Feasibility Study: A Totally Implantable Cochlear Implant (Mi2000) for Electrical Stimulation of the Auditory Pathway of Adults With Severe to Profound Sensorineural Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Safety of the study device
研究概览
简要总结
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
详细描述
Cochlear implants (CI) provide a large majority of recipients with a significant degree of speech understanding. However, CI systems rely on external parts, namely Behind-the-Ear (BTE) audio processors with coils or single-unit processors to function. This can have several disadvantages: for instance, the hardware is exposed to external trauma and to the effects of head movement and gravity. The device is also put at risk by humid, dusty, or dirty conditions as well as by physical activities that lead to water exposure such as swimming or sports in general (e.g. perspiration).
In addition, some patients are concerned with the cosmetic appearance of the external parts which are visible (more so than modern behind-the-ear hearing aids), something that may not be desirable to many potential candidates.
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Minimum age of eighteen (18) years at time of enrolment
- •Bilateral sensorineural hearing loss with no or limited benefit from a hearing aid (>70 dB HL PTA4)
- •Post-lingual onset of deafness
- •No or limited benefit from hearing aids for less than 10 years.
- •A maximum score of 50% on a monosyllables test in the language of the test centre in the ear to be implanted
- •General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study and realistic expectations, as deemed appropriate by the implanting surgeon/implant board
- •Fluency in the test language with excellent proficiency, as appropriate to perform speech testing
- •Evidence of up-to-date vaccinations against meningitis, as per recommendations by the applicable national body
- •Signed and dated informed consent before the start of any study-specific procedure
排除标准
- •Lack of compliance with any inclusion criterion
- •Previously having received an implant on the location chosen for placing the cochlear implant
- •Having received a hearing implant from another manufacturer than MED-EL on the contralateral ear
- •Pre-existing condition known to necessitate MRI scans after implantation of the Mi2000
- •Women being pregnant or nursing
- •Women of child-bearing age not reporting to use effective contraception
- •Contraindication to surgery in the middle and inner ear
- •Contraindication to general anaesthesia
- •Cochlear malformations, ossification or other obliteration of the cochlea, history of meningitis preventing placement of the electrode array, as confirmed by medical examination
- •Acute cholesteatoma
- •Acute external or middle ear infections
- •Perforated tympanic membrane
- •Known intolerance to any of the materials used for the implant or accessories
- •Non-functional auditory nerve and/or upper auditory pathway including a history of vestibular schwannoma
- •Factors preventing appropriate placement of the stimulator housing and the microphone, including fixation with screws, in the bone of the skull
- •Unstable Meniere's disease, Auditory Neuropathy, Epilepsy not responding to treatment
- •Unrealistic expectations of the subject
- •Permanent inability and/or unwillingness to participation in post-operative care and rehabilitation
- •Known intellectual disability and/or psychological diseases
- •Participation in other pharmacological clinical trials within four weeks prior to enrolment
结局指标
主要结局
Safety of the study device
时间窗: up to 16 weeks
Safety of the study device in the intended population will be assessed by an analysis of adverse events (AEs) reported
次要结局
- Safety of the study device(up to 52 weeks)
- Speech perception in noise(up to 52 weeks)
- Audiograms(up to 52 weeks)
- Hardware and device parameters stored in the internal memory(up to 52 weeks)
- Speech perception in quiet(up to 52 weeks)
- Auditory Nerve Response Telemetry (ART)(up to 52 weeks)
- Nijmegen Cochlear Implant Questionnaire (NCIQ)(up to 52 weeks)
- Impedance Field Telemetry(up to 52 weeks)
- Questionnaire on usability of the device(up to 52 weeks)
- Health Utilities Index 2/3 (HUI2/3)(up to 52 weeks)
- Sound quality ratings(up to 52 weeks)
- Speech, Spatial and Qualities of Hearing (12 item version) (SSQ12)(up to 52 weeks)