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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT01616576
First received: June 1, 2012
Last updated: August 28, 2014
Last verified: August 2014

June 1, 2012
August 28, 2014
May 2012
September 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Device-related adverse events will be assessed to determine whether they impact current device safety performance.
Administration of AzBio Sentences in recorded format in speech-spectrum noise, multi-talker babble and in quiet. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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.

Complete list of historical versions of study NCT01616576 on ClinicalTrials.gov Archive Site
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Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
Not Provided

The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Severe-to-profound Hearing Loss,
  • in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2012
September 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01616576
CR0611
No
Advanced Bionics
Advanced Bionics
Not Provided
Not Provided
Advanced Bionics
August 2014

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