Evidence map›Paper›PMID 41094222›Full record

ArticleEuropean 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 Surgery2026

Clinical outcomes of 188 patients implanted with Med-El stapes prostheses.

Wendelin Wolfram, Paul Martin Zwittag, Lisa Niederwanger, Nina Rubicz, Georg Sprinzl, Astrid Magele, Dirk Beutner, Nicholas Bevis, Esther Schimanski, Susan Arndt and 11 more

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in 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, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05565339 (PMEI Post-Market Clinical Follow-Up), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05565339 completednot on this map

PMEI Post-Market Clinical Follow-Up

TypeobservationalSponsorMED-EL Elektromedizinische Geräte GesmbHRan2020 to 2023Enrolled497ConditionsPre-existing ConditionArmsPMEIs
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Wendelin Wolfram *Department of Otorhinolaryngology, Klinikum Wels-Grieskirchen, 4600, Wels, Austria.
Paul Martin Zwittag *Department of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, 4020, Linz, Austria.
Lisa NiederwangerDepartment of Otorhinolaryngology, Klinikum Wels-Grieskirchen, 4600, Wels, Austria.
Nina RubiczDepartment of Otorhinolaryngology, Head and Neck Surgery, Kepler University Hospital GmbH, 4020, Linz, Austria.
Georg SprinzlDepartment of Otorhinolaryngology, Head & Neck Surgery, University Clinic St. Poelten, 3100, St. Pölten, Austria.
Astrid MageleDepartment of Otorhinolaryngology, Head & Neck Surgery, University Clinic St. Poelten, 3100, St. Pölten, Austria.
Dirk BeutnerDepartment of Otolaryngology, University of Goettingen, 37075, Göttingen, Germany.
Nicholas BevisDepartment of Otolaryngology, University of Goettingen, 37075, Göttingen, Germany.
Esther SchimanskiZentrum Fuer Mittelohrchirurgie (Centre for Middle Ear Surgery), ENT Practice, 44536, Luenen, Germany.
Susan ArndtDepartment of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Medical Center-University of Freiburg, University of Freiburg, 79106, Freiburg, Germany.
Christian OffergeldDepartment of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Medical Center-University of Freiburg, University of Freiburg, 79106, Freiburg, Germany.
Christoph ArnoldnerDepartment of Otorhinolaryngology, Medical University of Vienna, 1090, Vienna, Austria.
Dominik RissDepartment of Otorhinolaryngology, Medical University of Vienna, 1090, Vienna, Austria.
Piotr H SkarżyńskiClinical Trials Department, Center of Hearing and Speech MEDINCUS, Kajetany, Poland.
Łukasz PlichtaClinical Trials Department, Center of Hearing and Speech MEDINCUS, Kajetany, Poland.
Joachim HornungDepartment of Otorhinolaryngology, Head & Neck Surgery, University of Erlangen-Nuremberg, 91054, Erlangen, Germany.
Lava TahaDepartment of Otorhinolaryngology, Head & Neck Surgery, University of Erlangen-Nuremberg, 91054, Erlangen, Germany.
Thomas LenarzDepartment of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.
Susan BuschDepartment of Otolaryngology, Hannover Medical School, 30625, Hannover, Germany.
Franz WindischDepartment of Otorhinolaryngology, Head and Neck Surgery, Klinik Landstraße, Wiener Gesundheitsverbund, 1030, Vienna, Austria.
Benjamin LoaderDepartment of Otorhinolaryngology, Head and Neck Surgery, Klinik Landstraße, Wiener Gesundheitsverbund, 1030, Vienna, Austria. benjamin.loader@gesundheitsverbund.at.ORCID http://orcid.org/0000-0003-4387-5993

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis 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.

methodsPatients 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

results189 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

conclusionClinical 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).

Indexed as

Hearing Loss, ConductiveOssicular ProsthesisOtosclerosisStapes SurgeryAdolescentAdultAgedAudiometry, Pure-ToneBone ConductionChildFemaleFollow-Up StudiesHumansMaleMiddle AgedProsthesis DesignHearing restorationMAXIS Stapes ProsthesisMFIX Stapes ProsthesisMLOOP Stapes ProsthesisMZAM Stapes ProsthesisOtosclerosisPassive middle ear implantsStapedectomyStapedotomy

Identifiers

PMID41094222
PMCPMC12987915

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