FDA clears remote adjustments for Cochlear’s Nucleus implants

November 21, 2017 By Fink Densford Leave a Comment

The FDA last week approved remote programming adjustments for Cochlear Ltd.‘s (ASX:COH) Nucleus cochlear implant, removing the need for a select group of users to make repeat visits for in-person programming sessions.

The newly-cleared remote programming feature is indicated for patients with 6 months of experience with their cochlear implant sound processors and who are comfortable with the programming process, according to an FDA release.

Normally, such implants would require regular programming visits with an audiologist in which electronic settings that control how the implant stimulates nerves in the ear are adjusted. This can include changes to sensitivity to low-level sound and limits on loud sounds, according to the release, and affect how patients perceive different sounds.

The approval was supported by a clinical study of 39 patients over the age of 12 who had a cochlear implant for at least 1 year. Each patient in the trial had 1 in-person programming session and 2 remote programming sessions with each two months apart.

Speech perception tests one month post-programming session showed no significant difference between remote and in person programming, the FDA said.

The federal watchdog also evaluated patients’ self-assessment of their ability to hear speech in the presence of other sounds as well as their ability to sense direction, distance and motion of sound. Cybersecurity risks and measures were also considered, the agency said.

“Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. 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,” FDA Center for Devices and Radiological Health Division of Ophthalmic, and Ear, Nose and Throat Devices director Dr. Malvina Eydelman said in a press relese.

In July, Cochlear launched its Nucleus 7 sound processor cochlear implant, touting it as the smallest and lightest behind-the-ear implant sound processor available.

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