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Biotechnology News Magazine

The FDA Just Approved Remote Care For Cochlear Implants: Here’s What That Could Mean for You

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Cochlear implants are often held up as an alternative to hearing aids. Although they’re considerably more expensive than most other hearing assistance devices, they often allow patients with severe or profound hearing loss to process sound. This is not without its drawbacks, however.

A cochlear implant is a complex piece of technology. And as noted by Johns Hopkins Medicine, it’s also a lifelong commitment. Patients must schedule at least three to four monthly appointments after first receiving the implant, then an appointment every three to six months for the first year, and an annual appointment after that.

In a time when in-person appointments still carry an element of significant risk, this isn’t especially feasible. The same goes for patients with limited mobility. To this point, there’s been little recourse—but in 2022, that’s going to change.

Cochlear Limited, a globally-recognized leader in implantable hearing solutions, announced last month that it had received clearance and approval from the Food and Drug Administration for a new function known as Remote Assist.

Through Remote Assist, audiologists can directly troubleshoot implants and modify programming, eliminating the need for regular in-person visits to a clinic. According to Cochlear, this innovation is part of an ongoing initiative known as Connected Care, in which the company seeks to transform hearing care through modern technology.

“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,” Mia Visconti, Director of Connected Care Innovation Products & Services at Cochlear Americas, explained in a prepared statement. “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.”

In all fairness, this functionality isn’t new to hearing assistance devices. Standard hearing aids have had remote care functionality for some time. However, it still represents a considerable leap forward for cochlear implants.

Remote Assist is specifically available to cochlear implants with Cochlear’s Nucleus 7 and Kanso 2 processors, and to bone conduction devices with Baha 6 Max sound processors. For the former, Remote Assist is actually the second remote care option available to the devices. The first, Remote Check, combines a hearing test with live video chat.

Cochlear is currently in the process of securing approval from Health Canada. It hopes to finalize approval for Nucleus/Kanso processors before the end of the year, and for Baha processors by early 2022. It also plans to immediately begin a controlled release to the U.S. market, working in close collaboration with both hospitals and audiologists.

Cochlear implants represent some of the most advanced and sophisticated hearing aid technology on the market. The fact that they lagged behind other hearing assistance devices in remote care was a considerable oversight, and one that has finally been corrected.

About the Author:

Dr. Renee Flanagan is the Director of Audiological Care at Hearing Planet. She works with the training and development of Hearing Care staff so they may help the hearing impaired population by following best in class hearing healthcare practices.

Executives

Intelligent Implants Taps Leading Medical Device Entrepreneur, Benjamin A. Hertzog, PhD, as CEO

Dr. Hertzog will lead the progression of product development, clinical, and commercial activities for the company’s novel and proprietary smart orthopedic implant platform.

US Med-Equip Appoints 4 New Chief Executives

"We sought out superstars and brought in the best executives in their fields to join our burgeoning team. They will be instrumental in building on the growth of our company and our community of employees and healthcare partners we support," Salario said. Read who they are.

Perineologic Appoints Jim Fortune as President and Promotes Matthew Allaway, DO, to Chief Executive Officer

Mr. Fortune served as chief operating officer at Ocular Therapeutix, Inc. Dr. Allaway is the founder of Perineologic and has been a practicing urologist and managing partner at Urology Associates in Cumberland, Maryland.

FDA Updates

Medtronic Reports FDA Approval of Spinal Cord Stimulation Therapy for Treating Chronic Pain Resulting from Diabetic Peripheral Neuropathy

This new indication enables us to apply Medtronic's more than 40 years of proven SCS experience, as well as the company's deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients.

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon

Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease.

Nevro Reports FDA Approval for Expanded Labeling for Senza® Spinal Cord Stimulation System

This approval is specific to Nevro's proprietary 10 kHz Therapy and differentiates Nevro's Senza System as the only SCS system with specific labeling to treat NSRBP patients.
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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
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Diagnostic Imaging

Carestream Continues Drive to Improve Image Quality and Workflow With 45 Patents in 2021

“Carestream continuously strives to deliver cutting-edge technologies worldwide, and these patents demonstrate our commitment to meet the evolving needs of providers and patients alike,” said Eugene Shkurko, Intellectual Property Counsel at Carestream.

Aidoc Partners with Novant Health

By incorporating Aidoc's AI platform, which includes seven FDA-cleared solutions for triage and notification of patients with acute medical conditions, Novant Health is taking proactive steps to improve patient outcomes and reduce emergency department (ED) length of stay amid resource constraints inflicted by the Omicron variant.

Trials

NEJM: New Data on COVID-19 Lung Transplants

The analysis of more than 3,000 lung transplants in the U.S. between Aug. 1, 2020, and Sept. 30, 2021, showed that during the pandemic, 7% of the nation’s lung transplants were performed to treat severe, irreversible lung damage caused by COVID-19. More than half of these patients needed ventilators or extracorporeal membrane oxygenation, or ECMO, before their transplant.

Preclinical Study Provides Guidance for Optimizing Safety and Efficacy of Endovascular Hepatic Denervation Devices to Treat Diabetes

“This study leveraged our deep experience in preclinical evaluation of denervation therapies and could not have been performed in a timely manner without the digital morphometry techniques we developed in-house. We remain excited about the potential of neuromodulation technologies and are committed to supporting further innovation in this space,” explained Rami Tzafriri, PhD, lead author and Director of Research and Innovation at CBSET.

Other News

NEJM: New Data on COVID-19 Lung Transplants

The analysis of more than 3,000 lung transplants in the U.S. between Aug. 1, 2020, and Sept. 30, 2021, showed that during the pandemic, 7% of the nation’s lung transplants were performed to treat severe, irreversible lung damage caused by COVID-19. More than half of these patients needed ventilators or extracorporeal membrane oxygenation, or ECMO, before their transplant.

University of Colorado School of Medicine Will Work with DreaMed Diabetes to Deploy Its Advisor System as a New Resource for Diabetes Device Initiation

“We are truly honored to be part of this project,” said Ryan Hovey, general manager for North America at DreaMed. “We have been able to demonstrate the ability to support endocrinology practices by centralizing patient device data as well as providing evaluation reports and FDA cleared treatment recommendations.

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