Trial Outcomes & Findings for Outcomes in Children With Pre-operative Residual Hearing (NCT NCT03379870)

Last Updated: 2024-10-15

Results Overview

The Consonant Nucleus Consonant (CNC) word list is established as a standard test of speech perception outcomes. Results for EAS and FES Arms at 12 months post stimulation will be compared. Lower scores indicate a poorer outcome and higher scores a better outcome. Scale 0 - 100%

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

12 months post stimulation

Results posted on

2024-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	EAS Arm Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting. EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: FES fitting FES fitting: Full-electric stimulation for children with post-operative residual low frequency hearing averages greater than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Overall Study STARTED	16	12
Overall Study COMPLETED	14	11
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	EAS Arm Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting. EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: FES fitting FES fitting: Full-electric stimulation for children with post-operative residual low frequency hearing averages greater than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	1

Baseline Characteristics

Outcomes in Children With Pre-operative Residual Hearing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EAS Arm n=14 Participants Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better.	FES Arm n=11 Participants Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages greater than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.	Total n=25 Participants Total of all reporting groups
Age, Continuous	9.9 years STANDARD_DEVIATION 3.9 • n=5 Participants	10.5 years STANDARD_DEVIATION 3.3 • n=7 Participants	10.2 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Pre-operative Low Frequency Pure Tone Average (PTA)	29.9 Decibels (dB) STANDARD_DEVIATION 17.8 • n=5 Participants	57.5 Decibels (dB) STANDARD_DEVIATION 11.6 • n=7 Participants	43.1 Decibels (dB) STANDARD_DEVIATION 20.5 • n=5 Participants
Post-operative Low Frequency Pure Tone Average (PTA) at Enrollment	46.2 Decibels (dB) STANDARD_DEVIATION 14.5 • n=5 Participants	85.8 Decibels (dB) STANDARD_DEVIATION 16.4 • n=7 Participants	63.6 Decibels (dB) STANDARD_DEVIATION 25.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months post stimulation

Population: Subjects who completed the 12-month protocol

Outcome measures

Outcome measures
Measure	EAS Arm n=14 Participants Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm n=11 Participants Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages poorer than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Mean CNC Word Scores	71.0 Percent Correct Standard Deviation 18.0	68.4 Percent Correct Standard Deviation 26.0

PRIMARY outcome

Timeframe: 12 months post-stimulation

Population: Subjects who completed the 12-month protocol

Sentences and babble will be presented from the same speaker. An average score known as the SNR-50 will be obtained in both conditions. The SNR-50 score is an estimate of the signal-to-noise ratio associated with 50% correct based on word-level scoring. Results for EAS and FES listeners at 12 months post stimulation will be compared. In this test, lower scores indicate a better outcome and higher scores a poorer outcome. Scores range from -6 dB to +21 dB.

Outcome measures

Outcome measures
Measure	EAS Arm n=14 Participants Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm n=11 Participants Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages poorer than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Mean BKB-SIN SNR-50 Scores	6.9 Signal to noise ratio (SNR) in decibels Standard Deviation 9.3	5.5 Signal to noise ratio (SNR) in decibels Standard Deviation 7.7

SECONDARY outcome

Timeframe: Baseline, 12 months post-stimulation

Population: Subjects who completed the 12-month protocol

The Speech, Spatial, and Qualities of Hearing (SSQ) Scale assesses performance in three domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items), which address sound segregation and listening effort. Each item is rated on a 11-point scale, with 0 as the lowest possible performance and 10 as the highest. Domain scores represent an average of item ratings. There is a version for children that will be used for this study. Lower scores indicate a poorer outcome, and higher scores a better outcome.

Outcome measures

Outcome measures
Measure	EAS Arm n=14 Participants Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm n=11 Participants Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages poorer than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Mean Pediatric SSQ Scores Pre-operative	4.5 score on a scale Standard Deviation 2.3	4.4 score on a scale Standard Deviation 2.1
Mean Pediatric SSQ Scores 12-months post activation	7.1 score on a scale Standard Deviation 2.1	6.7 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 months post-stimulation

Population: Not all participants were tested pre-operatively

Mean receptive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A scores of 100 indicated the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a receptive language delay.

Outcome measures

Outcome measures
Measure	EAS Arm n=13 Participants Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm n=10 Participants Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages poorer than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Receptive Language Scores Pre-operatively	98.8 T-score Standard Deviation 19.5	99.8 T-score Standard Deviation 20.3
Receptive Language Scores 12-months post activation	100.1 T-score Standard Deviation 16.2	89.7 T-score Standard Deviation 22.0

SECONDARY outcome

Timeframe: 12 months post-stimulation

Population: Data reported for all subjects who completed pre-operative testing.

Mean articulation scores as measured by the Goldman-Fristoe Test of Articulation, 3rd edition (GFTA3), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a articulation delay.

Outcome measures

Outcome measures
Measure	EAS Arm n=12 Participants Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm n=10 Participants Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages poorer than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Articulation Scores Pre-operative	86.8 T-score Standard Deviation 14.4	83.6 T-score Standard Deviation 23.2
Articulation Scores 12-months post activation	99.3 T-score Standard Deviation 20.1	88.3 T-score Standard Deviation 18.8

SECONDARY outcome

Timeframe: 12 months post-stimulation

Population: Not all subjects completed pre-operative testing

Mean expressive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of an expressive language delay.

Outcome measures

Outcome measures
Measure	EAS Arm n=13 Participants Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm n=10 Participants Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages poorer than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Expressive Language Scores Pre-operative	96.8 T-score Standard Deviation 17.2	99.7 T-score Standard Deviation 12.2
Expressive Language Scores 12-months post activation	101.9 T-score Standard Deviation 18.0	97.6 T-score Standard Deviation 22.0

Adverse Events

EAS Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

FES Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EAS Arm n=16 participants at risk Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	FES Arm n=12 participants at risk Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of \> 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages poorer than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better.
Ear and labyrinth disorders Pain	6.2% 1/16 • Number of events 1 • From the time of signing informed consent through 12 months post-activation.	0.00% 0/12 • From the time of signing informed consent through 12 months post-activation.

Additional Information

Lisa Park, AuD

The Children's Cochlear Implant Center at UNC

Phone: 919-419-1449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place