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; Christian Offergeld; Christoph Arnoldner; Dominik Riss; Piotr H Skarżyński; Łukasz Plichta; Joachim Hornung; Lava Taha; Thomas Lenarz; Susan Busch; Franz Windisch; Benjamin Loader

doi:10.1007/s00405-025-09733-x

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
, Christian Offergeld
, Christoph Arnoldner
, Dominik Riss
, Piotr H Skarżyński
, Łukasz Plichta
, Joachim Hornung
, Lava Taha
, Thomas Lenarz
, Susan Busch
, Franz Windisch

Benjamin Loader

Department of Otorhinolaryngology
Kepler University Hospital GmbH
University Clinic St. Pölten
University of Göttingen
Zentrum Fuer Mittelohrchirurgie (Centre for Middle Ear Surgery)
University of Freiburg Medical Center
Medical University of Vienna
Center of Hearing and Speech MEDINCUS
University of Erlangen-Nuremberg
Hannover Medical School
Head and Neck Surgery
Klinik Landstrasse
Vienna Health Care Group

Research output: Contribution to journal › Article › peer-review

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 (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative PTA4 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 PTA4 ABG ≤ 10 dB. 154 (91.7%) patients achieved a post-operative PTA4 ABG ≤ 20 dB and therefore successful rehabilitation. Individual bone conduction (BC) PTA4 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).

Original language	English
Pages (from-to)	781-790
Number of pages	10
Journal	European Archives of Oto-Rhino-Laryngology
Volume	283
Issue number	2
DOIs	https://doi.org/10.1007/s00405-025-09733-x
Publication status	Published - Feb 2026

Keywords

Humans
Female
Male
Retrospective Studies
Ossicular Prosthesis
Middle Aged
Adult
Stapes Surgery/methods
Treatment Outcome
Otosclerosis/surgery
Audiometry, Pure-Tone
Hearing Loss, Conductive/surgery
Aged
Prosthesis Design
Young Adult
Adolescent
Child
Bone Conduction
Follow-Up Studies

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Wolfram, W., Zwittag, P. M., Niederwanger, L., Rubicz, N., Sprinzl, G., Magele, A., Beutner, D., Bevis, N., Schimanski, E., Arndt, S., Offergeld, C., Arnoldner, C., Riss, D., Skarżyński, P. H., Plichta, Ł., Hornung, J., Taha, L., Lenarz, T., Busch, S., ... Loader, B. (2026). Clinical outcomes of 188 patients implanted with Med-El stapes prostheses. European Archives of Oto-Rhino-Laryngology, 283(2), 781-790. https://doi.org/10.1007/s00405-025-09733-x

@article{1c19cd9751ce4515a85dbce6010c98a9,

title = "Clinical outcomes of 188 patients implanted with Med-El stapes prostheses",

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 (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative PTA4 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 PTA4 ABG ≤ 10 dB. 154 (91.7\%) patients achieved a post-operative PTA4 ABG ≤ 20 dB and therefore successful rehabilitation. Individual bone conduction (BC) PTA4 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).",

keywords = "Humans, Female, Male, Retrospective Studies, Ossicular Prosthesis, Middle Aged, Adult, Stapes Surgery/methods, Treatment Outcome, Otosclerosis/surgery, Audiometry, Pure-Tone, Hearing Loss, Conductive/surgery, Aged, Prosthesis Design, Young Adult, Adolescent, Child, Bone Conduction, Follow-Up Studies",

author = "Wendelin Wolfram and Zwittag, \{Paul Martin\} and Lisa Niederwanger and Nina Rubicz and Georg Sprinzl and Astrid Magele and Dirk Beutner and Nicholas Bevis and Esther Schimanski and Susan Arndt and Christian Offergeld and Christoph Arnoldner and Dominik Riss and Skar{\.z}y{\'n}ski, \{Piotr H\} and {\L}ukasz Plichta and Joachim Hornung and Lava Taha and Thomas Lenarz and Susan Busch and Franz Windisch and Benjamin Loader",

note = "{\textcopyright} 2025. The Author(s).",

year = "2026",

month = feb,

doi = "10.1007/s00405-025-09733-x",

language = "English",

volume = "283",

pages = "781--790",

journal = "European Archives of Oto-Rhino-Laryngology",

issn = "0937-4477",

publisher = "Springer Science and Business Media Deutschland GmbH",

number = "2",

}

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, Skarżyński, PH, Plichta, Ł, Hornung, J, Taha, L, Lenarz, T, Busch, S, Windisch, F & Loader, B 2026, 'Clinical outcomes of 188 patients implanted with Med-El stapes prostheses', European Archives of Oto-Rhino-Laryngology, vol. 283, no. 2, pp. 781-790. https://doi.org/10.1007/s00405-025-09733-x

TY - JOUR

T1 - Clinical outcomes of 188 patients implanted with Med-El stapes prostheses

AU - Wolfram, Wendelin

AU - Zwittag, Paul Martin

AU - Niederwanger, Lisa

AU - Rubicz, Nina

AU - Sprinzl, Georg

AU - Magele, Astrid

AU - Beutner, Dirk

AU - Bevis, Nicholas

AU - Schimanski, Esther

AU - Arndt, Susan

AU - Offergeld, Christian

AU - Arnoldner, Christoph

AU - Riss, Dominik

AU - Skarżyński, Piotr H

AU - Plichta, Łukasz

AU - Hornung, Joachim

AU - Taha, Lava

AU - Lenarz, Thomas

AU - Busch, Susan

AU - Windisch, Franz

AU - Loader, Benjamin

PY - 2026/2

Y1 - 2026/2

N2 - 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 (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative PTA4 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 PTA4 ABG ≤ 10 dB. 154 (91.7%) patients achieved a post-operative PTA4 ABG ≤ 20 dB and therefore successful rehabilitation. Individual bone conduction (BC) PTA4 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).

AB - 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 (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative PTA4 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 PTA4 ABG ≤ 10 dB. 154 (91.7%) patients achieved a post-operative PTA4 ABG ≤ 20 dB and therefore successful rehabilitation. Individual bone conduction (BC) PTA4 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).

KW - Humans

KW - Female

KW - Male

KW - Retrospective Studies

KW - Ossicular Prosthesis

KW - Middle Aged

KW - Adult

KW - Stapes Surgery/methods

KW - Treatment Outcome

KW - Otosclerosis/surgery

KW - Audiometry, Pure-Tone

KW - Hearing Loss, Conductive/surgery

KW - Aged

KW - Prosthesis Design

KW - Young Adult

KW - Adolescent

KW - Child

KW - Bone Conduction

KW - Follow-Up Studies

U2 - 10.1007/s00405-025-09733-x

DO - 10.1007/s00405-025-09733-x

M3 - Article

C2 - 41094222

SN - 0937-4477

VL - 283

SP - 781

EP - 790

JO - European Archives of Oto-Rhino-Laryngology

JF - European Archives of Oto-Rhino-Laryngology

IS - 2

ER -

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

Abstract

Keywords

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