Magnetic Resonance Imaging Safety of the Floating Mass Transducer

Todt, Ingo; Rademacher, G.; Wagner, Friederike; Schedlbauer, Eva; Wagner, J.; Basta, Dietmar; Ernst, Arne

doi:10.1097/mao.0b013e3181f7ad5a

Cited by 12 publications

(6 citation statements)

References 12 publications

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“…For patients with middle ear implants containing electromagnetic actuators, there is an additional increased risk of migration of the implanted actuator that may possibly damage the recipient's ossicular chain or functioning inner ear. Prior work by Todt et al [12,13] and Jesacher et al [14] has indicated that this was a severe risk for patient's implanted with the previous generation of the MED EL Vibrant Soundbridge 1 implant. The present study has provided more insights on how severe the risk of actuator migration could be for patient's implanted with a Cochlear™Carina 1 fully-implantable AMEI.…”

Section: Discussionmentioning

confidence: 99%

“…In a prior version of this device, several issues have been detected related to the device's electromagnetic actuator [12]. Studies by Todt et al [12,13] indicated that the implanted actuator could move due to magnetically-induced forces, leading to a number of actuator dislocations. Patients have also reported tremendous pain in the middle ear when being scanned with this device, leading to a premature ending of the procedure [12].…”

Section: Introductionmentioning

confidence: 99%

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Stability of the standard incus coupling of the Carina middle ear actuator after 1.5T MRI

et al. 2020

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Limited data is available concerning the safety of active middle ear implants (AMEI) during Magnetic Resonance Imaging (MRI). Measurements in temporal bones are the gold standard for preclinical assessment of device safety. In this study the coupling stability of an actuator as used in a fully implantable AMEI was determined in temporal bones. Eleven temporal bones were implanted with the actuator according to the manufacturer's surgical guidelines. The actuator was coupled on the incus short process as recommended for sensorineural hearing loss. Temporal bones were exposed 10 times to the MRI magnetic field by entering the MRI suite in a clinically relevant way. Computed Tomography (CT) images were acquired before and after the experiment to investigate the risk of actuator dislocation. Based on the electrical impedance of the actuator, the loading of the actuator to the incus was confirmed. Relative actuator displacement was determined on the CT images by comparing the initial with the final actuator position in 3D space. Impedance curves were analyzed after each exposure to check the loading of the actuator to the ossicles. Analysis of CT images with a 0.30.6 mm in-plane resolution indicate no actuator displacement. The maximum detected change in impedance for all actuators was 8.43 Ω at the actuator's resonance frequency. Impedance curves measured when the actuator was retracted from the short process after the experiment still indicate the presence of a clear resonance peak. No actuator displacement or dislocation could be detected in the analysis of CT images and the measured impedance curves. Impedance curves obtained when the actuator was retracted from the incus short process still show a clear resonance peak, indicating the device is still functional after the MRI exposures.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stability of the standard incus coupling of the Carina middle ear actuator after 1.5T MRI

et al. 2020

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“…Positional changes after MRI could be detected in FMT couplings to the long process of the incus as well as in couplings to the round window. Interestingly, the functional integrity was not significantly influenced . In a retrospective clinical observation, Todt and co‐workers analysed 19 patients with VSB who underwent one or more MRI scans.…”

Section: Discussionmentioning

confidence: 99%

“…Interestingly, the functional integrity was not significantly influenced. 15 In a retrospective clinical observation, Todt and co-workers analysed 19 patients with VSB who underwent one or more MRI scans. Pain in the middle ear, scanner-related impulse noise, pressure at the receiver bed, as well as changes to the transfer function of the FMT were the frequently observed effects.…”

Section: Introductionmentioning

confidence: 99%

Prospective evaluation of reliability of cone‐beam computed tomography in detecting different position of vibroplasty middle ear implants

Güldner

Heinrichs

Weiß

et al. 2013

Clinical Otolaryngology

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Cone-beam CT as a radiological control for Vibrant Soundbridge is safe and adequately sensitive and reliable and is therefore suitable for clinical investigation. The position of the ferromagnetic transducer in the middle ear and the presence or absence of an additional coupler could be determined in this study. Therefore, cone-beam-CT is useful for the assessment of device failure when there has been gross displacement of the ferromagnetic transducer (or smaller displacements in case of a baseline postoperative cone-beam CT). Regarding the quality of imaging, cone-beam CT produced accurate results with different observers with widely varying radiological experience.

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“…Sokolowski et al [35] used LDV to measure round window movability, and to assess ossicular chain functioning after malleus stapes assembly reconstruction. Todt et al [36] studied safety of MRI scanning of implantable hearing devices (floating mass transducers) using LDV.…”

Section: Biomedical and Bioengineering Applications Of Ldvmentioning

confidence: 99%

Novel Applications of Laser Doppler Vibration Measurements to Medical Imaging

Tabatabai

Oliver²,

Rohrbaugh

et al. 2013

Sens Imaging

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Laser Doppler Vibrometry (LDV) has been widely used in engineering applications involving non-contact vibration and sound measurements. This technique has also been used in some biomedical applications including hearing research. The detectable frequencies are in the range of near-DC to 1 GHz or higher. This paper reviews applications of LDV in biomedical engineering and proposes new medical imaging applications based on measuring surface vibrations of tissues and organs. Tests were conducted on human skin using single point and scanning laser vibrometers. These tests suggest that skin vibrations due to the forcing excitation from the heart can be used in imaging of blood flow. The results of these tests illustrate the potential of such vibration measurements in a variety of diagnostic medical imaging applications including blood flow/restrictions, real-time monitoring of blood pressure variations, wound healing, muscle movements, etc. The fact that the measurements can be conducted remotely (non-contact) is an important benefit that adds to the promise of this approach.Electronic supplementary materialThe online version of this article (doi:10.1007/s11220-013-0077-1) contains supplementary material, which is available to authorized users.

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Magnetic Resonance Imaging Safety of the Floating Mass Transducer

Cited by 12 publications

References 12 publications

Stability of the standard incus coupling of the Carina middle ear actuator after 1.5T MRI

Stability of the standard incus coupling of the Carina middle ear actuator after 1.5T MRI

Prospective evaluation of reliability of cone‐beam computed tomography in detecting different position of vibroplasty middle ear implants

Novel Applications of Laser Doppler Vibration Measurements to Medical Imaging

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