1) To assess long-term hearing results after endoskeletal ossicular chain reconstruction (eOCR) using the titanium Kraus K-Helix Crown prosthesis, implanted incus to stapes, with glass-ionomer cement (GIC) in chronic ears and 2) to determine safety of the prosthesis and cement.
Prospective, nonrandomized, sequential, single center, single surgeon.
Private practice, ambulatory surgical center.
N = 15 males (42%) and 21 females (58%). Mean age was 40.4 years (range, 6–81 years); 38 ears (22 right ears [58%] and 16 left ears [42%]).
eOCR in chronic ears. Comprehensive preoperative and postoperative hearing measurements were performed for up to 9 years.
Main Outcome Measures
Postoperative hearing results at 1 year showed statistically significant improvement as compared with preoperative hearing. Long-term hearing results remained stable and showed no statistically significant change over 9 years.
Estimated mean pure-tone air conduction average improved by 14.5 dB (95% confidence interval = 10.3–18.7). Estimated mean speech reception thresholds improved by 15.5 dB (10.8–20.2). Word recognition scores improved by −2.2% (−5.3 to 1.0). The estimated mean postoperative air–bone gap was 10.5 dB (7.2–13.8). The estimated mean calculated air–bone gap was 11.3 dB (8.0–14.5). The estimated mean change in high-tone bone conduction (HTBC) average was +3.5 dB (0.9–6.0). Two prostheses extruded (5%). No patients experienced any unanticipated serious adverse effects or events.
eOCR using the K-Helix Crown prosthesis, incus to stapes, and GIC can significantly improve hearing at 1 year and maintain stable hearing over 9 years. Both prosthesis and cement are safe.