The U.S. Food and Drug Administration approved the first option for remotely programming cochlear hearing implants Nov. 17.
The telehealth feature, developed by Cochlear Americas, is indicated for patients who have six months of experience with the company's Cochlear Nucleus Implant System. A cochlear implant aims to support individuals with hearing loss by electrically stimulating nerves inside of the inner ear. The device often needs regular programming visits with an audiologist, who adjusts various settings related to sensitivity and volume.
To inform its decision, the FDA evaluated data from a clinical study of 39 patients who had used a cochlear implant for at least one year. For the study, each patient had one in-person programming session and two remote programming sessions roughly two months apart. The FDA determined there were no significant differences between in-person and remote programming based on a review of speech perception tests one month after each session.
"Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to patients and their families, especially those who must travel great distances or need frequent adjustments," said Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose and throat devices in the FDA's Center for Devices and Radiological Health.