loss, at multiple US sites. Study participants' hearing was assessed in various conditions: using traditional hearing aids, using AirPods Pro in transparency mode (which amplifies environmental sounds), and without any assistive device. They found that Apple AirPods Pro offered some hearing improvement, particularly in quiet environments, but weren't as effective as traditional hearing aids, especially in noisy environments. The study drew attention because it showed that consumer earbuds with features like transparency mode could benefit people with milder hearing losses.
)
The independent HearAdvisor lab found similar results during its testing of Apple Airpods Pro 2. The devices, when in transparency mode and configured to compensate for a common type of mild-to-moderate (N4) hearing loss, attained a SoundGrade of "C," placing AirPods Pro near the middle (ranked 34th of 54) of all OTC hearing aids and hearables tested by the lab. However, the testing also suggested that the devices could attain significantly better results if properly tuned to more audiometrically accurate settings.
According to the FDA, the HAF is a software-only mobile medical application that is intended to be used with compatible versions of the AirPods Pro. The HAF utilizes a self-fitting strategy, and users may adjust it to meet their hearing needs without the assistance of a hearing professional. It is set up using an iOS device (e.g., iPhone, iPad), and the user’s hearing levels are accessed from the iOS HealthKit to customize the HAF. Users can refine the volume, tone, and balance settings after setting up the HAF.
For more details, please see the article Apple to Convert All AirPods Pro 2 Earbuds into FDA-Registered Hearing Aids. HearingTracker expects an announcement from Apple regarding the HAF mode availability soon.
)