NCT07139327进行中（未招募）不适用
A Pre-market, Prospective, Interventional, Multicenter, Pivotal Study to Evaluate Efficacy and Safety of a Totally Implantable Cochlear Implant System in an Adult Population With Sensorineural Hearing Loss
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Cochlear
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Speech recognition performance in quiet
研究概览
简要总结
This clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment allowing the option to hear without the need of an external sound processor. This implant will be tested in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Individuals aged 18 years and older at time of consent.
- •Clinically established post-linguistic moderately severe to profound sensorineural hearing loss (PTA4 of >55 dB HL), in the ear to be implanted.
- •Meets local candidacy criteria for cochlear implantation.
- •Compromised functional hearing with a hearing aid in the ear to be implanted, as determined by the investigator.
- •Willing to undergo unilateral cochlear implantation.
- •Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator
- •Direct access to a compatible Smart Phone.
- •Willing and able to provide written informed consent.
排除标准
- •Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
- •Candidates with single-sided deafness as determined by the investigator.
- •Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
- •Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
- •Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
- •Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.
- •Cochlear ossification, cochlear malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.
- •Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.
- •Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the participant.
- •Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported by the participant, in the ear to be implanted.
- •Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the investigator.
- •Preexisting skin condition that could jeopardize wound healing, as determined by the investigator e.g., psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.
- •Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.
- •Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
- •Women who are pregnant.
- •Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child or sibling.
- •Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of the investigation.
- •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
研究组 & 干预措施
TICI G2 Clinical Investigation System
Experimental
Participants will be implanted with the TICI G2 Implant
干预措施: Cochlear Implant (Device)
结局指标
主要结局
Speech recognition performance in quiet
时间窗: Preimplantation to 6 months post-activation
Percent correct word score from preimplantation to post-activation
Incidence of adverse events and device deficiencies
时间窗: Implantation to 6 and 12 months post-activation
Frequency and severity of device and procedure-related adverse events, including device deficiencies
次要结局
- Speech Spatial Qualities questionnaire (SSQ-12)(Preimplantation to 12 months post-activation)
- Cochlear Implant Quality of Life Profile (CIQOL-35)(Preimplantation to 12-months post-activation)
- Health Utilities Index (HUI 2/3)(Preimplantation to 12 months post-activation)
- Living with Cochlear Implants Questionnaire (LivCI)(Preimplantation to 12 months post-activation)
- Short Form (SF)-36 Health Survey(8 to 10 months post-activation)
- Speech recognition in quiet and noise(Preimplantation to 12 months post-activation)
- Speech recognition in quiet and noise(Preimplantation to 12 months post-activation)
- Speech Spatial Qualities questionnaire (SSQ-12)(Preimplantation to 12 months post-activation)
- Cochlear Implant Quality of Life Profile (CIQOL-35)(Preimplantation to 12-months post-activation)
- Health Utilities Index (HUI 2/3)(Preimplantation to 12 months post-activation)
- Living with Cochlear Implants Questionnaire (LivCI)(Preimplantation to 12 months post-activation)
- Patient Satisfaction Survey(6 to 12 months post-activation)
- Short Form (SF)-36 Health Survey(8 to 10 months post-activation)
- Time on air(Initial activation to 12 months post-activation)
研究者
研究点 (8)
Loading locations...
相似试验
进行中（未招募）
不适用
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing LossHearing Loss, Bilateral or UnilateralHearing Loss, SensorineuralHearing Loss, CochlearNCT06642935Cochlear18
招募中
不适用
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided DeafnessHearing Loss, UnilateralDeafness, UnilateralNCT05318417Cochlear60
已完成
不适用
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activationHearing LossNCT05709223Cochlear17
已完成
不适用
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.Sensorineural Hearing Loss, BilateralCochlear ImplantsNCT04571333MED-EL Elektromedizinische Geräte GesmbH6
已完成
不适用
Clinical Trials of Implantable Medical device to address Disabled Hearing Loss.CTRI/2021/11/038186HCL TECHNOLOGIES LIMITED3