NCT01822119已完成不适用
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months Follow-up
Cochlear Bone Anchored Solutions6 个研究点 分布在 4 个国家目标入组 27 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- Hearing Performance, PTA4 at 12 Weeks
研究概览
简要总结
The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery:
- To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband
- Which sound processor to select, i.e. BP100 vs BP110
- Improve the fitting process for the sound processor
- Selection of sound processor magnet at time of fitting and over time
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
- •Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 decibel (dB) hearing level (HL)
- •Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 dB hearing level (HL) in the best ear
- •Signed informed consent
排除标准
- •Uncontrolled diabetes as judged by the investigator
- •Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
- •Unable to follow investigational procedures, e.g. to complete quality of life scales
- •Less than 4mm of soft tissue pre-operatively
- •Participation in another investigation with pharmaceuticals and/or device
- •Condition that may have an impact on the outcome of the investigation as judged by the investigator
- •Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned
- •Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
结局指标
主要结局
Hearing Performance, PTA4 at 12 Weeks
时间窗: Baseline before surgery and 12 weeks after surgery
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.
Hearing Performance, PTA4 at 36 Weeks
时间窗: Baseline before surgery and 36 weeks after surgery
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
次要结局
- Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks(Baseline before surgery and 36 weeks after surgery)
- Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks(Baseline before surgery and 36 weeks after surgery)
- Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks(Baseline before surgery and 36 weeks after surgery)
- Hearing Performance, Individual Frequencies(Baseline before surgery and 36 weeks after surgery)
- Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks(Baseline before surgery and 36 weeks after surgery)
- Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks(Baseline before surgery and 36 weeks after surgery)
- Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks(Baseline before surgery and 36 weeks after surgery)
- Abbreviated Profile of Hearing Aid Benefit (APHAB)(Baseline before surgery and 36 weeks after surgery)
研究者
研究点 (6)
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