A Phase IV, Single-center Study of the Benefits of the Advanced Bionics Naída CI Q90 Acoustic Earhook in Adults Cochlear Implant Recipients.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Speech recognition testing, with and without acoustic earhook
研究概览
简要总结
The primary objective of this study is to obtain a greater understanding of the range in benefit from acoustic amplification combined with electric stimulation in cochlear implant recipients with low-frequency hearing who do not currently use the commercially approved Advanced Bionics Acoustic Earhook. The aims of this study are to 1) obtain subjective sound quality judgements of recorded speech and music samples, 2) assess vocal emotion perception, and 3) evaluate post-operative speech perception and sound field detection thresholds in CI recipients both with and without use of the acoustic ear hook.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent
- •Implanted with an Advanced Bionics Advanced Bionics HiRes Ultra, 90K, or CII implant, and using a Naída Q90 sound processor
- •18 years of age or older with post-lingual hearing loss
- •Aided open-set speech recognition scores greater than 30% correct in quiet in the ear to be tested
- •Unaided low frequency audiometric hearing thresholds of 90 dB HL or better at .125, .25, and .5 kHz
- •Participants must have a working understanding of and ability to verbalize in English as the evaluation measures are available exclusively in English
- •Willingness to use an acoustic component with their ear-level sound processor postoperatively for the duration of the study
- •Willingness to participate in all scheduled procedures outlined in the protocol
排除标准
- •Exclusive use of a body worn external sound processor
- •Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear
- •Postoperative unaided low frequency audiometric hearing thresholds in the implanted ear exceeding 90 dB HL at any frequency from 125 - 500 Hz.
- •Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation or outcomes measures.
结局指标
主要结局
Change in Speech recognition testing, with and without acoustic earhook
时间窗: 3 Months, 6 Months, 12 Months
5-alternative identification task to measure vocal emotion recognition (Toronto Emotional Speech Test (TESS) at initial fitting, and 3, 6, and 12 months after fitting
Change in Sound quality judgements, with and without acoustic earhook
时间窗: 3 Months, 6 Months, 12 Months
Ratings of sound quality (Judgement of Sound Quality {JSQ} test) of speech and music samples at initial fitting, and 3, 6, and 12 months after fitting
Change in Vocal emotion perception task, with and without acoustic earhook
时间窗: 3 Months, 6 Months, 12 Months
次要结局
未报告次要终点