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

Not Applicable

Completed

• Conditions: Implant
• Interventions: Device: ClearVoice

• Registration Number: NCT01066780
• Lead Sponsor: Advanced Bionics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Disposition First Submitted: 2011-09-01
• Disposition First Submitted QC: 2011-09-01
• Disposition First Posted: 2011-09-12
• Results First Submitted: 2012-05-01
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-23
• Results First Posted: 2012-10-25
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B: ClearVoice High	ClearVoice	Chronic use of ClearVoice HIGH for two weeks followed by chronic use of ClearVoice MEDIUM for two weeks.
Group A: ClearVoice Medium	ClearVoice	Chronic use of ClearVoice MEDIUM for two weeks followed by chronic use of ClearVoice HIGH for two weeks.

Primary Outcome Measures

Name	Time	Method
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise	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

Name	Time	Method
The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.	2-4 weeks

Trial Locations

Locations (11)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

House Ear Clinic; 🇺🇸 Los Angeles, California, United States

The Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Carle Clinic Association; 🇺🇸 Urbana, Illinois, United States

Midwest Ear Institute; 🇺🇸 Kansas City, Missouri, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Nova Scotia Hearing and Speech Centres; 🇨🇦 Halifax, Nova Scotia, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Canada