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Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
NCT00205881 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00205881
The ClinicalTrials.gov registry entry for NCT00205881 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advanced Bionics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00205881 reports 9 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00205881?
The interventions under investigation include: HiRes 90K Bionic Ear System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00205881?
This trial is sponsored by Advanced Bionics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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