ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users
This study has been completed.
Sponsor:
Advanced Bionics
Information provided by (Responsible Party):
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT01066780
First received: February 9, 2010
Last updated: October 23, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.
| Condition | Intervention |
|---|---|
|
Implant |
Device: ClearVoice |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing |
Resource links provided by NLM:
Further study details as provided by Advanced Bionics:
Primary Outcome Measures:
- Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]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:
- The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 48 |
| Study Start Date: | March 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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®)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066780
Locations
| United States, California | |
| House Ear Clinic | |
| Los Angeles, California, United States, 90057 | |
| United States, Illinois | |
| Carle Clinic Association | |
| Urbana, Illinois, United States, 61801 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40506-9983 | |
| United States, Maryland | |
| The Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Midwest Ear Institute | |
| Kansas City, Missouri, United States, 64111 | |
| Washington University Medical Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Nova Scotia | |
| Nova Scotia Hearing and Speech Centres | |
| Halifax, Nova Scotia, Canada, B3J 3R4 | |
| Canada | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Canada, M4N 3M5 | |
Sponsors and Collaborators
Advanced Bionics
More Information
No publications provided
| Responsible Party: | Advanced Bionics |
| ClinicalTrials.gov Identifier: | NCT01066780 History of Changes |
| Other Study ID Numbers: | CR0309 |
| Study First Received: | February 9, 2010 |
| Results First Received: | May 1, 2012 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Advanced Bionics:
|
cochlear implant adults HiResolution Fidelity 120 |
listening benefits noise cochlear implant benefit |
ClinicalTrials.gov processed this record on May 21, 2013