A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing Strategies and Their Effect on Speech Understanding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bernafon AG
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Speech perception with narrowband noise
研究概览
简要总结
The purpose of this study is to show that the performance of the new digital signal processing system is better than the system used in the currently CE marked devices. Speech in narrowband noise and acceptable levels of noise should be improved with the new system, and speech understanding overall should not be negatively affected. There should be no artefacts or unwanted noises caused by the new system.
详细描述
This is a controlled, double-blinded, comparative clinical evaluation conducted monocentric at the premised of Bernafon AG in Bern, Switzerland.
For this study, Bernafon AG will carry out testing with participants with hearing loss to validate the performance of a new digital signal processing (DSP). System testing of the DSP shows an improved signal, yet it must be tested with humans to be sure of an improvement in real-life situations. The current study will compare the new DSP to the one that is used in the Bernafon hearing aids that are CE- marked and currently available on the market. The goal is to determine whether the new DSP is better in real-life situations than the current system.
Primary Endpoint: The primary objective is to assess the new DSP system with various hearing losses and levels of amplification. Speech testing will be used to analyse the speech perception of participants.
Secondary Endpoint: The secondary objective is to verify the overall performance of the new device. Acceptable noise levels will be measured as well as further speech testing. Questionnaires will be used to measure subjective responses to the performance.
Other Endpoints: The subjective performance of an optimized fitting versus a standard fitting and the acceptance of new domes will be measured with questionnaires.
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
- Double (Participant, Investigator)
盲法说明
The subjects will not know which device they are using in each period (new or current) because they look exactly the same. The PI will also not know which device is used as they will be prepared for the PI before the Appointments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hearing loss (sensorineural, conductive, mixed-must have doctor approval for mixed and conductive Hearing loss)
- •Severity of Hearing loss ranging from mild to profound
- •German speaking
- •Current Hearing aid users
- •Ability and willingness to sign the consent form
排除标准
- •Contraindications for amplification
- •New Hearing aid users
- •Inability to follow the procedures
- •Inability to attend Weekly study Appointments
- •Strongly reduced dexterity
- •Central Hearing disorders
- •Bernafon employees
- •Family members of Bernafon employees
结局指标
主要结局
Speech perception with narrowband noise
时间窗: Week 3
Speech perception is tested using a standardized speech test that requires subjects to repeat sentences presented among narrowband background noise. The test is adaptive with the background noise getting louder or softer so that the subject answers 50% correct. The scores are measured in dB SNR (signal-to-noise ratio) and a lower score is better. The lowest possible score is -15 dB SNR and the highest is +20 dB SNR. It is measured in the aided condition with the new device or the current device depending on the randomization.
次要结局
- Acceptance of noise(Week 3)
- Speech perception with broadband noise(Week 3)