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Clinical Trials/NCT01066780
NCT01066780
Completed
N/A

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

Advanced Bionics11 sites in 2 countries48 target enrollmentMarch 2010
ConditionsImplant

Overview

Phase
N/A
Intervention
Not specified
Conditions
Implant
Sponsor
Advanced Bionics
Enrollment
48
Locations
11
Primary Endpoint
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
September 2010
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.(2-4 weeks)

Study Sites (11)

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