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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: Completed NA study of Hearing Loss, sponsored by Med-El Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2007-02 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT00747435 record still lists
NCT00747435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower).
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 lists 14 locations in 13 states (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.
Learn More About Clinical Trials
Similar trials for Hearing Loss
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00747435's enrollment target sits among peer trials
73 34th of 58 higher than 25 of 58 other Hearing Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hearing Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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