FDA clears telehealth option to remotely program cochlear implants
The Food and Drug Administration has approved the first telehealth option to remotely program electronic hearing devices called cochlear implants, rather than having audiologists make programming adjustments to them at specialized centers or clinics.
“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.
The remote programming feature for Cochlear Americas’ Nucleus Cochlear Implant System has been cleared by the FDA and is indicated for patients who have had six months of experience with their implant’s sound processor and are comfortable with the programming process.
In making its decision to approve the remote programming feature, the regulatory agency evaluated data from a clinical study of 39 patients—aged 12 or older—each of whom had a cochlear implant for at least one year. The FDA’s study included one in-person programming session and two remote programming sessions for each participant.
“Speech perception tests one month after each session showed no significant difference between in-person and remote programing,” contends the agency. “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. In addition, the FDA also assessed the cybersecurity measures for the remote interaction.”