Evaluation of Fitting Modification for Extended Wear Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Subjective Ratings of Occlusion With Both Devices
研究概览
简要总结
Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.
详细描述
A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants will not know which device is in each ear, only that they are being fit with Lyric devices.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild, Moderate and Moderate Severe Hearing loss
- •Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues
排除标准
- •Participants who can only wear a size XXS (extra-extra small) extended wear device
- •asymmetrical hearing loss
- •other diagnosis that may cause hearing fluctuation
- •inability to tolerate physical fit of Lyric devices
- •inability to be seen for four lab visits
研究组 & 干预措施
First Intervention
Participants will be fit with currently available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for 14 days (Day 1 - Day 14 of study). They will then switch and be fit with Lyric extended wear hearing aid with fitting modification device B in the right ear and the commercially available Lyric device A in the left ear for 14 days (Day 15-Day 28 of study)
干预措施: Lyric extended wear hearing aid device A (Device)
First Intervention
Participants will be fit with currently available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for 14 days (Day 1 - Day 14 of study). They will then switch and be fit with Lyric extended wear hearing aid with fitting modification device B in the right ear and the commercially available Lyric device A in the left ear for 14 days (Day 15-Day 28 of study)
干预措施: Lyric extended wear hearing aid with fitting modification device B (Device)
结局指标
主要结局
Subjective Ratings of Occlusion With Both Devices
时间窗: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
Subjective Questionnaire of Comfort
时间窗: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
次要结局
未报告次要终点