Hearing Disorders in Children, High Frequency Sensorineural Hearing Impairment
Conditions
Keywords
cochlear implant, electric acoustic stimulation, EAS, hearing loss, pediatric
Brief summary
Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low frequency residual hearing. Subjects in Arm 1 (EAS Arm; electric-acoustic stimulation) will present with a post-operative low frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 (FES Arm; full-electric stimulation) will present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL. Procedures (methods): Subjects will complete speech perception and quality of life testing during post-operative intervals. Subjects in the EAS Arm will be evaluated with combined electric-acoustic stimulation (EAS). Subjects in FES Arm will be evaluated with FES alone.
Detailed description
As children with more residual hearing are receiving cochlear implants (CIs), there is an opportunity to preserve that hearing and provide combined electric and acoustic stimulation (EAS). The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. Specifically, the investigators intend to compare speech understanding using EAS and traditional full electric stimulation. While hearing preservation rates are good, they are not guaranteed. Children with progressive hearing loss may continue to lose hearing, even if they maintain some residual hearing immediately after surgery. As a secondary aim, the investigators intend to study outcomes in children who do not maintain residual hearing and are fit with traditional CI programming methods. Children with more residual hearing are being implanted, and this study design allows validation of outcomes in both populations. Subject enrollment will occur on the initial stimulation date. Those who have maintained a low frequency hearing average of 75 dB HL or better will be fit with a SONNET EAS or SONNET 2 EAS device using combined acoustic and electric stimulation. Those who have not maintained low frequency hearing will be fit with a SONNET EAS or SONNET 2 EAS device using electric stimulation only. Subjects will be followed at regular intervals throughout the year duration of the study and will be tested on measures of speech understanding in quiet, speech understanding in noise, quality of life, and discrimination of prosody or pitch changes.
Interventions
DEVICEElectric Acoustic Speech Processor: Electric-acoustic stimulation fitting
Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,
DEVICEElectric Acoustic Speech Processor: Full-electric stimulation fitting
Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.
Sponsors
Med-El Corporation
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Months to 215 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 5 through 17 years * Spoken English as the primary language (speech perception testing conducted in English). * Recipient of a MED-EL SYNCHRONY Cochlear Implant device. * Pre-operative LFPTA of ≤ 75 dB HL. * Willing and able to participate in study procedures. * Realistic parental/patient expectations. * Language skills judged to be adequate enough to perform study tasks.
Exclusion criteria
* Inability to perform open set speech perception due to oral motor delays. * Inability to perform test battery due to behavior or cognitive impairment * Unwilling or unable to participate in study procedures. * Cochlear nerve deficiency. * Anatomical considerations that necessitated surgical modifications such as ossification, incomplete insertion, or placement in scala vestibuli.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean CNC Word Scores | 12 months post stimulation | 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% |
| Mean BKB-SIN SNR-50 Scores | 12 months post-stimulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pediatric SSQ Scores | Baseline, 12 months post-stimulation | 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. |
| Receptive Language Scores | 12 months post-stimulation | 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. |
| Articulation Scores | 12 months post-stimulation | 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. |
| Expressive Language Scores | 12 months post-stimulation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EAS Arm 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. | 14 |
| 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: 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. | 11 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | EAS Arm | FES Arm | Total |
|---|---|---|---|
| Age, Continuous | 9.9 years STANDARD_DEVIATION 3.9 | 10.5 years STANDARD_DEVIATION 3.3 | 10.2 years STANDARD_DEVIATION 3.6 |
| Post-operative Low Frequency Pure Tone Average (PTA) at Enrollment | 46.2 Decibels (dB) STANDARD_DEVIATION 14.5 | 85.8 Decibels (dB) STANDARD_DEVIATION 16.4 | 63.6 Decibels (dB) STANDARD_DEVIATION 25.1 |
| Pre-operative Low Frequency Pure Tone Average (PTA) | 29.9 Decibels (dB) STANDARD_DEVIATION 17.8 | 57.5 Decibels (dB) STANDARD_DEVIATION 11.6 | 43.1 Decibels (dB) STANDARD_DEVIATION 20.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 18 Participants |
| Region of Enrollment United States | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 12 |
| other Total, other adverse events | 1 / 16 | 0 / 12 |
| serious Total, serious adverse events | 0 / 16 | 0 / 12 |
Outcome results
Primary
Mean BKB-SIN SNR-50 Scores
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.
Time frame: 12 months post-stimulation
Population: Subjects who completed the 12-month protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EAS Arm | Mean BKB-SIN SNR-50 Scores | 6.9 Signal to noise ratio (SNR) in decibels | Standard Deviation 9.3 |
| FES Arm | Mean BKB-SIN SNR-50 Scores | 5.5 Signal to noise ratio (SNR) in decibels | Standard Deviation 7.7 |
p-value: 0.529Mixed Models Analysis
Primary
Mean CNC Word Scores
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%
Time frame: 12 months post stimulation
Population: Subjects who completed the 12-month protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EAS Arm | Mean CNC Word Scores | 71.0 Percent Correct | Standard Deviation 18 |
| FES Arm | Mean CNC Word Scores | 68.4 Percent Correct | Standard Deviation 26 |
p-value: 0.768Mixed Models Analysis
Secondary
Articulation Scores
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.
Time frame: 12 months post-stimulation
Population: Data reported for all subjects who completed pre-operative testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EAS Arm | Articulation Scores | Pre-operative | 86.8 T-score | Standard Deviation 14.4 |
| EAS Arm | Articulation Scores | 12-months post activation | 99.3 T-score | Standard Deviation 20.1 |
| FES Arm | Articulation Scores | Pre-operative | 83.6 T-score | Standard Deviation 23.2 |
| FES Arm | Articulation Scores | 12-months post activation | 88.3 T-score | Standard Deviation 18.8 |
p-value: 0.02Mixed Models Analysis
Secondary
Expressive Language Scores
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.
Time frame: 12 months post-stimulation
Population: Not all subjects completed pre-operative testing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EAS Arm | Expressive Language Scores | Pre-operative | 96.8 T-score | Standard Deviation 17.2 |
| EAS Arm | Expressive Language Scores | 12-months post activation | 101.9 T-score | Standard Deviation 18 |
| FES Arm | Expressive Language Scores | Pre-operative | 99.7 T-score | Standard Deviation 12.2 |
| FES Arm | Expressive Language Scores | 12-months post activation | 97.6 T-score | Standard Deviation 22 |
p-value: 0.007Mixed Models Analysis
Secondary
Mean Pediatric SSQ Scores
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.
Time frame: Baseline, 12 months post-stimulation
Population: Subjects who completed the 12-month protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EAS Arm | Mean Pediatric SSQ Scores | Pre-operative | 4.5 score on a scale | Standard Deviation 2.3 |
| EAS Arm | Mean Pediatric SSQ Scores | 12-months post activation | 7.1 score on a scale | Standard Deviation 2.1 |
| FES Arm | Mean Pediatric SSQ Scores | Pre-operative | 4.4 score on a scale | Standard Deviation 2.1 |
| FES Arm | Mean Pediatric SSQ Scores | 12-months post activation | 6.7 score on a scale | Standard Deviation 1.9 |
p-value: 0.01Mixed Models Analysis
Secondary
Receptive Language Scores
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.
Time frame: 12 months post-stimulation
Population: Not all participants were tested pre-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EAS Arm | Receptive Language Scores | 12-months post activation | 100.1 T-score | Standard Deviation 16.2 |
| EAS Arm | Receptive Language Scores | Pre-operatively | 98.8 T-score | Standard Deviation 19.5 |
| FES Arm | Receptive Language Scores | Pre-operatively | 99.8 T-score | Standard Deviation 20.3 |
| FES Arm | Receptive Language Scores | 12-months post activation | 89.7 T-score | Standard Deviation 22 |
p-value: >0.069Mixed Models Analysis