FDA expedites approval of Cochlear's Remote Check for cochlear implants

Thursday April 9, 2020 0 comments Tags: Centennial, Cochlear Limited, Remote Check, FDA, COVID-19, Tony Manna

CENTENNIAL -- Cochlear Limited (ASX: COH), a leader in implantable hearing solutions, announced it has obtained U.S. Food and Drug Administration (FDA) approval for its Remote Check solution.

The approval is the first step in commercializing the product offering, which is anticipated by the end of 2020.Cochlear_logoUSE 

Cochlear said it will immediately begin a controlled market release of Remote Check in the U.S. and Canada by partnering with hearing healthcare providers and hospitals to quickly reach those most in need of audiological care during the COVID-19 pandemic, which supports social distancing by providing an alternative to in-person appointments.

Remote Check is designed to be a convenient, at-home testing tool that allows Cochlear recipients with a Cochlear Nucleus 7 Sound Processor to complete a series of hearing tests from their compatible iOS device using the Nucleus Smart App.

Results are then sent remotely to the recipient’s clinic for review by their clinician, so a clinician can quickly determine whether a patient is progressing well, or whether further clinical intervention is required.

The clinician can review the results by logging into their myCochlear Clinic professional portal, where they can access a comprehensive overview of their patient's hearing health.

Remote Check is designed to provide a snapshot of a patient's hearing health so a clinician can quickly determine whether a patient is progressing well, or whether further clinical intervention is required.

"The FDA's expedited approval of our Remote Check offering during the COVID-19 crisis underscores that at-home hearing healthcare support needs to be prioritized, more accessible and convenient for patients now more than ever," said Patricia Trautwein, Cochlear’s VP of marketing & product management.

"When elective surgeries become available again after the COVID-19 crisis, clinicians are going to see a wave of patients coming in to seek hearing implant treatment. Having a solution like Remote Check will help clinicians prioritize their case load, so they can reduce unnecessary visits for patients progressing well, spend more quality time with patients who have complex needs, and help more patients seeking initial cochlear implant candidacy assessment."

For the Cochlear recipient, Remote Check is designed to reduce unnecessary travel burdens to get into their clinic, provide immediate hearing and patient data to their clinician for troubleshooting requests, and provides a convenient, time-saving option for care that does not require travel to the clinic.

Using this technology, clinicians will not only be able to provide a more convenient avenue of care, but they can also free up more appointment times to manage the anticipated growth in the hearing implant market.

"Our clinic is eager to provide our patients with more remote servicing opportunities, and we are excited to start using Cochlear's Remote Check offering," said Regina Presley, senior Cochlear Implant audiologist.

"Many patients travel long distances for in-clinic care, need a caregiver to help get to their appointments, have competing school, personal and professional priorities, so if we can provide at-home service options, we believe they will have a more positive healthcare experience overall.

Every patient deserves timely, quality service to get the most from their hearing devices. Remote Check will ensure that patients receive the best care no matter where life and times like this take us."

"Over the last decade, Cochlear has been heavily focused on expanding and improving our digital and remote care services,” said Tony Manna, president, Cochlear Americas.

“We've brought to market first-of-its-kind solutions, like Remote Check, remote programming, myCochlear Clinic, Cochlear Link and SignHEAR, to help improve clinic efficiency, support a range of clinical practice preferences and provide the best hearing experience for our recipients.

“During unprecedented times like we're experiencing right now, we're proud Cochlear is the leader in providing innovative solutions that allow our clinic partners to continue treating their patients without the need for an in-person appointment, ultimately ensuring our recipients continue to hear and stay connected."