Trial Outcomes & Findings for Clinical Evaluation of a Cochlear Implant Sound Processor (NCT NCT04237207)
NCT ID: NCT04237207
Last Updated: 2022-05-13
Results Overview
The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
1 Day
Results posted on
2022-05-13
Participant Flow
Investigators recruited study subjects from their clinical practices. The first patient first visit occurred on December 17, 2019 and last patient last visit occurred on October 15, 2020. A total of 22 subjects were enrolled; 10 subjects were enrolled in the Electric Only cohort and 12 subjects were enrolled in the Aidable Residual Hearing cohort based on the results of their audiometric testing. All 22 subjects completed the study; there were no withdrawals or losses to follow-up.
After undergoing the Informed Consent Form process, subjects completed audiometric testing and speech perception testing to determine eligibility and assignment to either the electric only (EO) or aidable residual hearing (ARH) cohort. Subjects that did not meet the audiometric threshold hearing or speech testing inclusion criteria were discontinued at baseline.
Participant milestones
| Measure |
Electric Only (EO) Cohort
Control Device followed by experimental Device.
Naída Cochlear Implant Q90 (Naída CI Q90) sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
Aidable Residual Hearing (ARH) Cohort
Control Device followed by experimental Device.
Naída Cochlea Implant Q90 (Naída CI Q90) sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Three subjects failed ARH baseline and 1 failed EO baseline.
Baseline characteristics by cohort
| Measure |
Aidable Residual Hearing (ARH) Cohort
n=12 Participants
Control Device followed by experimental Device.
Naída Cochlear Implant Q90 (Naída CI Q90) sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
Electric Only (EO) Cohort
n=10 Participants
Control Device followed by experimental Device.
Naída Cochlear Implant Q90 (Naída CI Q90) sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
0 Participants
n=10 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
0 Participants
n=22 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=12 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
3 Participants
n=10 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
9 Participants
n=22 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
|
Age, Categorical
>=65 years
|
6 Participants
n=12 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
7 Participants
n=10 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
13 Participants
n=22 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 9.66 • n=12 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
67.2 years
STANDARD_DEVIATION 9.28 • n=10 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
64.5 years
STANDARD_DEVIATION 9.74 • n=22 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
|
Sex: Female, Male
Female
|
9 Participants
n=12 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
5 Participants
n=10 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
14 Participants
n=22 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
|
Sex: Female, Male
Male
|
3 Participants
n=12 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
5 Participants
n=10 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
8 Participants
n=22 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
10 participants
n=10 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
22 participants
n=22 Participants • Three subjects failed ARH baseline and 1 failed EO baseline.
|
|
Audiometric Threshold Testing and Speech Perception Testing
|
12 Participants
n=12 Participants • Four subjects did not meet inclusion criteria and were therefore discontinued at baseline.
|
10 Participants
n=10 Participants • Four subjects did not meet inclusion criteria and were therefore discontinued at baseline.
|
22 Participants
n=22 Participants • Four subjects did not meet inclusion criteria and were therefore discontinued at baseline.
|
PRIMARY outcome
Timeframe: 1 DayThe primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Outcome measures
| Measure |
EO Cohort
n=10 Participants
Control Device followed by experimental Device.
Naída CI Q90 sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
ARH Cohort
n=12 Participants
Control Device followed by experimental Device.
Naída CI Q90 sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
|---|---|---|
|
Speech Recognition in Quiet
Baseline AutoSound
|
88.31 percentage of correct words
Standard Deviation 5.817
|
89.39 percentage of correct words
Standard Deviation 10.535
|
|
Speech Recognition in Quiet
Baseline AutoSense
|
87.30 percentage of correct words
Standard Deviation 10.214
|
88.09 percentage of correct words
Standard Deviation 9.848
|
SECONDARY outcome
Timeframe: 1 DayDemonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Outcome measures
| Measure |
EO Cohort
n=10 Participants
Control Device followed by experimental Device.
Naída CI Q90 sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
ARH Cohort
n=12 Participants
Control Device followed by experimental Device.
Naída CI Q90 sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
|---|---|---|
|
Speech Recognition in Noise
AutoSound
|
52.95 percentage of correct word responses
Standard Deviation 31.163
|
66.04 percentage of correct word responses
Standard Deviation 25.939
|
|
Speech Recognition in Noise
AutoSense
|
76.37 percentage of correct word responses
Standard Deviation 19.078
|
84.98 percentage of correct word responses
Standard Deviation 13.108
|
SECONDARY outcome
Timeframe: 1 DayDemonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Outcome measures
| Measure |
EO Cohort
n=10 Participants
Control Device followed by experimental Device.
Naída CI Q90 sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
ARH Cohort
n=12 Participants
Control Device followed by experimental Device.
Naída CI Q90 sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
|---|---|---|
|
Increased Speech Recognition in Noise
Omnidirectional
|
42.93 percentage of correct words recognized
Standard Deviation 30.801
|
51.37 percentage of correct words recognized
Standard Deviation 28.604
|
|
Increased Speech Recognition in Noise
AutoSense
|
76.37 percentage of correct words recognized
Standard Deviation 19.078
|
84.98 percentage of correct words recognized
Standard Deviation 13.108
|
Adverse Events
EO Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ARH Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EO Cohort
n=10 participants at risk
Control Device followed by experimental Device.
Naída CI Q90 sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
ARH Cohort
n=12 participants at risk
Control Device followed by experimental Device.
Naída CI Q90 sound processor \& software: Control cochlear implant sound processor
301-M062 sound processor \& software: New cochlear implant sound processor
|
|---|---|---|
|
Product Issues
Patient discomfort
|
0.00%
0/10 • AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks.
All device-related and non-device-related adverse events (AEs) was tracked and reported accordingly throughout the study as defined in the investigational plan and in accordance with requirements of an IDE investigation. The number and percent of all subjects experiencing adverse events was summarized by type, status and frequency of event.
|
8.3%
1/12 • Number of events 1 • AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks.
All device-related and non-device-related adverse events (AEs) was tracked and reported accordingly throughout the study as defined in the investigational plan and in accordance with requirements of an IDE investigation. The number and percent of all subjects experiencing adverse events was summarized by type, status and frequency of event.
|
|
Infections and infestations
Upper Respiratory
|
10.0%
1/10 • Number of events 1 • AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks.
All device-related and non-device-related adverse events (AEs) was tracked and reported accordingly throughout the study as defined in the investigational plan and in accordance with requirements of an IDE investigation. The number and percent of all subjects experiencing adverse events was summarized by type, status and frequency of event.
|
0.00%
0/12 • AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks.
All device-related and non-device-related adverse events (AEs) was tracked and reported accordingly throughout the study as defined in the investigational plan and in accordance with requirements of an IDE investigation. The number and percent of all subjects experiencing adverse events was summarized by type, status and frequency of event.
|
|
Musculoskeletal and connective tissue disorders
Sprained ankle
|
10.0%
1/10 • Number of events 1 • AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks.
All device-related and non-device-related adverse events (AEs) was tracked and reported accordingly throughout the study as defined in the investigational plan and in accordance with requirements of an IDE investigation. The number and percent of all subjects experiencing adverse events was summarized by type, status and frequency of event.
|
0.00%
0/12 • AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks.
All device-related and non-device-related adverse events (AEs) was tracked and reported accordingly throughout the study as defined in the investigational plan and in accordance with requirements of an IDE investigation. The number and percent of all subjects experiencing adverse events was summarized by type, status and frequency of event.
|
Additional Information
Ankur Kaushal, VP of Global Regulatory Affairs
Advanced Bionics, LLC
Phone: 661 362 1400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees to submit any publication to Sponsor at least 30 days before submission. Within 30 days of its receipt, Sponsor advises PI in writing of any information contained therein which is Confidential Information (other than Study Data) or which may impair availability of patent protection for Inventions. Sponsor has the right to require PI to remove specifically identified CI and/or to delay the publication for an additional 60 days to enable Sponsor to seek patent protection for Inventions.
- Publication restrictions are in place
Restriction type: OTHER