Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

February 28, 2012 updated by: Advanced Bionics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90057
        • House Clinic/House Ear Institute
      • Palo Alto, California, United States, 94303
        • California Ear Institute (Let Them Hear Foundation)
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami - Cochlear Implant Center
      • Tampa, Florida, United States, 33606
        • Tampa Bay Hearing and Balance Center
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Clinic Association
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Spectrum Health
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Midwest Ear Institute
    • New York
      • New York, New York, United States, 10016
        • New York University Cochlear Implant Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Otolaryngology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. No previous implant experience.
  2. Age 18 years or older.
  3. Postlingual onset of hearing loss.
  4. Sensorineural hearing loss of a severe or greater degree in both ears.
  5. Normal/patent cochlear anatomy in each ear.
  6. English language proficiency.
  7. Willingness and ability to participate in all scheduled procedures.

Exclusion Criteria:

No exclusion criteria specified, except for the opposite of inclusion criteria listed above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Bilaterally Implanted with HiRes 90K device.
Device: HiRes 90K Bionic Ear System
Cochlear implant system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
Time Frame: 8 months of bilateral cochlear implant use
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.
8 months of bilateral cochlear implant use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HINT Sentences in Noise
Time Frame: 8 months of bilateral cochlear implant use
20 sentences presented in noise at fixed levels
8 months of bilateral cochlear implant use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Bionics

Investigators

  • Study Chair: Mary Joe Osberger, Advanced Bionics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 1, 2012

Last Update Submitted That Met QC Criteria

February 28, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUD-BL-070705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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