The food and Drug Administration (FDA) has made waves this week by approving software for Apple's AirPods Pro 2 earbuds to act as over-the-counter hearing aids. This decision is significant for the millions of Americans experiencing mild to moderate hearing loss, offering them access to hearing aids through widely used consumer technology rather than traditional, often costly, medical devices.
The approval is part of the FDA's broader effort to increase accessibility to hearing health resources. Since the first over-the-counter hearing aids were approved back in 2022, this marks the first time the FDA has authorized software to transform everyday headphones—specifically, Apple's AirPods—into hearing aids.
Reports indicate the new feature will utilize the AirPods Pro 2 to amplify sound, especially helpful frequencies like voices, and reduce background noise, aiming to provide users with clearer sound quality. Users can assess their hearing through the Apple Health app, which will help calibrate the sound based on the results of their hearing test. This innovative solution is set to roll out through software updates to eligible devices within 100 countries shortly.
Jackie Clark, an audiology professor at the University of Texas at Dallas, commented on the importance of this development, noting how even mild hearing loss can lead to social isolation and diminished quality of life. She highlighted Apple’s move as offering users who might otherwise shy away from traditional hearing aids—a bridge back to connecting with the world of sound they may have been missing.
Cost remains one of the most significant barriers for many individuals needing hearing assistance, with traditional hearing aids often costing upwards of $5,000. The price point of the AirPods Pro 2, which stands at $249, presents a more approachable alternative. “Many brands have attempted to break through the over-the-counter hearing aid market, but Apple’s extensive market reach—holding 19.2 percent of the global headphone market—could create lasting improvements,” IDC analyst Jitesh Ubrani explained.
Clinical studies—carried out on 118 participants who believed they had mild to moderate hearing impairment—found comparable benefits from Apple’s device as those received through professionally fitted hearing aids. Apple is expected to have set the stage for consumers, particularly those aged 40 and above, who are reluctant to purchase traditional hearing aids due to concerns about appearance or stigma.
Despite the promise, experts caution this technology may not be suitable for everyone, particularly those with severe hearing loss. They note, too, these devices would not replace the need for specialized audiological assessments for some users who require more significant adjustments.
The FDA's approval of the HAF (Hearing Aid Feature) on AirPods showcases how regulatory changes can reshape the market dynamics for products aimed at improving daily life. For years, companies have controlled most of the hearing aid market, stifling competition and pushing prices higher. This latest step signals change on the horizon, likely sparking increased market competition, providing consumers with more options, and potentially lowering prices across the board.
Critics and experts alike recognize the historical backdrop of this move; it follows years of advocacy for easier access to hearing devices. After President Trump signed bipartisan legislation manding the FDA to approve over-the-counter devices, the FDA faced pressure to comply, culminating in the current developments. President Biden also issued executive orders aimed at facilitating competition within the hearing aid industry, contributing to the evolution seen today.
The reaction within the hearing aid industry to Apple’s entry has not been entirely negative. Several existing companies have positioned themselves strategically to adjust to this changing environment, partnering with audiologists and healthcare providers to maintain their status. Still, many concern how traditional players will adapt to meet this new kind of competition.
Overall, the convergence of technology and healthcare provides exciting opportunities for many consumers facing hearing challenges. By integrating hearing aid technology directly within the headphones people know and love, the goal is for users to seamlessly transition from casual listening to enhanced hearing assistance without feeling the burden of traditional hearing devices.
It will be interesting to see how this integration will develop and how it may impact users globally, but one thing is certain: Apple's entrance has the potential to change the narrative around hearing aids and accessibility.
