On Tuesday, March 24, a patient at UNC Hospitals became the first in the U.S. to be implanted with the newly FDA-approved SYNCHRONY cochlear implant, manufactured by Durham-based MED-EL.
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.
“With age comes an increased risk for diseases that rely on the latest diagnostic technology, like 3.0 T MRI. UNC is proud to be the first facility in the country to offer SYNCHRONY’s cutting-edge cochlear implant technology.”
“The upper age limit of cochlear implant candidates continues to rise,” said Harold Pillsbury, MD, Chair, Department of Otolaryngology/Head and Neck Surgery, University of North Carolina School of Medicine. “With age comes an increased risk for diseases that rely on the latest diagnostic technology, like 3.0 T MRI. UNC is proud to be the first facility in the country to offer SYNCHRONY’s cutting-edge cochlear implant technology.”
SYNCHRONY was approved by the FDA in January 2015. Widespread commercial availability will be announced in the coming weeks. The implant’s magnet design is approved for 3.0 T MRI examinations which allow imaging of organs and tissues at higher resolution. MRI usage is on the rise, at a rate of approximately 10 percent per year. The SYNCHRONY implant is the first and only cochlear implant that is conditionally safe at 3.0 T without the surgical removal of the internal magnet.
The magnet of a cochlear implant device holds the external audio processor in place. Previous magnet designs are only robust against MRI field strength of up to 1.5 T. SYNCHRONY’s diametrically aligned magnet freely rotates within its titanium housing and aligns itself with the magnetic field in the MRI tube. Due to the self-alignment feature, there is no risk in a loss of implant magnet strength during MRI scans and no torque acts on the magnet in the MRI tube.
Mr. Long underwent his first back surgery 50 years ago and has had two more surgeries since then. His bilateral moderately-severe to profound sensorineural progressive hearing loss began more than 13 years ago. He used hearing aids for more than a decade, but his hearing loss progressed to the point that he continued to struggle with everyday understanding and communication with the use of traditional hearing aids. With SYNCHRONY cochlear implants, MRI technology can be used to monitor his back regularly in the future.
“Providing the sense of hearing, together with the peace of mind knowing that future MRIs are possible without the need for additional surgery, is a major quality-of-life advancement and MED-EL is proud to be the leader in making this technology available,” said Raymond Gamble, President & CEO, MED-EL North America.