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
Results First Received: September 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hearing Loss
Intervention: Device: HiRes 90K Bionic Ear System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bilaterally Implanted 31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.

Participant Flow:   Overall Study
    Bilaterally Implanted  
STARTED     32  
COMPLETED     16 [1]
NOT COMPLETED     16  
Withdrawal by Subject                 16  
[1] 32 enrolled. 1 unilateral. 25 bilateral for data analysis at 8 months. 16 completed study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Bilaterally Implanted 31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.

Baseline Measures
    Bilaterally Implanted  
Number of Participants  
[units: participants]
  32  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     27  
>=65 years     5  
Age  
[units: years]
Mean ± Standard Deviation
  52.6  ± 12.56  
Gender  
[units: participants]
 
Female     21  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     32  



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   HINT Sentences in Noise   [ Time Frame: 8 months of bilateral cochlear implant use ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kenneth Ripley
Organization: Advanced Bionics, LLC
phone: (661) 362-4572 ext N/A
e-mail: Kenneth.Ripley@advancedbionics.com


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