3D PRINTING AND CUSTOM IMPLANTS IN OSSICULOPLASTY A PILOT FEASIBILITY STUDY

Abstract

In this prospective, single‐arm pilot feasibility study, we evaluated a rapid, end‐to‐end workflow for designing, 3D‐printing, and implanting patient‐specific titanium ossicular prostheses in ten adults (aged 18–65 years) with chronic conductive hearing loss due to cholesteatoma, trauma, or otosclerosis. Preoperative CT images were segmented into 3D middle‐ear models, from which lattice‐structured implants were fabricated via selective laser melting (mean design time 128 ± 9.8 min; print time 47.4 ± 4.2 min). Intraoperative fit was rated on a five‐point congruence scale (mean score 4.2 ± 0.8), and implant stability was confirmed without extrusion or infection. Audiometric outcomes demonstrated statistically significant air–bone gap (ABG) reductions of 12.9 ± 2.4 dB at one month and 16.0 ± 2.7 dB at three months postoperatively (both p < .001 vs. baseline 28.5 ± 3.2 dB), surpassing conventional ossiculoplasty benchmarks and correlating positively with fit score (r = 0.72). Patient satisfaction, measured via a five-item Likert questionnaire, yielded high mean scores across domains—fit and comfort (4.3 ± 0.5), hearing improvement (4.5 ± 0.5), surgical experience (4.7 ± 0.4), information clarity (4.4 ± 0.6), and overall satisfaction (4.6 ± 0.5)—with only two minor adverse events (10% minor pain; 10% transient vertigo). The total workflow interval from image acquisition to implantation averaged under three hours, demonstrating feasibility for integration into standard otologic practice. These findings underscore that anatomically tailored, 3D‐printed ossicular implants can address sizing mismatches and enhance acoustic transmission while maintaining a safe and efficient surgical pathway. Future work will expand patient cohorts, explore alternative biomaterials, and assess long‐term outcomes to validate personalized ossiculoplasty as a new standard in middle‐ear.