The U.S. Food and Drug Administration (FDA) has approved the Hearing Aid Feature (HAF), an over-the-counter (OTC) software that turns Apple AirPods Pro into a hearing aid for those with mild to moderate hearing loss. The HAF is the first FDA-authorized over-the-counter hearing aid software.
With this software, users can customize their hearing experience directly from an iOS device, fine-tuning settings like volume and tone to match their needs. This approval builds on the FDA’s 2022 initiative to simplify access to hearing aids, eliminating the need for prescriptions.
According to a Thursday (Sept. 12) release, the HAF was tested with 118 participants and demonstrated performance on par with professionally fitted devices. In an interview with PYMNTS, an FDA spokesperson talked about the motivation behind authorizing the HAF software for AirPods Pro.
“The FDA authorized the Hearing Aid Feature as the sponsor demonstrated the device met the applicable criteria to market this product to consumers,” the spokesperson said. “The FDA believes this technology will further advance the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
The spokesperson noted that the HAF was evaluated in a clinical study of participants at multiple U.S. sites.
“The results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device,” the spokesperson said. “Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study.”
According to the spokesperson, “this over-the-counter hearing aid software is available on a widely used consumer audio product, thus expanding the potential reach of hearing support for adults with perceived mild to moderate hearing loss.”
The FDA has addressed the limitations of OTC hearing aids:
“If you are 18 years of age or older and believe you have perceived mild to moderate hearing loss, you can buy an OTC hearing aid in a store or online without seeing an ear-nose-throat (ENT) doctor, or a licensed hearing health care professional (audiologist). … If you, or a friend, or family member suspect that you have a more severe or profound hearing loss, you should consult with a licensed hearing health care professional, as OTC hearing aids may not provide adequate benefit for more severe hearing losses. This is because OTC hearing aids are limited in their maximum output and may not be adequate to treat more severe hearing losses.”
According to the spokesperson, the HAF uses a self-fitting strategy and users can adjust it to meet their hearing needs without the assistance of a hearing professional.
“The HAF is set up using an iOS device (e.g., iPhone, iPad), and the user’s hearing levels are accessed from the iOS HealthKit to customize the HAF,” the spokesperson said. “Users can refine the volume, tone and balance settings after setting up the HAF.”
According to the release, more than 30 million American adults report some degree of hearing loss and “using hearing aids has been linked to reductions in the frequency or severity of cognitive decline, depression, and other health problems in older adults.”
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