MRI Safety Information

For Advanced Bionics Cochlear Implants, Uruguay

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}

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.

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