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
- 8
- 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
研究组 & 干预措施
Lyric self-replacement
This cohort of experienced Lyric patients are required to meet the candidacy criteria to be eligible for the self-replacement procedure. They will also be required to demonstrate proficiency with the self-replacement procedure before proceeding with independent self-replacement.
干预措施: Phonak Lyric self-replacement procedure (Device)
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)