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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00205881
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : February 10, 2012
Last Update Posted : March 1, 2012
Information provided by (Responsible Party):
Advanced Bionics

Brief 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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: HiRes 90K Bionic Ear System Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Study Start Date : October 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. HINT Sentences in Noise [ Time Frame: 8 months of bilateral cochlear implant use ]
    20 sentences presented in noise at fixed levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00205881

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

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Responsible Party: Advanced Bionics Identifier: NCT00205881     History of Changes
Other Study ID Numbers: AUD-BL-070705
First Posted: September 21, 2005    Key Record Dates
Results First Posted: February 10, 2012
Last Update Posted: March 1, 2012
Last Verified: February 2012

Keywords provided by Advanced Bionics:
HiResolution Bionic Ear
severe to profound hearing loss
bilateral implantation

Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms