NCT03859648终止不适用
Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Number and Proportion of Subjects Experiencing Device Related Adverse Events
研究概览
简要总结
Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.
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, 18 years of age or older at the time of implantation
- •Conductive or mixed hearing loss, defined as:
- •Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz
- •Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz
- •Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz
- •Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better
- •Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears
- •Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
- •Able to complete testing materials in English
- •CT scan indicating the patient's anatomy is adequate to enable placement of the implant
- •Ability to undergo general anesthesia
- •Appropriate motivation and expectation levels
- •Stated willingness to comply with all study procedures for the duration of the study
排除标准
- •Evidence that hearing loss is retrocochlear in origin
- •Skin or scalp condition precluding use of external audio processor
- •Suspected cognitive impairment or organic brain dysfunction
研究组 & 干预措施
Bone Conduction Implant
Experimental
All subjects will be implanted with the bone conduction implant.
干预措施: BONEBRIDGE (Device)
结局指标
主要结局
Number and Proportion of Subjects Experiencing Device Related Adverse Events
时间窗: Up to three (3 months) post activation
Adverse events will be collected and reported throughout the duration of the study.
Percentage Change in AZ Bio Sentence Score in Noise
时间窗: Baseline and 3 months post activation
Percent improvement in AZ Bio sentence in noise scores will be compared from baseline to 3 months post activation.
次要结局
- Number of Subjects With Stable or Better Soundfield Thresholds(Baseline and 3 months post activation)
- Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance(Baseline and 3 months post activation)
- Percentage Change in CNC Word Score(Baseline and 3 months post activation)
- Number of Subjects With Stable Unaided Bone Conduction Thresholds(Baseline and 2 weeks post surgery)
研究者
研究点 (3)
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