Multicenter study results of the med-el partial ossicular replacement prostheses

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Audiology

Background:

• Middle ear reconstruction often involves partial ossicular replacement prostheses.
• Evaluating the safety and effectiveness of specific prostheses is crucial for clinical decision-making.

Purpose of the Study:

• To analyze the safety and effectiveness of mXACT, mXACT PRO, mCLIP, and mCLIP ARC partial ossicular replacement prostheses.
• To compare outcomes based on coupling type (bell vs. clip).

Main Methods:

• Retrospective analysis of clinical data from 203 patients undergoing partial ossicular replacement.
• Evaluation of adverse events (AEs) and audiological outcomes via pure-tone audiometry (PTA4).
• Success defined as a post-operative PTA4 air bone gap (ABG) ≤ 20 dB.

Main Results:

• Successful rehabilitation (PTA4 ABG ≤ 20 dB) was achieved in 69.8% of the bell group and 72.4% of the clip group.
• The bell group reported 5.9% AEs, while the clip group reported 11.2% AEs.
• Mean post-operative PTA4 ABG was 17.8 dB (bell) and 16.3 dB (clip), with stable bone conduction thresholds in over 95% of patients.

Conclusions:

• mXACT and mCLIP partial ossicular replacement prostheses demonstrate satisfactory short-term audiological results.
• These prostheses are considered safe and effective for partial ossicular replacement.
• The study supports the use of these devices in middle ear reconstruction.