MRI Safety Information

For Advanced Bionics Cochlear Implants, El Salvador

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.

HiRes™ 90k Cochlear Implant Family

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

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:

  • The diagnostic image in situ will be distorted. With worst-case scan parameters, an image shadow around the implant area was produced. The image distortion was largest in the axial scans. The MRI static field exerts a small force on the implant.
     

MRI Guidelines

  • Use only MRI systems operating at a static magnetic field strength of 0.3 Tesla or 1.5 Tesla. MRI safety at higher energy levels has not been tested.
  • Select MRI imaging parameters to ensure a specific absorption rate (SAR) less than 1.0 W/kg in the head.
  • Carefully perform continuous verbal and visual monitoring of the patient throughout the MRI procedure
     
MRI Warnings

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 an MRI procedure with the magnet left in place or,
  • The internal magnet is surgically removed and possibly replaced with the Magnet 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.

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.


Customer Service

We Appreciate Your Request

Thank you for contacting us to assist with your hearing solutions. Count on us—a community of hearing health professionals and recipients of cochlear implants—to help you Hear and Be Heard™. A representative from Advanced Bionics will be in touch soon!

If your request needs immediate attention or you have additional questions, please contact hear@AdvancedBionics.com.

 

 

 

 

 

 

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