Apple to Convert All AirPods Pro 2 Earbuds into FDA-Registered Hearing Aids, According to Plans

Apple announced today at its Glowtime launch that it is finally making the leap into over-the-counter (OTC) hearing aids with new software updates to its AirPods Pro 2 hearing aids. The “clinical grade” hearing aid mode Apple is implementing will allow users to enhance their hearing capabilities using the same AirPods they may already own. Apple expects the feature to gain FDA approval later this year.

If approved, the new feature essentially gives current users of Apple AirPods Pro 2 earbuds a free OTC hearing aid option, and non-users can buy them online or at Best Buy and other stores for around $250—an exceptional value. With some 100 million users of AirPods worldwide, this arguably makes the announcement the biggest leap ever in the global accessibility of amplification.

Apple's announcement of a hearing aid mode was widely expected: HearingTracker predicted in early 2023 that Apple would, stated or unstated, deliver an OTC hearing aid using its AirPods, and we also published an article in March about how Apple would continue to be “disrupting the disrupters” who are coming to define the products found in the 2-year-old OTC hearing aid market.

Apple also reports it is introducing an end-to-end experience focused on prevention, awareness, and assistance.

The Glowtime event also included the launch of the iPhone 16 and 16 Plus, Apple Watch Series 10, and sleep apnea alerts for Apple Watch—a continuation of Apple's commitment to make products that contribute to healthier lifestyles.

“With Apple Watch, we continue to offer our users the ability to uncover important health conditions with new sleep apnea notifications,” said Apple’s Vice President of Health Sumbul Desai, MD, in a press statement. “And on AirPods Pro, powerful features put users’ hearing health front and center, bringing new ways to help test for and receive assistance for hearing loss.”

How Apple AirPods Pro 2 earbuds compare to other OTC hearing aids

HearingTracker has reviewed positively and provided instructions about how to use Apple AirPods Pro 2 earbuds as assistive listening devices. Using its current configuration with the earbuds in Transparency Mode with hearing loss accommodations, Airpods Pro 2 is in the middle of the pack of OTC devices in terms of performance. The independent hearing test lab, HearAdvisor, ranks AirPods Pro 2 as the 34th best of 54 OTC hearing aids and hearables tested to date. It notes, “The Apple AirPods Pro 2 is a budget amplifier that fits in the ear and uses rechargeable batteries. It achieved a SoundGrade of C which places it in the top 50% in its category and the bottom 25% of all devices [including prescription hearing aids] tested.”

But with their already wide distribution and a $250 price tag, AirPods Pro 2 is an exceptional value—and obviously an even better value if you already own them. According to HearAdvisor data, only three other OTC hearing aids available for less than $250 performed better when amplifying sound for a common type (N4) of mild-to-moderate hearing loss: JLab Hear OTC ($99), Linner Saturn ($129), Lucid Enrich Pro ($199)—and these devices don’t come with Apple’s designs, app support, or necessarily their exceptional sound quality for streamed audio (see HearAdvisor for more detailed ratings).

It's unknown if the soon-to-come "OTC hearing aid mode" will deliver acoustic changes that would improve the hearing loss compensation technology already available in AirPods Pro 2. HearingTracker is planning to review the new features when they become available, so please stay tuned.

Apple's new awareness, assistance, and prevention features for better hearing health

Let's take a brief look at the three areas of hearing health that Apple focused on during today's Glowtime event.

Awareness: Apple’s new hearing test

As early as Apple’s 2018 WWDC, the company has offered software developers the Hughson-Westlake method for assessing pure-tone hearing thresholds online, as well as a method for assessing noise levels in the test environment. Currently, users of Apple AirPods Pro 2 can take a hearing test within Apple’s Health app using online hearing tests like Mimi and SonicCloud, or by entering their audiograms into the app if they’ve already been tested by an audiologist or hearing aid specialist. Once this is done, the test results are used to amplify and compensate for the appropriate frequencies automatically when listening to music, movies, games, and phone calls across their devices without needing to adjust any settings.

However, this has always been a somewhat clunky process that isn’t well known and is not always easy to set up for people who aren’t tech-savvy. In fact, simply having a more visible and automatic "hearing aid mode" that users can see and click on may be the most exciting facet of Apple's announcement.

In line with Apple’s All-in-One Hearing Health Experience, the new integrated hearing test is designed to be easy to complete. It follows a traditional pure-tone audiometry method and offers an interactive experience as before. The results are presented in a clear summary of the user's hearing status in a customized hearing profile for AirPods Pro. As with previous versions, the results are securely saved in the Health app, and users can opt to share them with their healthcare providers if desired.

Assistance: Apple Airpods Pro 2 as OTC hearing aids

A growing body of research supports the use of Apple AirPods Pro as OTC hearing aids for people with mild-to-moderate hearing loss. For example, researchers from the National Acoustic Laboratories (NAL) in Australia showed that the Conversation Boost and Ambient Noise Reduction features of AirPods Pro can improve hearing in background noise up to about 7 decibels (dB)—a large margin in terms of signal in noise benefit. A follow-up study by the same group also showed the AirPod Pro’s Active Noise Cancellation (ANC) system can reduce ambient noise levels by an average of 27 dB across frequencies—so you can add moderate hearing protection as one more important benefit for the devices.

“These changes just announced by Apple will allow the devices to be marketed as hearing aids and for hearing loss, and also will make it much easier to use the functionality that was previously buried deep within the iOS settings,” wrote NAL Director Brent Edwards, PhD. “I'm curious if there are any new hearing aid features in the AirPods themselves beyond what we have already tested.”

According to Apple, both the Hearing Test and Hearing Aid features are expected to receive marketing authorization from global health authorities soon. They are expected to be available this fall in more than 100 countries and regions, including the United States, Germany, and Japan.

“Hearing health is an essential part of our overall wellbeing, yet it can often be overlooked — in fact, according to the Apple Hearing Study, a staggering 75% of people diagnosed with hearing loss go untreated,” said Apple's Dr. Desai. “We’re thrilled to provide breakthrough software features with AirPods Pro that put users’ hearing health front and center, bringing new ways to help test for and receive assistance for hearing loss.”

Prevention: Loud Sound Reduction feature

Apple reports it is introducing Loud Sound Reduction to help AirPod Pro 2 users prevent exposure to loud environmental noise while preserving the sound signature of what they’re listening to. The H2 chip helps to actively reduce loud intermittent noise at 48,000 times per second, while the ear tips provide some passive noise reduction by blocking out sound. Activated by default across all listening modes, “Loud Sound Reduction is helpful in a variety of loud settings,” says Apple. “Plus, with an all-new multiband high dynamic range algorithm, sounds at live events like concerts remain natural and vibrant so users don’t miss a beat.”

Blurring the lines in hearables and OTC hearing aids?

Since at least the 1990s, hearing industry experts have predicted an age when we would start to see "total communication devices," an era when the lines between a hearing aid and all other communication devices would blur as they merge into a seamless network. Of course, this has already happened with the majority of advanced hearing aids that offer Bluetooth audio streaming including phone calls, artificial intelligence and digital assistants, fall alerts for caregivers, and more.

OTC hearing aids were created, at least in part, to disrupt the prescription-fit hearing aid market that features professionally dispensed devices that typically cost $1,500-$6,000+, with the goal of increasing affordability and accessibility. The OTC hearing aid market, with devices that cost $99-$2,500+, may now start to see more pressure and competition from products that have previously been considered the hearables, like AirPods Pro 2 and Samsung Galaxy Buds Pro. If, as expected, the FDA approves the Apple AirPods Pro 2 as FDA-registered OTC hearing aids, it should be interesting to see if more global consumer electronics giants follow suit and join brands like Sennheiser, Sony, Jabra, and Bose with products that offer better hearing.

This article was published on September 9, 2024 and updated on September 10, 2024.