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Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
This study is ongoing, but not recruiting participants.
Study NCT00205881   Information provided by Advanced Bionics
First Received: September 13, 2005   Last Updated: September 19, 2008   History of Changes

September 13, 2005
September 19, 2008
October 2004
March 2009   (final data collection date for primary outcome measure)
The study will evaluate bilateral vs. unilateral benefit in adults with two Bionic ears. [ Time Frame: Various time points post-activation ] [ Designated as safety issue: Yes ]
  • 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 ClinicalTrials.gov Archive Site
The study will assess the bilateral benefit of HiResolution sound processing and conventional sound processing. [ Time Frame: Various time points post-activation ] [ Designated as safety issue: No ]
Not applicable
 
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 listening with only one ear. 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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
Hearing Loss
  • Device: HiRes 90K Bionic Ear System
  • Other: HiRes 90K Bionic Ear System
  • Active Comparator: CIS strategy
  • Active Comparator: HiRes strategy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
56
March 2009
March 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205881
Andrew Quick, Advanced Bionics Corporation
AUD-BL-070705
Advanced Bionics
 
Study Chair: Mary Joe Osberger Advanced Bionics
Advanced Bionics
September 2008

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