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

Hearing restoration Total ossicular replacement prostheses Tympanoplasty type 3 mXACT PRO Total Prosthesis mXACT Total Prosthesis Center mXACT Total Prosthesis Offcenter

Journal

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
ISSN: 1434-4726
Titre abrégé: Eur Arch Otorhinolaryngol
Pays: Germany
ID NLM: 9002937

Informations de publication

Date de publication:
13 Jul 2024
Historique:
received: 30 04 2024
accepted: 07 06 2024
medline: 14 7 2024
pubmed: 14 7 2024
entrez: 13 7 2024
Statut: aheadofprint

Résumé

This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP). 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 (PTA 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 PTA The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered.

Identifiants

DOI: 10.1007/s00405-024-08784-w PMID: 39001922
pubmed: 39001922
doi: 10.1007/s00405-024-08784-w
pii: 10.1007/s00405-024-08784-w
doi:

Banques de données

ClinicalTrials.gov
['NCT05565339']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

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Auteurs

Esther Schimanski (E)

ENT Practice, Zentrum fuer Mittelohrchirurgie (Centre for Middle Ear Surgery), 44536, Luenen, Germany. e.schimanski@mittelohr.de.
ORCID: 0009-0001-8581-4649

Thomas Lenarz (T)

Department of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.

Susan Busch (S)

Department of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.

Susan Arndt (S)

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

Christian Offergeld (C)

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

Christoph Arnoldner (C)

Department of Otorhinolaryngology, Medical University of Vienna, 1090, Vienna, Austria.

Dominik Riss (D)

Department of Otorhinolaryngology, Medical University of Vienna, 1090, Vienna, Austria.

Joachim Hornung (J)

Department of Otorhinolaryngology, Head & Neck Surgery, University of Erlangen-Nuremberg, 91054, Erlangen, Germany.

Lava Taha (L)

Department of Otorhinolaryngology, Head & Neck Surgery, University of Erlangen-Nuremberg, 91054, Erlangen, Germany.

Paul Martin Zwittag (PM)

Department of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, 4020, Linz, Austria.
Medical Faculity, Johannes Kepler University Linz, Altenbergerstrasse 69, 4040, Linz, Austria.

Nina Rubicz (N)

Department of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, 4020, Linz, Austria.
Medical Faculity, Johannes Kepler University Linz, Altenbergerstrasse 69, 4040, Linz, Austria.

Dirk Beutner (D)

Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Göttingen, 37075, Göttingen, Germany.

Nicholas Bevis (N)

Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Göttingen, 37075, Göttingen, Germany.

Benjamin Loader (B)

Department of Otorhinolaryngology, Head and Neck Surgery, 1030 Wiener Gesundheitsverbund, Klinik Landstraße, 1030, Vienna, Austria.

Franz Windisch (F)

Department of Otorhinolaryngology, Head and Neck Surgery, 1030 Wiener Gesundheitsverbund, Klinik Landstraße, 1030, Vienna, Austria.

Georg Sprinzl (G)

University Clinic St. Poelten, Department of Otorhinolaryngology, Head & Neck Surgery, 3100, St. Pölten, Austria.

Astrid Magele (A)

University Clinic St. Poelten, Department of Otorhinolaryngology, Head & Neck Surgery, 3100, St. Pölten, Austria.

Wendelin Wolfram (W)

Department of Otorhinolaryngology-Klinikum Wels-Grieskirchen, 4600, Wels, Austria.

Lisa Niederwanger (L)

Department of Otorhinolaryngology-Klinikum Wels-Grieskirchen, 4600, Wels, Austria.

Łukasz Plichta (Ł)

Center of Hearing and Speech MEDINCUS, Clinical Trials Department, Kajetany, Poland.
World Hearing Center of the Institute of Physiology and Pathology of Hearing, Kajetany, Poland.

Piotr H Skarżyński (PH)

Center of Hearing and Speech MEDINCUS, Clinical Trials Department, Kajetany, Poland.
Institute of Sensory Organs, Kajetany, Poland.
World Hearing Center of the Institute of Physiology and Pathology of Hearing, Kajetany, Poland.
Department of Teleaudiology and Screening, World Hearing Center, Institute of Physiology and Pathology of Hearing, 10 Mochnackiego Street, 02-042, Warsaw, Poland.

Classifications MeSH