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Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear

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.
 
ClinicalTrials.gov Identifier: NCT01616576
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : August 15, 2014
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics

Tracking Information
First Submitted Date  ICMJE June 1, 2012
First Posted Date  ICMJE June 12, 2012
Results First Submitted Date  ICMJE February 26, 2014
Results First Posted Date  ICMJE August 15, 2014
Last Update Posted Date September 5, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
  • Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. [ Time Frame: 2 weeks ]
    Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.
  • Device-related Adverse Events [ Time Frame: 2 weeks ]
    Device-related adverse events will be assessed to determine whether they impact current device safety performance.
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
Administration of AzBio Sentences in recorded format in speech-spectrum noise, multi-talker babble and in quiet. [ Time Frame: 2 weeks ]
Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Device-related adverse events will also be assessed to determine whether they impact device safety.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Severe-to-profound Hearing Loss,
  • in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Intervention  ICMJE
  • Device: Control first, then Experimental
    Control condition is currently marketed sound processing strategy.
  • Device: Experimental first, then Control
    Experimental condition is newly modified sound processing strategy.
Study Arms  ICMJE
  • Experimental: Control first, then Experimental (Group A)
    Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
    Intervention: Device: Control first, then Experimental
  • Experimental: Experimental first, then Control (Group B)
    Initial subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.
    Intervention: Device: Experimental first, then Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2012)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy
  • 18 years of age or older at time of implant
  • Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age)
  • At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users)
  • English language proficiency
  • Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study
  • Willingness and ability to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

• Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01616576
Other Study ID Numbers  ICMJE CR0611
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Advanced Bionics
Study Sponsor  ICMJE Advanced Bionics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Advanced Bionics
Verification Date August 2014

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