Lyric Self-replacement Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 57
- 试验地点
- 15
- 主要终点
- Change in aided audiometric threshold testing between standard and experimental replacement procedures
研究概览
简要总结
This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.
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
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets requirements outlined on Lyric self-replacement candidacy form
- •Current Lyric hearing instrument user with 3+ months of Lyric experience
- •22 years of age or older at the time of enrollment in the study
- •Mild-to-moderately severe sensorineural hearing loss (bilaterally or unilaterally)
- •Good understanding (read/write/speak) of the English language
- •Willingness to comply with all study requirements
排除标准
- •Does not meet requirements outlined on Lyric self-replacement candidacy form
- •Difficulty understanding/reading instructions when corrected for vision loss
- •Impairments that would restrict participation in any of the evaluations
- •Ear health conditions present at baseline that prevent immediate device replacement
- •Conditions that would indicate the need for medical referral prior to hearing aid fitting according to local regulations
结局指标
主要结局
Change in aided audiometric threshold testing between standard and experimental replacement procedures
时间窗: Baseline, during intervention, immediately after intervention
Aided audiometric test measures: threshold testing. Thresholds will be measured in decibels Hearing Level (dBHL), with a range of -10 - 120 dBHL. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures.
Change in aided speech-in-noise testing between standard and experimental replacement procedures
时间窗: Baseline, during intervention, immediately after intervention
Aided audiometric test measures: speech-in-noise testing. Scores will be measured using signal-to-noise ratio loss, with scores ranging from 0 - 25.5. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures.
次要结局
- Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures(Through study completion, an average of 5 months)