MRI Safety Information

For Advanced Bionics Cochlear Implants, Israel

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.



Select the Implant name below for further MRI information

HiRes Ultra HiRes 90K Implant Family

 

HiRes™ Ultra Cochlear Implant 


Device HiRes Ultra
Instructions For Use
HiResolution Bionic Ear System: HiRes Ultra 
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
3.0T magnet removed Scanning ok under certain conditions

1.5T with the magnet removed

MRI Warnings

Do not allow patients with a HiRes Ultra cochlear implant to be in the area of an MRI scanner unless the following conditions have been met:

  • The bandaging protocol [Refer to the MRI Antenna Coil Cover (CI-7521) IFU for details] recommended by Advanced Bionics is followed when the patient undergoes an 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 internal magnet is surgically removed and possibly replaced with the temporary nonmagnetic plug before the patient undergoes an MRI procedure.
  • The external sound processor and headpiece are MR Unsafe and must be removed before entering a room containing an MR scanner.
     

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.

For additional information regarding the use of an MRI scanner with a HiRes Ultra device, please contact Advanced Bionics Technical Support.



For 1.5T MRI scans with the magnet removed

  • Horizontal closed bore scanners with a static magnetic field of 1.5T (magnet removed).
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2.0 W/kg at 1.5T for quadrature transmit RF body coils.
  • Maximum MR system reported, head averaged SAR of ≤ 3.2 W/kg at 1.5T for quadrature transmit RF head coils.
  • RMS gradient field of 30 T/s and peak gradient field of 150 T/s.
  • Maximum spatial field gradient of 13.90T/m at 1.5T with magnet removed
     

When tested under the scan conditions defined above the HiRes Ultra implant produced a maximum temperature of < 3° after 15 minutes of continuous 1.5T Scanning.

In MRI testing of unilateral recipient conditions, the image artifact caused by the device extends from the HiRes Ultra implant approximately 3.1 cm in a 1.5T MRI with the temporary non-magnetic plug and In MRI testing of bilateral recipient conditions 4.2 cm in a 1.5T MRI with the temporary non-magnetic plug using a spin echo or gradient echo pulse sequence.

These artifacts may result in a loss of diagnostic information in the implant vicinity.

Please note that the MRI Antenna Coil Cover CI-7521 and bandaging supplies must be on hand at the time of the MRI procedure.


Magnet Removal/Replacement Using the HiRes Ultra Magnet Tool Kit, CI‑1418

These tools must be sterilized prior to use. See the ”Guide for Reprocessing HiRes Ultra Reusable Tools” provided in the kit. 

HiRes Ultra Magnet Tool Kit contains Two (2) Magnet Insertion Tools and Two (2) Magnet Pusher Tools





1.5T with the magnet in place

MRI Warnings

Do not allow patients with a HiRes Ultra cochlear implant to be in the area of an MRI scanner unless the following conditions have been met:

  • The bandaging protocol [Refer to the MRI Antenna Coil Cover (CI-7521) IFU for details] recommended by Advanced Bionics is followed when the patient undergoes an 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 internal magnet is surgically removed and possibly replaced with the temporary nonmagnetic plug before the patient undergoes an MRI procedure.
  • The external sound processor and headpiece are MR Unsafe and must be removed before entering a room containing an MR scanner.
     

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.

For additional information regarding the use of an MRI scanner with a HiRes Ultra device, please contact Advanced Bionics Technical Support.



For 1.5T MRI scans with the magnet in place

  • Horizontal closed bore scanners with a static magnetic field of 1.5T (magnet in place).
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2.0 W/kg at 1.5T for quadrature transmit RF body coils.
  • Maximum MR system reported, head averaged SAR of ≤ 3.2 W/kg at 1.5T for quadrature transmit RF head coils.
  • RMS gradient field of 30 T/s and peak gradient field of 150 T/s.
  • Maximum spatial field gradient of 3.47 T/m at 1.5T with the magnet in place.

When tested under the scan conditions defined above the HiRes Ultra implant produced a maximum temperature of < 3° after 15 minutes of continuous 1.5T Scanning.

In MRI testing of unilateral recipient conditions, the image artifact caused by the device extends from the HiRes Ultra implant approximately 7.9 cm in a 1.5T MRI with the magnet in place and In MRI testing of bilateral recipient conditions >9.5 cm in a 1.5T MRI with the magnet in place using a spin echo or gradient echo pulse sequence.

These artifacts may result in a loss of diagnostic information in the implant vicinity.

Please note that the MRI Antenna Coil Cover CI-7521 and bandaging supplies must be on hand at the time of the MRI procedure.




3.0T with the magnet removed

MRI Warnings

The internal magnet is surgically removed and possibly replaced with the temporary non-magnetic plug before the patient undergoes an MRI procedure.

Do not allow patients with a HiRes Ultra cochlear implant to be in the area of an MRI scanner unless the following conditions have been met:

  • The bandaging protocol [Refer to the MRI Antenna Coil Cover (CI-7521) IFU for details] recommended by Advanced Bionics is followed when the patient undergoes an 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 internal magnet is surgically removed and possibly replaced with the temporary nonmagnetic plug before the patient undergoes an MRI procedure.
  • The external sound processor and headpiece are MR Unsafe and must be removed before entering a room containing an MR scanner.
     

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.

For additional information regarding the use of an MRI scanner with a HiRes Ultra device, please contact Advanced Bionics Technical Support.



For 3.0T MRI scans with the magnet removed

  • Horizontal closed bore scanners with a static magnetic field of 3.0T (magnet removed)
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2.0 W/kg at 3.0T for quadrature transmit RF body coils.
  • Maximum MR system reported, head averaged SAR of ≤ 2.6 W/kg at 3.0T for quadrature transmit RF head coils.
  • RMS gradient field of 30 T/s and peak gradient field of 150 T/s.
  • Maximum spatial field gradient of 6.90T/m at 3.0T with magnet removed
     

When tested under the scan conditions defined above the HiRes Ultra implant produced a maximum temperature of < 3° after 15 minutes of continuous 1.5T Scanning.

In MRI testing of unilateral recipient conditions, the image artifact caused by the device extends from the HiRes Ultra implant approximately 4.7 cm in a 3.0T MRI with the temporary non-magnetic plug.

In MRI testing of bilateral recipient conditions 4.7 cm in a 3.0T MRI with the temporary non-magnetic plug using a spin echo or gradient echo pulse sequence.

These artifacts may result in a loss of diagnostic information in the implant vicinity.

Please note that the MRI Antenna Coil Cover CI-7521 and bandaging supplies must be on hand at the time of the MRI procedure.



Magnet Removal/Replacement Using the HiRes Ultra Magnet Tool Kit, CI‑1418

These tools must be sterilized prior to use. See the ”Guide for Reprocessing HiRes Ultra Reusable Tools” provided in the kit. 

HiRes Ultra Magnet Tool Kit contains Two (2) Magnet Insertion Tools and Two (2) Magnet Pusher Tools



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 Warning

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


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