Non-significant Risk Study of a Cochlear Implant Headpiece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Subjective Report of Headpiece Comfort and Retention
研究概览
简要总结
This study aims to evaluate a cochlear implant headpiece.
详细描述
The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre- or post-lingually deafened.
- •Fluent in English, French, or Spanish or capable of communication with a caregiver who is providing consent.
- •Adult or child implanted with a commercially available Advanced Bionics cochlear implant. Children and adult participants are included to ensure device retention is appropriate for all implant populations.
- •Have (or caregivers have) the cognitive and functional capability to comply with all directions during the study
- •Be able to remove their own headpiece
- •Have (or caregivers have) the cognitive and functional capability to complete the questionnaire required for the study
- •Capable (or caregivers are capable) of reading and understanding patient information materials and giving written informed consent
排除标准
- •Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.
结局指标
主要结局
Subjective Report of Headpiece Comfort and Retention
时间窗: Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.
Comfort and subjective retention of the headpiece were rated via questionnaire for baseline headpiece and investigational headpiece acute and chronic use. Subjects were provided with ratings questionnaires and asked to chronically evaluate the headpiece and associated magnet for comfort and retention every two months. Results are presented as total count of participants who rated retention and comfort as favorable ("no opinion," "acceptable," or "very acceptable") at study close out. The baseline/investigational headpiece questionnaires included 2 questions: 1. Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable) 2. Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)
次要结局
未报告次要终点