Pilot Study Evaluating Surgical Optimizing of a Middle Ear Implant (MET )With Laser Velocimetry in Patients With Moderate to Severe Hearing Loss in Case of Failure of Conventional Equipment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 主要终点
- Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry
研究概览
简要总结
The aging of the population, and greater exposure to noise, are responsible for an increased incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that has become a real public health problem. The main means of rehabilitation of this disability is represented by the apparatus of patients with conventional hearing aids. However, these hearing aids have several drawbacks that limit their profits, often abandoning the prosthesis by the patient.
Middle ear implants were developed to answer these problems. They are intended to amplify the sound signal by transmitting directly to the middle ear to compensate for the hearing loss and are indicated in case of failure or contraindication of conventional equipment. However, these middle ear implants currently have limitations as performance failure. Recent data show that the performance of the ossicles repair techniques are dependent on the coupling of the ossicular prosthesis to the ossicles. Furthermore, advances in the understanding of the biomechanics of the ossicles confirm the importance of the placement and linkage of surgical restoration processes. This data can be applied to middle ear implants to improve performance. Indeed, a preliminary experimental study on anatomical parts, using analysis of the vibration of the middle ear structures by laser velocimetry, allowed the investigators to define the transducer placement method and coupling method to ossicles.
Investigators wish to validate in vivo results in a pilot study on a small number of patients by comparing two surgical techniques guided by velocimetric measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age between 18 to 60 years;
- •Having given written informed consent prior to any procedure related to the study;
- •Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
- •Indication and IOM implantation request by the patient with a patient physically, psychologically and legally able to ask its implementation
- •Average deafness to severe (mean thresholds between 40 to 90 dB) with speech discrimination> 40% to 75 dB.
- •Deafness of pure perception or mixed hearing loss
- •Non-fluctuating deafness over the last two years
- •Failed or cons-indication to conventional equipment
- •Rocky Scanner and MRI normal brain
- •Patient fluent in French (to ensure validity audiological measures
排除标准
- •Pregnant women or likely to be during the study.
- •Not affiliated with a social security scheme Patients
- •Major Patients protected by provisions of the law (Public Health Code).
- •Refusal of consent.
- •Ongoing Participation in another study that may interfere with the proposed study (investigator assessment).
- •Existence of a cons-indication for surgery or port of the implant
- •Motivation only aesthetic, evaluated by the principal investigator.
- •Inability of predictable medium-term monitoring.
- •Acoustic neuroma, tumors and other evolutionary processes of the rock and the cerebellopontine angle.
- •Pathology requiring follow-up MRI (IOM against-indicating MRI).
- •Patient with against-indication to MRI.
- •Contraindication to the establishment of a pacemaker ossicular MET
结局指标
主要结局
Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry
时间窗: at baseline (day 0) and 8 months
The hearing will be measured by tone and speech audiometry in silence and in noise (dB) Results will be averaged per patient.
次要结局
- Change in the quality of life measured by SSQ (Speech Saptial Qualiteies) score(day 0, and 2, 3, 5, 8 and 14 months.)
- Number of surgical implantation performed for the surgical laser velocimetry optimization technique(at 14 months)
- Middle ear transfer function measured by laser velocimetry(pre-operatively at day 0 and then at 2, 3, 8 and 14 months.)
- Change in the quality of life measured by GHSI (Glasgow Health Status Inventory) score(day 0, and 2, 3, 5, 8 and 14 months.)
- Change in the quality of life measured by GBI (Glasgow Benefit Inventory) score(day 0, and 2, 3, 5, 8 and 14 months.)
- description of adverse events throughout the study(pre and post-operatively at day 0, at day 4, day 8 and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.)
- Change in the quality of life measured by APHAB ( Abbreviated Profile of Hearing Aid Benefit) score(day 0, and 2, 3, 5, 8 and 14 months.)
- Tone and speech audiometry in silence and in noise (dB)(Baseline at inclusion visit, day 0, and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.)