Mid-term results after a newly designed nitinol stapes prosthesis use in 46 patients

Abstract

OBJECTIVE: Analysis of 12-month midterm clinical and audiometric data of patients with otosclerosis who underwent stapedotomy using a newly designed prosthesis made of nitinol, a shape memory alloy.

PATIENTS: Fifty-five ears of 50 consecutive patients who underwent stapetotomy between March 2010 and July 2011 were included. They met the inclusion criteria of primary procedures, a clinical follow-up and absence of nickel allergy.

INTERVENTION: Stapedotomy and insertion of a newly designed stapes prosthesis.

MAIN OUTCOME MEASURES: Preoperative and postoperative (3 and 12 mo) air and bone conduction thresholds were recorded. Pure tone average and air bone gap (difference of air and bone conduction thresholds) were calculated for 500, 1,000, 2,000, and 3,000 Hz. The occurrence of complications was assessed.

RESULTS: Air conduction thresholds, pure tone average, and air-bone gap improved significantly 3 and 12 months postoperatively. Bone conduction threshold improved significantly at 2,000 Hz 3 months postoperatively and at 1,000 and 2,000 Hz 12 months postoperatively. A PTA of less than 20 dB was achieved in 96% of ears. No sensorineural hearing loss or other prosthesis-related adverse effects were observed.

CONCLUSION: Postoperative hearing results are comparable to the results obtained with other self-crimping prostheses. No complications or failures related to the prosthesis occurred. A longer follow-up is necessary to prove long-term stability of hearing results and safety of the new prosthesis.