NCT05318417NARecruiting
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Cochlear
Start Date
8/19/2022
Completion Date
6/1/2027
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.
Eligibility Criteria
Age Range: 5 years to No maximum
Inclusion Criteria:
• 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
Exclusion Criteria:
* 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.
Interventions
DEVICE
The Cochlear™ Nucleus® Cochlear Implant (CI) System
Conditions
Hearing Loss, UnilateralDeafness, Unilateral
Locations
Stanford University
Palo Alto, California 94304
United States
Rocky Mountain Ear Center
Englewood, Colorado 80113
United States
University of Iowa
Iowa City, Iowa 52242
United States
New York Eye and Ear Infirmary
New York, New York 10003
United States
University of North Carolina
Chapel Hill, North Carolina 27517
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
Dallas, Texas 75390
United States
Virginia Mason Medical Center
Seattle, Washington 98101
United States