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

July 8, 2020 updated by: Advanced Bionics

Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing

The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3R4
        • Nova Scotia Hearing and Speech Centres
  • United States
    • California
      • Los Angeles, California, United States, 90057
        • House Ear Clinic
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Clinic Association
    • Kentucky
      • Lexington, Kentucky, United States, 40506-9983
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • The Johns Hopkins University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Midwest Ear Institute
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.
Time Frame: 2-4 weeks
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Bionics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR0309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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