Effects of Parameters of the Electrical Stimulation on Loudness in Oticon Medical Cochlear Implant Patients. Investigational Study for Cochlear Implant Fitting Facilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Experiment 2: the effect of number of electrodes on loudness
研究概览
简要总结
The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.
详细描述
Primary objective:
- To assess the effect of the number and spatial distribution of active electrodes on the stimulation charge required to achieve the loudness associated with C and T levels (Experiment 2).
Secondary objectives:
- To assess how loudness is affected by changes in electrical charge of individual pulses made by adjusting the pulse amplitude versus adjusting pulse duration (Experiment 1).
- To assess how loudness elicited by a train of pulses is affected by the duration of that pulse train (Experiment 3).
Experiment 1:
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
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
- •Neuro One or Neuro 2 user
- •Unilateral or bilateral recipient
- •12 months CI experience to allow for acclimatization to the CI sound processing and pathological changes that could alter the electrode - tissue interface and therefore T- & C-levels.
- •Having at least 7 step sizes on three electrodes in their current clinical map (for experimentation 1).
- •Able and willing to provide reliable threshold and comfort level judgements
排除标准
- •Medical conditions that contraindicate the study tests (e.g. tinnitus, dizziness)
- •Unrealistic expectations from the candidate regarding the possible benefits, risks, and limitations that are inherent to the device
- •Unwillingness or inability of the candidate to comply with all investigational requirements
- •Vulnerable population
研究组 & 干预措施
Experimental : experiment 1,2 and 3
One user included participates all experiments:
- Visit 1 : experiment 1
- Visit 2 : experiment 2
- Visit 3 : experiment 3
干预措施: Experiment 1 (Device)
Experimental : experiment 1,2 and 3
One user included participates all experiments:
- Visit 1 : experiment 1
- Visit 2 : experiment 2
- Visit 3 : experiment 3
干预措施: Experiment 2: (Device)
Experimental : experiment 1,2 and 3
One user included participates all experiments:
- Visit 1 : experiment 1
- Visit 2 : experiment 2
- Visit 3 : experiment 3
干预措施: Experiment 3 (Device)
结局指标
主要结局
Experiment 2: the effect of number of electrodes on loudness
时间窗: 2 hours
Changes in electrical charge (nC) needed to achieve C-level and T-level. The charge is the results of Intensity\*Duration of a pulse, in µA and µs respectivelly. If either the amplitude or the duration of the pulse is modified, the charge will be modified as well.
次要结局
- Experiment 1 : the effect of pulse amplitude and pulse duration on loudness(2 hours)
- Experiment 3 : the effect of stimulation duration on loudness(2 hours)