Evaluation of the Benefits of Bilateral Fitting in Bone-anchored Hearing System Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Minimum Audible Angle test
研究概览
简要总结
The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition) will not only improve localization abilities, but it will also increase the ability to retain words in working memory, compared to performance with only one BAHS (unilateral condition).
详细描述
The patients included in this study are adult patients with a bilateral conductive or mixed hearing loss, that are already bilaterally implanted with two percutaneous bone-anchored devices (BAHS). The study consists of two visits. At visit 1, the patients are fitted unilaterally and bilaterally with the investigational device (Ponto 3 SuperPower). After fitting, the patients perform a test of spatial resolution (minimum audible angle, visit 1) and an auditory working memory test (visit 2). These two outcome measures are conducted in the laboratory using the Ponto 3 SuperPower unilaterally and bilaterally. Additionally, the patients fill in a questionnaire (SSQ12) to report perceived performance in their everyday life with their own devices. This is a post market study and all products used are CE marked and used in clinical practice worldwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The participants are blinded to the tested condition (unilateral vs bilateral)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult BAHS users, minimum 18 years and maximum 75 years.
- •Native English speakers.
- •Patients that are already bilaterally implanted.
- •Patients with a bilateral conductive or mixed conductive-sensorineural hearing loss.
- •Experience with bilateral Ponto of at least 6 months.
- •Patients that are using both their sound processors daily.
- •PTA BC (at 0.5, 1, 2, 3 kHz) on both sides lower or equal to 65 dB HL.
- •If the masked BC is available on the patient's journal, the average difference in masked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
- •If the masked BC is not available on the patient's journal, the average difference in unmasked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
排除标准
- •Not deemed suited by the principal investigator.
- •If the physician assesses that the patient is not fit for trial participation at any stage.
- •Audiogram at 1st visit shows too large masked BC thresholds (PTA BC - at 0.5, 1, 2, 3 kHz - on either side larger than 65 dB HL).
- •Audiogram at 1st visit shows asymmetric masked BC thresholds (average difference in masked BC - at 0.5, 1, 2, 4 kHz - between L and R ear larger or equal to 15 dB).
结局指标
主要结局
Minimum Audible Angle test
时间窗: 4 months
Minimum angle at which noise bursts are accurately localized (Right/Left) in the unilateral and bilateral conditions
次要结局
- SWIR test(4 months)
- SSQ12(4 months)