Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome

Dirk Beutner; Nicholas Bevis; Benjamin Loader; Franz Windisch; Susan Arndt; Christian Offergeld; Wendelin Wolfram; Lisa Niederwanger; Paul Martin Zwittag; Nina Rubicz; Esther Schimanski; Christoph Arnoldner; Dominik Riss; Piotr H Skarżyński; Łukasz Plichta; Joachim Hornung; Lava Taha; Thomas Lenarz; Susan Busch; Astrid Magele; Georg Sprinzl

doi:10.1097/MAO.0000000000004462

Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome

Dirk Beutner, Nicholas Bevis, Benjamin Loader, Franz Windisch, Susan Arndt, Christian Offergeld, Wendelin Wolfram, Lisa Niederwanger, Paul Martin Zwittag, Nina Rubicz, Esther Schimanski, Christoph Arnoldner, Dominik Riss, Piotr H Skarżyński, Łukasz Plichta, Joachim Hornung, Lava Taha, Thomas Lenarz, Susan Busch, Astrid MageleGeorg Sprinzl

Division of Otorhinolaryngology (University Hospital St. Pölten)

Research output: Journal article (peer-reviewed) › Journal article

Abstract

OBJECTIVE: Otosclerosis leads to ossification of the stapes footplate and is responsible for a significant number of patients having hearing loss. Stapes surgery is a treatment for otosclerosis with excellent postoperative hearing outcomes. The aim of this retrospective study was to analyze the safety and effectiveness of the titanium mAXIS prosthesis in a multicentric setting.

METHODS: Ninety-four surgeries with implantation of the mAXIS stapes prosthesis took place in a multicenter study group. During follow-up at 59 (±48.1) days, pure-tone audiometry was performed. The pure-tone averages of 0.5, 1, 2, and 3 kHz (PTA-4) were determined.

RESULTS: No device-related adverse events were reported. There were 88 patients who reported for follow-up, at which pure-tone audiometry was performed. The PTA-4 air-bone gap (ABG) at follow-up was 8.8 (±6.0) dB. In 64.8% of the patients, the postoperative PTA-4 ABG was within 10 dB and in 94.3% it was within 20 dB. The postoperative PTA-4 thresholds for bone conduction were stable in 95.5% of cases.

CONCLUSION: The results of this multicentric study demonstrate the safety of the mAXIS titanium stapes prosthesis. The prosthesis shows promising audiological outcomes. Future studies are needed to assess long-term efficacy.

Original language	English
Journal	Otology and Neurotology
DOIs	https://doi.org/10.1097/MAO.0000000000004462
Publication status	E-pub ahead of print - 19 Feb 2025

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Beutner, D., Bevis, N., Loader, B., Windisch, F., Arndt, S., Offergeld, C., Wolfram, W., Niederwanger, L., Zwittag, P. M., Rubicz, N., Schimanski, E., Arnoldner, C., Riss, D., Skarżyński, P. H., Plichta, Ł., Hornung, J., Taha, L., Lenarz, T., Busch, S., ... Sprinzl, G. (2025). Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome. Otology and Neurotology. Advance online publication. https://doi.org/10.1097/MAO.0000000000004462

@article{414f2fa8f6544c2ea48c22f3f40dfef4,

title = "Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome",

abstract = "OBJECTIVE: Otosclerosis leads to ossification of the stapes footplate and is responsible for a significant number of patients having hearing loss. Stapes surgery is a treatment for otosclerosis with excellent postoperative hearing outcomes. The aim of this retrospective study was to analyze the safety and effectiveness of the titanium mAXIS prosthesis in a multicentric setting.METHODS: Ninety-four surgeries with implantation of the mAXIS stapes prosthesis took place in a multicenter study group. During follow-up at 59 (±48.1) days, pure-tone audiometry was performed. The pure-tone averages of 0.5, 1, 2, and 3 kHz (PTA-4) were determined.RESULTS: No device-related adverse events were reported. There were 88 patients who reported for follow-up, at which pure-tone audiometry was performed. The PTA-4 air-bone gap (ABG) at follow-up was 8.8 (±6.0) dB. In 64.8% of the patients, the postoperative PTA-4 ABG was within 10 dB and in 94.3% it was within 20 dB. The postoperative PTA-4 thresholds for bone conduction were stable in 95.5% of cases.CONCLUSION: The results of this multicentric study demonstrate the safety of the mAXIS titanium stapes prosthesis. The prosthesis shows promising audiological outcomes. Future studies are needed to assess long-term efficacy.",

author = "Dirk Beutner and Nicholas Bevis and Benjamin Loader and Franz Windisch and Susan Arndt and Christian Offergeld and Wendelin Wolfram and Lisa Niederwanger and Zwittag, {Paul Martin} and Nina Rubicz and Esther Schimanski 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 Astrid Magele and Georg Sprinzl",

year = "2025",

month = feb,

day = "19",

doi = "10.1097/MAO.0000000000004462",

language = "English",

journal = "Otology and Neurotology",

issn = "1531-7129",

publisher = "Lippincott Williams and Wilkins",

}

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, Skarżyński, PH, Plichta, Ł, Hornung, J, Taha, L, Lenarz, T, Busch, S, Magele, A & Sprinzl, G 2025, 'Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome', Otology and Neurotology. https://doi.org/10.1097/MAO.0000000000004462

TY - JOUR

T1 - Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis

T2 - Multicentric Short-Term Outcome

AU - Beutner, Dirk

AU - Bevis, Nicholas

AU - Loader, Benjamin

AU - Windisch, Franz

AU - Arndt, Susan

AU - Offergeld, Christian

AU - Wolfram, Wendelin

AU - Niederwanger, Lisa

AU - Zwittag, Paul Martin

AU - Rubicz, Nina

AU - Schimanski, Esther

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 - Magele, Astrid

AU - Sprinzl, Georg

PY - 2025/2/19

Y1 - 2025/2/19

N2 - OBJECTIVE: Otosclerosis leads to ossification of the stapes footplate and is responsible for a significant number of patients having hearing loss. Stapes surgery is a treatment for otosclerosis with excellent postoperative hearing outcomes. The aim of this retrospective study was to analyze the safety and effectiveness of the titanium mAXIS prosthesis in a multicentric setting.METHODS: Ninety-four surgeries with implantation of the mAXIS stapes prosthesis took place in a multicenter study group. During follow-up at 59 (±48.1) days, pure-tone audiometry was performed. The pure-tone averages of 0.5, 1, 2, and 3 kHz (PTA-4) were determined.RESULTS: No device-related adverse events were reported. There were 88 patients who reported for follow-up, at which pure-tone audiometry was performed. The PTA-4 air-bone gap (ABG) at follow-up was 8.8 (±6.0) dB. In 64.8% of the patients, the postoperative PTA-4 ABG was within 10 dB and in 94.3% it was within 20 dB. The postoperative PTA-4 thresholds for bone conduction were stable in 95.5% of cases.CONCLUSION: The results of this multicentric study demonstrate the safety of the mAXIS titanium stapes prosthesis. The prosthesis shows promising audiological outcomes. Future studies are needed to assess long-term efficacy.

AB - OBJECTIVE: Otosclerosis leads to ossification of the stapes footplate and is responsible for a significant number of patients having hearing loss. Stapes surgery is a treatment for otosclerosis with excellent postoperative hearing outcomes. The aim of this retrospective study was to analyze the safety and effectiveness of the titanium mAXIS prosthesis in a multicentric setting.METHODS: Ninety-four surgeries with implantation of the mAXIS stapes prosthesis took place in a multicenter study group. During follow-up at 59 (±48.1) days, pure-tone audiometry was performed. The pure-tone averages of 0.5, 1, 2, and 3 kHz (PTA-4) were determined.RESULTS: No device-related adverse events were reported. There were 88 patients who reported for follow-up, at which pure-tone audiometry was performed. The PTA-4 air-bone gap (ABG) at follow-up was 8.8 (±6.0) dB. In 64.8% of the patients, the postoperative PTA-4 ABG was within 10 dB and in 94.3% it was within 20 dB. The postoperative PTA-4 thresholds for bone conduction were stable in 95.5% of cases.CONCLUSION: The results of this multicentric study demonstrate the safety of the mAXIS titanium stapes prosthesis. The prosthesis shows promising audiological outcomes. Future studies are needed to assess long-term efficacy.

UR - http://www.scopus.com/inward/record.url?scp=105001701274&partnerID=8YFLogxK

U2 - 10.1097/MAO.0000000000004462

DO - 10.1097/MAO.0000000000004462

M3 - Journal article

C2 - 40059729

SN - 1531-7129

JO - Otology and Neurotology

JF - Otology and Neurotology

ER -

Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome

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