Could Apple Disrupt OTC Hearing Aid Business?

13.09.2024 16:00

Twice.com

Buried within Apple’s grandiose iPhone 16 announcement on Sept. 9 was this tidbit: this fall, the company’s popular AirPods Pro 2 earbuds will be transformed into OTC hearing aids via software updates.

This seemingly minor announcement could radically transform the still-developing OTC hearing aid business. Consumers now need to spend only $250 for a pair of AirPods Pro 2 instead of more than $1,000 on current self-fitting OTC hearing aids – unless they are already one of the millions of existing AirPods Pro 2 owners.

“We are very excited about the Apple announcement,” enthuses Barbara Kelley, executive director of the Hearing Loss Association of America (HLAA). “It brings hearing help into the mainstream, encourages people to pay attention to hearing health, and helps reduce stigma around hearing loss treatment.”

Coming with updates to the AirPods Pro 2 firmware and iOS 18 will be what Apple calls a five-minute “clinically validated” hearing test similar to those found on current self-fitting hearing aids. The resulting hearing profile will be applied to the AirPods Pro 2 to create not only hearing aids similar to what an audiologist would create, but will automatically apply those settings to listening to music, movies, and phone calls across all Apple devices.

According to Dr. Sumbul Desai, Apple’s vice president of health, consumer test results “will be stored privately and securely in the [Apple] health app, where you can take regular tests learn more about hearing loss and share your results with your healthcare provider.” The updates will be available to AirPod Pro 2 and iPhone owners in more than 100 countries and regions including the U.S., Germany, and Japan.

FDA Approval, AirPods Popularity, Pricing

Apple is awaiting U.S. FDA clearance, likely to grant the AirPods Pro 2 QUH self-fitting status. However, the FDA just officially authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature (HAF), a software-only mobile medical application, intended for the AirPods Pro 2. The federal agency also granted marketing authorization of HAF to Apple.

Apple already controls around a third of the TWS earbud business and the AirPods Pro 2 are the most popular AirPods version, which makes them the best-selling TWS buds in the world. The Airpod Pro 2’s popularity means the market will soon be flooded with more than a hundred million inexpensive and ready-made self-fitting OTC hearing aids, which could dramatically impact the current OTC hearing aid business model.

“This may prove a reset in retail pricing,” opines John Luna, chair of CTA’s OTC hearing aid working group. “This week’s announcement of Apple’s innovation makes it clear that we are entering an era where hearing health is integrated into everyday wearables, ensuring that hearing aids and audio enhancements are as discreet as they are powerful.”

What Kind of Hearing Aids?

Transforming AirPods Pro 2 into OTC hearing aids brings more advantages to consumers and retailers beyond just a lower price and wider availability – and some question marks.

For one thing, since millions already wear AirPods in public, the stigma of visible hearing aids is removed. As such, more consumers might be induced to check their hearing. According to the World Health Organization, 1.5 billion people around the world suffer from some level of hearing loss. Dr. Desai cited an Apple hearing study that found “a staggering 75% of people diagnosed with hearing loss haven’t received the assistive support they need,” and that “80% of adults in the US have not had their hearing checked in the last five years.”

In addition, AirPods Pro 2 provides far higher quality Bluetooth music and phone call sound than current RIC (rest-in-canal) hearing aids – the one with the battery and control module behind the ear – and far tighter Apple iPhone and ecosystem integration.

For retailers, AirPods Pro 2 are far easier to stock and present a far easier sell than often difficult-to-acquire and explain standalone OTC hearing aids.

In terms of performance, it’s unclear if Apple’s transparency feature of the ear canal-sealing AirPods Pro 2 can provide the same open and natural ambiance hearing experience provided by pricier and less physically obvious OTC RIC or in-ear hearing aid buds such as those from Eargo and Sony. In addition, AirPods Pro 2 optimum single-charge 6-hour battery life represents just a fraction of the “all-day” – 16-20 hours – battery life provided by other standard hearing aids.

But the AirPods Pro 2 combined low price and high-quality Bluetooth capabilities could represent an OTC hearing aid business disruption. “When the OTC hearing aid market opened two years ago, we hoped it would spur this kind of innovation to give more people options to treat hearing loss sooner,” Kelley noted.

“With the FDA’s final rule on OTC hearing aids in full effect, we’re seeing products that will continue to empower the consumer base in taking charge of their hearing needs,” Luna agrees. “The focus on user-friendly, tech-enhanced solutions will continue to drive innovation and awareness, helping millions of individuals improve their quality of life.”