Year: 2025
Type: article
Study design: Observational Study
Abstract: Purpose This multicentric, retrospective study aimed to analyze the safety and effectiveness of the mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis, and mFIX Stapes Prosthesis. Methods Patients underwent stapes surgery and implantation of a mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis, or mFIX Stapes Prosthesis (MED-EL, Innsbruck, Austria). The clinical data was retrospectively analyzed. Follow-up examination included access to medical records (for adverse events) 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 (PTA 4 ). The post-operative PTA 4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative PTA 4 ABG ≤ 20 dB was defined as successful rehabilitation. A post-operative minimum and maximum follow-up period was not defined. Results 189 patients were implanted with a MED-EL stapes prosthesis mainly as treatment of hearing loss caused by otosclerosis. 188 (186 adults, 2 children; 57 conductive hearing loss (CHL), 131 mixed hearing loss (MHL)) patients were examined for adverse events (AEs). 168 (166 adults, 2 children, 51 CHL, 117 MHL) patients underwent audiological examination. Audiology: 110 (65.5%) patients achieved a post-operative PTA 4 ABG ≤ 10 dB. 154 (91.7%) patients achieved a post-operative PTA 4 ABG ≤ 20 dB and therefore successful rehabilitation. Individual bone conduction (BC) PTA 4 thresholds were stable in 159 (94.6%) patients. AEs: 12 (6.4%, adults only) patients had 13 AEs. Conclusion Clinical data demonstrated satisfactory audiological results after implantation of the mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis, and mFIX Stapes Prosthesis. The MED-EL stapes prostheses are safe and effective. Trial registration number NCT05565339 (clinicaltrials.gov).
Authors: Wendelin Wolfram, Paul Martin Zwittag, Lisa Niederwanger, Nina Rubicz, Georg Sprinzl, Astrid Magele, Dirk Beutner, Nicholas Bevis, Esther Schimanski, Susan Arndt, Christian Offergeld, Christoph Arnoldner, Dominik Riss, Piotr H. Skarżyński, Łukasz Plichta, Joachim Hornung, Lava Taha, Thomas Lenarz, Susan Busch, Franz Windisch, Benjamin Loader
Institutions: Klinikum Wels-Grieskirchen, Johannes Kepler University of Linz, Kepler Universitätsklinikum, Universitätsklinikum St. Pölten, University of Göttingen, University of Freiburg, University Medical Center Freiburg, Medical University of Vienna, Institute of Physiology and Pathology of Hearing, Friedrich-Alexander-Universität Erlangen-Nürnberg, Medizinische Hochschule Hannover, Hearing4all, Wiener Krankenanstaltenverbund, Sigmund Freud Privatuniversität Wien
Language: English
Topic: Ear Surgery and Otitis Media
Subfield: Otorhinolaryngology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,890
OpenAlex ID: W4415219048