Phonak Behind-The-Ear Quality Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Speech in Noise Test
研究概览
简要总结
Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.
详细描述
Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.
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)
盲法说明
Participants will be blinded as to which hearing device they are wearing during lab testing.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
- •18+ years old
- •Good written and spoken English language skills
- •Able to fill in a questionnaire conscientiously
- •Experienced hearing aid user
- •Able to produce a reliable hearing test result
- •Able to describe listening impressions/experiences and the use of the hearing aids
排除标准
- •Not willing to test the hearing aids
- •Has auricle deformities that prevents secure placement of the hearing aids
- •Has limited mobility and is not able to attend the appointments
- •Not willing to wear the hearing aids for at least 8 hours per day
- •Known hypersensitivity or allergy with synthetic materials
- •Self reports symptoms of vertigo, dizziness, fluctuating hearing loss
- •Hints of psychological problems
- •Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)
结局指标
主要结局
Speech in Noise Test
时间窗: Day 14 of the study
Sentences are presented to either the left or right side of the participant's head through a speaker that is 1 meter away. Background noise is presented through the remaining seven speakers that are arranged in a circular pattern around the participant. The sentences are presented at varying levels which may be both louder and softer than the fixed level of noise. The SNR50 is the Signal to Noise Ratio (SNR) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3 dB louder than the noise. Lower SNR50 scores indicate better performance.
Subjective measure of listening effort
时间窗: Day 14 of the study
A rating scale will be given to the participants following the Speech in Noise Test in which they will rate their perceived listening effort during the test.
次要结局
未报告次要终点