N/A
Completed N=20
Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
Hearing Loss, Unilateral
Source: ClinicalTrials.gov NCT02963974 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.