Nitinol Prosthesis in Stapes Surgery: Evolution from Heat-Activated to Superelastic Nitinol: A Systematic Review

Abstract

Background/Objectives: Stapes surgery is a well-established treatment for conductive hearing loss caused by otosclerosis, with the choice of prosthesis playing a pivotal role in audiological outcomes and safety. Heat-activated and superelastic nitinol prostheses are widely used, but their comparative effectiveness and complication profiles remain debated. This systematic review and meta-analysis aimed to evaluate the audiological outcomes, complication rates, and overall performance of these two prosthesis types. Methods: A systematic review was conducted following PRISMA guidelines. Seven studies involving 273 patients were included. Data on mean air–bone gap (ABG) reduction, complication rates, and follow-up outcomes were extracted. Meta-analyses were performed using a random-effects model, and odds ratios (OR) with 95% confidence intervals (CI) were calculated for comparative analysis. Results: The pooled mean ABG reduction was 20.2 dB (95% CI: 19.47–20.95), indicating substantial and comparable improvements in hearing for both prosthesis types. Heat-activated prostheses achieved slightly higher ABG reduction in individual studies, while superelastic prostheses offered advantages in procedural simplicity. Complication rates were 6.0% for heat-activated and 5.6% for superelastic prostheses. The most common complications included sensorineural hearing loss (2.0–2.4%) and incus-related issues such as necrosis and lateralization. Conclusions: Both prosthesis types provide comparable audiological outcomes and surgical success rates. However, the slightly lower complication rate observed with superelastic prostheses emphasizes their safety and predictability. The choice of prosthesis should be guided by patient anatomy, surgeon expertise, and procedural considerations. Future studies should prioritize long-term outcomes and standardized reporting to further refine prosthesis selection.