Cochlear obtains FDA approval for first remote programming option for cochlear implants

Tuesday November 28, 2017 0 comments Tags: Centennial, Cochlear Limited, Cochlear Americas, Allison Biever, Tony Manna, Mickey Brown

CENTENNIAL -- Cochlear Limited (ASX: COH), a leader in implantable hearing solutions, has received U.S. Food and Drug Administration (FDA) approval for the first remote feature to allow follow-up programming sessions for the Nucleus® Cochlear Implant System through a telemedicine platform.

The approval is the first in the cochlear implant industry and one of many steps Cochlear is taking to enable remote care for Nucleus Cochlear Implant recipients and clinicians, the company said.Cochlear_logoUSE 

"This approval will open the door for so many cochlear implant patients who have trouble accessing continued care because they can't travel to an implant center," said Allison Biever, director of cochlear implants at Rocky Mountain Ear Center in Englewood.

"Cochlear implant technology is life transforming and the technology is maximized when coupled with adequate follow-up appointments so adjustments can be made to provide the best hearing performance for each patient. It is exciting that our industry and its patients will have access to remote care in the future."

For most cochlear implant recipients, there are regularly scheduled follow-up appointments after the initial programming visit, Cochlear said.

These follow-up appointments help maximize the patient's hearing and typically mean taking time off work or time out of school for the visit to the audiologist's office.

Leveraging telehealth within the cochlear implant industry provides clinics with more options to care for their patients no matter where their office is located, and it allows Nucleus Cochlear Implant recipients to receive care from the comfort of their own home.

In addition, the expanded access to Internet, smartphones and tablets coupled with Cochlear's advanced wireless and Bluetooth connectivity provide the technological foundation to open telehealth for its customers.

"We know clinicians are looking for options in providing care to their patients,” said Tony Manna, Cochlear Americas president.

“We also know that for many cochlear implant recipients, follow-up programming means taking time out of their personal lives and many have to travel long distances. As we continue to build our remote care offering and technology platforms, we can make access to care easier for both recipients and clinicians."  

"Improved care delivery for those needing cochlear implant service should account for those who are medically fragile, geographically isolated, in need of transportation or impacted by weather-related issues," said Mickey Brown, Cochlear Americas VP of health economics and access.

"Through remote technology, we can help our cochlear implant recipients connect to their audiologist when they need care and where they want care. With this approval, clinicians interested in providing remote programming services can now approach healthcare providers in obtaining appropriate codes for reimbursement of these services."

Early next year, supplemental labelling, including instructions for use, will be added to Custom Sound®, the Cochlear fitting software, to guide clinicians in remote programming.

This approval is an important building block for Cochlear's future to build out a full-service telehealth platform for Nucleus Cochlear Implant recipients and clinicians, the company said.