Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Subjective questionnaire feedback
研究概览
简要总结
The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are:
- Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while providing a satisfactory user experience?
- Does the rechargeable behind-the-ear hearing device kit improve speech understanding in noise in a lab setting?
Researchers will compare participants' performance with the rechargeable behind-the-ear hearing device kit to the unaided condition to see if it works to treat hearing loss. The rechargeable behind-the-ear hearing device kit will be subjectively compared to their personal hearing device experience.
Participants will:
- Use the rechargeable behind-the-ear hearing device kit for approximately 2 weeks.
- Visit the clinic for the initial fitting and follow-up testing at the end of the study. Additional study visits may take place, as needed.
- Complete questionnaires to identify challenging listening situations and provide feedback on their experience with the devices.
- Complete lab testing to assess speech intelligibility in the presence of background noise and provide subjective feedback on features in the Mobile application.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (aged 18 years or older)
- •Current and experienced hearing aid users (actively using hearing aids for at least 3 months)
- •Audiograms that fit within the fitting range of the devices (mild to profound bilateral hearing loss)
- •Cognitive and functional capability to consent to study procedures, operate the controls for the devices and comply with all directions during the study.
- •Good understanding (read/write/speak) of the English language.
- •Willingness to comply with all study requirements including minimum wear-time (6-8 hrs/day) of binaural BTE(RIC) investigational devices.
- •Good overall health including healthy outer ear with no excessive wax/debris.
- •Ear canal size/shape must accommodate appropriate fitting of the hearing device.
- •Socially engaged participants are a top priority (out & active socially) who frequently encounter the noisy situations in which the devices are meant to be used.
- •Use/ownership of a smartphone to pair hearing aids with for use with phone calls and streaming.
- •Otherwise, the study population is representative of typical hearing instrument users in age and presence of hearing loss
排除标准
- •Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study endpoint.
- •Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes.
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid.
- •Acute tinnitus (<three months after onset).
- •Inability to attend scheduled visits (mobility and/or scheduling).
研究组 & 干预措施
Hearing device kit users
Participants will use the rechargeable behind-the-ear hearing device kit for the duration of their study participation in the lab and during their take home trial.
干预措施: Rechargeable behind-the-ear hearing device kit (Device)
结局指标
主要结局
Subjective questionnaire feedback
时间窗: From enrollment to the end of treatment at 2 weeks
Participants will complete subjective feedback questionnaires: Client Oriented Scale of Improvement (COSI), Online questionnaire, Mobile Application questionnaire. Results will be analyzed descriptively to assess the user experience with the hearing device kit.
次要结局
- Hearing in Noise Test (HINT)(At the end of treatment, after two weeks of device use.)