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

Susan Arndt; Christian Offergeld; Wendelin Wolfram; Lisa Niederwanger; Dirk Beutner; Nicholas Bevis; Joachim Hornung; Lava Taha; Piotr H Skarżyński; Łukasz Plichta; Thomas Lenarz; Susan Busch; Esther Schimanski; Georg Sprinzl; Astrid Magele; Benjamin Loader; Franz Windisch; Nina Rubicz; Paul Martin Zwittag; Dominik Riss; Christoph Arnoldner

doi:10.1007/s00405-025-09799-7

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

Eur Arch Otorhinolaryngol. 2025 Nov 16. doi: 10.1007/s00405-025-09799-7. Online ahead of print.

Authors

Susan Arndt¹, Christian Offergeld¹, Wendelin Wolfram², Lisa Niederwanger², Dirk Beutner³, Nicholas Bevis³, Joachim Hornung⁴, Lava Taha⁴, Piotr H Skarżyński^{5

6

7

8}, Łukasz Plichta^{5

7}, Thomas Lenarz⁹, Susan Busch^{9

10}, Esther Schimanski¹¹, Georg Sprinzl¹², Astrid Magele¹², Benjamin Loader^{13

14}, Franz Windisch¹³, Nina Rubicz^{15

16}, Paul Martin Zwittag^{6

17}, Dominik Riss¹⁸, Christoph Arnoldner¹⁸

Affiliations

¹ Department of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Medical Center-University of Freiburg, University of Freiburg, 79106, Freiburg, Germany.
² Department of Otorhinolaryngology, Klinikum Wels-Grieskirchen, Wels, 4600, Austria.
³ Department of Otolaryngology, University of Goettingen, 37075, Göttingen, Germany.
⁴ Department of Otorhinolaryngology, Head & Neck Surgery, University of Erlangen- Nuremberg, 91054, Erlangen, Germany.
⁵ Center of Hearing and Speech MEDINCUS, Clinical Trials Department, Kajetany, Poland.
⁶ Institute of Sensory Organs, Kajetany, Poland.
⁷ World Hearing Center of the Institute of Physiology and Pathology of Hearing, Kajetany, Poland.
⁸ Department of Teleaudiology and Screening, World Hearing Center, Institute of Physiology and Pathology of Hearing, 10 Mochnackiego Street, Warsaw, 02-042, Poland.
⁹ Department of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.
¹⁰ Cluster of Excellence Hearing4all, Medical University Hannover, 30625, Hannover, Germany.
¹¹ Zentrum fuer Mittelohrchirurgie (Centre for Middle Ear Surgery), ENT Practice, Brechtener Straße 59, 44536, Luenen, Germany.
¹² Department of Otorhinolaryngology, Head & Neck Surgery, University Clinic St. Poelten, St. Pölten, 3100, Austria.
¹³ Department of Otorhinolaryngology, Head and Neck Surgery, 1030 Wiener Gesundheitsverbund, Klinik Landstraße, Vienna, 1030, Austria.
¹⁴ Sigmund Freud Private University, Vienna, 1020, Austria.
¹⁵ Department of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, Krankenhausstrasse 9, Linz, 4020, Austria. nina.rubicz@kepleruniklinikum.at.
¹⁶ Medical Faculty, Johannes Kepler University Linz, Altenbergerstrasse 69, Linz, 4040, Austria. nina.rubicz@kepleruniklinikum.at.
¹⁷ Department of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, Krankenhausstrasse 9, Linz, 4020, Austria.
¹⁸ Department of Otorhinolaryngology, Medical University of Vienna, Vienna, 1090, Austria.

PMID: 41243016
DOI: 10.1007/s00405-025-09799-7

Abstract

Purpose: This multicentric, retrospective study aimed to analyze the safety and effectiveness of the mXACT Partial Prosthesis, mXACT PRO Partial Prosthesis, mCLIP Partial Prosthesis, and mCLIP ARC Partial Prosthesis.

Methods: Patients underwent partial ossicular replacement with a mXACT Partial Prosthesis, mXACT PRO Partial Prosthesis, mCLIP Partial Prosthesis, or mCLIP ARC Partial Prosthesis (MED-EL). The clinical data was retrospectively analyzed according to the coupling type, bell or clip. Follow-up examination included access to medical records (for adverse events (AE) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA₄)). The post-operative PTA₄ air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative PTA₄ ABG ≤ 20 dB was defined as successful rehabilitation. A post-operative minimum and maximum follow-up period was not defined.

Results: 203 patients were implanted, 202 patients were examined for AEs (bell group: 68 patients, clip group: 134 patients), 186 patients were examined audiologically (bell group: 63 patients, clip group: 123 patients). In the bell group, 4 patients (5.9%) had 4 AE (thereof 2 revision surgeries and 2 dislocations/extrusions), and in the clip group 15 patients (11.2%) had 28 AEs (thereof 2 revision surgeries and 1 dislocation/extrusion). A post-operative PTA₄ ABG of ≤ 20 dB and therefore successful rehabilitation was reached by 44 patients (69.8%) in the bell, and by 89 patients (72.4%) in the clip group. The mean post-operative PTA₄ ABG was 17.8 ± 10.2 dB for patients implanted with a bell prosthesis and 16.3 ± 10.1 dB for patients implanted with a clip prosthesis. Individual bone conduction (BC) PTA₄ thresholds were stable in 60 patients (95.2%) implanted with a bell prosthesis and 120 patients (97.6%) implanted with a bell prosthesis.

Conclusion: Clinical data demonstrated satisfactory short-term audiological results after implantation of the mXACT Partial Prosthesis, mXACT PRO Partial Prosthesis, mCLIP Partial Prosthesis, and mCLIP ARC Partial Prosthesis in the majority of patients. The partial ossicular replacement prostheses are safe and effective.

Keywords: MCLIP ARC partial prosthesis; MCLIP partial prosthesis; MXACT PRO partial prosthesis; MXACT partial prosthesis; Partial ossicular replacement prostheses.