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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 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.

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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.

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

FieldValue
Enrollment Target 32 participants
Start Date 2004-10
Est. Completion 2009-05
Phase Phase 4

Sponsor

Advanced Bionics

8 total trials

What the Registry Record Tells You About NCT00205881

The ClinicalTrials.gov registry entry for NCT00205881 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 32 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 Advanced Bionics, which has 8 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 HiRes 90K Bionic Ear System is the first listed.

NCT00205881 reports 9 study locations spanning 7 distinct geographic areas - top geographies include 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.

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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.