OBJECTIVE: Limitations in biocompatibility and hearing improvement with ossicular chain reconstruction prostheses are addressed with new, lightweight titanium prostheses designed to maximize visualization of the capitulum and footplate regions. The effectiveness of these new prostheses is being tested in a prospective multicenter study. STUDY DESIGN: Prospective case series. SETTING: Multicenter (8 sites), primarily tertiary private practice or academic otologic clinics. PATIENTS: A convenience sample of 31 patients undergoing ossiculoplasty, with 16 partial ossicular chain reconstructions using the Bell prosthesis and 15 total reconstructions using the Aerial prosthesis. INTERVENTION: Ossiculoplasty using new Kurz titanium prostheses. Cartilage was interposed between the tympanic membrane and the prosthesis. MAIN OUTCOME MEASURES: Air-bone gap for pure tone average and 3,000 and 4,000 Hz, assessed preoperatively and 3 months, 6 months, and 12 months postoperatively; percent of patients obtaining an air-bone gap of </=20 dB; high-frequency average (1,000, 2,000, and 4,000 Hz) to evaluate sensorineural hearing loss; and extrusion rate. RESULTS: A postoperative air-bone gap of </=20 dB was obtained in 81% of Bell prosthesis patients and 67% of Aerial prosthesis patients at 3 months. The results were stable to improved for later time intervals. High-frequency gaps were similar to the pure tone average gap. To date, there have been no instances of extrusion, and all the surgeons found the prostheses easy to use and thought that the design characteristics facilitated accurate placement. CONCLUSIONS: Initial evaluation of the Kurz titanium prostheses produced low extrusion rates (none to date) with excellent hearing results, including good high-frequency conduction. Good visualization and accurate placement were easy to achieve. Further studies are needed to confirm long-term efficacy.
OBJECTIVE: Limitations in biocompatibility and hearing improvement with ossicular chain reconstruction prostheses are addressed with new, lightweight titanium prostheses designed to maximize visualization of the capitulum and footplate regions. The effectiveness of these new prostheses is being tested in a prospective multicenter study. STUDY DESIGN: Prospective case series. SETTING: Multicenter (8 sites), primarily tertiary private practice or academic otologic clinics. PATIENTS: A convenience sample of 31 patients undergoing ossiculoplasty, with 16 partial ossicular chain reconstructions using the Bell prosthesis and 15 total reconstructions using the Aerial prosthesis. INTERVENTION: Ossiculoplasty using new Kurz titanium prostheses. Cartilage was interposed between the tympanic membrane and the prosthesis. MAIN OUTCOME MEASURES: Air-bone gap for pure tone average and 3,000 and 4,000 Hz, assessed preoperatively and 3 months, 6 months, and 12 months postoperatively; percent of patients obtaining an air-bone gap of </=20 dB; high-frequency average (1,000, 2,000, and 4,000 Hz) to evaluate sensorineural hearing loss; and extrusion rate. RESULTS: A postoperative air-bone gap of </=20 dB was obtained in 81% of Bell prosthesis patients and 67% of Aerial prosthesis patients at 3 months. The results were stable to improved for later time intervals. High-frequency gaps were similar to the pure tone average gap. To date, there have been no instances of extrusion, and all the surgeons found the prostheses easy to use and thought that the design characteristics facilitated accurate placement. CONCLUSIONS: Initial evaluation of the Kurz titanium prostheses produced low extrusion rates (none to date) with excellent hearing results, including good high-frequency conduction. Good visualization and accurate placement were easy to achieve. Further studies are needed to confirm long-term efficacy.