Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices
研究概览
简要总结
Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups.
详细描述
Within-subject comparison, standard of care CE marked Advanced Bionics device. Remote Evaluation of new CI Naida M sound processor through speech understanding in quiet and noise using standard clinical tests, subjective feedback on sound quality for a set of listening situations reflecting everyday use and a ease of use questionnaire. Two adult groups, one CI users and the other bimodal users. All tests completed remotely.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CI users with a CI, HiRes90K (Advantage) or HiRes Ultra cochlear implant system
- •Unilaterally implanted recipients using only a Naída Q sound processor
- •Bimodal users: additionally using hearing aid on their contralateral ear
- •Minimum of 18 years of age
- •Minimum of five years' experience with their Naída Q sound processor
- •Minimum of six months experience with their contralateral hearing aid (if applicable)
- •Ability to give feedback on sound quality
- •Speech intelligibility with the BKB sentence test in noise at a +10 dB SNR > 10% as obtained during previous visits in the clinical routine or BKB >50% in quiet conditions if noise has previously not been tested
- •Fluent in English language
排除标准
- •Difficulties additional to hearing impairment that would interfere with the study procedures
- •Concurrent participation in any other clinical hearing study
- •Not due to have their sound processor upgraded in line with normal clinical procedures
结局指标
主要结局
Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices
时间窗: 12 months
Understanding speech in presence of completing noise and quiet testing remotely through use of Gorilla software. This will be done through a percentage score calculated within the Gorilla software.
次要结局
- Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech(12 months)
研究者
Sophie McKenny
Clinical Researcher
Cambridge University Hospitals NHS Foundation Trust