Department of Otorhinolaryngology, Head and Neck Surgery, Nicholas Bevis, University Medical Center Goettingen, Robert-Koch- Straße 40, 37075, Goettingen, Germany.
Eur Arch Otorhinolaryngol. 2024 Dec;281(12):6317-6323. doi: 10.1007/s00405-024-08854-z. Epub 2024 Jul 28.
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.
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.
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.
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.
耳硬化症导致镫骨底板固定，从而导致听力损失。主要的治疗方法是手术，有多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。
34 例耳硬化症患者植入新型 mAXIS 镫骨假体。在短期（ST）随访时（25 ± 15 天）和中期（MT）随访时（181 ± 107 天）进行全面的临床评估，包括术前和术后纯音听阈测试。计算 0.5、1、2 和 3 kHz 的纯音平均听阈（PTA4）。
在所有病例中，假体的应用均成功且操作简单。术后 ST 随访时 PTA4 气骨导差为 10.7 ± 5.2 dB（n = 34），MT 随访时为 8.3 ± 4.1 dB（n = 18）。在 61%的病例中，ABG 闭合在 10 dB 以内，在 100%的病例中闭合在 20 dB 以内。
本研究结果支持 mAXIS 镫骨假体植入的安全性，并显示出有希望的听力结果。未来的研究将有助于其长期疗效和安全性。
