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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,
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.
The Children's Cochlear Implant Center at UNC
Durham, North Carolina, United States
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
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
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
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
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
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
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