MRI Safety Information

For Advanced Bionics Cochlear Implants, Bahrain

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.

MRI Safety Information by Type of Implant

Type of Implant	Model Number	MRI Field Strength (T)	Spatial Gradient Field (T/m)		Max Head SAR (W/kg)	Max Body SAR (W/kg)
Clarion 1.0*	MMT-5100 L/R	MRI is contraindicated	None		None	None
Clarion 1.2*	AB-5100 L/R	MRI is contraindicated	None		None	None
Clarion CII Bionic Ear*	AB-5100H	MRI is contraindicated	None		None	None
HiRes 90K*	CI-1400	1.5T	2.5 T/m		≤ 1 W/kg	≤ 1.7 W/kg
HiRes 90K Advantage	CI-1500	1.5T	2.5 T/m		≤ 1 W/kg	≤ 1.7 W/kg
HiRes Ultra	CI-1600	1.5T	3.47 T/m	13.90 T/m***	≤ 3.2 W/kg	≤ 2 W/kg
HiRes Ultra		3.0T**	6.9 T/m		≤ 2.6 W/kg	≤ 2 W/kg
HiRes Ultra 3D	CI-1601	1.5T	20 T/m		≤ 3.2 W/kg	≤ 2 W/kg
HiRes Ultra 3D		3.0T	20 T/m		≤ 2.6 W/kg	≤ 2 W/kg

^{* These devices are no longer sold in the EU or North America

** For MRI the magnet has to be removed surgically

*** With magnet removed}

Select the Implant name below for further MRI information

HiRes Ultra 3D HiRes Ultra HiRes 90K Implant Family

HiRes™ Ultra 3D Cochlear Implant

Device	HiRes Ultra 3D
Instructions For Use	HiResolution Bionic Ear System: HiRes Ultra 3D
1.5T magnet in place	Scanning ok under certain conditions
3.0T magnet in place	Scanning ok under certain conditions

MRI Warnings

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

The external sound processor and headpiece must be removed before entering a room containing an MRI scanner.
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.

Note: MRI procedures are contraindicated for CLARION (C1 and CII) cochlear implant recipients. For information regarding MRI use with HiRes 90K, HiRes 90K Advantage, and HiRes Ultra cochlear implant, please contact Advanced Bionics Technical Support.

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:

During the MRI procedure, you may experience pain, pressure or discomfort. If this occurs, please notify your physician.
Please consult with your physician prior to MRI to determine if the benefits of MRI are worthwhile over other imaging techniques.

MRI Safety Information

Testing has demonstrated that the HiRes Ultra 3D cochlear implant is MR Conditional. Unilateral and bilateral recipients with this device can be safely scanned in a horizontal closed bore quadrature coil MR system meeting the following conditions:

Strength	1.5T	3.0T
Maximum Spatial Field Gradient	20 T/m
RMS Gradient Field	34.4 T/s
Peak Slew Rate	200 T/m/s
Maximum whole body averaged SAR	2.0 W/kg	2.0 W/kg
Maximum head averaged SAR	3.2 W/kg	2.6 W/kg

When tested under the scan conditions defined above the HiRes Ultra 3D cochlear implant is expected to produce a maximum temperature rise of <3°C after 15 minutes of continuous 3.0T scanning

Note: During the scan, patients might perceive auditory sensations. Adequate counseling of the patient is advised prior to performing the MRI. The likelihood and intensity of the auditory sensations can be reduced by selecting sequences with a lower Specific Absorption Rate (SAR) and slower gradient slew rates. In MRI testing, the measured range of device image artifact radius extending from the HiRes Ultra 3D cochlear implant for spin and gradient echo sequences and all imaging planes are as follows:

Artifact at 3.0T MRI Field Strength

Magnet	Artifact	Range
Unilaterally	In Place	5.5 - 6.9 cm
	Removed	1.4 - 4.2 cm
Bilaterally	In Place	6.1 - 7.4 cm
	Removed	1.9 - 6.9 cm

Artifact at 1.5T MRI Field Strength

Magnet	Artifact	Range
Unilaterally	In Place	4.1 - 6.5 cm
	Removed	2.4 - 3.2 cm
Bilaterally	In Place	5.7 - 8.2 cm
	Removed	3.4 - 4.1 cm

Note: 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 a Temporary Non-Magnetic Plug before the recipient undergoes an MRI procedure. The HiRes Ultra 3D cochlear implant can withstand 5 replacement cycles.

For additional information regarding the use of an MRI scanner with a HiRes Ultra 3D cochlear implant, please contact Advanced Bionics Technical Support at technicalservices@advancedbionics.com, 1.877.454.5051, or visit advancedbionics.com/mri.

HiRes™ Ultra Cochlear Implant

MRI Safety Information by Type of Implant

Type of Implant	MRI Field Strength (T)
C1.0*	MRI is contraindicated
C1.2*	MRI is contraindicated
CII*	MRI is contraindicated
HiRes 90K*	1.5T
HiRes 90K Advantage	1.5T**
HiRes Ultra w/magnet	1.5T**
HiRes Ultra magnet removed	3.0T**

^{* These devices are no longer sold in North America or the EU

** The Magnet has to be removed}

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

MRI Warning

Do not allow patients with a HiRes™ 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 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.
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 Safety Information

Testing has demonstrated that the HiRes Ultra cochlear implant is MR Conditional. Unilateral and bilateral recipients with this device can be safely scanned in an MR system meeting the following conditions:

1.5T with the magnet in place

The external sound processor and headpiece are MR Unsafe and must be removed before entering a room containing an MR scanner.
A bandage must be applied using the bandaging protocol below.
Horizontal closed bore scanners with a static magnetic field of 1.5T.
Maximum spatial field gradient of 2,000 Gauss/cm (20 T/m).
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2 W/kg at 1.5T (Normal Operating Mode) for quadrature transmit RF body coils.
Maximum MR system reported, head averaged SAR of ≤ 3.2 W/kg at 1.5T (Normal Operating Mode) for quadrature transmit RF head coils.
RMS gradient field of 30 T/s and peak gradient field of 150 T/s.

Under the scan conditions defined above the HiRes Ultra implant is expected to produce a maximum temperature rise of <3°C after 15 minutes of continuous 1.5T scanning.

In MRI testing of unilateral and bilateral recipient conditions, respectively, the image artifact caused by the device extends from the HiRes Ultra implant approximately 8 cm using a gradient echo pulse sequence and >9.5 cm using a spin echo or gradient echo pulse sequence in a 1.5T scanner with the magnet in place. These artifacts may result in a loss of diagnostic information in the implant vicinity.

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

Please note that the MRI Antenna Coil Cover, CI-7521, and bandaging supplies must be on hand at the time of the MRI procedure. Please contact Advanced Bionics at customerservice@advancedbionics.com or 1-877-829-0026 prior to the MRI procedure to request these supplies.

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.

1.5T with the magnet removed

The internal magnet must be removed. See the “Surgeon Manual for the HiRes Ultra Cochlear Implant” for removal instructions.
The external sound processor and headpiece are MR Unsafe and must be removed before entering a room containing an MR scanner.
Horizontal closed bore scanners with a static magnetic field of 1.5T.
Maximum spatial field gradient of 2,000 Gauss/cm (20 T/m).
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2 W/kg at 1.5T (Normal Operating Mode) for quadrature transmit RF body coils.
Maximum MR system reported, head averaged SAR of ≤ 3.2 W/kg at 1.5T (Normal Operating Mode) for quadrature transmit RF head coils
RMS gradient field of 30 T/s and peak gradient field of 150 T/s.

Under the scan conditions defined above the HiRes Ultra implant is expected to produce a maximum temperature rise of <3°C after 15 minutes of continuous 1.5T scanning.

In MRI testing of unilateral and bilateral recipient conditions, respectively, the image artifact caused by the device extends from the HiRes Ultra implant approximately 3 cm and 4 cm using a gradient echo pulse sequence in a 1.5T scanner with the temporary non-magnetic plug in place. These artifacts may result in a loss of diagnostic information in the implant vicinity.

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.

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 Took Kit, CI-1418

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

3.0T with the magnet removed

The internal magnet must be removed. See the “Surgeon Manual for the HiRes Ultra Cochlear Implant” for removal instructions.
The external sound processor and headpiece are MR Unsafe and must be removed before entering a room containing an MR scanner.
Horizontal closed bore scanners with a static magnetic field of 3.0T
Maximum spatial field gradient of 2,000 Gauss/cm (20 T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2 W/kg at 3.0T (Normal Operating Mode) for quadrature transmit RF body coils
Maximum MR system reported, head averaged SAR of ≤ 2.6 W/kg at 3.0T (Normal Operating Mode) for quadrature transmit RF head coils
RMS gradient field of 30 T/s and peak gradient field of 150 T/s
Under the scan conditions defined above the HiRes Ultra implant is expected to produce a maximum temperature rise of <3°C after 15 minutes of continuous 3.0T scanning.
In MRI testing of unilateral and bilateral recipient conditions, respectively, the image artifact caused by the device extends from the HiRes Ultra implant approximately 5cm using a spin echo pulse sequence in a 3.0T scanner with the temporary non-magnetic plug in place. These artifacts may result in a loss of diagnostic information in the implant vicinity
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.

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 Took Kit, CI-1418

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

MRI Antenna Coil Cover

The MRI Antenna Coil Cover is intended to be used along with a bandaging protocol to allow the patient to undergo an MRI procedure with the magnet left in place. Instructions for use must be followed, including the recommended bandaging protocol.

Compression Dressing prior to MRI Procedure with HiRes 90K Users

This document will provide general guidance for applying appropriate compression dressing over the site of the implanted device (and magnet) in order to perform an MRI procedure.

Required Materials

Hurt-Free Wrap – Hospital Grade

Latex Free
5 cm width
Johnson and Johnson (or equivalent)

Flexible Tape

Latex Free
2 – 2.5 cm width
3M – Nexcare (or equivalent)

MRI Antenna Coil Cover CI-7521 - Advanced Bionics

Patient Headpiece

Marking Pen

Coach Self-Adhering Elastic Bandage 3 inch (8 cm) width

Johnson and Johnson

MRI Antenna Coil Cover CI-7521 - Advanced Bionics

Patient Headpiece

Marking Pen

Advanced Bionics HiRes Ultra cochlear implant, magnet indicated.

Lateral view of a cochlear implant looking out toward the pinna of the ear showing magnet. Magnet must be covered by MRI Antenna Coil Cover.

Lateral x-ray in sagittal plane shows a cochlear implant in typical orientation relative to a patient’s skull with implant magnet indicated. Magnet must be covered by MRI Antenna Coil Cover.

Procedure

Place patient in sitting position to allow access to the implant site.

NOTE: If the patient is bilaterally implanted, prepare to locate both implant devices using the following steps. Both implant locations must have compression dressing placed over their magnets.

Secure MRI Antenna Coil Cover over implant magnet site. Place the patient headpiece (with cable removed) over the implant site. The magnets will hold the headpiece in place.

Patient headpiece magnetically attached

Cut a piece of the Coach bandage that is long enough to wrap around the head once..

Wrap this piece around the head, so that the bandage covers the patient headpiece. Make this wrap tight.

Patient headpiece under bandage

Outline the position of the headpiece on the bandage using a marker or pen.

Marked bandage showing outline of headpiece

Slip out the patient headpiece, but keep the bandage in place.

Removing headpiece with bandage in place

Slide the MRI Antenna Coil Cover under the bandage, lining it up with the marked outline of the headpiece.

Inserting MRI Antenna Coil Cover

MRI Antenna Coin Cover under marked outline

Measure head size and bandage length needed for compression wrapping. Take the remaining Coach bandage roll, and wrap the bandage around the head once, without stretching.

Remaining Coach bandage roll wrapped once around head

Mark the location on the bandage that is one full wrap around the head. This is the head circumference.

Mark bandage one full wrap

Marked head circumference around head

Unwrap the piece of bandage with the marked head circumference, and place it on a flat surface.

Marked head circumference

Unroll the remaining bandage roll. Fold over the bandage start and crease at the marked head circumference.

Cut or tear the remaining bandage where it overlaps with the bandage start. The resulting bandage piece length is twice the head circumference.

Apply compression bandaging. Wrap this cut piece, this time very tightly, by stretching the marked line an additional half turn around the head.

NOTE: After 1.5 turns, the marked line should be on the opposite side of the head from where you started the wrap.

Continue wrapping the bandage at 150% extension for an additional 1.5 turns, resulting in 3 full turns total.

NOTE: After 3 turns, the bandage should end where you started the wrap (further is acceptable also).

After the MRI

Once the MRI procedure has been completed, gently remove the Coach Wrap, tape, and the MRI Antenna Coil Cover.

Discard all components including the MRI Antenna Coil Cover.

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

MRI Safety Information

Testing has demonstrated that the HiRes 90K Advantage cochlear implant is MR Conditional. Unilateral and bilateral recipients with this device can be safely scanned only in an MR system that allows display of fractional mode SAR, and meeting the following conditions:

Static magnetic field of 1.5T with the magnet removed
Maximum MR system reported, head averaged SAR of ≤ 1 W/kg at 1.5T for all coils
RMS gradient field of 30 T/s and peak gradient field of 150 T/s
Maximum spatial field gradient of 620 gauss/cm (6.2 T/m) at 1.5T with the magnet removed

Under the scan conditions defined above the HiRes 90K Advantage device is expected to produce a maximum temperature rise of <2.4°C at the tip of the electrode after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 60 mm from the HiRes 90K Advantage with the magnet removed when imaged with a gradient echo pulse sequence and a 1.5 T MRI system. These artifacts may result in a loss of diagnostic information in the implant vicinity.

MRI Warnings

Do not allow patients with a HiRes 90K Advantage cochlear implant to be in the area of an MRI scanner unless the following conditions have been met:

The internal magnet is surgically removed and possibly replaced with the temporary non-magnetic plug 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.
It is recommended not to have an MRI scan if the patient has a fever.

For additional information regarding the use of an MRI scanner with a HiRes 90K Advantage device, please contact Advanced Bionics Technical Support.

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