Clip vibroplasty: experimental evaluation and first clinical results.

OBJECTIVE: To describe an active auditory rehabilitation method (clip vibroplasty) for conductive or mixed hearing loss in cases of a preserved stapes superstructure.

PATIENTS: After temporal bone experiments, the new clip vibroplasty was clinically used in 4 patients with chronic otitis media.

INTERVENTIONS: A new titanium double clip device (clip vibroplasty) was developed for a standardized and effective coupling of the floating mass transducer of the Vibrant Soundbridge to the intact stapes. Temporal bone experiments using laser Doppler vibrometry were performed to evaluate the device's acoustic efficiency. The audiologic outcomes of the first 4 patients were analyzed. The subjective benefits and satisfaction were assessed using the standardized International Outcome Inventory for Hearing Aids in all patients.

MAIN OUTCOME MEASURES: Transfer characteristics of laser Doppler vibrometry experiments; audiologic outcomes of the 4 patients.

RESULTS: In the temporal bone experiment, coupling of the FMT using the titanium double clip support produced transfer characteristics across all tested frequencies comparable to our former total ossicular reconstruction prosthesis or an optimal round window application. The intraoperative application of the clip vibroplasty was uneventful in all cases. No signs of prosthesis dislocation were noted within the follow-up period of approximately 12 months. The audiologic outcome of the first patients showed good hearing gain in pure-tone and speech audiometry, with results that are unobtainable using a conventional air conduction hearing aid.

CONCLUSION: The concept of a partial ossicular reconstruction prosthesis vibroplasty using a titanium clip support entails a straightforward procedure similar to a classic partial ossicular reconstruction prosthesis tympanoplasty. The unoccluded ear canal and the superior auditory performance offer an advantageous application of this "power clip" in cases of chronic middle ear dysfunction.