Eliminating the Limitations of Manual Crimping in Stapes Surgery: Mid‐Term Results of 90 Patients in the Nitinol Stapes Piston Multicenter Trial

Abstract

Our mid-term results continue to show that the self-crimping shape memory alloy Nitinol stapes piston overcomes the limitations of manual malcrimping in stapedotomy, thus simplifying and optimizing the surgical procedure. This so far has allowed reliable, safe, and consistent ABGC in patients with otosclerosis.

Treatment of Otosclerosis with a Superelastic Nitinol Piston: First Results

“…For this purpose, a CO 2 , Argon, or KTP laser and bipolar forceps or battery-powered heating units are available. The postoperative hearing results are comparable to those achieved with a conventional prosthesis [20][21][22][23][24][25].…”

Comparison of Audiometric and Functional Outcomes Between the Standard and Modified 360 Nitinol Shape Memory Stapes Prostheses

“…The invention of the nitinol prosthesis has been demonstrated in several publications to have excellent hearing outcomes with the added benefit of heat-activated self-crimping and thereby atraumatic application with interindividual reproducibility (5,16). Following studies demonstrating loosening or displacement of this prosthesis (4), the hook component of the original prosthesis was redesigned to confer a more secure circumferential fixation to the LPI.…”

“…This circumnavigated the previously mentioned crimping risks, introducing a reliable and reproducible crimping method independent of surgical technique, leading to better contact with the incus and hence better sound transmission (5,10). Previous studies have demonstrated excellent hearing outcomes (11Y13) and, in theory, because of the precise application to the incus, the risk of LPI necrosis would be reduced (5).…”

“…Made from differing materials with different properties that aid surgical application, some require manual crimping for application to the long process of the incus (LPI), whereas others follow the shape memory principle, such as the fluoroplastic piston. However, problems have been associated with various prostheses such as displacement (2,3), poor application to incus leading to loosening and subsequent reduced hearing outcomes (3,4), large interindividual variability (5), and iatrogenic risks to the ossicles themselves either during the crimping process (5,6) or potentially as a result of overcrimping leading to incus necrosis (7,8).…”

Biocompatibility of Nitinol Stapes Prosthesis

“…It allows a snug fit between the prosthesis and the incus and avoids the technically challenging manual crimping. Studies show comparable (7Y10) or better (11,12) sound transmission properties of heat-activated nitinol prostheses compared with conventional prosthesis.…”