Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
497 participants
OBSERVATIONAL
2020-09-29
2023-11-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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1
Total Ossicular Replacement Prostheses:
The primary objective for the total ossicular replacement prostheses was to achieve an ABG ≤ 20 dB by at least 25 % of the patients after the PMEI implantation
PMEIs
To evaluate audiological outcomes post-operatively, the air-bone gap (ABG) was assessed.
To evaluate safety of the devices, adverse events were collected.A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated. To assess whether implantation of PMEI affected residual hearing pre- and post-operative bone conduction thresholds were evaluated.
2
Partial Ossicular Replacement Prostheses:
The primary objective for the partial ossicular replacement prostheses was to achieve an ABG ≤ 20 dB by at least 53.8 % of the patients after the PMEI implantation.
PMEIs
To evaluate audiological outcomes post-operatively, the air-bone gap (ABG) was assessed.
To evaluate safety of the devices, adverse events were collected.A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated. To assess whether implantation of PMEI affected residual hearing pre- and post-operative bone conduction thresholds were evaluated.
3
Stapesplasty Prostheses:
The primary objective for the stapes prostheses was to achieve an ABG ≤ 20 dB by at least 86 % of the patients after the PMEI implantation.
PMEIs
To evaluate audiological outcomes post-operatively, the air-bone gap (ABG) was assessed.
To evaluate safety of the devices, adverse events were collected.A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated. To assess whether implantation of PMEI affected residual hearing pre- and post-operative bone conduction thresholds were evaluated.
Interventions
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PMEIs
To evaluate audiological outcomes post-operatively, the air-bone gap (ABG) was assessed.
To evaluate safety of the devices, adverse events were collected.A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated. To assess whether implantation of PMEI affected residual hearing pre- and post-operative bone conduction thresholds were evaluated.
Eligibility Criteria
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Inclusion Criteria
• Exclusion Criteria: None
0 Years
99 Years
ALL
No
Sponsors
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MED-EL Elektromedizinische Geräte GesmbH
INDUSTRY
Responsible Party
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Locations
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Linz Kepler Universitätsklinikum GmbH, Klinik für Hals-, Nasen- und Ohrenheilkunde
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH, Abteilung für Hals-, Nasen- und Ohrenkrankheiten, Logopädie
Wels, Upper Austria, Austria
Universitätsklinikum St. Pölten, Klinische Abteilung für Hals-Nasen-Ohren
Sankt Pölten, , Austria
Wiener Gesundheitsverbund, Klinik Landstraße, Hals-Nasen-Ohren-Allgemeine Ambulanz
Vienna, , Austria
Universitätskliniken der MedUni Wien/AKH Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
Vienna, , Austria
Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik, Kopf- und Halschirurgie der Universität Erlangen-Nürnberg
Erlangen, , Germany
Universitätsklinikum Freiburg, Universitätsklinik für Hals, - Nasen und Ohrenheilkunde Sektionsleitung Experimentell-klinische Otologie
Freiburg im Breisgau, , Germany
Universitätsmedizin Göttingen, Klinik für Hals-Nasen-Ohrenheilkunde
Göttingen, , Germany
Medizinische Hochschule Hannover, Klinik für HNO-Krankheiten
Hanover, , Germany
Zentrum für Mittelohrchirurgie, Belegabteilung für Abteilung Hals-Nasen-Ohrenheilkunde
Lünen, , Germany
Center of Hearing and Speech Medincus, Clinical Trials Department
Nadarzyn, Kajetany, Poland
Countries
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References
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Wolfram W, Zwittag PM, Niederwanger L, Rubicz N, Sprinzl G, Magele A, Beutner D, Bevis N, Schimanski E, Arndt S, Offergeld C, Arnoldner C, Riss D, Skarzynski PH, Plichta L, Hornung J, Taha L, Lenarz T, Busch S, Windisch F, Loader B. Clinical outcomes of 188 patients implanted with Med-El stapes prostheses. Eur Arch Otorhinolaryngol. 2025 Oct 15. doi: 10.1007/s00405-025-09733-x. Online ahead of print.
Beutner D, Bevis N, Loader B, Windisch F, Arndt S, Offergeld C, Wolfram W, Niederwanger L, Zwittag PM, Rubicz N, Schimanski E, Arnoldner C, Riss D, Skarzynski PH, Plichta L, Hornung J, Taha L, Lenarz T, Busch S, Magele A, Sprinzl G. Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome. Otol Neurotol. 2025 Jun 1;46(5):561-566. doi: 10.1097/MAO.0000000000004462. Epub 2025 Feb 19.
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 L, Skarzynski PH. Safety and performance of the new med-el total ossicular replacement prostheses. Eur Arch Otorhinolaryngol. 2024 Nov;281(11):5687-5697. doi: 10.1007/s00405-024-08784-w. Epub 2024 Jul 13.
Rasse T, Niederwanger L, Hornung J, Taha L, Arndt S, Offergeld C, Beutner D, Bevis N, Lenarz T, Teschner M, Schimanski E, Georg Sprinzl, Magele A, Skarzynski PH, Plichta L, Arnoldner C, Riss D, Loader B, Windisch F, Rubicz N, Zwittag PM. Short-term safety and effectiveness of the mCLIP partial prosthesis. Eur Arch Otorhinolaryngol. 2024 May;281(5):2353-2363. doi: 10.1007/s00405-023-08359-1. Epub 2023 Dec 22.
Other Identifiers
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2020PMEI001
Identifier Type: -
Identifier Source: org_study_id