WASHINGTON, D.C. — In a groundbreaking move aimed at enhancing accessibility and innovation in hearing aid technology, the U.S. Food and Drug Administration (FDA) recently authorized the first over-the-counter (OTC) hearing aid software device. Named the Hearing Aid Feature, this software can be installed on compatible versions of the Apple AirPods Pro, transforming them into OTC hearing aids for individuals aged 18 and older with perceived mild to moderate hearing impairment.
Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, highlighted the importance of this advancement, stating, “Hearing loss is a significant public health issue impacting millions of Americans. Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
With more than 30 million American adults reporting some degree of hearing loss, the impact of hearing impairment on communication, relationships, and overall well-being is profound. The FDA’s authorization of this software represents a significant step in making hearing aids more accessible without the need for medical exams or prescriptions, aligning with the agency’s regulations introduced in October 2022.
The Hearing Aid Feature (HAF) is a software-only mobile medical application compatible with Apple AirPods Pro. It employs a self-fitting strategy, allowing users to adjust their hearing aids independently using an iOS device like an iPhone or iPad. The software accesses hearing levels from the iOS HealthKit to customize settings, enabling users to fine-tune volume, tone, and balance.
In a clinical evaluation involving 118 subjects with perceived mild to moderate hearing loss, the HAF demonstrated comparable effectiveness to professionally fitted devices. Participants reported similar perceived benefits, and the software showed equivalent performance in tests measuring amplification and speech understanding in noisy environments. Importantly, no adverse events were associated with the device during the study.
The Hearing Aid Feature was reviewed under the FDA’s De Novo premarket review pathway, which is designed for novel, low- to moderate-risk devices. This decision aligns with the FDA’s mission to advance health equity and support innovations that bring essential healthcare solutions directly to consumers.
Apple Inc. has been granted marketing authorization for the Hearing Aid Feature, marking a significant milestone in the integration of consumer technology with medical device functionality. This development not only expands the options available to individuals with hearing loss but also sets a precedent for future innovations in the field, promising greater accessibility and improved quality of life for millions.
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