- June 12, 2018
Traditionally, patients who receive cochlear devices to help their hearing must repeatedly return to the clinic after implantation. At these visits, audiologists adjust the settings of the implant to alter how the patient perceives sounds. The aim is to improve the patient’s ability to understand speech and cope with loud environments by altering how the device stimulates nerves inside the ear.
Now, users of Cochlear Americas’ Nucleus Cochlear Implant System can get their implants changed remotely. Rather than meet in person, the audiologist uses a telemedicine platform to program the implant remotely. This should improve the quality of life of patients with hearing loss. “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,” Malvina Eydelman, M.D., Director of the FDA’s Division of Ophthalmic, and Ear, Nose and Throat Devices, said in a statement.
Cochlear Americas secured the regulatory clearance through supplementary filings to three of its premarket approvals. The filings drew on data from a clinical trial that enrolled 39 patients aged 12 years or older who had lived with a cochlear implant for at least one year. Each patient underwent one in-person programming session and two remote sessions. The sessions took place about two months apart. Speech perception tests were performed one month after each session.
The perception tests showed no significant difference between the performance of patients after in-person or remote-programming sessions, suggesting the telemedicine-enabled approach is as effective as face-to-face visits. Regulatory officials also evaluated hearing self-assessment data from patients and the cybersecurity measures covering remote modifications.
In signing off on the device, the FDA has placed some restrictions on the use of the remote approach; although, in some ways, these are less restrictive than the inclusion/exclusion criteria for the clinical trial. The FDA is limiting use of remote approach to patients who have six months of experience with the implant and are comfortable with the programming process.
REFERENCE: Fierce BioTech; 20 NOV 2017; Nick Paul Taylor