Department of Otolaryngology-Head and Neck Surgery, University of California, San Francisco San Francisco, California 94115, USA.
Otol Neurotol. 2013 Jul;34(5):790-4. doi: 10.1097/MAO.0b013e318291c651.
To summarize available peer-reviewed literature to describe the range and rate of complications related to osseointegrated hearing aids in adult and pediatric patients.
We searched PubMed using the terms bone-anchored hearing aid for articles published in English between 2000 and 2011. We included all articles reporting complications rates, except those that were case reports, general review (not systematic review), or commentary, as well as those that did not include patient outcomes, that reported outcomes associated with nonstandard implantation (e.g., 8.5-mm abutment) or were of poor study or reporting quality.
After excluding articles that did not meet criteria, 20 articles were identified, comprising 2,134 patients who underwent a total of 2,310 osseoimplants. Complications reported in the literature were typically minor in nature. Skin reactions from Holgers Grade 2 to 4 ranged from 2.4% to 38.1%. Failure of osseointegration ranged from 0% to 18% in adult and mixed populations, and 0% to 14.3% in pediatric populations. The rate of revision surgery ranges from 1.7% to 34.5% in adult and mixed populations and 0.0% to 44.4% in pediatric patients, whereas the total rate of implant loss ranged from 1.6% to 17.4% in adult and mixed populations and from 0.0% to 25% in pediatric patients.
Overall, the quality of large scale and/or prospective studies reporting the incidence of complications after osseointegrated hearing aid surgery is poor and lacks uniformity. However, based on available data, which shows a lack of major complications, osseointegrated implantation is a safe procedure in both adult and pediatric populations. Well-designed, prospective studies with uniform reporting standards would allow greater comparison between techniques and more reliable analysis of complications of osseointegration surgery of the temporal bone for cochlear stimulation.
总结可获得的同行评议文献，描述成人和儿童患者的骨整合听力植入物相关并发症的范围和发生率。
我们使用“骨锚定听力植入物”一词在 PubMed 中进行搜索，以查找 2000 年至 2011 年间发表的英文文章。我们纳入了所有报告并发症发生率的文章，除了病例报告、一般综述（非系统综述）或评论文章，以及那些不包括患者结果、报告与非标准植入物（例如 8.5 毫米的接体）相关的结果或研究或报告质量较差的文章。
排除不符合标准的文章后，共确定了 20 篇文章，其中包括 2134 名接受了总共 2310 例骨植入物的患者。文献中报道的并发症通常性质较轻。Holgers 分级 2 至 4 级的皮肤反应发生率为 2.4%至 38.1%。成人和混合人群中骨整合失败的发生率为 0%至 18%，儿科人群中为 0%至 14.3%。成人和混合人群中翻修手术的比例为 1.7%至 34.5%，儿科患者为 0.0%至 44.4%，而总的植入物丢失率在成人和混合人群中为 1.6%至 17.4%，儿科患者为 0.0%至 25%。
总体而言，报告骨整合听力植入物手术后并发症发生率的大型和/或前瞻性研究的质量较差，缺乏一致性。然而，基于现有数据，即显示缺乏重大并发症，骨整合植入术在成人和儿科人群中是一种安全的手术。设计良好、采用统一报告标准的前瞻性研究将允许在技术之间进行更好的比较，并更可靠地分析用于耳蜗刺激的颞骨骨整合手术的并发症。
