The FDA has approved hearing implant maker Cochlear Limited’s submission for a new remote feature that would allow specialists to perform follow-up programming on a patient’s cochlear implant remotely, a la a telemedicine platform. The feature for the company’s Nucleus Cochlear Implant System is indicated for those who have had at least six months of experience with their implant sound processor, and according to the FDA could serve as a substantial relief to certain hearing loss patients.
“Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants,” Dr. Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
Cochlear implants are often reprogrammed to adjust how the implant stimulates the nerves of a patient’s inner ear. According to the FDA, these adjustments can greatly increase a user’s ability to understand speech or music, remain comfortable in loud environments, and generally improve quality of life.
Approval of the remote programming feature was based on clinical data submitted to the agency. In this study, 39 patients aged 12 years or older who had the implant for at least one year received one in-person and two remote programming sessions, each spaced two months apart. There were no significant differences in speech perception test results collected one month after each session type, or in hearing self-assessments also collected by the agency. The agency also took cybersecurity measures during the remote programming into account when making its decision.
The approval comes just months after the FDA also approved Cochlear’s Nucleus 7 Sound Processor, the first cochlear implant for hearing developed specifically for use with iPhones, iPods, and iPads. Along with holding the distinction of being the market’s smallest and lightest behind-the-ear cochlear implant, the product allows users to stream sound directly from a compatible device to their sound processor.
“An iPhone is used every minute of the day nationwide,” Jan Janssen, senior vice president of research and development at Cohclear, said in July. “Taking phone calls, accessing audio-based apps, streaming music and making FaceTime calls are often taken for granted, but for those with hearing loss, this everyday technology can be very challenging. This is especially true for those with cochlear implants who have had to use external devices to successfully complete these tasks.”