Implant
Conditions
Keywords
cochlear implant, adults, HiResolution, Fidelity 120, listening benefits, noise, cochlear implant benefit
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.
Interventions
DEVICEClearVoice
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®)
Sponsors
Advanced Bionics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. | 2-4 weeks |
Countries
Canada, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ClearVoice | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawn prior to ClearVoice exposure. | 1 | 1 |
Baseline characteristics
| Characteristic | ClearVoice |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 58.5 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
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.
Time frame: 4 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise | ClearVoice Setting Medium | 8.7 percentage of words scored correctly | Standard Deviation 10.1 |
| Group 1 | Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise | ClearVoice Setting High | 10.6 percentage of words scored correctly | Standard Deviation 10.2 |
Secondary
The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.
Time frame: 2-4 weeks