Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users

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: NCT01066780
Recruitment Status : Completed
First Posted : February 10, 2010
Results First Posted : October 25, 2012
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.

Condition or disease Intervention/treatment Phase
Implant Device: ClearVoice Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group A: ClearVoice Medium
Chronic use of ClearVoice MEDIUM for two weeks followed by chronic use of ClearVoice HIGH for two weeks.
 Device: ClearVoice
ClearVoice is a sound processing strategy designed to improve listening ability in some challenging everyday listening environments for users of the Harmony® HiResolution® Bionic Ear System (Harmony®)
Experimental: Group B: ClearVoice High
Chronic use of ClearVoice HIGH for two weeks followed by chronic use of ClearVoice MEDIUM for two weeks.
 Device: ClearVoice
ClearVoice is a sound processing strategy designed to improve listening ability in some challenging everyday listening environments for users of the Harmony® HiResolution® Bionic Ear System (Harmony®)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise [ Time Frame: 4 Weeks ]
    This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.


Secondary Outcome Measures :
  1. The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. [ Time Frame: 2-4 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-lingually deafened,
  • experienced (6 months device use),
  • adult users of the Harmony HiResolution Bionic Ear System and HiRes Fidelity 120 sound processing.
  • English language proficiency
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066780


Locations
Layout table for location information
United States, California
House Ear Clinic
Los Angeles, California, United States, 90057
United States, Illinois
Carle Clinic Association
Urbana, Illinois, United States, 61801
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506-9983
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Midwest Ear Institute
Kansas City, Missouri, United States, 64111
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Nova Scotia
Nova Scotia Hearing and Speech Centres
Halifax, Nova Scotia, Canada, B3J 3R4
Canada
Sunnybrook Health Sciences Centre
Toronto, Canada, M4N 3M5
Sponsors and Collaborators
Advanced Bionics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT01066780    
Other Study ID Numbers: CR0309
First Posted: February 10, 2010    Key Record Dates
Results First Posted: October 25, 2012
Last Update Posted: July 22, 2020
Last Verified: October 2012
Keywords provided by Advanced Bionics:
cochlear implant
adults
HiResolution
Fidelity 120
 listening benefits
noise
cochlear implant benefit