in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System, Severe to Profound Hearing Loss
Conditions
Keywords
cochlear implant, adults, HiResolution™, Fidelity 120™, listening benefits, noise, cochlear implant benefit
Brief summary
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
Interventions
DEVICEControl first, then Experimental
Control condition is currently marketed sound processing strategy.
DEVICEExperimental first, then Control
Experimental condition is newly modified sound processing strategy.
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
* Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy * 18 years of age or older at time of implant * Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age) * At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users) * English language proficiency * Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study * Willingness and ability to participate in all scheduled procedures outlined in the protocol
Exclusion criteria
• Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | 2 weeks | Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis. |
| Device-related Adverse Events | 2 weeks | Device-related adverse events will be assessed to determine whether they impact current device safety performance. |
Countries
United States
Participant flow
Recruitment details
Investigators recruited study subjects from their clinic practice. Subjects were randomized to either Group A or Group B at the time of the baseline visit. First patient first visit occurred on May 25, 2012 and last patient last visit occurred on September 07, 2012.
Participants by arm
| Arm | Count |
|---|---|
| Control First, Then Experimental (Group A) Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System. | 18 |
| Experimental First, Then Control (Group B) Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System. | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Experimental First, Then Control (Group B) | Control First, Then Experimental (Group A) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 21 Participants |
| Age, Continuous | 58.9 years STANDARD_DEVIATION 13.86 | 62.0 years STANDARD_DEVIATION 14.81 | 60.4 years STANDARD_DEVIATION 14.22 |
| Region of Enrollment United States | 18 participants | 18 participants | 36 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 18 | 3 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Device-related Adverse Events
Device-related adverse events will be assessed to determine whether they impact current device safety performance.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A and Group B Data Pooled | Device-related Adverse Events | 0 Events |
| Control | Device-related Adverse Events | 0 Events |
Primary
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A and Group B Data Pooled | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | SSN | 2.8 Percent Correct | Standard Deviation 8.28 |
| Group A and Group B Data Pooled | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | Quiet | 0.2 Percent Correct | Standard Deviation 6.06 |
| Group A and Group B Data Pooled | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | MTB | 2.2 Percent Correct | Standard Deviation 6.89 |
| Control | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | SSN | 61.2 Percent Correct | Standard Deviation 18.98 |
| Control | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | Quiet | 88.3 Percent Correct | Standard Deviation 11.15 |
| Control | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | MTB | 67.8 Percent Correct | Standard Deviation 17.13 |
| Experimental | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | Quiet | 88.5 Percent Correct | Standard Deviation 12.43 |
| Experimental | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | MTB | 70.0 Percent Correct | Standard Deviation 16.53 |
| Experimental | Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | SSN | 64.0 Percent Correct | Standard Deviation 18.11 |