Quest Sound Recover (SR2) vs. Venture SR2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Functional gain
研究概览
简要总结
Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform.
To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Ability to fill in a question conscientious
- •Healthy outer ear (w/o previous surgical procedures)
- •Sensorineural symmetric hearing loss (HL)
- •N4 to N7 (degree of HL)
排除标准
- •Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product,
- •Limited mobility and not in the position to attend weekly appointments
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid
- •Inability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
- •Massively limited dexterity
- •Known Psychological problems
- •Central hearing problems
研究组 & 干预措施
Intervention group
Hearing aid
干预措施: hearing aid (Device)
Test group
Hearing aid
干预措施: hearing aid (Device)
结局指标
主要结局
Functional gain
时间窗: after 8 weeks
Functional gain is to measure the aided threshold (in dB hearing level \[HL\]) in free field via loudspeaker.
Phoneme Perception Test
时间窗: after 8 weeks
Change of detection thresholds after 4 weeks hearing instrument wearing time
Functional gain
时间窗: after 2 weeks
Functional gain is to measure the aided threshold (in dB hearing level \[HL\]) in free field via loudspeaker.
Phoneme Perception Test
时间窗: after 2
Change of Detection thresholds after 4 weeks hearing instrument wearing time
次要结局
- sound quality ratings(after 6 and 12 weeks)
- questionnaires(after 2, 6, 8 and 12 weeks)