Cochlear Implantation in Children with Asymmetric Hearing Loss or Single Sided Deafness Clinical Trial

摘要 具有挑战性的听觉环境，例如教室、学校食堂、操场，包括一个重要的 孩子一天中的一部分。双耳听力有助于在这些环境中理解语音，其中声音 和语音重叠，来自多个来源，并在水平上不同。双耳听觉提示是必要的 理解语音并在复杂的声学环境中定位说话者；然而，双耳提示会退化或 消除儿童不对称听力损失(AHL，定义为单耳严重到严重的听力损失 和轻度至中度听力损失)或单侧耳聋(SSD，定义为严重到严重 一只耳朵听力丧失，另一只耳朵听力正常或接近正常)。人工耳蜗术(CI)是唯一的 可以为听力严重到严重听力损失的耳朵提供听力的治疗，因此，唯一的机会 用于双耳听证。然而，患有AHL/SSD的儿童并不经常被植入贫穷的耳朵，因为 耳朵受益于放大(AHL)或听力正常(SSD)。最近，FDA批准了 植入部分AHL/SSD儿童；然而，批准是有限的，因为它仅限于患有AHL/SSD的儿童 严重听力损失和≤5%的单词识别在穷人的耳朵。此外，在以下问题上没有达成共识 CI候选人资格标准、评估工具或这些孩子随着时间的推移而取得的成绩。一个纵向的， 使用FDA批准的方案的前瞻性多中心临床试验是解决缺陷的关键 对AHL/SSD儿童进行治疗，并探索CI的治疗方法。我们提议的两个阶段的顺序研究允许 当前助听器(HA)技术植入前与植入后的表现增长比较 带着一个线人。目的1获得AHL/SSD患儿在弱耳接受CI治疗的初步疗效数据。 将单独使用CI的植入后性能与使用HA的植入前性能进行比较。措施 包括单词识别和声场检测级别。目的2评估双峰听力的有效性 定义为较差耳的CI和较好耳的HA(AHL)，或定义为较差耳和听力正常的 The Better Ear(SSD)。通过比较种植后和种植前的双峰评分来衡量双峰的疗效 最佳辅助评分，2)植入后，双峰评分更好的单独耳朵评分，以及3)双峰改变 性能随时间变化(CI阶段)到最佳辅助性能随时间变化(HA阶段)。措施 包括噪音和软级别的语音识别、本地化和生活质量指标。基本要素 与患者选择、检测方法和方法相关的信息将为临床管理人员提供这些信息 服务不足的人群。总而言之，研究结果将提供关键的循证数据，关于 听力较差的AHL或SSD儿童接受CI治疗后双耳听力的发展 这是建立标准化治疗不可或缺的一部分。

ABSTRACT Challenging auditory environments, e.g., classrooms, school cafeterias, playgrounds, comprise a significant portion of a child's day. Binaural hearing facilitates speech understanding in these environments where sounds and speech overlap, originate from multiple sources, and vary in level. Binaural auditory cues are necessary to understand speech and locate talkers in acoustically complex settings; however, binaural cues are degraded or eliminated for children with asymmetric hearing loss (AHL, defined as severe to profound hearing loss in one ear and mild to moderate hearing loss in the other) or single-sided deafness (SSD, defined as severe to profound hearing loss in one ear and normal or near normal hearing in the other). A cochlear implant (CI) is the only treatment that can provide hearing to an ear with severe to profound hearing loss and thus, the only opportunity for binaural hearing. Yet, children with AHL/SSD are not routinely implanted in the poor ear because the better ear benefits from amplification (AHL) or has normal hearing (SSD). Recently, the FDA granted approval to implant a subset of children with AHL/SSD; however, the approval is restrictive as it is limited to children with profound hearing loss and ≤ 5% word recognition in the poor ear. Furthermore, there is no consensus regarding CI candidacy criteria, assessment tools, or performance outcomes over time for these children. A longitudinal, prospective, multi-center clinical trial employing an FDA-approved protocol is critically needed to address deficits of children with AHL/SSD and explore treatment with a CI. Our proposed sequential, two-phase study allows for comparison of performance growth pre-implant with current hearing aid (HA) technology versus post-implant with a CI. Aim 1 obtains preliminary efficacy data in children with AHL/SSD who receive a CI in the poor ear. Post-implant performance with a CI alone is compared with pre-implant performance with a HA. Measures include word recognition and sound field detection levels. Aim 2 evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear (AHL) or a CI in the poor ear and normal hearing in the better ear (SSD). Bimodal efficacy is measured by comparing: 1) post-implant bimodal scores to pre-implant best-aided scores, 2) post-implant, bimodal scores to better ear alone scores, and 3) change in bimodal performance across time (CI phase) to change in best-aided performance over time (HA phase). Measures encompass speech recognition in noise and at soft levels, localization, and Quality of Life metrics. Essential information related to patient selection, test measures, and methodology will inform clinical management of these underserved populations. In summary, study outcomes will provide crucial evidence-based data regarding the development of binaural hearing abilities in children with AHL or SSD who receive a CI in the poor hearing ear, which is integral to the establishment of standardized treatment.