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:
- The bandaging protocol recommended by Advanced Bionics is followed when the patient undergoes a 1.5Tan MRI procedure with the magnet left in place, or
- For cases that would clinically benefit from reduced device artifact (for example some head or neck scans), the,
- The internal magnet is surgically removed and possibly replaced with the temporary non-magnetic plugMagnet Insert Dummy before the patient undergoes an MRI procedure.
- The external sound processor and headpiece are removed before entering a room where an MRI scanner is located.
- The recommended minimum duration of time post implant surgery prior to undergoing an MRI scan is 2 to 4 weeks in order to allow any inflammation to subside.
- An MRI scan is not recommended if the patient has a fever.
- Caution: The bandaging protocol with use of the MRI Antenna Coil Cover was developed and approved to prevent magnet displacement and counteract magnet torque during a 1.5T MRI procedure, but some discomfort and pain at the implant site may still be experienced. Please consult with your physician if this is an issue
- Caution: If discomfort persists following an MRI, please notify your physician
- Caution: Failure to secure the MRI Antenna Coil Cover and internal magnet in place during MRI may result in magnet displacement or the need for surgical revision
- Caution: Please consult with your physician prior to MRI to determine if the benefits of MRI are worthwhile over other imaging techniques
- MRI preparations must be conducted outside of the MRI room.
- Verify that the implant, or both implants if bilaterally implanted, are compatible for conducting an MRI before proceeding. Failure to do so can lead to device movement, device damage, magnet movement, patient discomfort, or trauma and pain to the patient.
MRI procedures are contraindicated for CLARION (C1 and CII) Cochlear Implant recipients.
For additional information regarding the use of an MRI scanner with a HiRes 90K/Advantage device, please contact Advanced Bionics Technical Support.
MRI testing of the HiRes 90K cochlear implant family
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.
In EU (European Union): Medical personnel must contact Advanced Bionics Technical Support prior to MRI procedure for completion of the “MRI Examination Request Form,” for review of the technical specifications of the specific MRI equipment and for additional guidelines.
Note: In the EU, MRI Examination Request Form (029-M569) must be provided to Advanced Bionics for review and approval prior to performing the MRI