Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

NACompletedINTERVENTIONAL
Enrollment

247

Participants

Timeline

Start Date

June 17, 2019

Primary Completion Date

November 1, 2023

Study Completion Date

November 1, 2023

Conditions
Hearing Loss, Sensorineural
Interventions
DEVICE

MED-EL SYNCHRONY PIN Cochlear Implant

Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors.

OTHER

Cochlear Implant

Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.

Trial Locations (8)

27514

University of North Carolina Hospitals, Chapel Hill

33136

University of Miami Health System, Miami

39216

University of Mississippi Medical Center, Jackson

53226

Medical College of Wisconsin, Milwaukee

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

75019

ENT for Children, Coppell

94609

UCSF Benioff Children's Hospital Oakland, Oakland

97239-3098

Oregon Health and Sciences University, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Med-El Corporation

INDUSTRY

NCT03900897 - Expanded Indications in the MED-EL Pediatric Cochlear Implant Population | Biotech Hunter | Biotech Hunter