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NCT00205881 · ClinicalTrials.gov registry record · Phase 4
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
A Phase 4 study of Hearing Loss, sponsored by Advanced Bionics.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
- 9
- Study locations
NCT00205881: Completed Phase 4 study of Hearing Loss, sponsored by Advanced Bionics.
NCT00205881 is a Phase 4 study of Hearing Loss that has completed, run by Advanced Bionics. The registered enrollment target is 32 participants, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00205881, a Phase 4 study of Hearing Loss, has completed, sponsored by Advanced Bionics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
- 9
- Study locations
Study Summary
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.
Primary Outcome
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.
Conditions Studied
Interventions
- DEVICE HiRes 90K Bionic Ear System
Study Locations (9)
California
- House Clinic/House Ear Institute - Los Angeles
- California Ear Institute (Let Them Hear Foundation) - Palo Alto
Florida
- University of Miami - Cochlear Implant Center - Miami
- Tampa Bay Hearing and Balance Center - Tampa
Illinois
- Carle Clinic Association - Urbana
Michigan
- Spectrum Health - Grand Rapids
Missouri
- Midwest Ear Institute - Kansas City
New York
- New York University Cochlear Implant Center - New York
Texas
- Dallas Otolaryngology Associates - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2004-10 |
| Est. Completion | 2009-05 |
| Phase | Phase 4 |
What the finished NCT00205881 record still lists
NCT00205881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 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 HiRes 90K Bionic Ear System is the first listed.
NCT00205881 lists 9 locations in 7 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT00205881 about?
NCT00205881 is a clinical study titled "Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System". Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and unders...
What is the current status of trial NCT00205881?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2004-10. Estimated completion is 2009-05.
What conditions does trial NCT00205881 study?
This clinical trial studies the following conditions: Hearing Loss.
What interventions are being tested in trial NCT00205881?
The interventions under investigation include: HiRes 90K Bionic Ear System (DEVICE).
Who is sponsoring clinical trial NCT00205881?
This trial is sponsored by Advanced Bionics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00205881 being conducted?
This trial has 9 study locations across California, Florida, Illinois, Michigan, Missouri. 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 NCT00205881's enrollment target sits among peer trials
32 48th of 58 higher than 11 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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