FDA approves 1st telehealth feature for cochlear implants

The U.S. Food and Drug Administration (FDA) has approved a remote feature allowing programming sessions given through telehealth platforms to patients who have had at least six months of experience with their cochlear implant sound processor.

Currently, patients with cochlear implants must visit the audiologist for routine programming of electronic settings to ensure patients receive appropriate sensitivity with their device. The approval of the remote programming feature allows for the programming to be completed through a telehealth platform that could save time and money.

In researching if remote programming is as effective as in-person programming visits, the FDA evaluated data from a clinical study of 39 patients who had a cochlear implant for at least a year.  Each participant attended one in-person programming visit and two remote programming sessions two months apart. Results taken after each session showed no significant difference in programming between remote and in-person visits.

“Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. 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.