Schilder Anne Gm, Chong Lee Yee, Ftouh Saoussen, Burton Martin J
evidENT, Ear Institute, Faculty of Brain Sciences, University College London, 330 Grays Inn Road, London, UK, WC1X 8DA.
Cochrane Database Syst Rev. 2017 Dec 19;12(12):CD012665. doi: 10.1002/14651858.CD012665.pub2.
BACKGROUND: Acquired hearing loss is common and its incidence increases markedly with age. In most people, 'age-related' hearing loss is sensorineural (due to the loss of cochlear hair cells) and bilateral, affecting both ears to the same degree. Hearing loss categorised as mild, moderate or severe is primarily managed with hearing aids. People with bilateral hearing loss may be offered one aid, fitted to one specific ear, or two aids fitted to both ears. There is uncertainty about the relative benefits to people with hearing loss of these different strategies. OBJECTIVES: To assess the effects of bilateral versus unilateral hearing aids in adults with a bilateral hearing impairment. SEARCH METHODS: The Cochrane ENT Information Specialist searched the ENT Trials Register; Cochrane Register of Studies Online; PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 8 June 2017. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing the fitting of two versus one ear-level acoustic hearing aids in adults (over 18 years) with a bilateral hearing impairment, both ears being eligible for hearing aids. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcomes were patient preference for bilateral or unilateral aids, hearing-specific health-related quality of life and adverse effects (pain or discomfort in the ear, initiation or exacerbation of middle or outer ear infection). Secondary outcomes included: usage of hearing aids (as measured by, for example, data logging or battery consumption), generic health-related quality of life, listening ability and audiometric benefit measured as binaural loudness summation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: We included four cross-over RCTs with a total of 209 participants, ranging in age from 23 to 85 and with a preponderance of men. All the studies allowed the use of hearing aids for a total period of at least eight weeks before questions on preference were asked. All studies recruited patients with bilateral hearing loss but there was considerable variation in the types and degree of sensorineural hearing loss that the participants were experiencing.Three of the studies were published before the mid-1990s whereas the fourth study was published in 2011. Therefore, only the most recent study used hearing aids incorporating technology comparable to that currently readily available in high-income settings. Of the four studies, two were conducted in the UK in National Health Service (NHS - public sector) patients: one recruited patients from primary care with hearing loss detected by a screening programme whereas the other recruited patients who had been referred by their primary care practitioner to an otolaryngology department for hearing aids. The other two studies were conducted in the United States: one study recruited only military personnel or veterans with noise-induced hearing loss whereas about half of the participants in the other study were veterans.Only one primary outcome (patient preference) was reported in all studies. The percentage of patients who preferred bilateral hearing aids varied between studies: this was 54% (51 out of 94 participants), 39% (22 out of 56), 55% (16 out of 29) and 77% (23 out of 30), respectively. We have not combined the data from these four studies. The evidence for this outcome is of very low quality.The other outcomes of interest were not reported in the included studies. AUTHORS' CONCLUSIONS: This review identified only four studies comparing the use of one hearing aid with two. The studies were small and included participants of widely varying ages. There was also considerable variation in the types and degree of sensorineural hearing loss that the participants were experiencing.For the most part, the types of hearing aid evaluated would now be regarded, in high-income settings, as 'old technology', with only one study looking at 'modern' digital aids. However, the relevance of this is uncertain, as this review did not evaluate the differences in outcomes between the different types of technology.We were unable to pool data from the four studies and the very low quality of the evidence leads us to conclude that we do not know if people with hearing loss have a preference for one aid or two. Similarly, we do not know if hearing-specific health-related quality of life, or any of our other outcomes, are better with bilateral or unilateral aids.
背景:获得性听力损失很常见,其发病率随年龄显著增加。在大多数人中,“年龄相关性”听力损失是感音神经性的(由于耳蜗毛细胞损失)且为双侧性,双耳受影响程度相同。分类为轻度、中度或重度的听力损失主要通过助听器进行处理。双侧听力损失的患者可以选择佩戴一个助听器,安装在一只特定耳朵上,或者两只耳朵各佩戴一个助听器。对于听力损失患者而言,这些不同策略的相对益处尚不确定。 目的:评估双侧与单侧助听器对双侧听力障碍成年人的影响。 检索方法:Cochrane耳鼻喉科信息专家检索了耳鼻喉科试验注册库;Cochrane在线研究注册库;PubMed;Ovid Embase;CINAHL;科学引文索引;ClinicalTrials.gov;国际临床试验注册平台及其他已发表和未发表试验的来源。检索日期为2017年6月8日。 入选标准:随机对照试验(RCT),比较为双侧听力障碍的成年人(18岁以上)双耳各佩戴一个与单耳佩戴一个耳级声学助听器的效果,双耳均适合佩戴助听器。 数据收集与分析:我们采用了Cochrane预期的标准方法程序。我们的主要结局包括患者对双侧或单侧助听器的偏好、听力相关的健康相关生活质量以及不良反应(耳部疼痛或不适、中耳或外耳感染的引发或加重)。次要结局包括:助听器的使用情况(例如通过数据记录或电池消耗来衡量)、一般健康相关生活质量、听力能力以及以双耳响度总和衡量的听力测定益处。我们使用GRADE来评估每个结局的证据质量;以斜体表示。 主要结果:我们纳入了四项交叉RCT,共有209名参与者,年龄在23至85岁之间,男性居多。所有研究在询问偏好问题之前,允许使用助听器的总时长至少为八周。所有研究均招募了双侧听力损失患者,但参与者所经历的感音神经性听力损失的类型和程度存在相当大的差异。其中三项研究在20世纪90年代中期之前发表,而第四项研究于2011年发表。因此,只有最近的研究使用了与高收入环境中当前 readily available相当的技术的助听器。在这四项研究中,两项在英国针对国民健康服务(NHS - 公共部门)患者进行:一项从初级保健中招募通过筛查计划检测出听力损失的患者,而另一项招募由初级保健医生转介至耳鼻喉科部门寻求助听器的患者。另外两项研究在美国进行:一项研究仅招募患有噪声性听力损失的军事人员或退伍军人,而另一项研究中约一半的参与者为退伍军人。所有研究仅报告了一项主要结局(患者偏好)。不同研究中偏好双侧助听器的患者百分比有所不同:分别为54%(94名参与者中的51名)、39%(56名中的22名)、55%(29名中的16名)和77%(30名中的23名)。我们未合并这四项研究的数据。该结局的证据质量非常低。纳入研究未报告其他感兴趣的结局。 作者结论:本综述仅确定了四项比较使用一个助听器与两个助听器的研究。这些研究规模较小,且纳入的参与者年龄差异很大。参与者所经历的感音神经性听力损失的类型和程度也存在相当大的差异。在很大程度上,在高收入环境中,目前评估的助听器类型会被视为“旧技术”,只有一项研究关注“现代”数字助听器。然而,其相关性尚不确定,因为本综述未评估不同技术类型之间结局的差异。我们无法合并这四项研究的数据,且证据质量非常低,这使我们得出结论,我们不知道听力损失患者是偏好一个助听器还是两个。同样,我们不知道听力相关的健康相关生活质量或我们的任何其他结局在双侧或单侧助听器使用情况下是否更好。
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