Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Word recognition scores in quiet
研究概览
简要总结
Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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) cochlear implant recipients
- •Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
- •User of commercially available Freedom, CP810 or CP900 series sound processor
- •User of the ACE strategy or MP3000 strategy
- •At least 3 months experience with the cochlear implant
- •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
研究组 & 干预措施
MP3000-ACE strategy
MP3000 sound coding strategy or ACE strategy with lower stimulation rate
干预措施: MP3000 sound coding strategy or ACE strategy with lower stimulation (Device)
结局指标
主要结局
Word recognition scores in quiet
时间窗: Testing over 18 weeks
Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy
Sentence recognition scores in quiet
时间窗: Testing over 18 weeks
Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy
次要结局
- Fundamental frequency (F0) discrimination(Testing over 18 weeks)
- Speech intelligibility and helpfulness subjective ratings(Testing over 18 weeks)
- Sentence in noise scores(Testing over 18 weeks)