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

Susan Arndt1, Christian Offergeld1, Wendelin Wolfram2

  • 1Department of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Medical Center-University of Freiburg, University of Freiburg, 79106, Freiburg, Germany.

European Archives of Oto-Rhino-Laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery
|November 16, 2025
PubMed
Summary

Partial ossicular replacement prostheses, including mXACT and mCLIP, show safe and effective outcomes. Most patients achieved successful audiological results with satisfactory short-term hearing improvement.

Keywords:
MCLIP ARC partial prosthesisMCLIP partial prosthesisMXACT PRO partial prosthesisMXACT partial prosthesisPartial ossicular replacement prostheses

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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.