Evaluation of a Sound Processor for a Transcutaneous System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To Assess the Improvement of Hearing With the Sentio1 (PTA4)
研究概览
简要总结
A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and self-evaluation questionnaires.
详细描述
Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.
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
- •Signed Informed Consent Form
- •Adult subjects (18 years or older)
- •Subjects implanted with an I1 implant
- •Fluent in Swedish
排除标准
- •Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion.
- •Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.
研究组 & 干预措施
Sentio 1 sound processor
The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
干预措施: Sentio 1 (Device)
结局指标
主要结局
To Assess the Improvement of Hearing With the Sentio1 (PTA4)
时间窗: 1 month
Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4. The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor).
次要结局
- Subjective Evaluation of Sound Processor Performance.(1 month)
- Subjective Sound Processor Preference(1 month)
- Assess Safety With the Sentio 1 Sound Processor(12 months)
- To Assess the Improvement of Hearing With the Sentio1(1 month)
- To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry.(1 month)
- To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss(1 month)