The U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter (OTC) hearing aid software device, the Hearing Aid Feature (HAF), designed for use with Apple AirPods Pro. This decision marks a significant step in increasing the accessibility of hearing support for adults with mild to moderate hearing impairment.
The HAF is intended for individuals 18 years and older who experience perceived mild to moderate hearing loss. Once installed and customized, the software amplifies sounds to address specific hearing needs. Users can set up the HAF using an iOS device, such as an iPhone or iPad, and adjust the settings themselves, eliminating the need for professional assistance.
Clinical Validation
The FDA's authorization was based on a clinical study involving 118 participants with perceived mild to moderate hearing loss. The study demonstrated that subjects using the HAF self-fitting strategy achieved similar perceived benefits as those who received professional fitting of the same device. Comparable performance was also observed in tests measuring amplification levels in the ear canal and speech understanding in noisy environments. No adverse events related to the device were reported during the study.
"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," said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.
Broader Accessibility
This authorization aligns with the FDA's 2022 OTC hearing aid regulations, which allow individuals with mild to moderate hearing loss to purchase hearing aids without a prescription, medical exam, or audiologist consultation. This move aims to provide more affordable and accessible options for the millions of Americans experiencing hearing loss.
According to the FDA, more than 30 million American adults have some degree of hearing loss, which can result from aging, exposure to loud noises, medical conditions, and other factors. Hearing loss can negatively impact communication, relationships, work or school performance, and emotional well-being. Studies have shown that using hearing aids can reduce the risk of cognitive decline and depression in older adults.
How it Works
The HAF is a software-only application designed for iOS devices. It employs a self-fitting strategy, allowing users to adjust volume, tone, and balance settings based on their specific hearing needs. The software utilizes the user's hearing data stored in Apple's HealthKit to enable a personalized hearing aid experience.
The FDA reviewed Apple's application through its De Novo premarket review pathway, which is used for novel, low- to moderate-risk medical devices for which there is no prior legally marketed device.
