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临床试验/NCT05055453
NCT05055453已完成不适用

ESolutions Functions for Children and Young People With the myPhonak App

Sonova AG2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年10月4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
16
试验地点
2
主要终点
dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test

研究概览

简要总结

Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.

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
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents between the ages of 7 and 17 years old.
  • bilateral mild to severe hearing loss
  • experienced hearing aid users for 6+ months

排除标准

  • any additional disabilities to the hearing impairment
  • inability to complete the study procedures

结局指标

主要结局

dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test

时间窗: Day 1 of study, repeated on Day 14 of study

Target speech is presented from a speaker in front of participant while background noise is presented from 4 surrounding speakers. The level of noise is presented at 65 dB SPL (Sound Pressure Level),with target speech presented at variable levels, both louder and softer than the noise. The dB SNR is the level at which the participant can correctly repeat 50% of the words. A lower/negative dB SNR is better, indicating that 50% of the speech is understood when noise is louder than or close to the level of speech. This test was given in three, randomized conditions for each participant at two visits: 1) hearing aids in Automatic, 2) hearing aids in Automatic but Directionality and Noise Reduction customized by participant using the app (i.e. "preferred" settings), and 3) hearing aids in Automatic but with the Directionality set to lowest level 0, (i.e. omnidirectional), and Noise Reduction set to the highest level 10,or all the way on (i.e., "extreme").Results of both visits was averaged

次要结局

  • Assessment of Hearing Situations in Children's Every Day Lives Questionnaire(Completion of first home trial at day 7, and completion of second home trial at day 14)

研究者

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

研究点 (2)

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