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NCT00747435 · ClinicalTrials.gov registry record · NA

Safety and Effectiveness of the MED-EL Electric-Acoustic System

A NA study of Hearing Loss, sponsored by Med-El Corporation.

Completed
Registry status
NA
Development phase
73
Enrollment target
14
Study locations

NCT00747435 is a NA study of Hearing Loss that has completed, run by Med-El Corporation. The registered enrollment target is 73 participants, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The trial reports 14 study locations across 13 states.

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The verdict

NCT00747435, a NA study of Hearing Loss, has completed, sponsored by Med-El Corporation.

COMPLETED
Registry status
NA
Development phase
73 participants
Enrollment target
14
Study locations

Study Summary

The purpose of this investigation is to demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear implant with an external electric-acoustic processor designed to provide benefit in speech perception and sound quality to individuals with a sensorineural hearing loss with minimal changes in residual hearing. The acoustic component of the processor will aid residual acoustic hearing in low frequency ranges, while the cochlear implant and electric component of the processor will be used to electrically stimulate the auditory nerve across a wide range of frequencies necessary for speech perception.

Conditions Studied

Hearing Loss

Interventions

  • DEVICE Electric Acoustic System

Study Locations (14)

North Carolina

  • University of North Carolina Hospital - Chapel Hill
  • Duke University Medical Center - Durham

California

  • Stanford University Medical Center - Stanford

Florida

  • University of Miami - Miami

Indiana

  • Indiana University School of Medicine - Indianapolis

Kansas

  • University of Kansas Medical Center - Kansas City

Michigan

  • University of Michigan - Ann Arbor

Nebraska

  • Boys Town - Omaha

New York

  • New York Eye & Ear - New York

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2007-02
Est. Completion 2016-02
Phase NA

Sponsor

Med-El Corporation

14 total trials

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What the Registry Record Tells You About NCT00747435

The ClinicalTrials.gov registry entry for NCT00747435 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The listed sponsor is Med-El Corporation, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hearing Loss appearing as the primary indexed condition, and to 1 intervention - of which Electric Acoustic System is the first listed.

NCT00747435 reports 14 study locations spanning 13 distinct geographic areas - top geographies include North Carolina, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00747435 about?

NCT00747435 is a clinical study titled "Safety and Effectiveness of the MED-EL Electric-Acoustic System". The purpose of this investigation is to demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear implant with an external electric-acoustic processor designed to provide benefit in speech perception and sound quality ...

What is the current status of trial NCT00747435?

This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2007-02. Estimated completion is 2016-02.

What conditions does trial NCT00747435 study?

This clinical trial studies the following conditions: Hearing Loss.

What interventions are being tested in trial NCT00747435?

The interventions under investigation include: Electric Acoustic System (DEVICE).

Who is sponsoring clinical trial NCT00747435?

This trial is sponsored by Med-El Corporation, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00747435 being conducted?

This trial has 14 study locations across California, Florida, Indiana, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.