Apple has officially secured clearance from the U.S. Food and Drug Administration (FDA) to market its AirPods Pro 2 wireless earbuds as over-the-counter (OTC) hearing aids. This groundbreaking development marks a significant shift in the accessibility and potential impact of hearing assistance technology. The evolution of these popular personal audio devices into full-fledged hearing aids could reshape the nascent OTC hearing aid market and significantly influence people’s willingness to embrace these devices.
Apple’s announcement during its iPhone 16 launch event in September, outlining plans to introduce several new hearing health features to its flagship earbuds later this fall, has generated considerable buzz. While Apple refrains from disclosing specific sales figures for its AirPods family, estimates suggest that approximately 75 million units were sold in 2023, with the AirPods Pro 2 accounting for a substantial 63% of those sales. This inherently makes the AirPods Pro 2 the most successful OTC hearing aids in the market, even though not all units will necessarily be utilized for this purpose.
The U.S. OTC hearing aid market, currently estimated to be under 200,000 units, stands to benefit immensely from the widespread adoption of the AirPods Pro 2 as hearing aids. This could act as a catalyst for growth within the entire market. As the sight of individuals wearing the iconic white earbuds in various social settings becomes more commonplace, public perception and attitudes toward OTC hearing aids are likely to undergo a positive transformation.
The Hearing Loss Association of America (HLAA) views Apple’s entry into the OTC hearing aid market as a positive development. “We don’t advocate for one product over another,” stated Meredith Resnick, director of strategic communications at HLAA, in an email to Digital Trends. “But we think the announcement by Apple this week is exciting. This is really the kind of innovation we hoped the opening of the OTC hearing aid market would spur to give people more choices.” Resnick emphasizes the potential impact of the AirPods Pro 2’s popularity on the adoption of OTC hearing aids. “It helps raise awareness that hearing is an important part of overall health and wellness, and should be protected, tested and treated if needed,” she wrote.
Apple’s traditional rivals in the wireless earbuds space, including Sony, Sennheiser, Jabra, and Bose, have been actively pursuing entry into the OTC hearing aid category for several years. Each brand has either developed dedicated OTC products or collaborated with third parties to bring their technology to market. However, none have leveraged their existing personal audio products for this purpose. With Apple’s groundbreaking announcement, this situation could change rapidly, potentially leading to a wave of innovation and competition within the OTC hearing aid market.
