N/A
N=28
Outcomes in Children With Pre-operative Residual Hearing
High Frequency Sensorineural Hearing Impairment · Hearing Disorders in Children
Bottom Line
View on ClinicalTrials.gov: NCT03379870 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Mean CNC Word Scores — 71.0; 68.4 Percent Correct — p=.768
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting (Device); Electric Acoustic Speech Processor: Full-electric stimulation fitting (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean CNC Word Scores |
71.0; 68.4 | .768 |
| PRIMARY Mean BKB-SIN SNR-50 Scores |
6.9; 5.5 | .529 |
| SECONDARY Mean Pediatric SSQ Scores |
4.5; 4.4; 7.1; 6.7 | .010 sig |
| SECONDARY Receptive Language Scores |
98.8; 99.8; 100.1; 89.7 | >.069 |
| SECONDARY Articulation Scores |
86.8; 83.6; 99.3; 88.3 | .02 sig |
| SECONDARY Expressive Language Scores |
96.8; 99.7; 101.9; 97.6 | .007 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03379870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.