Cochlear announces FDA approval and FDA clearance of first-of-its-kind Remote Care capabilities for Nucleus and Baha Systems

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The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution are the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

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Retrieved on: 
Tuesday, October 12, 2021
Information
Tags: 
Manna, Health, Life, Bone conduction, Food and Drug Administration, Food, Program, Multimedia, Time, Software, ASX, FDA, Hearing loss, Review, Hospital, Feedback, Nucleus, Patient, Bass, Research, AUD, Medical device, Instrumentation, Medical imaging, Dentistry, Pharmaceutical industry
Geotags: 
Colorado, COLO, CANADA, BAHA
Organisation: 
COCHLEAR LIMITED
Website: 
http://www.Cochlear.com/US
Summary
Key Points: 
  • The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution are the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.
  • Cochlear's Remote Care solutions offer hearing implant patients the convenience of quality hearing care without the need to visit a clinic.
  • Connected Care offers new tools that give hearing care professionals the flexibility to customize patient care, increase clinic efficiency and maximize their time delivering quality patient care.
  • Cochlear anticipates Remote Assist approval in Canada to be obtained in late 2021 for the Nucleus System and early 2022 for the Baha System.


Cochlear announces FDA approval and FDA clearance of first-of-its-kind Remote Care capabilities for Nucleus and Baha Systems

LONE TREE, Colo., Oct. 12, 2021 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval and clearance in the last month for its Cochlear™ Remote Assist solution in the Nucleus® and Baha® Systems. The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution are the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

Cochlear's Remote Assist provides remote programming, processor adjustments and counselling

Quality care, anywhere
Remote Assist delivers the ability for clinicians to engage with their patients through a live video, audio or chat session in the fitting software and connect to the sound processor via the patient's Nucleus or Baha Smart App.* Once connected to the patient, the hearing health provider can make programming adjustments, enable processor settings and provide counselling via a live video session. Any changes are saved remotely to the patient's sound processor.

Cochlear's Remote Care solutions offer hearing implant patients the convenience of quality hearing care without the need to visit a clinic. With new flexibility to manage patient progress remotely, hearing health providers have time to offer care to more patients, including those who may be limited by location, health, mobility or work commitments.

For cochlear implant patients with Nucleus 7 and Kanso® 2 Sound Processors, Remote Care consists of two options:

  • Remote Check, FDA approved in April 2020, which allows patients to complete a convenient, at-home hearing review without visiting the clinic.** Results are then sent remotely to their clinician for review. Clinicians can analyze information gathered during the Remote Check to determine if and how further follow up is needed at that time.
  • Remote Assist, which is available to clinicians in Custom Sound® Pro and connects to the patient's sound processor via the Nucleus Smart App to make live global changes to the patient's programs via Master Volume, Bass & Treble (MVBT) adjustments and enable other processor features.

For bone conduction patients with Baha 6 Max Sound Processors, Remote Assist is available to clinicians in Baha Fitting Software 6 with connection to the sound processor via the Baha Smart App. Remote Assist for Baha 6 Max allows clinicians to fully program and adjust the sound processor for the patient, including performing BC Direct (in situ audiometry) and Feedback Analyzer functions.

"Through Cochlear's Remote Check and Remote Assist, our innovative and secure Remote Care solutions further enhance clinical practice by bringing more options for monitoring patient performance and optimizing hearing outcomes remotely – ultimately providing care when and where it's needed," said Tony Manna, President, Cochlear Americas. "Our Remote Care solutions have been carefully designed and tested to meet rigorous quality and security standards, giving our hearing implant recipients and their hearing care professionals the confidence to receive and deliver quality care outside of a medical office."

Inspired by connecting people with care
The Remote Care offerings are part of Cochlear's Connected Care portfolio, transforming how people connect with hearing care across different care settings – from the surgical suite to the clinic, and into a patient's everyday life. Connected Care offers new tools that give hearing care professionals the flexibility to customize patient care, increase clinic efficiency and maximize their time delivering quality patient care. For patients, Connected Care provides convenient ways to access quality hearing care when and where they need it throughout their hearing journey.

"We understand that the expectations and preferences of those using a Cochlear hearing implant change over time. That's why we use our innovative technology to develop new digital tools that support an evolving care model to meet changing needs," said Mia Visconti, Director, Connected Care Innovation Product & Services, Cochlear Americas. "With Cochlear's Remote Care solutions, we can securely provide quality hearing care without requiring a recipient to visit a clinic by leveraging the advanced connectivity features of our Nucleus and Baha Sound Processors and our leading app technology."

Cochlear will immediately begin a controlled market release of Remote Assist in the U.S. by partnering with hearing healthcare providers and hospitals to provide professionals with more options for monitoring patient performance and optimizing hearing outcomes – providing patient care when and where it's needed.

Cochlear anticipates Remote Assist approval in Canada to be obtained in late 2021 for the Nucleus System and early 2022 for the Baha System.

For further details about Cochlear's Connected Care portfolio, visit www.cochlear.us/ConnectedCare.

About Cochlear Limited (ASX: COH)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people and invests more than AUD$190 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss.

Since 1981, Cochlear has provided more than 650,000 implantable devices, helping people of all ages, in more than 180 countries, to hear.

www.cochlear.com/US 

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* For compatibility information, visit www.Cochlear.com/compatibility.

** Remote Check is intended for ages 6 and older. The Remote Check feature is only visible and accessible if the feature is enabled by a clinician. Clinicians should consider the suitability of the feature before enabling Remote Check. Remote Check does not replace clinical care and does not involve remote programming of the sound processor. Remote Check is not compatible with Baha 6 Max Sound Processors.

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.

© Cochlear Limited 2021. All rights reserved.

 

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SOURCE Cochlear Limited

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