A Systematic Review of Surgical Characteristics and Adverse Events of an Active, Transcutaneous Bone Conduction Device.

IF 1.3 4区 医学 Q3 OTORHINOLARYNGOLOGY
Alma Jukic, Christopher C Munhall, Shawn M Stevens
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引用次数: 0

Abstract

Objective: A new, active transcutaneous bone conduction device (BCD) was FDA-approved in 2019 in the USA. This systematic review sought to evaluate early outcomes associated with Osia implantation.

Methods: A systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Four databases were reviewed: PubMed, Scopus, Cochrane CENTRAL, and CINAHL. Studies were included if they described audiometric, surgical characteristics/complications, or adverse events associated with the Osia BCD. Exclusion criteria: non-English language studies, animal investigations, reviews/meta-analyses, case reports, database studies.

Results: Eighteen studies with 336 patients were included. Mean age at implantation was 37.9 years. About 79.5% of patients had MHL/CHL and 19.5% had SSD/SHL. Mean operative time was 71.6 minutes. Mean PTA gain from unaided conditions was 35.4 dB. Mean functional gain at high frequency (6 kHz and above) from aided conditions was 16.1 dB. Mean improvement in speech recognition thresholds was 19.1 dB from unaided conditions. Adverse events (all types) were reported in 20.1% of cases. Across all studies, the postoperative infection rate was 5%. About 2% of patients reported magnet retention issues. About 1.65% of cases were complicated by hematomas.

Conclusions: Under systematic literature review, the Osia BCD has been associated with low complication rates, relatively short operative times, and good audiometric and speech outcomes, notably high frequency gain >6 kHz. More advanced audiometric outcome reporting remains limited and audiometric data and patient reported outcome measures were reported heterogeneously.

主动式经皮骨传导设备手术特点和不良事件的系统性回顾。
目的:2019 年,美国 FDA 批准了一种新型主动经皮骨传导装置 (BCD)。本系统综述旨在评估与Osia植入相关的早期结果:根据系统综述和元分析首选报告项目(PRISMA)指南进行了系统综述。我们查阅了四个数据库:PubMed、Scopus、Cochrane CENTRAL 和 CINAHL。如果研究描述了与 Osia BCD 相关的听力测量、手术特征/并发症或不良事件,则将其纳入研究。排除标准:非英语研究、动物实验、综述/元分析、病例报告、数据库研究:结果:共纳入18项研究,336名患者。植入时的平均年龄为 37.9 岁。约79.5%的患者患有MHL/CHL,19.5%的患者患有SSD/SHL。平均手术时间为 71.6 分钟。无辅助条件下的平均 PTA 增益为 35.4 dB。辅助条件下高频(6 kHz 及以上)的平均功能增益为 16.1 dB。与无辅助条件相比,语音识别阈值的平均提高幅度为 19.1 分贝。20.1%的病例报告了不良事件(所有类型)。在所有研究中,术后感染率为 5%。约 2% 的患者报告了磁铁滞留问题。约 1.65% 的病例并发血肿:根据系统文献回顾,Osia BCD 的并发症发生率低,手术时间相对较短,听力和言语效果良好,尤其是高频增益大于 6 kHz。更先进的听力测量结果报告仍然有限,听力测量数据和患者报告的结果测量报告也不尽相同。
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
CiteScore
3.10
自引率
7.10%
发文量
171
审稿时长
4-8 weeks
期刊介绍: The Annals of Otology, Rhinology & Laryngology publishes original manuscripts of clinical and research importance in otolaryngology–head and neck medicine and surgery, otology, neurotology, bronchoesophagology, laryngology, rhinology, head and neck oncology and surgery, plastic and reconstructive surgery, pediatric otolaryngology, audiology, and speech pathology. In-depth studies (supplements), papers of historical interest, and reviews of computer software and applications in otolaryngology are also published, as well as imaging, pathology, and clinicopathology studies, book reviews, and letters to the editor. AOR is the official journal of the American Broncho-Esophagological Association.
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