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.