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临床试验/NCT05150964
NCT05150964已完成不适用

Measuring Comfort and Clarity Using Low Gain Feature in Pediatric Hearing Aid Users

Sonova AG1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年6月1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
16
试验地点
1
主要终点
Speech Reception Threshold

研究概览

简要总结

Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.

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

入选标准

  • clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
  • Must use oral mode of communication
  • must speak English

排除标准

  • 未提供

研究组 & 干预措施

Experimental

Experimental

One group will be fit with commercially available hearing aids that will have different program settings

干预措施: Phonak Audeo hearing aid (Device)

结局指标

主要结局

Speech Reception Threshold

时间窗: Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)

A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.

Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula

时间窗: 2nd appointment (day 14 of study)

Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.

Multi-word Recognition at 40 dB SPL and 70 dB SPL

时间窗: Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)

Out of a list of seven words, the participant repeats back as many words as they can recall. Percentage of correct words repeated back is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. One fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. A higher percentage score indicates better multi-word recognition.

Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.

时间窗: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

A word learning task used to determine participant's ability to associate novel/nonsense words with novel images as rapidly as possible. Five nonsense words are paired with five novel images displayed on response buttons. The words are presented randomly 10 times each. The participant selects one picture per word. Scores are presented as percent correct. A higher percentage indicates better word learning. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off.

Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.

时间窗: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

Familiar monosyllabic word list presented at 40 dB and 70 dB. Percentage of words correctly repeated is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. The higher the score, the better the word recognition in each condition.

Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.

时间窗: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

A list of 10 3-word phrases are presented to the participant. The participant indicates if the phrase contains a nonsense word by selecting the numbered response button (i.e. "1", "2", or "3") that corresponds to the position oof the nonsense word in the phrase. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. . The score is the percent correct, a higher score is better.

次要结局

未报告次要终点

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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