Reinforced active middle ear implant fixation in incus vibroplasty

The active middle ear implant Vibrant Soundbridge® was originally designed to treat mild-to-severe sensorineural hearing losses. The floating mass transducer (FMT) is crimped onto the long incus process. The procedure is termed incus vibroplasty to distinguish from other attachment sites or stimulus modi for treating conductive and mixed hearing losses. Rare but possible complications are difficult incus anatomy, necrosis of the long incus process, secondary detachment, and loosening of the FMT with concomitant amplification loss. The aim of this study was to functionally evaluate reinforcement of the standard attachment of the FMT to the long incus process. The head of a Soft CliP® stapes prosthesis was used for reinforcement. Functional evaluation was performed in temporal-bone preparations and in clinical practice.

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 vibrometer (LDV). FMT-induced vibration responses of the stapes and RW were then measured for standard attachment and attachment reinforced with the head of a Soft CliP® stapes prosthesis. Additionally, the outcome in two groups of patients with incus vibroplasty using standard and the reinforced FMT attachment were compared. Eleven patients were treated by standard coupling; nine patients obtained reinforcement with the head of the Soft CliP® stapes prosthesis. Three to six months postoperatively, auditory thresholds for frequency-modulated (warble) tones and vibroplasty thresholds for pure tones were measured.

In temporal bone, laser Doppler vibrometer measurements showed significantly enhanced vibration amplitudes of the stapes footplate and the RW membrane for the reinforced attachment compared with those for the standard attachment (on average, 5-10 dB at frequencies below 1 kHz and above 4 kHz). Interindividual amplitude variations were also smaller for reinforced attachment (on average, the standard deviation was 4-7 dB smaller). The clinical data showed lower vibroplasty thresholds for reinforced attachment compared with standard attachment, which amounted to, on average, 16 dB at 500 Hz and 12 dB at 4 kHz.

Auxiliary fixation of the FMT by reinforcing the attachment to the long incus process, in these experiments with the head of a Soft CliP stapes prosthesis, leads to enhanced mechanical and functional coupling, evidenced by lower vibroplasty thresholds and increased bandwidth together with reduced variability of the vibrational frequency responses of the stapes footplate and RW membrane.