Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 11
- 主要终点
- Unaided Pure-tone Average (PTA) Hearing Threshold Measurements
研究概览
简要总结
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Newly Implanted Group:
- •Ability to provide informed consent
- •No previous cochlear implant experience in either ear
- •18 years of age or older
- •Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB 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, 3000, 4,000, and 8,000 Hz) in the ear to be implanted
- •Aided CNC word recognition score up to 50% in ear to be implanted
- •Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB 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, 3000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
- •Aided CNC word recognition score up to 80% in the contralateral ear
- •English language proficiency
- •Willingness to use an ear-level sound processor postoperatively for the duration of the study trial
- •Willingness to participate in all scheduled procedures outlined in the protocol
排除标准
- •Newly Implanted Group:
- •Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or more in range of 500-1000 Hz in the ear to be implanted
- •Congenital hearing loss (for purpose of this study, onset prior to age 2 years*). *Based on critical period for speech and language development
- •Duration greater than 30 years of severe-to-profound high-frequency hearing loss
- •Cochlear malformation or obstruction that would preclude full insertion of electrode array in the ear to be implanted
- •Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
- •Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
- •Active middle-ear disease/infection in the ear to be implanted
- •Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator
- •Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
- •EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups
- •Ability to provide informed consent
- •18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor (i.e. Naída family device)
- •Postoperative unaided low frequency audiometric hearing thresholds in the treated ear up to 80 dB HL for at least one frequency from 125 - 1000 Hz
- •English Language Proficiency
- •Willingness to participate in all scheduled procedures outlined in the study protocol
- •EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups
- •Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix® and HiFocus™ 1j electrode
- •Exclusive use of a body worn external sound processor
- •Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear
- •Postoperative unaided low frequency audiometric hearing thresholds in the treated ear exceeding 80 dB HL at each frequency from 125 - 1000 Hz Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
研究组 & 干预措施
Newly Implanted Group
HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor.
干预措施: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode (Device)
Newly Implanted Group
HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor.
干预措施: EAS sound processor (Device)
Existing Implanted Group
Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.
干预措施: EAS sound processor (Device)
EAS Extended Use Arm
Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in either the Newly Implanted Group or Existing Implanted Group.
干预措施: EAS sound processor (Device)
结局指标
主要结局
Unaided Pure-tone Average (PTA) Hearing Threshold Measurements
时间窗: Twelve months post device activation
Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet
时间窗: Up to 12 months post device activation
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Speech Perception Testing (AzBio) in Noise.
时间窗: up to 12 months post device activation
Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
次要结局
未报告次要终点