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临床试验/NCT04953390
NCT04953390已完成不适用

Evaluating Benefits of Hearing Aid Microphone Directionality Technologies on Spatial Awareness and Speech Intelligibility

Sonova AG1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年5月3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
19
试验地点
1
主要终点
Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments

研究概览

简要总结

This study will evaluate the impact of hearing aid microphone directionality technologies and settings on speech understanding in noise for experienced hearing aid users. It will also evaluate the participant's spatial awareness of sounds using these different hearing aid microphone directionality technologies.

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

盲法说明

During lab testing, participants will be aware of the device they are wearing, but will not be aware of which microphone setting is being tested.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years or older
  • •experienced hearing aid users
  • •moderate to moderate severe sensorineural symmetrical hearing loss defined as a difference of less than 10 dB between ears
  • •must be able to use app and smart phone

排除标准

  • •asymmetrical hearing losses
  • •unable or unwilling to use app and smart phone

研究组 & 干预措施

Experimental

Experimental

All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period.

干预措施: Phonak Audeo hearing aid (Device)

Experimental

Experimental

All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period.

干预措施: Phonak hearing aid with multiple directionality settings, adjustable via a mobile app (Device)

结局指标

主要结局

Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments

时间窗: Third appointment (day 28 of study)

Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments. This is purely subjective and there is no better or worse answer.

Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment

时间窗: Third appointment (day 28 of study)

Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome.

Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment

时间窗: Third appointment (day 28 of study)

Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome.

Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments

时间窗: Third appointment (day 28 of study)

Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments.

次要结局

  • Speech Reception Threshold(2nd appointment (Day 14 of study))
  • Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting(Third appointment (day 28 of study))
  • Observations and Ratings of Satisfaction of Microphone Directionality in Real Life(4 weeks)

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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