Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
- Conditions
- Hearing Loss, UnilateralDeafness, Unilateral
- Interventions
- Device: The Cochlear™ Nucleus® Cochlear Implant (CI) System
- Registration Number
- NCT05318417
- Lead Sponsor
- Cochlear
- Brief Summary
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
• Individuals 18 years or older (Group A)
Ear to be Implanted:
Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and
Normal Hearing Ear:
Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL
• Children 5 years to 17 years, 11 months (Group B)
Ear to be Implanted:
Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and
Normal Hearing Ear:
Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL
- Previous experience with a current conventional treatment option for unilateral [SSD] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required
- English spoken as a primary language
- Willing and able to provide written informed consent
- Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Previous cochlear implantation
- Hearing loss of neural or central origin, including auditory neuropathy
- Duration of profound sensorineural HL >10 years per self-report
- Active / chronic middle-ear infection; conductive HL in either ear
- Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
- Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
- Evidence of and/or suspected cognitive or developmental concern
- 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 Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation
- Pregnant or breastfeeding women
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Children and adults with unilateral hearing loss/single-sided deafness The Cochlear™ Nucleus® Cochlear Implant (CI) System -
- Primary Outcome Measures
Name Time Method Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations. pre-implantation, 12 months post-activation Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear.
Number of procedure and device related adverse events classified by type, frequency and severity. 36 months post-activation
- Secondary Outcome Measures
Name Time Method Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone. pre-implantation, 12 months post-activation Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better.
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings. pre-implantation, 12 months post-activation Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities.
Trial Locations
- Locations (8)
New York Eye and Ear Infirmary
🇺🇸New York, New York, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Stanford University
🇺🇸Palo Alto, California, United States
Rocky Mountain Ear Center
🇺🇸Englewood, Colorado, United States
University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
🇺🇸Dallas, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States