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
- 30
- 试验地点
- 2
- 主要终点
- Individual binaural Hearing abilities
研究概览
简要总结
A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements will be carried out. This will be a controlled, single blinded and randomised 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)
盲法说明
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
- 否
入选标准
- •Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
- •Sensorineural hearing loss (N4-N6 according to ISO 60118-15)
- •Good written and spoken (Swiss) German language skills
- •Healthy outer ear
- •Informed Consent as documented by signature
- •Symmetric hearing loss below 1000 Hz
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 on study site
- •Inability to produce a reliable hearing test result
- •Known psychological problems
- •Central hearing disorders
研究组 & 干预措施
Hearing Aid with beam form principle_A
Device: Hearing Aid beam former principle_A (simulation of real ear condition). Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
干预措施: Bolero B90-SP (Device)
Hearing Aid with beam form principle_B
Device: Hearing Aid beam former principle_B. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
干预措施: Bolero B90-SP (Device)
Hearing Aid with beam form principle_C
Device: Hearing Aid beam former principle_C. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
干预措施: Bolero B90-SP (Device)
结局指标
主要结局
Individual binaural Hearing abilities
时间窗: 2 weeks
Primary Outcome measurement is to measure the speech understanding in noise \[SNR in dB\] for the beam former principles A, B and C
次要结局
- Speechunderstanding for different beam form principles(2 weeks)