Magnetic resonance imaging compatibility and safety of the SOUNDTEC Direct System.

OBJECTIVE/HYPOTHESIS: The purpose of this study was to evaluate magnetic resonance imaging (MRI) compatibility and safety of an electromagnetic implanted hearing device (the SOUNDTEC Direct System; SOUNDTEC, Inc., Oklahoma City, OK) implant during a 0.3-Tesla open MRI imaging examination of the head and neck and to develop an MRI protocol that maximizes patient safety while minimizing the need for implant removal. The current literature regarding MRI compatibility of implantable hearing devices was reviewed.

STUDY DESIGN

Linear and torsional forces, heating, and implant magnetization were evaluated in vitro. Implanted fresh-frozen human temporal bones were used to evaluate image distortion. A prospective study of 11 volunteers previously implanted with the SOUNDTEC Direct System was conducted to evaluate MRI compatibility and safety. A MEDLINE search of the literature between 1980 and July 2005 was reviewed to summarize MRI compatibility testing of implantable hearing devices.

METHODS

Torsional and linear forces experienced by eight implant magnets were measured using calibrated neurologic Von Frey Hairs and compared with finite element analysis predictions as well as forces required to separate the incudostapedial joints of 12 fresh-frozen human temporal bones. Implant heating was determined by measuring the temperature change of eight implant vials compared with saline controls immediately after a head MRI scan. Implant magnetization was evaluated after repeated exposure to a 0.3-Tesla magnetic field. An 11-patient prospective study was performed to evaluate MRI compatibility in a 0.3-Tesla open MRI environment using adult volunteers previously implanted with the SOUNDTEC Direct System. A modified MRI protocol was developed to maximize patient safety. Each individual underwent an audiometric and otologic examination immediately before and after MRI.

RESULTS

Peak linear force at the MRI entry measured 0.5 g +/- 0.2 standard deviation (SD). Maximum torque occurred at isocenter and measured 11.4 g-cm +/- 1.2 SD. The mean torque required to separate the incudostapedial joint was 33.8 g-cm +/- 20.4 SD. The average increase in temperature of the eight implant vials was 0.45 degrees C +/- 0.11 SD, whereas the increase in temperature of the three saline controls measured 0.47 degrees C +/- 0.11 SD. The average change in magnetic flux density of the 14 implant magnets tested was 22.0 gauss. Maximum image distortion occurred during the gradient echo sequence and measured 8.6 cm in diameter with a volume of 5,096 mm. Eleven patients completed a total of 12 head, one shoulder, and three lumbar 0.3-Tesla open MRI scans without patient- or device-related complications other than degradation of the MR image. There was no report of discomfort, tinnitus, dizziness, change in hearing, or change in device performance. All post-MRI changes in pure-tone thresholds, speech discrimination, soundfield thresholds, and aided soundfield thresholds were within the range of test-retest variability.

CONCLUSION

When considering MRI of implantable ferromagnetic hearing devices, issues related to mechanical forces, implant heating, current induction, implant demagnetization, image degradation, and acoustic trauma must be considered. The SOUNDTEC Direct System is both MRI-compatible and safe in a 0.3-Tesla open MRI environment when a modified protocol is used. Degradation of the head MRI image may impair visualization of the ipsilateral temporal bone and adjacent structures within a 2.5- to 4.3-cm radius of the implant and is minimized by using a fast spin echo sequence.