SpeechSensor and StereoZoom for Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Sonova AG
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Speech intelligibility using AZBio sentences Verbal response accuracy based on percent of words correctly repeated on an open-set sentence recognition in noise task.
研究概览
简要总结
The study seeks to evaluate the impact of SpeechSensor and StereoZoom 2.0 on speech understanding in noise in dynamic listening conditions in pediatric hearing aid users.
详细描述
The purpose of this study is to substantiate clinical performance claims regarding the benefit of the SpeechSensor feature on speech recognition in noise for side and rear speech as well as StereoZoom 2.0 benefit data for front speech in noise. In addition, the study will yield myPhonak app usability data and claims regarding children's impressions (confidence, anxiety) when given the opportunity to personalize their beamformer settings in noise during a home trial. Finally, this work will confirm hearing aid intended use for pediatric hearing aid users. Results will inform feature setting, provide critical post-market clinical hearing aid data and support for claims.
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
For objectives 1-3, it is single blinded because all test conditions are implemented in the same hearing aid with the beamformer setting being unknown to the test participant but known to the investigator who enacts program changes.
For the remaining objectives (4-8), it is non-blinded as participants will be trained on the app before completing a skills test (4), will compare impressions using versus not using the app to change their beamformer (5-7) and speech understanding with versus without amplification (8).
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experienced (> 6 months), full-time hearing aid user
- •10 years up to but not including 18 years of age
- •Spoken English
- •Ability to understand oral instruction
- •Ability to describe listening experiences
- •No known neurological issues or cognitive impairment
- •Ability to attend the in-person appointment(s)
- •No speech/language deficits that could compromising ability to perform tasks
- •Healthy outer and middle ear
- •Hearing loss consistent with fitting range of the investigational product
- •Access to a smartphone that can be used during a home trial
- •Informed consent (signature) of parent and consent or assent (verbal) of child
排除标准
- •Clinical contraindications (e.g., closed ear canal, absence of pinna)
- •Known hypersensitivity or allergy to materials comprising hear-ing aid or acoustic coupling
- •Unwilling to wear the hearing aid
- •Unwilling or not permitted to use a smartphone
- •Aided open-set aided speech recognition scores for speech front (+15 dB SNR) < 30%
结局指标
主要结局
Speech intelligibility using AZBio sentences Verbal response accuracy based on percent of words correctly repeated on an open-set sentence recognition in noise task.
时间窗: 3 hours
Verbal response accuracy based on percent of words correctly repeated on an open-set sentence recognition in noise task. 1. Initial - Personalized Signal-to-Noise-Ratio (SNR) is determined for each participant by finding the point where the participant scores 50% correct individual words within sentences. The personalized SNR is determined from the average of two list for a given condition. (SpeechSensor and SZ2.0 objectives) 2. For comparison conditions - Speech as noise will be presented at the participant's personalized SNR. Speech intelligibility will be determined by accuracy of individual words within sentences. The total words correct is determined for a single list for each condition. (Aided versus unaided, intended use objective).
次要结局
- Confidence and Anxiety(Up to 4 weeks)
- Speech Focus Slider Usability - Performance on a modified PHAST (Practical Hearing Aid Skills Test) tool will be used to document whether participants can successfully modify the Speech Focus slider.(3 hours)
- Preference for having slider(Up to 4 weeks)