Trial Outcomes & Findings for Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System (NCT NCT00205881)
NCT ID: NCT00205881
Last Updated: 2012-03-01
Results Overview
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.
COMPLETED
PHASE4
32 participants
8 months of bilateral cochlear implant use
2012-03-01
Participant Flow
Participant milestones
| Measure |
Bilaterally Implanted
31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Bilaterally Implanted
31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
Baseline Characteristics
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Baseline characteristics by cohort
| Measure |
Bilaterally Implanted
n=32 Participants
31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
52.6 years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 months of bilateral cochlear implant usePopulation: Adults with severe-to-profound hearing loss who received bilateral cochlear implants in the same operation.
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.
Outcome measures
| Measure |
Baseline
n=24 Participants
Testing with hearing aids in best-aided condition.
|
8 Months Post-device Activation
n=25 Participants
Testing conducted with bilateral implants.
|
|---|---|---|
|
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
|
4.0 percent of words correct
Standard Deviation 8.0
|
69.0 percent of words correct
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: 8 months of bilateral cochlear implant use20 sentences presented in noise at fixed levels
Outcome measures
Outcome data not reported
Adverse Events
Bilaterally Implanted
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bilaterally Implanted
n=31 participants at risk
31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
|
|---|---|
|
Ear and labyrinth disorders
Dizziness
|
22.6%
7/31 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators were not permitted to disclose study results until the Sponsor had completed data analyses and report generation for regulatory purposes, and/or received regulatory approval. The Sponsor agreed to notify the Investigators when they were free to publish, present or use any results arising out of this study for their own instructional, research, or publication objectives, provided that such publication did not disclose any of the Sponsor's proprietary information.
- Publication restrictions are in place
Restriction type: OTHER