A Feasibility, Prospective, Multi-centre, Repeated Measures Investigation Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Cochlear
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Adaptive sentence in noise scores (AuSTIN)
研究概览
简要总结
A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients
详细描述
The Research System is comprised of several components: the processing unit, fitting software and accessories. The sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation. The application of hearing aid technologies to Cochlear Implant recipients may provide benefit through matching the signal processing technologies across ears for bimodal listeners, enhance performance for CI-alone listening, and potentially lead to efficiency in algorithm development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen years of age or older
- •User of CI600, CI500 or CI24RE implant
- •At least 3 months experience with a TGA approved Nucleus cochlear implant in at least one ear
- •Fluent speaker of English
- •A word speech recognition score of 20% or more when using the cochlear implant alone*
- •Willing and able to provide written informed consent *This can be based on clinical data if collected within the last 12 months
排除标准
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- •Investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling
- •Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device. (Unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.
结局指标
主要结局
Adaptive sentence in noise scores (AuSTIN)
时间窗: 3 months
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.
Percent correct monosyllabic word scores.
时间窗: 3 months
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for monosyllabic words in quiet CNC words at 60 dB SPL (sound pressure level) Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
次要结局
未报告次要终点