Abstract
BACKGROUND: Stapes prostheses play a crucial role in improving auditory performance and facilitating the patient's reintegration into social life. However, determining the ideal characteristics of a prosthesis and identifying the best commercially available option remain challenging. This study aims to compare the outcomes of two different types of prostheses: the MatriX Stapes Prosthesis and the new mAXIS Stapes Prosthesis. METHODS: A prospective study was conducted on patients diagnosed with suspected otosclerosis who underwent stapedotomy, receiving either the MatriX or mAXIS prosthesis randomly during surgery. Postoperative follow-ups were conducted for at least one year. Audiometric evaluations were analyzed using statistical tests. Additionally, a systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. RESULTS: The prospective study included 84 patients, divided into two groups (G1: MatriX, G2: mAXIS). The auditory results were satisfactory for both prostheses, demonstrating their effectiveness in improving hearing thresholds. We observed a gain for air conduction threshold of 26.2 dB vs 21.2 dB with an ABG closure of 20.7 dB vs and 21.2 dB in G1 and G2 respectively. The literature review encompassed 15 studies, revealing overall positive outcomes with different prosthetic materials. CONCLUSIONS: The study revealed effective auditory improvement with both prostheses, yet no statistically significant differences in air-bone gap closure or average hearing gain. Titanium emerged as the preferred material due to its biocompatibility, lightweight nature, and stability under magnetic resonance imaging. The mAXIS prosthesis is introduced as a cost-effective alternative with favorable intraoperative features.