Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Speech, Spatial and Qualities of Hearing (SSQ) scale
研究概览
简要总结
When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of modifying this parameter will be investigated in this study. To avoid the research being confounded by prior bias for a particular frequency allocation, the study will be conducted with newly implanted recipients.
This study will also investigate whether tests which measure the ability to use low frequency hearing and objective measures can predict the preferred Fc and speech performance benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult (≥18 years of age)
- •Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
- •Implanted with the CI500 or CI24RE-series cochlear implants
- •User of the commercially available Nucleus 6 sound processor
- •User of the ACE strategy
- •Native speaker in the language used to assess speech perception performance
- •Willingness to participate in and to comply with all requirements of the protocol
排除标准
- •Additional handicaps that would prevent participation in evaluations
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
结局指标
主要结局
Speech, Spatial and Qualities of Hearing (SSQ) scale
时间窗: Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant
Preference rating assessed using SSQ scale
Speech recognition in noise
时间窗: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Open-set speech recognition in noise
Word recognition scores in quiet
时间窗: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Open-set monosyllabic word scores in quiet
次要结局
未报告次要终点