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 ≤1.0 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.