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临床试验/NCT07501312
NCT07501312已完成不适用

Remote Microphone Performance Comparison in Adults With Hearing Loss

Sonova AG1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2026年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Sonova AG
入组人数
19
试验地点
1

研究概览

简要总结

This study will compare far-field speech understanding in noise using a hearing aid alone, with using a hearing aid plus a Roger remote microphone. It will also compare the HA+Roger mic to two other manufacturers' hearing aids plus remote mic systems in the same condition.

详细描述

This study will recruit 15-20 hearing impaired experienced hearing aid adult users. Participants will be fit with three sets of hearing aids (Phonak devices, plus two competitor devices) and the associated remote microphone from each manufacturer. Speech perception will be measured using the validated AZ Bio test, and will be given in both the hearing aid alone condition, as well as the hearing aid plus remote microphone condition. The participant will be seated in the center of a room approximately 7m by 5.25m with a loudspeaker approximately 3 m away, at 0 degree azimuth. Four loudspeakers will also be placed in the corners of the room. For the quiet condition, target speech will be presented from the loudspeaker in front of the participant, for the noise condition speech will be presented from the front with speech babble presented from each of the corner loudspeakers. The speech understanding score in both quiet and in noise will be measured for hearing aids alone, and hearing aids plus the appropriate compatible remote microphone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be blinded as to which devices they are fitted with during the testing.

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bilateral sensorineural hearing loss
  • Experienced bilateral hearing aid users
  • Fluent in English, ability to read and write in English
  • Able to produce a reliable study result
  • Willing to comply with all study requirements

排除标准

  • Limited/inconsistent/no prior use of hearing aids
  • Self-reported ear-related pathology(including but not limited to: otorrhea within the past 90 days, dizziness, sudden onset or worsening hearing loss within the past 90 days, otalgia)
  • Visible deformity of the ear
  • Chronic, severe tinnitus
  • Unilateral hearing loss
  • Single sided deafness

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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