Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 6
- 主要终点
- Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array
研究概览
简要总结
The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.
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
- •No previous cochlear implant experience
- •18 years of age or older
- •Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the ear to be implanted
- •Aided monosyllabic word score of 10-50% in the ear to be implanted
- •Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
- •English language proficiency
- •Willingness to participate in all scheduled procedures outlined in the protocol
排除标准
- •Previous inner ear surgery
- •Cochlear malformation or obstruction that would preclude full insertion of electrode array
- •Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
- •Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
- •Evidence of central auditory lesion or compromised auditory nerve
研究组 & 干预措施
HiRes90K™ Advantage Cochlear Implant
HiRes90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies.
干预措施: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode (Device)
结局指标
主要结局
Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array
时间窗: One month
Unaided low-frequency acoustic hearing thresholds (under earphones) in the implanted ear one month after device activation will be compared to baseline (pre-implant) thresholds in the same ear for audiometric frequencies 125-1000Hz. Threshold changes from baseline will be calculated as: * Complete preservation of hearing: threshold shift ≤ 15 dB * Partial preservation of hearing: threshold shift ≥ 16 dB with measurable thresholds * No preservation of hearing: no measurable thresholds at ≤ 80 dB HL
次要结局
- Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array(One month)