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Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss

NCT02963974 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-06

Study results available
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Summary

This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.

Conditions

  • Hearing Loss, Unilateral

Interventions

DEVICE

Cochlear implant

Implantation

Sponsors & Collaborators

  • Med-El Corporation

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Kevin D Brown, MD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
42 Months
Max Age
78 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2021-05-07
Completion
2021-05-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02963974 on ClinicalTrials.gov