An Early Feasibility, Prospective, Exploratory Study Investigating the Use of Objective Measures to Inform Focused Multipolar Fitting in Adult Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.
研究概览
简要总结
The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.
详细描述
This study will compare various objective and behavioural fitting methods for the programming of Focused Multipolar Stimulation. Fitting methods will be assessed for both performance and clinician-rated experience to determine the most practical and beneficial method to balance ease of fitting and performance. Focused Multipolar Stimulation (FMS) is an alternative to the standard of care Monopolar Stimulation (MP). FMS may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical improvement over MP stimulation.
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
- •Moderately severe to profound sensorineural hearing loss in both ears. (i.e., >55 dB HL pure-tone average loss)
- •Candidate for unilateral cochlear implantation according to locally approved criteria.
- •Aged 18 years or over.
- •Fluent speaker in the language used to assess speech perception performance.
- •Willing and able to provide written informed consent.
排除标准
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- •Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- •Pregnant at the time of surgery.
- •Prisoners, or anyone in custody.
- •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
- •Previous or existing cochlear-implant recipient.
- •Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
- •Duration of severe to profound hearing loss >20 years in the ear to be implanted.
- •Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
- •Diagnosis of auditory neuropathy.
- •Deafness due to lesions of the acoustic nerve or central auditory pathway.
- •Additional handicaps that would prevent or restrict participation in the audiological evaluations.
- •Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
研究组 & 干预措施
Adult Cochlear Implant
Adult cochlear implant recipients receiving different focused multipolar maps that are programmed using either behavioural or objective methods
干预措施: The Phoenix Research System (Device)
结局指标
主要结局
Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.
时间窗: 6 months
Difference in speech reception threshold (SRT) between objectively fit and behaviourally fit maps using the Spanish Hearing in Noise Test (HINT) to measure the SRT, reported as a signal-to-noise ratio for 50% correct score.
次要结局
未报告次要终点