NCT07691853招募中不适用
Anatomy-Based Fitting in Bimodal Cochlear Implant Users
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Speech recognition test in quiet
研究概览
简要总结
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age ≥ 18 years
- •Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- •Post-operative Computed Tomography (CT) scan of the CI electrode available
- •Subject implanted with MED-EL cochlear implant(s)
- •Subject received a Flex28, FlexSoft or Standard electrode
- •Subject uses a SONNET 2 or RONDO 3 audio processor
- •Subject has experience of at least 6 months with cochlear implant
- •The most apical active electrode contact has to be inserted at least 540°
- •Minimum of 10 active channels are activated
- •Subject wears an adequately fitted hearing aid on the contralateral side
- •Fluent in the language of the test centre
- •Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
排除标准
- •Lack of compliance with any inclusion criteria
- •Implanted with C40+, C40X and C40C
- •Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
- •Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study
结局指标
主要结局
Speech recognition test in quiet
时间窗: Day 1 (single study visit), post intervention
Percentage correctly identified phonemes
次要结局
- Speech recognition test in noise (S0N0, S0N90)(Day 1 (single study visit), post- intervention)
- Vowel and consonant identification task (ASSE)(Day 1 (single study visit), post-intervention)
- Pitch and timbre ranking(Day 1 (single study visit), post intervention)
研究者
研究点 (2)
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