Cochlear Receives FDA Approval for MRI on Several Implants

mri-magnetom-skyra-mediaviewer_10-00092827-10The US FDA Approves many Cochlear (brand) implants for 1.5T MRI with magnet in place with the use of the Cochlear Nucleus Implant Bandage and Splint Kit, and for 3.0T MRI with magnet removed.

The following Nucleus Profile and Freedom implants are covered with this approval:

• Nucleus Profile: CI512, CI522, CI532
• Nucleus CI24RE: CI422, CI24REH, CI24RE(CA), and CI24RE(ST)

*Does not apply to CI24R, CI24M, CI22M

FDA notice of PMA supplement approval

Credits to Bob MacPherson for coming up with the scoop!

First U.S. Patient Receives New SYNCHRONY Cochlear Implant from MED-EL

March 24, 2015 – (DURHAM, NC) – MED-EL USA announced today that the first SYNCHRONY cochlear implant has successfully been implanted at the University of North Carolina Hospitals. The surgery was performed on Joe Long, 83, who has a history of back surgery, and a likelihood of future 3.0 Tesla (T) Magnetic Resonance Imaging (MRI) examinations.

Read more here!

Advanced Bionics Receives CE Mark Approval of Expanded MRI Compatibility for Cochlear Implants

— HiRes 90K and HiRes 90K Advantage cochlear implants allow 1.5T MRI scans with the CI magnet in place —

Valencia, Calif., February 3, 2015— Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that the HiRes 90K™ and HiRes 90K™ Advantage cochlear implants have received CE Mark approval from the European Notified Body, TÜV, to undergo 1.5T MRI scans without removing the internal magnet. Previously, these devices had regulatory approval to undergo MRI scans only if the magnet was removed.

Magnetic Resonance Imaging (MRI) is an increasingly common tool for diagnosing conditions such as cancer and heart disease. This additional compatibility for MRI scans while the CI magnet remains in place helps simplify the diagnostic process by avoiding additional pre- and post-MRI procedures to remove and then to replace the magnet. “Advanced Bionics prioritizes the safety and well-being of patients with our cochlear implants. We are very pleased to offer patients this additional compatibility with MRI diagnostic equipment,” said Hansjuerg Emch, Group Vice President Medical of the Sonova Group.

Cochlear implants are implanted just beneath the skin, and use magnets to link the internal and external components of the CI system. The internal component of the AB cochlear implant system includes electronics and an electrode array that deliver AB’s proprietary current steering technology for hearing that more closely resembles normal hearing. The newest AB electrode array, the HiFocus™ Mid-Scalaelectrode, was designed for optimal placement in the cochlea with low insertion force to protect its delicate structures. The HiFocus Mid-Scala electrode accommodates the latest soft surgery approaches, including round window insertion, to suit surgeon preferences and individual recipient needs. The patented design allows for ideal placement so recipients have the opportunity to hear the most pitches possible for enjoying music and improved speech understanding.

The external component of the AB cochlear implant system includes a sound processor that sends signals via the headpiece to the internal component. Partnering with Phonak, the world leader in hearing instruments, AB brings its innovative, industry-leading technology to help people with significant hearing loss for whom hearing aids are no longer sufficient. The combination of AB and Phonak technologies makes the Naída CI the most advanced sound processor available, offering high-performance hearing in all environments, 100% wireless connectivity to consumer electronics, bimodal capabilities that allow streaming to the processor and a compatible Phonak hearing aid at the same time.

For more information about AB’s innovative hearing technology, visit AdvancedBionics.com, or follow AB on FacebookTwitterYouTube, and Pinterest.

About Advanced Bionics

Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. Founded in 1993 and a subsidiary of the Sonova Group since 2009, AB develops cutting-edge cochlear implant technology that allows recipients to hear their best.

AB offers the most sophisticated cochlear implant system on the market, the HiResolution™ Bionic Ear System, with five times more sound resolution than its competitors, designed to help recipients hear in noisy settings and enjoy the full dimensions of music and tonal languages.

With sales in over 50 countries and a proven track record for developing high-performing, state of-the-art products, AB’s talented group of technologists and professionals from all over the world are driven to succeed, work with integrity and stay firmly committed to quality.

To learn more about AB and its innovative cochlear implant technology, please visit
AdvancedBionics.com.

Media Contact:
Cheryl Garma
Advanced Bionics
661.362.1400
MediaInquiries@AdvancedBionics.com

Should I Wear Medical ID?

Medic-Alert-02Cochlear implant recipients and candidates often ask whether they should wear some form of medical ID.  Cochlear Implant HELP has cut through the anecdotes, interviewed medical professionals, and has assembled the information to help you make your own decision.

Read more at Should I Wear Medical ID?