RecruitingHearing Loss, UnilateralDeafness, Unilateral
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Eligible age
5+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Cochlear
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
California
Palo Alto
Colorado
Englewood
Iowa
Iowa City
New York
New York
North Carolina
Chapel Hill
Ohio
Columbus
Texas
Dallas
Washington
Seattle
Source: ClinicalTrials.gov · NCT05318417 · last updated 2025-09-02