PDF(Pubmed)
Abstract：
In the new revised National Institute for Health & Care Excellence (NICE, TA566, 2019) guidelines for cochlear implantation (CI) have clearly stipulated that the hearing loss must be bilateral. Prior to this revision, children and young people (CYP) with asymmetrical thresholds have been considered for unilateral CI when one ear was in audiological criteria. Children with asymmetrical hearing loss represent an important cohort of potential CI candidates, who will continue to be prevented from benefiting from CI unless evidence is produced to support implantation and maximise subsequent benefit.The aim of this study is to evaluate the \'real-life\' hearing performance in a group of children who have received a unilateral CI and who have hearing thresholds in the contralateral ear that are outside the current UK NICE 2019 audiological criteria for CI. The contralateral ear will be aided using a conventional hearing aid (HA). The outcomes from this \'bimodal\' group will be compared with a group of children who have received bilateral CI, and a group of children using bilateral HA, to extend the current knowledge about the different performance levels between bilateral CI, bilateral HA and bimodal hearing in CYP.
Thirty CYP aged 6-17 years old, 10 bimodal users, 10 bilateral HA users and 10 bilateral cochlear implant users will be subjected to a test battery consisting of: (1) spatial release from masking, (2) complex pitch direction discrimination, (3) melodic identification, (4) perception of prosodic features in speech and (5) TEN test. Subjects will be tested in their optimal device modality. Standard demographic and hearing health information will be collected. In the absence of comparable published data to power the study, sample size was determined on pragmatic grounds. Tests are exploratory and for hypothesis generating purposes. Therefore, the standard criterion of p<0.05 will be used.
This has been approved by the Health Research Authority and NHS REC within the UK (22/EM/0104). Industry funding was secured via a competitive researcher-led grant application process. Trial results will be subject to publication according to the definition of the outcome presented in this protocol.
Thirty CYP aged 6-17 years old, 10 bimodal users, 10 bilateral HA users and 10 bilateral cochlear implant users will be subjected to a test battery consisting of: (1) spatial release from masking, (2) complex pitch direction discrimination, (3) melodic identification, (4) perception of prosodic features in speech and (5) TEN test. Subjects will be tested in their optimal device modality. Standard demographic and hearing health information will be collected. In the absence of comparable published data to power the study, sample size was determined on pragmatic grounds. Tests are exploratory and for hypothesis generating purposes. Therefore, the standard criterion of p<0.05 will be used.
This has been approved by the Health Research Authority and NHS REC within the UK (22/EM/0104). Industry funding was secured via a competitive researcher-led grant application process. Trial results will be subject to publication according to the definition of the outcome presented in this protocol.
摘要：
背景：在新修订的国家健康与护理卓越研究所（NICE，TA566，2019）人工耳蜗植入（CI）指南明确规定，听力损失必须是双侧的。在此修订之前，当一只耳朵符合听力学标准时,阈值不对称的儿童和年轻人(CYP)被认为是单耳CI.不对称听力损失的儿童代表了潜在CI候选的重要队列，除非有证据支持植入和最大化后续获益,否则将继续阻止患者从CI获益.这项研究的目的是评估一组儿童的“现实生活”听力表现，这些儿童接受了单方面的CI，并且对侧耳的听力阈值超出了当前的UKNICE2019听力标准。使用常规助听器(HA)辅助对侧耳。这个“双峰”组的结果将与一组接受双侧CI的儿童和一组使用双侧HA的儿童进行比较，以扩展有关CYP中双边CI，双边HA和双峰听力之间不同表现水平的当前知识。
方法：30岁6-17岁，10个双峰用户，10个双侧HA使用者和10个双侧人工耳蜗使用者将接受测试，包括：（1）掩蔽空间释放，（2）复杂的俯仰方向判别，（3）旋律识别，（4）语音中韵律特征的感知和（5）TEN测试。受试者将以其最佳设备模态进行测试。将收集标准的人口统计学和听力健康信息。在缺乏可比的已发表数据来支持这项研究的情况下，样本量是根据实用理由确定的。测试是探索性的，用于产生假设的目的。因此,将使用p<0.05的标准标准。
背景：这已得到英国卫生研究管理局和NHSREC的批准（22/EM/0104）。行业资金是通过竞争性研究人员主导的赠款申请流程获得的。试验结果将根据本方案中给出的结果的定义进行公布。
方法：30岁6-17岁，10个双峰用户，10个双侧HA使用者和10个双侧人工耳蜗使用者将接受测试，包括：（1）掩蔽空间释放，（2）复杂的俯仰方向判别，（3）旋律识别，（4）语音中韵律特征的感知和（5）TEN测试。受试者将以其最佳设备模态进行测试。将收集标准的人口统计学和听力健康信息。在缺乏可比的已发表数据来支持这项研究的情况下，样本量是根据实用理由确定的。测试是探索性的，用于产生假设的目的。因此,将使用p<0.05的标准标准。
背景：这已得到英国卫生研究管理局和NHSREC的批准（22/EM/0104）。行业资金是通过竞争性研究人员主导的赠款申请流程获得的。试验结果将根据本方案中给出的结果的定义进行公布。
