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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT01066780
First received: February 9, 2010
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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 Intervention
Implant
Device: ClearVoice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing

Resource links provided by NLM:


Further study details as provided by Advanced Bionics:

Primary Outcome Measures:
  • Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
    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:
  • The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066780

Locations
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
St. 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

No publications provided

Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT01066780     History of Changes
Other Study ID Numbers: CR0309
Study First Received: February 9, 2010
Results First Received: May 1, 2012
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Bionics:
cochlear implant
adults
HiResolution
Fidelity 120
listening benefits
noise
cochlear implant benefit

ClinicalTrials.gov processed this record on April 17, 2014