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

NCT ID: NCT01066780

Last Updated: 2020-07-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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Conditions

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Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: ClearVoice Medium

Chronic use of ClearVoice MEDIUM for two weeks followed by chronic use of ClearVoice HIGH for two weeks.

Group Type EXPERIMENTAL

ClearVoice

Intervention Type DEVICE

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®)

Group B: ClearVoice High

Chronic use of ClearVoice HIGH for two weeks followed by chronic use of ClearVoice MEDIUM for two weeks.

Group Type EXPERIMENTAL

ClearVoice

Intervention Type DEVICE

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®)

Interventions

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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®)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Bionics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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House Ear Clinic

Los Angeles, California, United States

Site Status

Carle Clinic Association

Urbana, Illinois, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

The Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Midwest Ear Institute

Kansas City, Missouri, United States

Site Status

Washington University Medical Center

St Louis, Missouri, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Nova Scotia Hearing and Speech Centres

Halifax, Nova Scotia, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CR0309

Identifier Type: -

Identifier Source: org_study_id

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