
For the United States
Testing has demonstrated that the HiRes Ultra is MR 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. Details and instructions are listed below.
For additional information regarding the use of an MRI scanner with a HiRes Ultra device, please contact Advanced Bionics Technical Support at technicalservices@advancedbionics.com or 1.877.454.5051.
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 |
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:
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 5 cm using a spin echo pulse sequence in a 3.0T scanner MRI 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.
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.
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 technical support at technicalservices@advancedbionics.com, or 1.877.454.5051 to request the MRI Antenna Coil Cover.
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.
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:
Before entering the area of an MRI scanner:
Secure MRI Antenna Coil Cover over implant magnet site:
Measure head size and bandage length needed for compression wrapping.
Apply compression bandaging:
For additional information regarding the use of an MRI scanner with a HiRes Ultra device, please contact Advanced Bionics Technical Support at technicalservices@advancedbionics.com or 1.877.454.5051