Reviewed “under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device,” the Agency has approved an OTC software solution that is compatible with certain Apple AirPods Pro headphones and provides, according to the FDA release (here), an option that “[O]nce installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.”
This represents the first software solution authorized to compliment the OTC availability of hearing aids under the FDA’s OTC hearing aid regulations (here) and offers those patients who currently have or purchase AirPods Pro to utilize these devices as hearing aids.
Those of us who aren’t members of the Apple community have an option available for affordable OTC hearing aids, in stores and online, too thanks to the FDA’s regulatory pathway.
