Testing has demonstrated that the Advanced Bionics HiRes implant family is MRI Conditional. Conditions vary by geography. A patient with the implant may be safely scanned with MRI only under very specific conditions. Scanning under different conditions may result in severe patient injury.
|Device||HiRes 90k and HiRes 90K Advantage|
|Instructions For Use||HiResolution Bionic Ear System: HiRes 90K and 90K Advantage|
|1.5T magnet removed||Scanning ok under certain conditions|
|1.5T magnet in place with MRI Antenna Coil Cover and bandaging protocol CI-7521||Scanning ok under certain conditions|
Magnetic Resonance Imaging Testing: MRI testing for the HiRes 90K Advantage cochlear implant, was performed according to two configurations:
with the internal magnet in place and with the internal magnet removed.
These tests were performed with MRI machines having a 1.5 Tesla static field, with a 64 MHz RF pulsed field, and a 0.3 Tesla static field, with a 12 MHz RF pulsed field, with the following results:
MRI is contraindicated except under the circumstances described below. Do not allow patients with a HiRes 90K or HiRes 90K Advantage cochlear implant to be in the area of an MRI scanner unless the following conditions have been met:
MRI testing performed for the HiRes 90K and HiRes 90K Advantage cochlear implant indicated that image shadowing may extend as far as 70 cm2 (with the magnet removed) and 210 cm2 (with the magnet in place) from the implant resulting in loss of diagnostic information in the implant vicinity. The extent of the shadowing may be minimized by adjusting the signal parameters.
MRI testing of the HiRes 90K and HiRes 90K Advantage cochlear implant with the internal magnet in place is only available in markets where regulatory approval has been received. Contact your Advanced Bionics representative for more information.
For additional information regarding the use of an MRI scanner with a HiRes 90K or HiRes 90K Advantage device, please contact Advanced Bionics Technical Support and please read the Magnetic Resonance Imaging (MRI) for the HiRes 90K and HiRes 90K Advantage CI (9050050269) or contact Advanced Bionics Technical Support.