Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Sonova AG
- 入组人数
- 170
- 主要终点
- Tinnitus-related Annoyance
研究概览
简要总结
Tinnitus, the perception of sound without an external source, affects around 15% of the global adult population (Jarach et al., 2022). For many, tinnitus is a mild annoyance, but a significant subset experiences severe distress, leading to reduced quality of life and increased healthcare burden. Hearing loss is a major risk factor for tinnitus (Biswas et al., 2023), and clinical guidelines recommend hearing aids as a therapeutic option (Langguth et al., 2023). In addition to amplification through hearing aids, sound therapy has long been used to help manage tinnitus (Sereda & Hoare, 2024).
A recent randomized controlled trial has demonstrated the clinical efficacy of Sonova hearing aids with integrated noise generator (further referred to as "Tinnitus-feature") in reducing tinnitus-related distress. However, the evidence is limited for newer generations of hearing aids and for individuals with severe to profound hearing loss. This study aims to address these gaps by evaluating the clinical benefit of the noise generator feature in newer generations of Sonova hearing aids for adults with tinnitus and hearing loss and in patients with severe to profound hearing loss during routine clinical practice.
详细描述
This study is designed to enroll subjects both retrospectively and prospectively. Eligible subjects will be identified and enrolled through the participating clinical site according to the Clinical Investigation Protocol, which was approved by the local Ethics Committee.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 18 years old
- •Participants with chronic tinnitus (≥ 6 months)
- •Participants with the Tinnitus feature activated
- •Participants that have completed the NRS during routine clinical practice and are at least a little bothered by their tinnitus (NRS ≥ 3)
- •Participants with at least one Sonova manufactured hearing aid with the tinnitus feature activated for at least 12 weeks
排除标准
- •- Participants reporting pulsatile tinnitus
结局指标
主要结局
Tinnitus-related Annoyance
时间窗: From enrollment to survey completion, roughly 15 minutes.
An 11-point Numeric Rating Scale (NRS) with values ranging from 0 to 10 with a verbal anchor at 0 ("not at all") and 10 ("very annoying").
次要结局
未报告次要终点