FDA Approves First Telehealth Option for Cochlear Implants

NOVEMBER 17, 2017
Jenna Payesko
Nucleus Cochlear Implant System, telemedicine, telehealthThe US Food and Drug Administration (FDA) has approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.

The remote programming feature is indicated for patients who have 6 months of experience with the cochlear implant sound processor and are comfortable with the programming process.

“Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants,” Malvina Eydelman, MD, director of the Division of Opthalmic, and Ear, Nose and Throat Devices, 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.”

According to the National Institutes of Health (NIH), in the US approximately 58,000 cochlear implants have been implanted in adults and 38,000 in children as of 2012.

The implants often require regular programming visits with an audiologist who adjusts various electronic settings that control how the implant stimulates the nerves inside the inner ear like adjustments in sensitivity to low-level sound or limits on loud sounds.

These adjustments can enhance the patient’s quality of life, allowing them to improve the ability to understand speech, comfort in loud environments or independence in performing daily tasks.

The FDA approval was based on data from a clinical study consisting of 39 patients, aged 12 and older, each with a cochlear implant for at least 1 year.

Each patient had 1 in-person programming session and 2 remote programming sessions, approximately 2 months apart. One month after each session, speech perception tests showed no significant difference between in-person and remote programming.

Data was also evaluated from patients’ self-assessment to hear speech in the presence of other sounds and sense the direction, distance and motion of sound.

Additionally, the FDA assessed cybersecurity measures for the remote interaction.

The Nucleus Cochlear Implant System has been granted approval to Cochlear Americas.

The FDA declined to comment to MD Magazine.

A press release has been made available.

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