Trial Outcomes & Findings for Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear (NCT NCT03867396)
NCT ID: NCT03867396
Last Updated: 2022-05-16
Results Overview
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
COMPLETED
NA
40 participants
12 minutes
2022-05-16
Participant Flow
Participant milestones
| Measure |
Cochlear Implant (CI) and Hearing Aid, Then CI and CROS, Then CI Alone
1. Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid.
2. Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.
3. Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.
|
Cochlear Implant (CI) and Hearing Aid, Then CI Alone, Then CI and CROS
1. Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.Hearing Aid: Advanced Bionics Naida hearing aid.
2. Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.
3. Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.
|
Cochlear Implant (CI) and CROS, Then CI and Hearing Aid, Then CI Alone.
1. Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.
2. Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid.
3. Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.
|
Cochlear Implant (CI) and CROS, Then CI Alone, Then CI and Hearing Aid
1. Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.
2. Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.
3. Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid.
|
Cochlear Implant (CI) Alone, Then CI and CROS, Then CI and Hearing Aid
1. Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.
2. Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.
3. Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid.
|
Cochlear Implant (CI) Alone, Then CI and Hearing Aid, Then CI and CROS
1. Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear.
2. Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Hearing Aid: Advanced Bionics Naida hearing aid.
3. Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS.
|
|---|---|---|---|---|---|---|
|
Intervention 1
STARTED
|
8
|
8
|
7
|
5
|
7
|
5
|
|
Intervention 1
Data Collection
|
8
|
5
|
7
|
5
|
0
|
0
|
|
Intervention 1
COMPLETED
|
8
|
5
|
7
|
5
|
0
|
0
|
|
Intervention 1
NOT COMPLETED
|
0
|
3
|
0
|
0
|
7
|
5
|
|
Intervention 2
STARTED
|
8
|
5
|
7
|
5
|
0
|
0
|
|
Intervention 2
COMPLETED
|
8
|
5
|
7
|
5
|
0
|
0
|
|
Intervention 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 3
STARTED
|
8
|
5
|
7
|
5
|
0
|
0
|
|
Intervention 3
COMPLETED
|
8
|
5
|
7
|
5
|
0
|
0
|
|
Intervention 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data was not collected for one participant
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
All participants in crossover study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
|
Implant Side
Left
|
9 Participants
n=25 Participants
|
|
Implant Side
Right
|
16 Participants
n=25 Participants
|
|
Implant Device
HiRes Ultra with HiFocus Mid-Scal
|
4 Participants
n=25 Participants
|
|
Implant Device
HiRes Ultra with HiFocus 1J
|
8 Participants
n=25 Participants
|
|
Implant Device
HiRes 90K
|
12 Participants
n=25 Participants
|
|
Implant Device
CII Bionic Ear
|
1 Participants
n=25 Participants
|
|
Contralateral Ear Device
Nothing
|
5 Participants
n=25 Participants
|
|
Contralateral Ear Device
Hearing Aid
|
19 Participants
n=25 Participants
|
|
Contralateral Ear Device
Contralateral Routing of Signal (CROS) device
|
1 Participants
n=25 Participants
|
|
Has Tinnitus
Tinnitus
|
14 Participants
n=25 Participants
|
|
Has Tinnitus
No Tinnitus
|
10 Participants
n=25 Participants
|
|
Has Tinnitus
Unknown
|
1 Participants
n=25 Participants
|
|
Tinnitus Frequency
Constant
|
7 Participants
n=25 Participants
|
|
Tinnitus Frequency
Intermittent
|
6 Participants
n=25 Participants
|
|
Tinnitus Frequency
Not Sure
|
1 Participants
n=25 Participants
|
|
Tinnitus Frequency
Missing
|
11 Participants
n=25 Participants
|
|
Tinnitus Ears
Right
|
2 Participants
n=25 Participants
|
|
Tinnitus Ears
Left
|
1 Participants
n=25 Participants
|
|
Tinnitus Ears
Both
|
8 Participants
n=25 Participants
|
|
Tinnitus Ears
Not Sure
|
3 Participants
n=25 Participants
|
|
Tinnitus Ears
None/Missing
|
11 Participants
n=25 Participants
|
|
Exposure to Excessive Noise
Exposure to Excessive Noise
|
11 Participants
n=25 Participants
|
|
Exposure to Excessive Noise
No Exposure to Excessive Noise
|
14 Participants
n=25 Participants
|
|
Ear Protection with Excessive Noise
Ear Protection
|
3 Participants
n=25 Participants
|
|
Ear Protection with Excessive Noise
No Ear Protection
|
8 Participants
n=25 Participants
|
|
Ear Protection with Excessive Noise
Missing
|
14 Participants
n=25 Participants
|
|
Head Trauma
Head Trauma
|
3 Participants
n=25 Participants
|
|
Head Trauma
No Head Trauma
|
21 Participants
n=25 Participants
|
|
Head Trauma
Missing
|
1 Participants
n=25 Participants
|
|
Cognition/Memory Concern
Cognition/Memory Concern
|
3 Participants
n=25 Participants
|
|
Cognition/Memory Concern
No Concern
|
21 Participants
n=25 Participants
|
|
Cognition/Memory Concern
Missing
|
1 Participants
n=25 Participants
|
|
Diagnosis Related to Cognition/Memory
Has Diagnosis Related to Cognition/Memory
|
2 Participants
n=25 Participants
|
|
Diagnosis Related to Cognition/Memory
No Diagnosis Related to Cognition/Memory
|
22 Participants
n=25 Participants
|
|
Diagnosis Related to Cognition/Memory
Missing
|
1 Participants
n=25 Participants
|
|
Hearing loss duration (years)
|
29.7 years
STANDARD_DEVIATION 16.6 • n=24 Participants • Data was not collected for one participant
|
|
Years since first hearing aid fit
|
20.8 years
STANDARD_DEVIATION 14.4 • n=24 Participants • Data was not collected for one participant
|
|
Daily Use of Implant (hours)
|
14.7 hours
STANDARD_DEVIATION 3.12 • n=21 Participants • Data was not collected for 4 participants
|
|
Unaided Right PTA
PTA (avg 500, 1000, 2000)
|
94.0 dB
STANDARD_DEVIATION 23.8 • n=24 Participants • Data is missing for one participant.
|
|
Unaided Right PTA
High Frequency PTA
|
98.8 dB
STANDARD_DEVIATION 23.2 • n=24 Participants • Data is missing for one participant.
|
|
Unaided Right PTA
Low Frequency PTA
|
80.5 dB
STANDARD_DEVIATION 28.3 • n=24 Participants • Data is missing for one participant.
|
|
Unaided Left PTA
PTA (avg 500, 1000, 2000)
|
94.0 dB
STANDARD_DEVIATION 24.1 • n=24 Participants • Data is missing for one participant (could not be collected)
|
|
Unaided Left PTA
High Frequency PTA
|
99.3 dB
STANDARD_DEVIATION 23.5 • n=24 Participants • Data is missing for one participant (could not be collected)
|
|
Unaided Left PTA
Low Frequency PTA
|
77.0 dB
STANDARD_DEVIATION 33.5 • n=24 Participants • Data is missing for one participant (could not be collected)
|
|
PTA: Cochlear Implant Alone
PTA (avg 500, 1000, 2000)
|
29.5 dB
STANDARD_DEVIATION 5.67 • n=22 Participants • Data could not be collected for 3 participants.
|
|
PTA: Cochlear Implant Alone
High Frequency PTA
|
28.2 dB
STANDARD_DEVIATION 4.87 • n=22 Participants • Data could not be collected for 3 participants.
|
|
PTA: Cochlear Implant Alone
Low Frequency PTA
|
31.1 dB
STANDARD_DEVIATION 7.0 • n=22 Participants • Data could not be collected for 3 participants.
|
PRIMARY outcome
Timeframe: 12 minutesPopulation: One participant did not have data collected while wearing the contralateral device. Data is only available for 5 participants in the "No Contralateral Device" group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Outcome measures
| Measure |
No Contralateral Device (Cochlear Implant Alone)
n=5 Participants
Subject only uses the cochlear implant; hearing on the contralateral side is unaided.
Cochlear Implant Alone: No hearing device on contralateral ear
|
Cochlear Implant and Contralateral Device
n=19 Participants
Subject wears a contralateral device
|
|---|---|---|
|
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CI, Ipsi Speech, Omni Noise
|
8.45 ratio
Standard Deviation 11.4
|
10.4 ratio
Standard Deviation 9.5
|
|
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CI, Contra Speech, Ipsi Noise
|
21.2 ratio
Standard Deviation 6.99
|
22.2 ratio
Standard Deviation 6.17
|
|
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CI, Contra Speech, Omni Noise
|
15.5 ratio
Standard Deviation 8.85
|
15.9 ratio
Standard Deviation 7.73
|
|
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CI, Front Speech, Front Noise
|
15.8 ratio
Standard Deviation 7.04
|
17.1 ratio
Standard Deviation 6.94
|
|
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CI, Front Speech, Omni Noise
|
8.85 ratio
Standard Deviation 5.95
|
12.6 ratio
Standard Deviation 8.27
|
PRIMARY outcome
Timeframe: 12 minutesPopulation: One participant did not have data collected while wearing the contralateral device. Data is only available for 5 participants in the "No Contralateral Device" group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Outcome measures
| Measure |
No Contralateral Device (Cochlear Implant Alone)
n=5 Participants
Subject only uses the cochlear implant; hearing on the contralateral side is unaided.
Cochlear Implant Alone: No hearing device on contralateral ear
|
Cochlear Implant and Contralateral Device
n=19 Participants
Subject wears a contralateral device
|
|---|---|---|
|
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CICROS, Ipsi Speech, Omni Noise
|
9.7 ratio
Standard Deviation 7.17
|
13.7 ratio
Standard Deviation 8.92
|
|
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CICROS, Contra Speech, Ipsi Noise
|
12.9 ratio
Standard Deviation 10.3
|
16.6 ratio
Standard Deviation 7.65
|
|
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CICROS, Contra Speech, Omni
|
9.9 ratio
Standard Deviation 9.96
|
13.1 ratio
Standard Deviation 8.2
|
|
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CICROS, Front Speech, Front Noise
|
15.3 ratio
Standard Deviation 6.29
|
16.0 ratio
Standard Deviation 7.26
|
|
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CICROS, Front Speech, Omni Noise
|
10.7 ratio
Standard Deviation 4.65
|
13.5 ratio
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: 12 minutesPopulation: Data could not be collected for one participant while wearing the Contralateral Device for condition "CIHA, Contra Speech, Omni Noise". Data is only available for 5 participants in the "No Contralateral Device" group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Outcome measures
| Measure |
No Contralateral Device (Cochlear Implant Alone)
n=5 Participants
Subject only uses the cochlear implant; hearing on the contralateral side is unaided.
Cochlear Implant Alone: No hearing device on contralateral ear
|
Cochlear Implant and Contralateral Device
n=20 Participants
Subject wears a contralateral device
|
|---|---|---|
|
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CIHA, Ipsi Speech, Omni Noise
|
8.62 ratio
Standard Deviation 10.5
|
9.05 ratio
Standard Deviation 7.06
|
|
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CIHA, Contra Speech, Ipsi Noise
|
16.4 ratio
Standard Deviation 8.19
|
16.9 ratio
Standard Deviation 8.44
|
|
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CIHA, Contra Speech, Omni Noise
|
11.6 ratio
Standard Deviation 10.1
|
11.5 ratio
Standard Deviation 8.17
|
|
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CIHA, Front Speech, Front Noise
|
14.0 ratio
Standard Deviation 6.78
|
14.6 ratio
Standard Deviation 6.62
|
|
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
CIHA, Front Speech, Omni Noise
|
8.65 ratio
Standard Deviation 6.67
|
9.51 ratio
Standard Deviation 7.49
|
Adverse Events
Cochlear Implant and Hearing Aid
Cochlear Implant Alone
Cochlear Implant and CROS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Melinda Anderson
University of Colorado Anschutz SOM
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60