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

Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066780
• Other study ID #: CR0309
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2012
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implant

Intervention

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®)

Locations

Country	Name	City	State
Canada	Nova Scotia Hearing and Speech Centres	Halifax	Nova Scotia
Canada	Sunnybrook Health Sciences Centre	Toronto
United States	The Johns Hopkins University	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Midwest Ear Institute	Kansas City	Missouri
United States	University of Kentucky	Lexington	Kentucky
United States	House Ear Clinic	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Carle Clinic Association	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.		2-4 weeks