Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Sonova AG
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- NASA Task Load Index (NASA-TLX)
研究概览
简要总结
This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.
详细描述
This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets requirements outlined on Lyric Candidacy Form
- •Current Lyric hearing instrument user
- •18 years of age or older at time of enrollment in the study
- •Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
- •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 Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
- •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 clinic's standard protocol
结局指标
主要结局
NASA Task Load Index (NASA-TLX)
时间窗: Day 1 of 1 day study
A raw score on six demensions (mental demand, physical demand, temporal demand, frustration, effort, performance) on a scale from 1 (low/good) to 20 (high/poor). A higher score indicates higher levels of subjective effort.
次要结局
- AZBio Speech in noise testing(Day 1 of 1 day study)