Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Electroencephalogram (EEG) data
研究概览
简要总结
An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.
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)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy outer ear (without previous surgical procedures)
- •Ability to fill in a questionnaire conscientiously
- •Informed Consent as documented by signature
排除标准
- •Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- •Limited mobility and not in the position to attend weekly appointments
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid
- •Inability to produce a reliable hearing test result
- •Massively limited dexterity
- •Known psychological problems
- •Known central hearing disorders
研究组 & 干预措施
Hearing Aid with BF
Hearing Aid with beam forming (BF) enabled.
干预措施: Hearing Aid with BF (Device)
Hearing Aid without NR and BF
Hearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition.
干预措施: Hearing Aid without NR and BF (Device)
Hearing Aid with NR
Hearing Aid with Noise Reduction (NR) enabled.
干预措施: Hearing Aid with NR (Device)
结局指标
主要结局
Electroencephalogram (EEG) data
时间窗: 8 weeks
Neural language processing will be assessed through the EEG data collected while the participant is listening to running speech (neurophysiological data). Analysis of the brainstem response, cortical entrainment, N400 and alpha power are planned. EEG data is measured in Volt (mV), and entrainment data is analysed through coherence (frequency-based measure of correlation between the acoustic and the neural signal). N400 and alpha power are measured on the variance of mV over time.
次要结局
- Subjective Listening Effort rating(8 weeks)