Actively Recruiting
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Led by Cochlear · Updated on 2025-09-02
60
Participants Needed
8
Research Sites
249 weeks
Total Duration
On this page
Sponsors
C
Cochlear
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals 18 years or older (Group A)
- Severe sensorineural hearing loss in the ear to be implanted defined as pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL and aided CNC score 5%
- Normal or near normal hearing in the other ear defined as an average of 0.5, 1, 2, 4 kHz 30 dB HL
- Children aged 5 years to 17 years, 11 months (Group B)
- Previous experience with a current conventional treatment option for unilateral hearing loss (HA, bone-conduction device, or CROS technology), or a minimum two-week trial if no previous experience
- English spoken as a primary language
- Willing and able to provide written informed consent
You will not qualify if you...
- Ossification, abnormal cochlear nerve, or other cochlear anomalies preventing complete electrode insertion
- Previous cochlear implantation
- Hearing loss of neural or central origin, including auditory neuropathy
- Duration of profound sensorineural hearing loss longer than 10 years
- Active or chronic middle-ear infection; conductive hearing loss in either ear
- Medical or psychological conditions contraindicating surgery
- Unrealistic expectations about benefits, risks, and limitations
- Evidence or suspicion of cognitive or developmental concerns
- Unable or unwilling to comply with study requirements
- Investigator site personnel or their immediate family members
- Cochlear employees or employees of Contract Research Organizations or contractors involved in this study
- Pregnant or breastfeeding women
- Currently participating or recently participated in another interventional clinical trial within the last 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
2
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
Actively Recruiting
3
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
New York Eye and Ear Infirmary
New York, New York, United States, 10003
Actively Recruiting
5
University of North Carolina
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
6
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Withdrawn
7
University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
Dallas, Texas, United States, 75390
Withdrawn
8
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
P
PRS Specialist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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