Cochlear

Cochlear obtains FDA approval of Kanso 2 Sound Processor, first off-the-ear cochlear implant sound processor with direct smartphone connectivity

Retrieved on: 
Monday, July 6, 2020

The approval of the Cochlear Nucleus Kanso 2 Sound Processor, Nucleus 7 Sound Processor for Nucleus 22 Implant recipients and Custom Sound Pro fitting softwarereflects Cochlear's ongoing commitment to innovation in hearing technology, providing access to smartphone connectivity and helping to improve hearing performance, and enhancing the cochlear implant fitting experience for hearing health professionals.

Key Points: 
  • The approval of the Cochlear Nucleus Kanso 2 Sound Processor, Nucleus 7 Sound Processor for Nucleus 22 Implant recipients and Custom Sound Pro fitting softwarereflects Cochlear's ongoing commitment to innovation in hearing technology, providing access to smartphone connectivity and helping to improve hearing performance, and enhancing the cochlear implant fitting experience for hearing health professionals.
  • The Kanso 2 Sound Processor is the world's smallest1 off-the-ear cochlear implant sound processor, and it is the first and only off-the-ear cochlear implant sound processor to offer direct streaming from compatible Appleor Android devices.
  • The Kanso 2 Sound Processor also features the highest possible water resistance rating for any off-the-ear cochlear implant sound processor, giving users the freedom to live an active lifestyle.
  • At commercial availability, the Kanso 2 Sound Processor is compatible with Cochlear N24, CI24RE, CI500, Profile and Profile Plus Series Implants.

Envoy Medical Receives FDA Breakthrough Device Designation for its Fully Implanted Acclaim® Cochlear Implant

Retrieved on: 
Monday, June 29, 2020

Envoy Medical Corporation , a hearing health company focused on providing innovative technologies across the hearing loss spectrum, today announced that its fully implanted Acclaim cochlear implant was granted the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Envoy Medical Corporation , a hearing health company focused on providing innovative technologies across the hearing loss spectrum, today announced that its fully implanted Acclaim cochlear implant was granted the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
  • The fully implanted Acclaim cochlear implant leverages the novel sensor technology from the Esteem osseointegrated AMEI.
  • The Acclaim cochlear implant leverages the proven and novel sensor technology from the fully implanted Esteem osseointegrated active middle ear implant.
  • Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem osseointegrated active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim cochlear implant, an investigational device.

Otology & Neurotology Fellows to Convene for Fifth Annual Advanced Course in Ear & Skull Base Surgery This Fall

Retrieved on: 
Thursday, May 21, 2020

The fifth annual Otology Fellows Congress and Advanced Course in Ear & Skull Base Surgery will be taking place October 23-25, 2020 at the Yasargil Surgical Skills Laboratory & Education Center at the University of Arkansas for Medical Sciences in Little Rock.

Key Points: 
  • The fifth annual Otology Fellows Congress and Advanced Course in Ear & Skull Base Surgery will be taking place October 23-25, 2020 at the Yasargil Surgical Skills Laboratory & Education Center at the University of Arkansas for Medical Sciences in Little Rock.
  • Upwards of ten renowned teaching faculty members, including international distinguished members, will be in attendance to guide the fellows throughout this course and provide expert insights.
  • Attendees will be covering topics such as soft tissue flaps in tympanomastoid surgery, revision stapes surgery, endoscopic ear surgery, and difficult cochlear implant cases/cochlear ossification.
  • Registration is now open on a 'first come, first served' basis, so fellows are encouraged to register as soon as possible.

As surgeries resume, pediatric cochlear implantation can now be done as young as 9 months

Retrieved on: 
Tuesday, May 19, 2020

* This FDA approval is extended to all current Cochlear Nucleus Implant models, as well as all models developed in the future by Cochlear.

Key Points: 
  • * This FDA approval is extended to all current Cochlear Nucleus Implant models, as well as all models developed in the future by Cochlear.
  • For more clinical information on the longitudinal outcomes of cochlear implantation for children with hearing impairment, visit: www.outcomes.nal.gov.au/key-findings .
  • Leigh J, Dettman S, Dowell R. Evidence-based guidelines for recommending cochlear implantation for young children: Audiological criteria and optimizing age at implantation.
  • And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB.

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

Retrieved on: 
Tuesday, April 7, 2020

CENTENNIAL, Colo., April 7, 2020 /PRNewswire/ --Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval on April 2 for its Remote Check solution.

Key Points: 
  • CENTENNIAL, Colo., April 7, 2020 /PRNewswire/ --Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval on April 2 for its Remote Check solution.
  • Remote Check will ensure that patients receive the best care no matter where life and times like this take us."
  • 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.
  • And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB.

Federal Circuit Affirms Alfred E. Mann Foundation's $268M Win Against Cochlear

Retrieved on: 
Thursday, March 19, 2020

The Federal Circuit issued a summary affirmance without opinion on March 16 after hearing oral arguments on the appeal on March 6 of this year.

Key Points: 
  • The Federal Circuit issued a summary affirmance without opinion on March 16 after hearing oral arguments on the appeal on March 6 of this year.
  • "We are gratified at the speedy disposition of this matter by the Federal Circuit following the oral argument.
  • The dispute dates back to 2007 when AMF a small nonprofit medical research organization sued Cochlear for infringing on its patented cochlear implant technology.
  • Founded in 1985 by serial healthcare entrepreneur Alfred E. Mann, the Alfred Mann Foundation for Scientific Research's (AMF) mission is to develop and commercialize innovative solutions for significant unmet or poorly met medical conditions.

Advanced Bionics Announces Voluntary Field Corrective Action of The HiRes Ultra / Ultra 3D Cochlear Implant

Retrieved on: 
Friday, February 21, 2020

Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 3D cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients.

Key Points: 
  • Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 3D cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients.
  • Existing recipients of HiRes Ultra and Ultra 3D may continue to use their device as normal.
  • AB will continue to distribute the HiRes 90K Advantage cochlear implant as well as the new version of HiRes Ultra and Ultra 3D based on market availability.
  • Previous generations of AB cochlear implants and external sound processors and accessories are not included in the scope of this voluntary field action.

Cochlear Implants Market Size Worth $3.4 Billion by 2026 | CAGR: 10.5%: Grand View Research, Inc.

Retrieved on: 
Thursday, February 20, 2020

The cochlear implants market is anticipated to witness significant growth during the forecast period, which can be attributed to a favorable reimbursement scenario, rising awareness about hearing aids, and increasing adoption of implants.

Key Points: 
  • The cochlear implants market is anticipated to witness significant growth during the forecast period, which can be attributed to a favorable reimbursement scenario, rising awareness about hearing aids, and increasing adoption of implants.
  • Increasing demand, ability to recognize the speech in noise, and good reimbursement are the key factors expected to drive the market during the forecast period.
  • In June 2019, Cochlear Limited received the approval from the U.S. FDA for its Cochlear Nucleus Profile Plus Series Cochlear Implant.
  • Grand View Research has segmented the cochlear implants market by type of fitting, by end use, and region:
    Cochlear Implants Type of Fitting Outlook (Market Revenue in USD Million, 2015 - 2026)
    Cochlear Implants End Use Outlook (Market Revenue in USD Million, 2015 - 2026)
    Cochlear Implants Regional Outlook (Market Revenue in USD Million, 2015 - 2026)

Cochlear Implants Market Size Worth $3.4 Billion by 2026 | CAGR: 10.5%: Grand View Research, Inc.

Retrieved on: 
Thursday, February 20, 2020

The cochlear implants market is anticipated to witness significant growth during the forecast period, which can be attributed to a favorable reimbursement scenario, rising awareness about hearing aids, and increasing adoption of implants.

Key Points: 
  • The cochlear implants market is anticipated to witness significant growth during the forecast period, which can be attributed to a favorable reimbursement scenario, rising awareness about hearing aids, and increasing adoption of implants.
  • Increasing demand, ability to recognize the speech in noise, and good reimbursement are the key factors expected to drive the market during the forecast period.
  • In June 2019, Cochlear Limited received the approval from the U.S. FDA for its Cochlear Nucleus Profile Plus Series Cochlear Implant.
  • Grand View Research has segmented the cochlear implants market by type of fitting, by end use, and region:
    Cochlear Implants Type of Fitting Outlook (Market Revenue in USD Million, 2015 - 2026)
    Cochlear Implants End Use Outlook (Market Revenue in USD Million, 2015 - 2026)
    Cochlear Implants Regional Outlook (Market Revenue in USD Million, 2015 - 2026)

The Asia Pacific cochlear implants market is expected to reach US$ 833.1 Mn in 2027 from US$ 291.6 Mn in 2018

Retrieved on: 
Wednesday, February 19, 2020

NEW YORK, Feb. 19, 2020 /PRNewswire/ -- The Asia Pacific cochlear implants market is expected to reach US$ 833.1 Mn in 2027 from US$ 291.6 Mn in 2018.

Key Points: 
  • NEW YORK, Feb. 19, 2020 /PRNewswire/ -- The Asia Pacific cochlear implants market is expected to reach US$ 833.1 Mn in 2027 from US$ 291.6 Mn in 2018.
  • On the other hand, the growing medical tourism industry in Asia Pacific countries is expected to have a positive effect on the growth of the Asia Pacific cochlear implants market in the coming years.
  • Thus the growing prevalence of hearing loss in the Asia Pacific region is likely to demand cochlear implants.
  • Asia Pacific cochlear implants market is segmented by type of fitting and end-user.Based on the type of fitting, the cochlear implant market is categorized as unilateral implantation and bilateral implantation.