N/A
N=20
Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
Hearing Loss, Unilateral
Bottom Line
View on ClinicalTrials.gov: NCT02963974 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing — 1.4; 14.4; 28.2; 45.0 percentage of words correct — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cochlear implant (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing |
1.4; 14.4; 28.2; 45.0; 50.3; 51.8 | < 0.001 sig |
| PRIMARY Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation |
1.8; 0.4; 1.9 | — |
| PRIMARY Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation |
1.6; 2.5; 3.5 | < 0.001 sig |
| PRIMARY Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use |
1.4; 1.7; 4.0 | < 0.001 sig |
| PRIMARY Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation |
14.7; -0.8; 18.8; 19.1 | — |
| PRIMARY Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation |
24.6; 15.8; 27.9; 24.9 | — |
| PRIMARY Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation |
37.7; 20.2; 27.5; 24.9 | — |
| PRIMARY Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation |
35.1; 17.9; 25.8; 21.1 | 0.01911 sig |
| PRIMARY Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire |
1.4; 0.7; 0.6; 0.7; 0.8; 0.9 | < 0.001 sig |
| PRIMARY Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire |
1.9; 0.7; 0.9; 1.4; 1.5; 1.4 | < 0.001 sig |
| PRIMARY Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale |
5.4; 4.6; 1.9; 2.5; -1.0; 4.0 | 0.1009 |
Summary
This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.
Eligibility Criteria
i) Inclusion Criteria
- Unilateral moderate-to-profound sensorineural hearing loss.
- Unaided residual hearing thresholds that yield a pure tone average (PTA) at frequencies 500 Hz, 1 kHz and 2 kHz of ≥70 dB HL in the ear to be implanted. It is possible that subjects may have hearing at other frequencies not included in this average.
- Hearing thresholds in the contralateral ear of ≤25 dB HL
- Between 3 years, 6 mos and 6 years, 6 mos of age at implantation.
- Anatomically normal cochlear nerve
- Cochlear anatomy that is amenable to cochlear implantation as evaluated by imaging (modality at the physician's discretion) including:
- Normal cochlear anatomy or
- Incomplete Partition Type II (IP2) with or without Enlarged Vestibular Aqueduct (EVA) or
- EVA with normal partitioning
- No evidence of progressive hearing loss.
- Willing to undergo 4 week hearing aid trial as warranted based on achieving desired audibility when fitted via real ear desired sensation level (DSL) method.
- Aided word recognition in the ear to be implanted of 30% or less as measured with Consonant Nucleus Consonant (CNC) words (50-word list)
- When listening with an appropriately fit hearing aid and masking applied to the contralateral ear (Turner, 2004).
- Aided testing will be conducted in a sound-proof booth with the participant seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB SPL.
- The hearing aid output will be measured using DSL targets.
- Realistic parental expectations: a verbal acknowledgement of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing.
- Willing to obtain recommended meningitis vaccinations per CDC recommendations.
(9) Development and cognition within the normal range as measured by the Leiter-R test of nonverbal intelligence and cognitive abilities and the Bracken Basic Concept Scale -Revised.
(10) Parental commitment to study parameters including being able and willing to participate in evaluation schedule, involvement in prescribed therapy, and travel to investigational site and study-related activities.
ii) Exclusion Criteria
- English is not primary language of the home
- Speech perception materials are presented in English
- Parental questionnaires are administered in English
- Conductive hearing loss in either ear
- Compromised auditory nerve
- Ossification of the cochlea
- Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
- History of condition that contraindicates middle or inner ear surgery or anesthesia (i.e. otitis media refractory to treatment)
- Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
Data sourced from ClinicalTrials.gov (NCT02963974). 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.