ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users
Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing
1 other identifier
interventional
48
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
October 25, 2012
CompletedJuly 22, 2020
October 1, 2012
6 months
February 9, 2010
May 1, 2012
July 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise
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.
4 Weeks
Secondary Outcomes (1)
The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.
2-4 weeks
Study Arms (2)
Group A: ClearVoice Medium
EXPERIMENTALChronic use of ClearVoice MEDIUM for two weeks followed by chronic use of ClearVoice HIGH for two weeks.
Group B: ClearVoice High
EXPERIMENTALChronic use of ClearVoice HIGH for two weeks followed by chronic use of ClearVoice MEDIUM for two weeks.
Interventions
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 Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanced Bionicslead
Study Sites (11)
House Ear Clinic
Los Angeles, California, 90057, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
University of Kentucky
Lexington, Kentucky, 40506-9983, United States
The Johns Hopkins University
Baltimore, Maryland, 21205, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Midwest Ear Institute
Kansas City, Missouri, 64111, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Nova Scotia Hearing and Speech Centres
Halifax, Nova Scotia, B3J 3R4, Canada
Sunnybrook Health Sciences Centre
Toronto, M4N 3M5, Canada
Results Point of Contact
- Title
- Kenneth Ripley, Director of Clinical Research
- Organization
- Advanced Bionics, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 10, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
July 22, 2020
Results First Posted
October 25, 2012
Record last verified: 2012-10