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临床试验/NCT05198713
NCT05198713已完成不适用

Evaluation of Hearing Aid Benefit

Sonova AG1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Sonova AG
入组人数
15
试验地点
1
主要终点
Speech Intelligibility in Quiet.

研究概览

简要总结

The present study will investigate the benefit of hearing aids for speech intelligibility (in both quiet and noisy environments) compared to the unaided condition. Participants will include adults with moderate to moderately severe hearing impairment. The participants will complete laboratory-based speech intelligibility assessments with binaural hearing aids and without hearing aids.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Moderate to moderately severe sensorineural hearing loss
  • •Willingness to wear custom hearing instruments during the study.
  • •Age-normal cognition
  • •Ability to attend on-site study visits.

排除标准

  • 未提供

研究组 & 干预措施

Experimental

Experimental

All participants will be fit with the study hearing aid and under go the same testing conditions.

干预措施: New hearing aid (Device)

结局指标

主要结局

Speech Intelligibility in Quiet.

时间窗: Day 1 and Day 15

Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions.

次要结局

  • Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words(Day 1 and Day 15)

研究者

发起方
Sonova AG
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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