Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 19, 2022

Primary Completion Date

May 31, 2027

Study Completion Date

June 30, 2027

Conditions
Hearing Loss, UnilateralDeafness, Unilateral
Interventions
DEVICE

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®."

Trial Locations (8)

10003

RECRUITING

New York Eye and Ear Infirmary, New York

27517

RECRUITING

University of North Carolina, Chapel Hill

43205

WITHDRAWN

Nationwide Children's Hospital, Columbus

52242

RECRUITING

University of Iowa, Iowa City

75390

WITHDRAWN

University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery, Dallas

80113

RECRUITING

Rocky Mountain Ear Center, Englewood

94304

RECRUITING

Stanford University, Palo Alto

98101

RECRUITING

Virginia Mason Medical Center, Seattle

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

NAMSA

OTHER

lead

Cochlear

INDUSTRY

NCT05318417 - Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness | Biotech Hunter | Biotech Hunter