A prospective evaluation of the Essen titanium stapes prosthesis.
OBJECTIVES: This is the first clinical trial to evaluate the suitability of a new titanium stapes prosthesis, which we developed jointly with the Kurz Company (Dusslingen). DESIGN: In a prospective clinical study, patients with otosclerosis underwent stapes surgery using our new titanium stapes prosthesis during a period of 14 months. One year after surgery pre- and postoperative audiograms were performed and all patients participated in a structured interview. SETTING: Tertiary otorhinolaryngological university department PARTICIPANTS: Of 49 patients with otosclerosis, entering the study, two patients were excluded, because they were not located any more. MAIN OUTCOME MEASURES AND RESULTS: All patients experienced a hearing improvement of 21 dB on average except one patient. Sixty percentage of patients achieved a reduction of the air-bone gap to less than 10 dB and 31% of patients having their air-bone gap closed to within 20 dB--averaged across 0.5, 1.0, 2.0 and 4 kHz. The hearing level improved significantly in the air and in the bone conduction thresholds. CONCLUSIONS: This paper presents our first '1 year postimplantation' results of our titanium stapes prosthesis. We consider the development of this implant to be beneficial. The results confirm significant improvement in hearing status and tinnitus levels.