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

September 13, 2005
September 21, 2005
September 29, 2011
February 10, 2012
March 1, 2012
October 2004
May 2009   (Final data collection date for primary outcome measure)
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.
  • The study will evaluate bilateral vs. unilateral benefit in adults with two Bionic ears.
  • The study will assess the bilateral benefit of HiResolution sound processing and conventional sound processing.
Complete list of historical versions of study NCT00205881 on Archive Site
HINT Sentences in Noise [ Time Frame: 8 months of bilateral cochlear implant use ]
20 sentences presented in noise at fixed levels
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Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
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 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.
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Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hearing Loss
Device: HiRes 90K Bionic Ear System
Cochlear implant system
Active Comparator: 1
Bilaterally Implanted with HiRes 90K device.
Intervention: Device: HiRes 90K Bionic Ear System
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2009
May 2009   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Advanced Bionics
Advanced Bionics
Not Provided
Study Chair: Mary Joe Osberger Advanced Bionics
Advanced Bionics
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP