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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT00205881
First received: September 13, 2005
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Hearing Loss
Device: HiRes 90K Bionic Ear System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

Resource links provided by NLM:


Further study details as provided by Advanced Bionics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • HINT Sentences in Noise [ Time Frame: 8 months of bilateral cochlear implant use ] [ Designated as safety issue: No ]
    20 sentences presented in noise at fixed levels


Enrollment: 32
Study Start Date: October 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bilaterally Implanted with HiRes 90K device.
Device: HiRes 90K Bionic Ear System
Cochlear implant system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205881

Locations
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
Investigators
Study Chair: Mary Joe Osberger Advanced Bionics
  More Information

No publications provided

Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT00205881     History of Changes
Other Study ID Numbers: AUD-BL-070705
Study First Received: September 13, 2005
Results First Received: September 29, 2011
Last Updated: February 28, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 23, 2014