ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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®)
|
Outcome Measures
Primary Outcome Measures
- 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
- The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. [2-4 weeks]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | House Ear Clinic | Los Angeles | California | United States | 90057 |
| 2 | Carle Clinic Association | Urbana | Illinois | United States | 61801 |
| 3 | University of Kentucky | Lexington | Kentucky | United States | 40506-9983 |
| 4 | The Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
| 5 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 6 | Midwest Ear Institute | Kansas City | Missouri | United States | 64111 |
| 7 | Washington University Medical Center | Saint Louis | Missouri | United States | 63110 |
| 8 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 9 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 10 | Nova Scotia Hearing and Speech Centres | Halifax | Nova Scotia | Canada | B3J 3R4 |
| 11 | Sunnybrook Health Sciences Centre | Toronto | Canada | M4N 3M5 |
Sponsors and Collaborators
- Advanced Bionics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR0309
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | All subjects were fit acutely at the Baseline Visit (Visit 1) with ClearVoice Low and underwent acute speech perception testing. Each subject was then randomized to Group A or Group B. |
| Arm/Group Title | Group A: Received ClearVoice MEDIUM Followed by HIGH | Group B: Received ClearVoice HIGH Followed by MEDIUM |
|---|---|---|
| Arm/Group Description | Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH. | Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM. |
| Period Title: Overall Study | ||
| STARTED | 24 | 24 |
| COMPLETED | 23 | 23 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | ClearVoice |
|---|---|
| Arm/Group Description | |
| Overall Participants | 46 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
29
63%
|
| >=65 years |
17
37%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
58.5
(16.00)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
21
45.7%
|
| Male |
25
54.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
46
100%
|
Outcome Measures
| Title | Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise |
|---|---|
| Description | 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. |
| Time Frame | 4 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | Primary efficacy analyses were based on data from the 46 subjects that completed the study. |
| Measure Participants | 46 |
| ClearVoice Setting Medium |
8.7
(10.10)
|
| ClearVoice Setting High |
10.6
(10.20)
|
| Title | The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. |
|---|---|
| Description | |
| Time Frame | 2-4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Group 1 | |
| Arm/Group Description | Primary efficacy analyses were based on data from the 46 subjects that completed the study. | |
All Cause Mortality |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/46 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/46 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
At least 60 days before submission for publication, presentation or use, Institution or Principal Investigator will submit to Sponsor for review and comment any proposed oral or written Publication. Sponsor will have the right to request any modification of any Publication if in Sponsor's reasonable opinion that Publication would jeopardize a patent application or patent.
Results Point of Contact
| Name/Title | Kenneth Ripley, Director of Clinical Research |
|---|---|
| Organization | Advanced Bionics, LLC |
| Phone | 1.661.362.1400 |
| clinical.research@advancedbionics.com |
- CR0309