BC109 - Investigation of an Updated Bone-anchored Sound Processor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.
研究概览
简要总结
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor.
The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.
详细描述
The investigation is a premarket investigation with the purpose of gathering knowledge on the performance of an updated sound processor compared to the CE marked Ponto 3 SuperPower sound processor to establish marketing claim(s) on the updated sound processor.
The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 3 SuperPower sound processor as a minimum three month prior to the study. 12-15 adult Ponto 3 SuperPower users with a conductive, mixed hearing loss or single-sided deafness will be included.
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. The study includes four laboratory visits and three field trial periods. After the first trial period, which is included to ensure a homogenous baseline, the study is designed as a two-period, two-sequence crossover trial to compare the two sound processors (Device A & Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.
This study is designed to combine audiological assessments (hearing and speech tests) in the laboratory and subjective self-reported outcomes collected during and after field trial periods with the investigational device and the comparator device (Ponto 3 SuperPower). The primary outcome of this study is to demonstrate that Open Sound Navigator in the updated sound processor provides subjects with improved speech recognition in noise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The participants are blinded to the tested conditions in the lab, used for assessment of the primary objective, but the participants are not blinded to the sound processors used during the three trial periods, due to different appearance of the sound processors, making it possible to distinguish between the sound processors.
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 using a Ponto 3 SuperPower on Oticon Medical compatible abutment
- •Experienced BAHS users with a minimum experience of 3 months.
- •Subjects with:
- •conductive or mixed hearing loss with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 65 dB HL as measured in situ with Ponto 3 SuperPower at Visit
- •OR subjects who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) as reported in the patient's Noah file.
- •OR subjects who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS (as per investigator discretion).
- •Fluent in Danish
排除标准
- •Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
- •Known abnormally progressive BC hearing loss as judged by the investigator
- •Subjects with known mixed losses where the sensorineural part of the hearing loss is of retro-cochlear or central origin
- •Participation in another clinical investigation which might cause interference with study participation.
- •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.
结局指标
主要结局
To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.
时间窗: 4 weeks or 6 weeks
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between OSN OFF and OSN ON after field trial with Device A (incl. automatics).
次要结局
- To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL(Baseline)
- To assess the improvement in speech recognition in noise with Device B in full directional settings as compared to omnidirectional.(4 weeks or 6 weeks)
- To assess the improvement of hearing with Device A.(Baseline)
- To assess the preference of BAHS sound processor.(6 weeks)
- To assess the difference in BC thresholds as measured in-situ with Device A and via conventional BC audiometry.(Baseline and 2 weeks)
- To assess performance in speech recognition in noise with Device A and Device B in Omni settings.(Baseline)
- To assess self-reported ratings of sound quality, speech intelligibility, and overall performance with Device A and Device B.(1 week, 4 weeks and 6 weeks)
- To assess the improvement in speech recognition with Device A in quiet.(2 weeks)
- To compare the improvement in speech recognition in noise with OSN ON in Device A (re Omni) with the improvement of full directionality in Device B (re Omni).(4 weeks or 6 weeks)
- To assess the difference in BC thresholds as measured in-situ with Device A and Device B.(Baseline)
- To assess self-reported performance with Device A and Device B.(4 weeks or 6 weeks)
- To confirm the safety profile of the Device A in terms of the occurrence of adverse events and serious adverse events.(1 week, 2 weeks, 4 weeks and 6 weeks)