Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.

NCT06930170 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2026-09-03

Last updated

2026-10-22

Condition(s) studied

Unilateral Hearing LossAsymmetric Hearing Loss

Investigational drug(s) / intervention(s)

Cochlear implantationCROS or BiCROS device fittingFrench simplified matrix test (FraSimat)Sound localization test (ERKI)Cortical Auditory Evoked Potentials (PEAc)Speech, Spatial and Qualities of Hearing Scale (SSQ)Peabody Picture Vocabulary Scale (PPVT or EVIP in french)NEPSY-II (A Developmental Neuropsychological Assessment)Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS)

Cochlear implantation: During surgery at 8 weeks after inclusion, cochlear implant is implanted

CROS or BiCROS device fitting: At 8 weeks after inclusion, CROS or BICROS (depending on the type of hearing loss) is fitting

French simplified matrix test (FraSimat): The FraSimat is an adaptive test that measures speech intelligibility in noise. It consists of 14 sentences of 3 words each, recorded in the presence of background noise. The FraSimat will be performed in two different configurations in relation to the source of the signal and noise before implantation or fitting, and 1, 2, 3 and 4 months after.

Sound localization test (ERKI): ERKI for German "Erfassung des Richtungshörens für Kinder" is an automated test that assesses spatial localization skills. The test is performed with the child seated facing a semi-circular table, surrounded by a set of 5 loudspeakers arranged 1 meter apart. The test consists of 5 stimuli, followed by 42 trials. Following the presentation of each stimulus, the child must turn a control knob and direct the LED light to the point where he or she has perceived it. The child validates his or her response by pressing the button. ERKI is evaluated before implantation or fitting, and 1, 2 and 3 months after.

Cortical Auditory Evoked Potentials (PEAc): The recording of Auditory Cortical Evoked Potentials provides an objective means of assessing the maturation of the auditory system and its ability to process auditory signals. AEPs consist of a series of cortical responses to an auditory stimulus. PEAc are assessed using a non-invasive EEG recording, made under quiet wakefulness. Four surface electrodes are glued to the patient's skull: one on the vertex, one on the forehead, and one on each mastoid. The latency (msec) and amplitude (mV) values of each of the four component waves will be analyzed. PEAc is evaluated before implantation or fitting, and 3 and 4 months after.

Speech, Spatial and Qualities of Hearing Scale (SSQ): The Speech, Spatial and Qualities of Hearing Scale is a questionnaire for subjective evaluation of listening performance in everyday listening situations. The parent version is adapted for parents of hearing-impaired children. SSQ is evaluated before implantation or fitting, and 4 months after.

Peabody Picture Vocabulary Scale (PPVT or EVIP in french): Peabody Picture Vocabulary Scale assesses the extent of French listening vocabulary acquired by the child. The PPVT is designed for patients aged from 2 years and 6 months to 18 years. The raw score is the number of images correctly identified. Peabody Picture Vocabulary Scale is evaluated before implantation or fitting, and 4 months after.

NEPSY-II (A Developmental Neuropsychological Assessment): The NEPSY-II (A Developmental Neuropsychological Assessment) is a battery of neuropsychological tests designed to assess children's skills in 6 major neuropsychological domains. The various tests are validated for the age range indicated in brackets, and will be used for patients aged 5 and over. NEPSY-II is evaluated before implantation or fitting, and 4 months after.

Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS): PedsQL MFS is a questionnaire used to assess subjective experiences of fatigue. The questionnaire consists of 18 items The parent version is adapted for parents of hearing-impaired children. PedsQL MFS is evaluated before implantation or fitting, and 4 months after.

Study summary

Today, unilateral hearing loss must be assessed and managed just as bilateral hearing loss is. It is recommended to consider the auditory difficulties caused by the loss of stereophonic hearing and to offer auditory rehabilitation as early as possible. Studies show that hearing devices can be effective in certain cases and for specific auditory modalities. The prognostic factors for successful hearing aid adaptation are linked to early intervention and the presence of residual hearing (using a BiCROS system). However, the cochlear implant remains the only device capable of potentially restoring contralateral auditory function in cases of single-sided deafness (SSD) and severe to profound unilateral hearing loss with asymmetrical deafness

Eligibility

Sex

ALL

Min age

2 Years

Max age

6 Years

Healthy volunteers

Inclusion Criteria: * Child aged 2 to 6 years at the time of inclusion * Using spoken French as the primary mode of communication * Diagnosed with unilateral or asymmetric hearing loss : Unilateral is defined by severe to profound hearing loss in the affected ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and normal hearing in the better ear (thresholds ≤ 25 dB between 500-4000 Hz, established by audiometry or ASSR). Asymmetric is defined by severe to profound hearing loss in the weaker ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and mild hearing loss in the better ear (thresholds between 30-40 dB at ≤ 4 frequencies, established by audiometry or ASSR). * Written informed consent from both legal guardians (or the sole guardian, if applicable) * Affiliated with a health insurance system or entitled to coverage Exclusion Criteria: * Severe neurological disorder, identified by MRI and/or a neuro-pediatric assessment * Severe cognitive, child psychiatric, or developmental delay * Severe cochleo-vestibular malformation * Severe cochlear nerve malformation * Social circumstances preventing long-term follow-up * Family not proficient in spoken French * Patient fitted with a CROS or BiCROS system * Patient with a contraindication to implantation surgery or anesthesia (including lack of meningitis/pneumococcal vaccination)

Primary outcome measure(s)

French simplified matrix test (FraSimat) SAABAN condition at Month 18 — 18 months after implantation or fitting
The primary endpoint is intervention success, defined as an increase ≥ 6dB SNR (Signal-to-Noise Ratio) at 18 months compared with the value at the pre-intervention visit. It is assessed in the SAABAN condition, i.e. by presenting the signal (speech) to the better ear and the noise to the better ear.

Trial sites (1)

Facility	City	Region	Status
Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale")	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06930170 on ClinicalTrials.gov ↗ ← All trials in France