Evaluation of Novel Noise Reduction Principles in Hearing Instruments to Determine Their Applicability.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)
研究概览
简要总结
In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
- •Written and spoken German,
- •Hearing loss range: N3-N4 Hearing loss (sensorineural)
- •Healthy outer ear,
- •Ability to understand and follow the instruction of the in-vestigator
- •Informed consent as documented by signature.
排除标准
- •Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
- •Pregnant or breastfeeding women
- •Age >85 years
- •known hypersensitivity or allergy,
- •limited mobility and not able to attend the appointments
研究组 & 干预措施
Hearing Aid Standard NR1
Hearing Aid with standard Noise Reduction (NR1) serves as reference condition.
干预措施: Measures of Standard Noise Reduction NR1 (Device)
Novel Noise reduction principles
Noise Reduction Principle NR2 and NR3.
干预措施: Measures of Noise Reduction Principle NR2 (Device)
Novel Noise reduction principles
Noise Reduction Principle NR2 and NR3.
干预措施: Measure of Noise Reduction Principle NR3 (Device)
结局指标
主要结局
Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)
时间窗: 4 weeks
SRTs are measured with the OLSA test.
次要结局
- Evaluation whether the novel noise reduction algorithm (NR3) provides different SRTs in noisy situation with speech from front compared to the current implemented "standard noise reduction" (NR1; Comparator)(4 weeks)
- Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator)(4 weeks)