主动中耳植入治疗感音神经性听力损失：系统评价与荟萃分析。
Active Middle Ear Implantation for Sensorineural Hearing Loss: A Systematic Review and Meta-Analysis.
文献信息
| PMID | 42826367 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Udi Shapira |
| 作者单位 | Department of Otolaryngology-Head and Neck Surgery and Maxillofacial Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Affiliated to the Gray School of Medicine, Tel-Aviv University, Tel Aviv, Israel. |
| 期刊 | Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology |
| SCI 分区 | Q2 |
| IF | 1.9 |
| 研究类型 | 综述 Meta · 临床 |
| 所属专科 | 耳科 |
中文摘要
目的： 评估Vibrant Soundbridge中耳植入体在中重度感音神经性听力损失患者中的听力学结局和安全性特征。检索数据库：PubMed、Embase、Google Scholar以及纳入论文的参考文献列表。
方法： 根据系统评价和荟萃分析首选报告条目指南进行系统文献评价。数据库检索获得194篇文章，其中48篇进行了全文审查。提取的数据包括年龄、性别、随访时间长度和功能性听力增益。
结果： 23项研究（917耳）纳入定性综合，其中16项（648耳）适合进行定量荟萃分析。术前纯音平均值的均值（标准差）为56.69（4.27）dB听力级。合并的平均功能性增益为24.29 dB（95% CI：20.09-28.49；P<0.01）听力级。研究间异质性高（I²=99%）。在平均23.2个月的随访期内，总体并发症发生率为8.3%，同一随访期内的翻修手术率为6.2%。内部设备故障发生在1.7%（n=7/413）的病例中。
结论： Vibrant Soundbridge在中重度感音神经性听力损失患者中提供了显著的功能性听力增益，并表现出良好的安全性特征。它为无法从传统助听器获益的个体提供了一种有前景的替代方案。
英文摘要
OBJECTIVE: To evaluate the audiological outcomes and safety profile of the Vibrant Soundbridge middle ear implant in patients with moderate-to-severe sensorineural hearing loss. Databases reviewed: PubMed, Embase, Google Scholar, and the enrolled papers' reference lists.
METHODS: A systematic literature review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The database search yielded 194 articles, of which 48 underwent full-text review. The extracted data included age, sex, length of follow-up period and functional hearing gain.
RESULTS: Twenty-three studies (917 ears) were included in the qualitative synthesis, of which 16 (648 ears) were suitable for quantitative meta-analysis. The mean (SD) preoperative pure-tone average was 56.69 (4.27) dB hearing level. The pooled mean functional gain was 24.29 dB (95% CI: 20.09-28.49; P<0.01) hearing level. There was high interstudy heterogeneity (I²=99%). The overall complication rate over a mean follow-up period of 23.2 months was 8.3%, and the revision surgery rate over the same follow-up period was 6.2%. Internal device failure occurred in 1.7% (n=7/413) cases.
CONCLUSION: The Vibrant Soundbridge provided significant functional hearing gain and demonstrated a favorable safety profile in patients with moderate-to-severe sensorineural hearing loss. It affords a promising alternative for individuals who do not benefit from conventional hearing aids.