Safety and performance of the new med-el total ossicular replacement prostheses

Schimanski E, Lenarz T, Busch S, Arndt S, Offergeld C, Arnoldner C, Riss D, Hornung J, Taha L, Zwittag PM, Rubicz N, Beutner D, Bevis N, Loader B, Windisch F, Sprinzl G, Magele A, Wolfram W, Niederwanger L, Plichta Ł, Skarżyński PH (2024)

Publication Type: Journal article

Publication year: 2024

Journal

European Archives of Oto-Rhino-Laryngology Springer

DOI: 10.1007/s00405-024-08784-w

Abstract

Purpose: This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP). Methods: Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (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 (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Results: 103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. Adverse events results (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. Audiological results (N = 92): 49 (53.3%) of the 92 patients had a PTA4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA4 (post-operative minus pre-operative BC PTA4) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA4 deterioration of 11.3 dB HL. Conclusion: The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered.

Authors with CRIS profile

Joachim Hornung Department of Otorhinolaryngology – Head and Neck Surgery Lava Taha Department of Otorhinolaryngology – Head and Neck Surgery

Involved external institutions

Medizinische Hochschule Hannover (MHH) / Hannover Medical School DE Germany (DE) Universitätsklinikum Freiburg DE Germany (DE) Medizinische Universität Wien AT Austria (AT) Clinic of the International Center of Hearing and Speech Medincus PL Poland (PL) Kepler Universitätsklinikum (KUK) AT Austria (AT) Universitätsklinikum Göttingen DE Germany (DE) Fachhochschule St. Pölten AT Austria (AT) Klinikum Wels-Grieskirchen AT Austria (AT)

How to cite

APA:

Schimanski, E., Lenarz, T., Busch, S., Arndt, S., Offergeld, C., Arnoldner, C.,... Skarżyński, P.H. (2024). Safety and performance of the new med-el total ossicular replacement prostheses. European Archives of Oto-Rhino-Laryngology. https://doi.org/10.1007/s00405-024-08784-w

MLA:

Schimanski, Esther, et al. "Safety and performance of the new med-el total ossicular replacement prostheses." European Archives of Oto-Rhino-Laryngology (2024).

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