Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a Prospective Multicenter Longitudinal Study Over 60-months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Tonal audiometry
研究概览
简要总结
Vibrant Soundbridge (VSB, MED-EL, Innsbruck) Active middle ear implants (AMEI) can benefit patients who are unable to use conventional hearing aids (HA) due to medical reasons, discomfort or unsuccessful rehabilitation. Long-term prospective longitudinal studies are lacking on the VSB notably for conductive and mixed hearing loss. The main aim of the present study was to prospectively assess aided hearing benefits in a 60-month, long-term study including conductive and mixed hearing loss adults implanted with the VSB. The secondary objective was to compare the hearing results according to the Floating Mass Transducer (FMT) site (Round/oval window (RW/OW) vs incus/stapes) and the type of pathology responsible for the hearing loss (Inflammatory vs non-inflammatory disease, ID vs NID).
详细描述
Introduction:
Active middle ear implants (AMEI) can benefit patients who are unable to use conventional hearing aids (HA) due to medical reasons, discomfort or unsuccessful rehabilitation.
AMEIs provide more hearing gain and consistency compared to middle ear surgery plus conventional hearing aids. Coletti et al. (2013) reported on long-term outcomes of patients implanted at the round window (RW) with the VSB. Brkic et al. (2019) presented a large number of subjects (n = 23) with a 20-year follow-up. The limitations of these studies were their retrospective design.
The best location for the surgeon to place the VSB's floating mass transducer (FMT) depends on various factors. A meta-analysis showed the hearing results at different FMT sites to be similar. None of these studies compared a FMT placed to a FMT clipped.
The impact of the etiology of deafness on a patient's outcome with an AMEI has been poorly studied. Only one study has shown that the difference between inflammatory disease (ID) and non-inflammatory disease (NID) groups was not significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adult patient (>= 18 years old) speaking French
- •with mixed hearing loss on at least one side
- •with a maximum bone conduction (BC) threshold of 45 dB hearing level (HL) at 500 Hz, 50 dB HL at 1000 Hz, 55 dB HL at 1500 Hz, and 60 dB HL at 2000 Hz.
- •with a 20 dB minimum air-bone gap (defined as the difference between bone- and air conduction thresholds).
- •with stable BC thresholds over the previous 24 months, and no sufficient benefit with the HA.
排除标准
- •fluctuating hearing loss,
- •cutaneous disease
- •subjects who need an MRI.
研究组 & 干预措施
VSB arm
longitudinal follow-up of VSB users preoperatively and at 1, 3, 6, 12 and 60 months post-implantation.
干预措施: Vibrant Soundbridge active middle ear implant (Device)
结局指标
主要结局
Tonal audiometry
时间窗: at 60 months post-implantation
Pure-tone audiograms
Tonal audiometry
时间窗: preoperatively
Pure-tone audiograms
Tonal audiometry
时间窗: at 1 month post-implantation
Pure-tone audiograms
Tonal audiometry
时间窗: at 3 months post-implantation
Pure-tone audiograms
Tonal audiometry
时间窗: at 6 months post-implantation
Pure-tone audiograms
Tonal audiometry
时间窗: at 12 months post-implantation
Pure-tone audiograms
次要结局
- Speech reception threshold(at 60 months post-implantation)
- Word recognition in quiet(at 60 months post-implantation)
- Word recognition in noise(at 60 months post-implantation)
- Word recognition in noise(at 1 month post-implantation)
- Word recognition in quiet(preoperatively)
- Word recognition in quiet(at 1 month post-implantation)
- Word recognition in quiet(at 3 months post-implantation)
- Word recognition in quiet(at 6 months post-implantation)
- Word recognition in quiet(at 12 months post-implantation)
- Word recognition in noise(preoperatively)
- Speech reception threshold(at 1 month post-implantation)
- Word recognition in noise(at 3 months post-implantation)
- Word recognition in noise(at 6 months post-implantation)
- Word recognition in noise(at 12 months post-implantation)
- Speech reception threshold(preoperatively)
- Speech reception threshold(at 3 months post-implantation)
- Speech reception threshold(at 6 months post-implantation)
- Speech reception threshold(at 12 months post-implantation)