Apple AirPods Pro 2 Cleared as OTC Hearing Aids

Hearing aids are essential devices for millions of people experiencing hearing loss, particularly among the aging population. According to the World Health Organization, nearly half of those over 75 and one-third of individuals aged 64 to 75 experience age-related hearing loss. This often manifests as difficulty discerning high-pitched sounds, such as electronic beeps or consonants like "s" and "th," while background noise becomes more intrusive.

Modern hearing aids have evolved significantly beyond merely amplifying sounds. These devices now employ digital signal processing to enhance speech clarity, filter background noise, and adjust for different sound environments, making conversations and daily interactions easier. Because of these advancements, traditional prescription hearing aids are expensive, averaging more than $3000 per device. The high cost stems not only from the technology itself but also from the necessary services provided by audiologists who custom-fit and program these devices to meet specific hearing needs. Although cheaper alternatives, such as personal sound amplification products (PSAPs), exist, they lack the sophisticated features of hearing aids and are not FDA-regulated medical devices. 

In response to the demand for more affordable options, over-the-counter (OTC) hearing aids have been introduced following an FDA ruling in 2022 (QH). These devices are intended for individuals with mild to moderate hearing loss and offer a less expensive and more accessible alternative to traditional hearing aids, filling the gap between costly prescription models and basic PSAPs.

Apple's AirPods, designed as wireless earbuds used with the iPhone, are evolving to become a potential health-monitoring tool, much like the Apple Watch. There has been speculation about incorporating health sensors, with early rumors suggesting the use of ballistocardiogram (BCG) technology for continuous heart monitoring, and more recently, reports have indicated that Apple could soon implement blood pressure monitoring in AirPods using pulse waveform analysis (QH).

None of the above has come to fruition yet, but instead the AirPods have entered the medical arena in a more direct application of its functionality: as hearing aids. Apple's AirPods Pro 2 could revolutionize the accessibility of hearing aids, offering a cost-effective and discreet solution for millions of people with mild to moderate hearing loss. Recently cleared by the FDA, new software updates will allow these popular earbuds to function as over-the-counter hearing aids taking advantage of the FDA’s authorization of OTC hearing aids mentioned above. With a simple hearing test and personalized settings, users can enhance their hearing, providing an accessible alternative to traditional hearing aids.

In an article for CNBC, reporter Ashley Capoot described her experience using the AirPods Pro 2 as a hearing aid. She found the new hearing health features easy to set up and appreciated the convenience of taking a hearing test at home. Though the results showed minimal hearing loss, the "Media Assist" feature enhanced the clarity of voices during calls. Out of curiosity, she activated the hearing aid function, which amplified environmental sounds and speech, giving the sensation of a "superpower." Despite not needing a hearing aid, the author appreciated how the AirPods discreetly served this purpose, and would recommend the feature to others.

When comparing AirPods Pro 2 to alternative over-the-counter (OTC) hearing aids, some price and performance differences are notable. AirPods Pro 2, priced at $249, are significantly cheaper than many OTC hearing aids, which can range from $200 to $2,000 for better-quality, self-fitting models. Of course one may also have to factor in the cost of an iPhone which is necessary to use the AirPods for those without one. One issue is that AirPods have a limited battery life of five to six hours. In contrast, OTC hearing aids, though more expensive, are often more powerful (with advanced features) and comfortable, designed for longer wear, and typically offer better warranties and return policies. However, the discreet nature of AirPods and their integration into daily use could reduce the stigma associated with hearing aids, making them a more attractive option for some users.

Medical experts view the use of Apple AirPods Pro 2 as hearing aids with cautious optimism. They recognize that the FDA's clearance of AirPods as an over-the-counter hearing aid opens new avenues for accessible and affordable hearing solutions, particularly for individuals with mild to moderate hearing loss. Experts appreciate the potential of AirPods to reduce stigma and encourage earlier adoption of hearing aids due to their discreet design and familiarity with users. However, they also caution that AirPods, while innovative, may not match the sophistication or power of traditional prescription hearing aids, particularly for severe hearing loss. Despite these limitations, they agree that Apple’s entry into this market could drive further innovation and awareness, helping more individuals seek hearing assistance sooner (NYTimes, NPR).

The prospects of AirPods Pro 2 as hearing aids are promising, offering a transformative approach to assistive hearing technology.  Although not as powerful as prescription aids or suitable for severe hearing loss, the widespread appeal, lower price, and convenience of AirPods Pro 2 may drive increased adoption and early intervention for hearing health. This innovation could also push more companies to follow suit, expanding the over-the-counter hearing aid market and further enhancing accessibility. According to the Apple website, this new capability should be available soon (Figure 1).

Figure 1. Apple's AirPods Pro 2 can serve as non-prescription hearing aids with a software update available in Fall 2024 (https://www.apple.com/airpods/).