Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
NCT ID: NCT05318417
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-08-19
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Children and adults with unilateral hearing loss/single-sided deafness
The Cochlear™ Nucleus® Cochlear Implant (CI) System
The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components.
Implanted component:
The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear.
External components:
The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.
Interventions
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The Cochlear™ Nucleus® Cochlear Implant (CI) System
The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components.
Implanted component:
The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear.
External components:
The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
5 Years
ALL
No
Sponsors
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NAMSA
OTHER
Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Jillian Crosson
Role: STUDY_DIRECTOR
Cochlear
Locations
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Stanford University
Palo Alto, California, United States
Rocky Mountain Ear Center
Englewood, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
New York Eye and Ear Infirmary
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, 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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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CAM5816
Identifier Type: -
Identifier Source: org_study_id
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