Durham, North Carolina - June 2003: The MED-EL COMBI 40+ is the first and only cochlear implant with a fixed internal magnet to receive US FDA approval for use with Magnetic Resonance Imaging (MRI). The MED-EL Cochlear Implant System is MRI safe at 0.2-Tesla with:
Many cochlear implant users will require an MRI at some point in their lifetime, so MRI compatibility can be an important consideration when selecting a cochlear implant. MED-EL, a leading manufacturer of cochlear implants, believes that patients should be able to receive the medical treatment they need - without disruption to their life and their hearing.
The MED-EL COMBI 40+ cochlear implant is manufactured with a robust ceramic material that allows patients to receive MRI scans without additional surgery. Because MED-EL's internal magnet is encased in ceramic, there is no risk that the magnet can become dislodged and no need to remove the magnet for MRI examinations.
The MED-EL Cochlear Implant System is safe and compatible for use with MRI at a strength of 0.2-Tesla. MRI systems operating at 0.2T are typically Open MRI devices. Open MRI systems help reduce patient discomfort and anxiety, while providing "great diagnostic images," according to Oscar Blabagno, radiologist at the Comprehensive Medical Imaging - Valley Imaging Center in Apple Valley, California. In addition to providing high quality images for a wide variety of applications, open MRI scanners offer a number of advantages compared to cylindrical MRI systems:
Did you know?
Applications for 0.2-Tesla scanners include:
Cochlear Implants & MRI
A cochlear implant system is a medical device that electrically stimulates the hearing nerve in the cochlea (inner ear). It consists of an internal part, the implant package, that is surgically implanted under the skin behind the ear, and an externally worn speech processor. The speech processor is typically worn behind the ear and is held in place by a magnet. Generally, all cochlear implants contain magnets.
Prior to MED-EL's FDA approval for MRI, the only way for a patient with an internal cochlear implant magnet to receive an MRI scan was to have the magnet surgically removed before the examination. Following the MRI scan, the internal magnet had to be surgically replaced, requiring up to 4 weeks for the surgical site to heal before resuming use of the cochlear implant. Thus, in addition to requiring additional surgery, patients were forced to live in silence for as much as a month following the MRI exam.
MED-EL cochlear implant recipients can have MRI scans at 0.2-Tesla, without surgery, and can immediately resume their normal daily activities and implant use (hearing).
For more information, please contact MED-EL.
Over 28 years ago researchers who later founded MED-EL developed one of the world's first cochlear implants. Today, MED-EL is growing faster than any other cochlear implant company and is the global leader in innovative technology in the field. MED-EL products are the result of collaborative efforts by MED-EL engineers, surgeons, audiologists, therapists, and of course, implant users.
MED-EL has 15 regional offices worldwide including a North American Headquarters in Durham, North Carolina and Worldwide Headquarters in Innsbruck, Austria. With over 13,000 TEMPO+ speech processors worldwide, recipients in 70 countries from over 400 cochlear implant centers are benefiting from MED-EL's COMBI 40+ Cochlear Implant system (April 2003).
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