Status:
RECRUITING
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Lead Sponsor:
Cochlear
Collaborating Sponsors:
NAMSA
Conditions:
Hearing Loss, Unilateral
Deafness, Unilateral
Eligibility:
All Genders
5+ years
Phase:
NA
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) suppo...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
August 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05318417
Start Date
August 19 2022
End Date
June 1 2027
Last Update
September 2 2025
Active Locations (8)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
New York Eye and Ear Infirmary
New York, New York, United States, 10003