Safety and efficacy of the mAXIS stapes prosthesis.

IF 1.9 3区医学 Q2 OTORHINOLARYNGOLOGY European Archives of Oto-Rhino-Laryngology Pub Date : 2024-12-01 Epub Date: 2024-07-28 DOI:10.1007/s00405-024-08854-z

Nicholas Bevis, Marc A Hüser, David Oestreicher, Dirk Beutner

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Abstract

Purpose: Otosclerosis leads to a fixed stapes footplate and thus to hearing loss. The predominant treatment method is surgery, with various types of stapes prostheses available. The aim of this study was to investigate the safety and efficacy of the new mAXIS Stapes Prosthesis.

Methods: 34 cases of otosclerosis were implanted with the new mAXIS Stapes Prosthesis. Comprehensive clinical assessments, including pre- and postoperative pure tone audiometry was performed at short-term (ST) follow-up at 25 (± 15) days and mid-term (MT) follow-up at 181 (± 107) days. The pure tone average of 0.5, 1, 2 and 3 kHz (PTA4) was calculated.

Results: In all cases, the application of the prosthesis was successful and straightforward. The postoperative PTA4 air-bone gap was 10.7 ± 5.2 dB at ST follow-up (n = 34) and 8.3 ± 4.1 dB at MT follow-up (n = 18). In 61% of cases, the ABG-closure was within 10 dB and in 100% of cases within 20 dB at MT follow-up.

Conclusion: Findings of this study support that the mAXIS Stapes Prosthesis is safe for implantation and shows promising audiological outcome. Future investigations will contribute its long-term efficacy and safety profile.

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mAXIS镫骨假体的安全性和有效性。

目的：耳硬化症会导致镫骨脚板固定，从而导致听力损失。目前最主要的治疗方法是手术，有各种类型的镫骨假体可供选择。本研究旨在探讨新型 mAXIS 镫骨假体的安全性和有效性。在25（± 15）天的短期（ST）随访和181（± 107）天的中期（MT）随访中进行了全面的临床评估，包括术前和术后纯音测听。计算了 0.5、1、2 和 3 kHz 的纯音平均值（PTA4）：结果：在所有病例中，假体的应用都非常成功和简单。术后 ST 随访（34 例）的 PTA4 气骨间隙为 10.7 ± 5.2 dB，MT 随访（18 例）的 PTA4 气骨间隙为 8.3 ± 4.1 dB。61%的病例在 MT 随访时 ABG 关闭在 10 dB 以内，100% 的病例在 20 dB 以内：本研究结果表明，mAXIS镫骨假体植入安全，听力效果良好。未来的研究将有助于了解其长期疗效和安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Archives of Oto-Rhino-Laryngology 医学-耳鼻喉科学

CiteScore

5.30

自引率

7.70%

发文量

537

审稿时长

2-4 weeks

期刊介绍： Official Journal of European Union of Medical Specialists – ORL Section and Board Official Journal of Confederation of European Oto-Rhino-Laryngology Head and Neck Surgery "European Archives of Oto-Rhino-Laryngology" publishes original clinical reports and clinically relevant experimental studies, as well as short communications presenting new results of special interest. With peer review by a respected international editorial board and prompt English-language publication, the journal provides rapid dissemination of information by authors from around the world. This particular feature makes it the journal of choice for readers who want to be informed about the continuing state of the art concerning basic sciences and the diagnosis and management of diseases of the head and neck on an international level. European Archives of Oto-Rhino-Laryngology was founded in 1864 as "Archiv für Ohrenheilkunde" by A. von Tröltsch, A. Politzer and H. Schwartze.