Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sonova AG
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall preference for a specific microphone setting/configuration
研究概览
简要总结
Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.
详细描述
People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate.
This study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences.
Of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.
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
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
- •Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- •Including adults with sensorineural mild to moderate-severe hearing loss
- •hearing aid experience (greater than 6 months)
- •who are able to complete the task in English.
- •Language: Can speak and understand English Fluently
- •Hearing loss within the fitting ranges of the investigational products.
- •Healthy outer ear.
- •Ability to understand instructions.
- •Ability to describe listening experiences.
- •Ability to fill out questionnaires.
- •Informed consent as documented by signature.
排除标准
- •The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:
- •Contraindications to the MD in this study (e.g. known hypersensitivity or allergy to the investigational product).
- •Limited mobility and not able to attend to appointments or not able to go in a car.
- •Reported symptoms of vertigo and dizziness by subject.
- •Severe Tinnitus
研究组 & 干预措施
Hearing Aid use for listening to speech in a common difficult situation
The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences.
干预措施: hearing aid -novel program (Device)
Hearing Aid use for listening to speech in a common difficult situation
The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences.
干预措施: hearing aid - standard program (Device)
结局指标
主要结局
Overall preference for a specific microphone setting/configuration
时间窗: 20 minutes
Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')
次要结局
- Rating of awareness of background noise(20 minutes)
- Rating of annoyance of artefacts(20 minutes)
- Rating of Listening effort(20 minutes)