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Medical Devices / Submissions and Approvals

First Telehealth Feature for Cochlear Implants Snags FDA Approval

Nov. 22, 2017

The FDA approved a remote programming feature for Cochlear Americas’ Nucleus Cochlear Implant System — the first telehealth option for remote adjustments to cochlear implants.

Patients must have used their cochlear implant for at least six months and feel comfortable with the process to receive remote programming adjustments from specialized centers or clinics aimed at improving their quality of life, the FDA said.

“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, director of CDRH’s Division of Ophthalmic, and Ear, Nose and Throat Devices.

Routine visits to an audiologist are required with standard cochlear implants — electronic hearing devices designed to stimulate nerves in the inner ear in order to provide hearing sensations — to receive adjustments to the stimulation electronic settings.

As part of the review process, the agency said it evaluated patient self-assessment data and assessed the feature’s cybersecurity.

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