Department of Otorhinolaryngology-Head and Neck Surgery, Donders Center for Neuroscience, Radboud University Medical Center, Radboud University, Nijmegen.
Department of Otorhinolaryngology, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.
Otol Neurotol. 2024 Oct 1;45(9):1037-1044. doi: 10.1097/MAO.0000000000004315. Epub 2024 Aug 26.
To investigate the clinical outcomes of bone-anchored hearing implant surgery using the MONO procedure.
Multicenter, multinational, single-arm, prospective trial with a 12-month follow-up.
Seven European university hospitals from the United Kingdom, Sweden, Denmark, and The Netherlands.
Fifty-one adult patients requiring surgical intervention for bone conduction hearing.
Bone-anchored hearing implant surgery using the MONO procedure.
The primary endpoint assessed implant usability 3 months after surgery. Implant status, soft tissue reactions, pain and numbness, postoperative events, and sound processor usage were assessed at all follow-up visits. Hearing-related quality of life was evaluated using the Glasgow Benefit Inventory (GBI).
At 3 months, 94.2% of the implant/abutment complexes provided reliable anchorage for sound processor usage. No severe intraoperative complications occurred. Sixty-nine percent of surgeries were performed under local anesthesia, with surgery lasting 10 minutes on average. Four implants were lost due to trauma (n = 2), spontaneous loss of osseointegration (n = 1), or incomplete insertion (n = 1). Adverse soft tissue reactions occurred in 2.6% of visits, with a maximum Holgers grade of 3 (n = 1) and grade 2 (n = 5) across patients. Hearing-related quality of life at 3 months improved in 96% of patients.
The MONO procedure provides a safe and efficient surgical technique for inserting bone-anchored hearing implants with few and minor intra- and postoperative complications.
研究使用 MONO 程序的骨锚式听力植入手术的临床结果。
多中心、多国、单臂、前瞻性试验，随访 12 个月。
来自英国、瑞典、丹麦和荷兰的 7 家欧洲大学医院。
51 名成人患者，需要进行手术干预以进行骨导听力。
使用 MONO 程序的骨锚式听力植入手术。
术后 3 个月评估植入物可用性，是主要终点。在所有随访中评估植入物状态、软组织反应、疼痛和麻木、术后事件和声音处理器使用情况。使用格拉斯哥受益量表（GBI）评估听力相关生活质量。
术后 3 个月，94.2%的植入物/基台复合体为声音处理器的使用提供了可靠的锚固。术中未发生严重并发症。69%的手术在局部麻醉下进行，平均手术时间为 10 分钟。由于创伤（n = 2）、自发性骨整合丧失（n = 1）或不完全插入（n = 1），有 4 个植入物丢失。在 2.6%的就诊中发生了不良的软组织反应，最大 Holgers 分级为 3（n = 1），在患者中分级为 2（n = 5）。术后 3 个月，96%的患者听力相关生活质量得到改善。
MONO 程序为插入骨锚式听力植入物提供了一种安全有效的手术技术，具有较少且轻微的围手术期并发症。
