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Monday, November 20, 2017

FDA Approves the First Telehealth Option to Program Cochlear Implants Remotely

The U.S. Food and Drug Administration has approved a remote feature for follow-up programming of Cochlear's Nucleus Implant System through a telemedicine platform. The FDA evaluated data supporting this feature's effectiveness, including those from a clinical study of 39 patients aged 12 or older, each of whom had a cochlear implant for at least one year. Each patient had one in-person programming session and two remote programming sessions, and speech perception tests showed no significant difference between in-person and remote programing. The FDA also evaluated data from patients' self-assessment of their ability to hear speech in the presence of other sounds and sense the direction, distance, and motion of sound. Cybersecurity measures for the remote interaction were also assessed.

​This feature is designed for patients who have had six months of experience with their cochlear implant sound processor and are comfortable with the programming process. "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.