The US Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature (HAF), which is compatible with compatible variants of Apple AirPods Pro headphones. Once installed and customized, the software allows the AirPods Pro to function as over-the-counter hearing aids, thereby assisting individuals aged 18 and older with modest to moderate hearing impairments by amplifying sound. Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health, highlighted the significance of this advancement, noting that "Hearing loss is a significant public health issue impacting millions of Americans."
Currently, over 30 million adults in the United States report experiencing some degree of hearing loss, which can have an impact on their ability to communicate, their emotional well-being, and their performance in academic or professional settings. A clinical investigation was conducted at multiple sites throughout the United States to evaluate the Hearing Aid Feature, which was perceived to be mild to moderate hearing loss by 118 participants. The FDA examined the device under the De Novo premarket review pathway, which is designed to evaluate novel, low- to moderate-risk devices. Following the FDA's 2022 OTC hearing aid regulations, which expanded access to hearing aids without the necessity of a medical exam, prescription, or audiologist consultation, this authorization is granted.
