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

27 November, 2017

Centennial, Colo. (November 27, 2017) - Cochlear™ Limited (ASX: COH), the world leader in implantable hearing solutions, has received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus® Cochlear Implant System through a telehealth platform. This 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.

"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, Au.D., CCC-A, Director of Cochlear Implants at Rocky Mountain Ear Center, Englewood, Colo. "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. 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. 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," said Tony Manna, President, Cochlear Americas. "As we continue to build our remote care offering and technology platforms, we can make access to care easier for both recipients and clinicians."

Telehealth continues to grow as a successful service option in healthcare systems today, with many states, large hospital networks, and even the Centers for Medicare and Medicaid Services (CMS) working toward better access to care through remote options. Access to services and changes in healthcare along with the growing demand for cochlear implant services require a change in the care delivery model in order to expand access.

"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, Vice President, Health Economics and Access, Cochlear Americas. "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.

About Cochlear Limited (ASX: COH)

Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 3,000 people and invests more than AUD$150 million a year in research and development. Products include hearing systems for cochlear implants, bone conduction and acoustic implants, which are designed to treat a range of moderate to profound types of hearing loss. Over 450,000 people of all ages, across more than 100 countries, now hear because of Cochlear.

For more information on Cochlear Implants, visit

Media Contacts
Jennifer Stevenson
Cochlear Limited
(+61) 2 9611 6959

Kristina Devon
Head of Investor Relations
(+61) 2 9611 6691


Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear is under license.

©Cochlear Limited 2017. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.