Single Center 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
- 10
- 试验地点
- 2
- 主要终点
- Aided Thresholds Fusion-unaided PTA
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 speech intelligibility 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
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects implanted with the Bridging Bone Conductor (BBC) implant
- •Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
- •Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
- •Active user of the BCI SP
排除标准
- •Inability to participate in follow-ups
- •Unsuitable as judged by the principle investigator or the sub-investigator
研究组 & 干预措施
Fusion 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: Fusion Sound Processor (Device)
结局指标
主要结局
Aided Thresholds Fusion-unaided PTA
时间窗: 6 months
Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
次要结局
- Aided Thresholds Fusion-unaided(6 months)
- Aided Thresholds Fusion PTA4(Baseline, 1 and 6 month(s))
- Aided Thresholds Fusion(Baseline, 1 and 6 month(s))
- Aided Thresholds Fusion-BCI PTA4(6 months)
- Aided Thresholds Fusion-BCI(6 months)
- Speech Intelligibility Fusion-unaided %(6 months)
- Speech Intelligibility Fusion-unaided Signal to Noise Ratio (SNR)(6 months)
- Speech Intelligibility Fusion %(Baseline, 1 and 6 month(s))
- Speech Intelligibility Fusion SNR(Baseline, 1 and 6 month(s))
- Speech Intelligibility Fusion-BCI %(6 months)
- Speech Intelligibility Fusion-BCI SNR(6 months)
- Magnet Strength(Baseline, 1 and 6 month(s))
- IPS (Inflammation, Pain, Skin Height/Numbness) Evaluation(Baseline, 1 and 6 month(s))
- Subjective Evaluation(Baseline, 1 and 6 month(s))
- Subjective Evaluation SSQ(Baseline, 1 and 6 month(s))