NCT01807559Unknown不适用
SoundBite Hearing System 24 Month Multi Site Patient Use Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 7
- 主要终点
- Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
研究概览
简要总结
The objective of this multi-site observational study is to further assess the long-term patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi Site Study (Protocol CLN006) for an additional 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects who previously were enrolled in SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN006) and completed the 12 month study visit.
- •Additionally, subjects must meet one of the two criteria for hearing loss:
- •Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.
- •Conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL.
排除标准
- •Subjects that do not meet one of the two the audiometric criteria as measured on the audiogram for the 12 month study appointment for Protocol CLN006:
- •A moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or -SSD‖). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.
- •Patients with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL
- •The SoundBite Hearing System and all portions of it are contraindicated for use in an MRI Environment and should be removed prior to MRI exposure
- •The SoundBite Hearing System is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers.
- •The SoundBite Hearing system is contraindicated for vulnerable populations that are unable to use their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.
结局指标
主要结局
Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
时间窗: 24 Months
Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A- New Formate, Hearing Aid Research Lab, University of Memphis, 1994) score at 24 months compared to baseline.
次要结局
- Aided Threshold Testing(24 Months)
研究者
研究点 (7)
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