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Reinforced implant fixation in Incus Vibroplasty
Mlynski R. , Dahlhoff E. , Heyd A. , Wildenstein D. , Hagen R. , Gummer A.W. , Schraven S.
University of Würzburg, Department of Oto-Rhino-Laryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery,
Comprehensive Hearing Center, Würzburg, Germany, 2University of Tübingen, Department of Otolaryngology, Section of Physiological
Acoustics and Communication, Tübingen, Germany
Introduction: The active middle ear implant Vibrant Soundbridge (VSB) was originally designed to treat mild-tosevere sensorineural hearing losses. The Floating Mass Transducer (FMT) is crimped on the long incus process
in these cases with proper middle-ear anatomy. The application is termed Incus Vibroplasty to distinguish it from
the applications in conductive and mixed hearing losses. Difficult incus anatomy, necrosis of the long incus
process, secondary detachment as well as loosening of the FMT with lack of amplification are rare but possible
complications. The aim of this study was to evaluate the FMT fixation at the long incus process with an additional
reinforcement using the head of a Soft CliP stapes prosthesis in temporal bones and in clinical practice.
Materials and methods: A subtotal mastoidectomy and a posterior tympanotomy were performed in ten fresh
human temporal bones. As a control for normal middle-ear function, the tympanic membrane was stimulated
acoustically and the vibration of the stapes footplate and the round-window (RW) membrane, respectively, were
measured by laser Doppler vibrometry (LDV). Fixation of a FMT to the long incus process (standard coupling)
was compared with an additional reinforcement of the FMT attachment using the head of a Soft CliP stapes
prosthesis. Additionally, the outcome in two groups of patients with Incus Vibroplasty using standard and
reinforced FMT fixation were compared. Eleven patients were treated by standard coupling; 9 patients obtained
the additional reinforcement with the head of Soft CliP stapes prosthesis. Three to six months postoperatively
auditory thresholds for frequency-modulated (warble) tones and Vibroplasty thresholds were measured.
Results: In temporal bone, LDV measurements show significantly enhanced displacement amplitudes of the
stapes footplate and the RW membrane for FMT attachment on the long incus process with additional
reinforcement with the head of a Soft CliP stapes prosthesis in comparison to the standard fixation (5-10 dB at
frequencies below 1 kHz and above 4 kHz). The clinical data showed lower thresholds in free field pure tone
audiometry as well as Vibroplasty thresholds of 5 dB in low and up to 15 dB at high frequencies in the group with
additional reinforcement by the head of a Soft CliP stapes prosthesis.
Conclusion: Supplemental reinforcement of the FMT fixation with a Soft CliP stapes prosthesis leads to an
enhanced mechanical and functional coupling of the FMT on the long incus process.