A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet
研究概览
简要总结
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None (Participant)
盲法说明
Participants were masked to which fitting method they had at any point in the study
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
- •Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding
- •At least three months of experience with the cochlear implant.
- •Older than 18 years when entering the study.
- •Subject is fluent speaker in the language used for assessments.
- •Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
- •Willing and able to provide written informed consent
排除标准
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- •Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- •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.
- •Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
研究组 & 干预措施
Study cohort
Recipients of cochlear implant or suitable for implantation Interrupted time series: recipients received standard and novel fitting method
干预措施: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique (Device)
结局指标
主要结局
Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet
时间窗: 0 to 4 weeks after fitting
The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method
次要结局
未报告次要终点