FDA Clears Remote Programming for Nucleus Cochlear Implant
The Food and Drug Administration (FDA) has approved a remote programming feature for the implanted electronic hearing device, the Nucleus Cochlear Implant System, through a telemedicine platform. The telemedicine program is available only to those who have had ≥6 months experience with the implant and are comfortable with the programming process.
The cochlear implant produces useful hearing sensations to patients with severe to profound hearing loss, by electrically stimulating nerves inside the inner ear. Before today's approval regular programming visits were required with an audiologist, to make adjustments to various electronic settings.
The approval was based on a clinical study of 39 patients who had the implant for at least 1 year. Each patient had one in-person programming session and two remote programming sessions, approximately 2 months apart. Speech perception tests 1 month after each session showed no significant difference between in-person and remote programming. The system was also tested for cybersecurity safety for remote interaction.
"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.
For more information visit FDA.gov.