NCT06597747已完成不适用
Evaluating Design Improvements With SONNET 3 in Experienced Cochlear Implant Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Participants Reporting Improvement With SONNET 3 Design
研究概览
简要总结
Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.
详细描述
This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.
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
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted with a MED-EL cochlear implant in at least one ear
- •≥ 12 months since activation of the MED-EL audio processor
- •Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor
- •Ability to complete all study procedures
- •Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study
排除标准
- •Evidence that hearing loss is retrocochlear in origin
- •Unable to provide reliable feedback during cochlear implant programming
- •Skin or scalp condition precluding use of the study device
- •Unrealistic participant or parent (if applicable) motivation or expectations
- •Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.
结局指标
主要结局
Participants Reporting Improvement With SONNET 3 Design
时间窗: Measured 1 month after baseline
The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey
次要结局
- Audiologist Satisfaction Ratings(Measured after study completion, an average of 7.5 months)
研究者
研究点 (2)
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