A comparative study of MED-EL FMT attachment to the long process of the incus in intact middle ears and its attachment to disarticulated stapes head.

The Vibrant Soundbridge ^© (VSB) active middle-ear implant provides an effective treatment for mild-to-severe sensorineural hearing loss in the case of normal middle ear anatomy and mixed hearing loss in middle ear malformation. The VSB floating mass transducer (FMT), with proper couplers, can be installed on various structures of the ossicular chain, e.g., the short and long process of the incus, the stapes head, and the stapes footplate. A long process (LP) coupler is most commonly used for FMT attachment to the long process of the incus with intact ossicular chain, while CliP and Bell couplers are two standardized and reliable methods for FMT attachment to the stapes head with missing incus and malleus. However, the difference and relationship of the vibration properties among these three FMT couplers remain unclear. In the present study, the stapes footplate velocity responses of the LP, CliP, and Bell couplers have been investigated in eight fresh temporal bones (TBs) to evaluate the vibration properties of these three couplers. Normal and reconstructed middle ear transfer functions (METFs) were determined from laser Doppler vibrometer (LDV) measurements. A mastoidectomy and a posterior tympanotomy were performed to expose the ossicular chain. The METFs of the normal middle ear and middle ear with LP-FMT-coupler were compared under acoustic stimulation, thus the mass effect of the FMT with LP coupler was evaluated. Additional comparisons were made between the stapes footplate vibrations of the LP-FMT-coupler (with the intact ossicular chain at the long process of the incus), CliP-FMT-coupler and Bell-FMT-coupler on the stapes head (after incus and malleus removed) under active electromechanical stimulation. After the installation of CliP-FMT-coupler and Bell-FMT-coupler to the middle ear, the average velocity amplitude of the stapes footplate, comparing to the LP-FMT-coupler, was about 15 dB higher between 1 and 6 kHz, and 10 dB lower at about 0.5 kHz. Quantitatively, there was no significant difference between the CliP-FMT-coupler and Bell-FMT-coupler. According to our study, installation of CliP-FMT-coupler or Bell-FMT-coupler on the stapes head provides considerable improvement of the middle ear mechanical and functional responses, comparing with the LP-FMT-coupler in the temporal bone experiments. Moreover, the installation of the Bell-FMT-coupler to the stapes head produces essentially the same footplate velocity responses in comparison to the CliP-FMT-coupler.
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