Magnetic Resonance Imaging Safety of the
Floating Mass Transducer
*Ingo Todt, †Grit Rademacher, *Friederike Wagner, *Eva Schedlbauer,
*Jan Wagner, *Dietmar Basta, and *Arne Ernst
Departments of *Otolaryngology, and ÞRadiology, Unfallkrankenhaus Berlin, Berlin, Germany
Hypothesis: The goals of this study are to observe 1.5-T
magnetic resonance imaging (MRI)Yrelated changes to the Vi-
brant Soundbridge floating mass transducer (FMT) magnetiza-
tion, function, and position in different coupling modes within
the middle ear; changes to middle ear structures; and effects on
the transfer function to the inner ear.
Background: The MRI safety of implantable hearing devices is
important in daily routine clinical care as well as in urgent care.
Methods: Nine FMTs were repeatedly investigated before and
after MRI scanning. Changes in the position of the FMT (round
window, incus, and stapes) and in the ossicular chain in tem-
poral bones were estimated by microscopy, microendoscopy,
and flat panel angiography. Functional investigations of the
FMT in different coupling modes were done using laser Doppler
vibrometry.
Results: Qualitative demagnetization could be ruled out in all
specimens after up to 11 MRI scans. In FMT couplings to the
long process of the incus (n = 18), positional changes were
found in 5 temporal bones. A disarticulation or exarticulation of
the ossicles was not observed. Mean laser Doppler vibrometry
measurements showed MRI-related changes in the stapes ve-
locity. In FMT couplings to the round window (n = 23), we
observed a fixation-dependent influence of MRI scanning on the
FMT position and mean transfer function.
Conclusion: The functional integrity of the FMT was not sig-
nificantly influenced after multiple MRI scans. Positional changes
of the FMT within the middle ear are possible, but we observed no
structural damage to middle ear structures. Effects on the transfer
function are possible. Key Words: Floating mass transducerV
Magnetic resonance imagingVVibrant Soundbridge.
Otol Neurotol 31:1435Y1440, 2010.
Magnetic resonance imaging (MRI) scanning in daily
clinical routine is important and may be required for
patients both with and without medical implants. This is
true for hearing implants, and it is important to know the
effects of MRI on the implant and nearby physical struc-
tures. Stapes prostheses have been widely investigated in
vitro (1,2) and in vivo (3) and have been shown to be MRI
safe in the commonly applied T-range of conventional
MRI scanners with 1 exception (1987, McGee piston).
The recommendations of cochlear implant manufac-
turers for MRI scanning at 1.5 T vary from removal of the
internal magnet (Advanced Bionics, Sylmar, CA, USA;
Cochlear Ltd, Melbourne, Australia) to using a tight
headband on the patient during scanning. This is to decrease
the risk of magnet dislocation and to minimize possible
discomfort in the magnetic field (Cochlear Ltd, Melbourne,
Australia; MED-EL, Innsbruck, Austria; MXM, Vallauris,
France).
The risk of MRI-induced currents has been shown to be
insignificant in currently used cochlear implants (4Y7).
However, demagnetization of the internal magnet has
been described (7,8). Results with present systems vary
between limited demagnetization (6) and no significant
demagnetization (4).
MRI safety studies of hearing implants other than co-
chlear implants are limited. MRI scanning does not have
any influence on the BAHA system because a nonmag-
netic titanium screw is used (9). Most other published
reports are of historical interest only because the devices
are no longer available. Reports on a previous active
middle ear implant showed a displacement of the incus-
attached magnet in the temporal bone (TB) (10), and
studies of the Soundtec implantable hearing aid showed
that the device is MRI safe at 0.3 T (11).
Our group published a case study of 2 patients who
underwent 1.5 T MRI scanning without impairment to
hearing or the functional integrity of the Vibrant Sound-
bridge (VSB) (12). An experimental study of the influence
Address correspondence and reprint requests to Ingo Todt, M.D.,
Department of Otolaryngology at ukb, Warener Str. 7, D-12683 Berlin,
Germany; E-mail Ingo.Todt@ukb.de
This study was supported by the Vibrant MED-EL Company.
Otology & Neurotology
31:1435Y1440 Ó 2010, Otology & Neurotology, Inc.
1435
Copyright © 2010 Otology & Neurotology, Inc. Unauthorized reproduction of this article is prohibited.