Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Speech intelligibility
研究概览
简要总结
An exploratory investigation of gain precalculation principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These gain precalculation principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strength and weaknesses of these gain precalculation principles in terms of speech intelligibility to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings will be carried out. 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
- 否
入选标准
- •Hearing impaired adult at a minimum age of 18 years
- •Good written and spoken german skills
- •Ability to fill in a questionnaire concientiously
- •Ability to produce a reliable hearing test result
- •Ability to describe listening impressions / experiences
- •Audiogram is in the fitting range of the hearing aids
排除标准
- •Unaidable hearing loss in one or both ears
- •Auricle deformities that prevent secure placement of the investigational device
- •Acute tinnitus in one or both ears
- •Unwillingness to test the investigational device
- •Asymmetrical hearing loss
- •Hypersensitivity or allergy against synthetic materials
- •Symptoms of vertigo or dizziness
- •Suffering from any otologic disease
研究组 & 干预措施
Hearing aid with gain precalculation principle 1
Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.
干预措施: Competitor device, hearing aid with standard gain precalculation principle (Device)
Hearing aid with gain precalculation principle 2
Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.
干预措施: Competitor device, hearing aid with standard gain precalculation principle (Device)
Competitor device, hearing aid with standard gain precalculation principle
Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device.
干预措施: Hearing aid with gain precalculation principle 1 (Device)
Competitor device, hearing aid with standard gain precalculation principle
Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device.
干预措施: Hearing aid with gain precalculation principle 2 (Device)
结局指标
主要结局
Speech intelligibility
时间窗: From enrollment to the end of treatment at 3 weeks
Speech intelligibility in % will be assessed with a monosyllabic word recognition test for each of the interventional conditions
次要结局
- Qualitative ratings on naturalness(From enrollment to the end of treatment at 3 weeks)
- Qualitative ratings on loudness(From enrollment to the end of treatment at 3 weeks)
- Qualitative ratings on own voice quality(From enrollment to the end of treatment at 3 weeks)
研究者
Sebastian Griepentrog
Clinical studies manager
Sonova AG