NCT07667140已完成不适用
WSA Standard PMCF Study 2026
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- WSAUD A/S
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities.
详细描述
This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 18 adult subjects with mild-to-moderate sensorineural hearing impairement. The subjects, all native German speakers, have 1 appointment of 1-2 hours including a fitting procedure with real-ear measurements and selected standard speech tests and tests of basic hearing-aid related task.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sensorineural hearing loss, mild-to-moderately severe (Pure tone average of 500, 1000, 2000 and 4000 Hz <65).
- •Hearing loss should fall within fitting range of study hearing aid
- •Subjects should be experienced hearing aid users who have had and used hearing aids daily for at least 1 year.
- •Air-Bone-Gap should be less or equal to 20 dB.
- •Asymmetry between left and right ear should not exceed 20dB for frequencies in the range of 250Hz to 4kHz
- •Healthy (outer and middle) ear
- •Older than 18 years
- •German is mother tongue
- •Able to understand the instructions
- •Willing to participate in laboratory tests and to wear the study HAs at home for 2 weeks
- •Informed consent
排除标准
- •Contraindication for HA treatment
- •Fluctuating or rapidly progressing hearing loss
- •"Central" hearing problems
- •Limited mobility
- •Limited dexterity (in handling the HA)
- •Known psychological or cognitive problems
- •Subjects must not show any injuries or a complete perforation of the ear drum. This must be clarified prior to the beginning of the study by means of otoscopy.
- •Subjects should be in good overall medical condition (e.g., they shall not suffer from dementia) and should not use medical treatments that might affect study results.
研究者
研究点 (1)
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