Next generation shape memory prosthesis (NiTiBOND) for stapedotomy: Short-term results.

OBJECTIVES/HYPOTHESIS: To review hearing results and complications for the NiTiBOND next generation shape memory prosthesis and compare them with results for the current shape memory prosthesis (SMart).

STUDY DESIGN: Retrospective, multicenter chart review.

METHODS: Primary laser stapedotomy was performed using either a NiTiBOND or a SMart prosthesis. Ninety-two ears in 79 patients were included in the study (67.4% female), 52 with the NiTiBOND prosthesis and 40 with the SMart prosthesis. Data collected included demographic variables, pre- and postoperative pure-tone air and bone conduction thresholds, speech discrimination scores, complications, and the need for revision surgery. Pure-tone average (PTA) and PTA air-bone gap (ABG) pre- and postoperative were computed. Success was defined as a postoperative ABG of ≤10 dB.

RESULTS: There were no significant differences between groups in hearing results, including improvement in ABG, change in speech discrimination, change in air or bone PTA, or change in high-frequency bone PTA. Short-term (mean = 4.4 and 4.9 weeks, respectively) success rates for the NiTiBOND and SMart prostheses were 84.6% and 70.0%, respectively, with this difference closing at the most recent test (83.7% and 80.0%, respectively). No revision surgery took place in either group, and there were no differences in complications such as dizziness, tinnitus, or taste disturbance, though the NiTiBOND group tended to have a lower rate of transient or permanent vertigo.

CONCLUSIONS: Compared with the SMart prosthesis, the NiTiBOND prosthesis is a safe prosthesis that achieves at least comparable hearing results and may offer some surgical advantages.

LEVEL OF EVIDENCE: 4 Laryngoscope, 127:915-920, 2017.