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Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

NCT03900897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2024-10-15

No results posted yet for this study

Summary

The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.

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.

Sponsors & Collaborators

  • Med-El Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2023-11-01
Completion
2023-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03900897 on ClinicalTrials.gov