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

Not Applicable

Not yet recruiting

• Conditions: Unilateral Hearing Loss; Asymmetric Hearing Loss

• Registration Number: NCT06930170
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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

Detailed Description

Unilateral congenital deafness has significant repercussions on a child's development. Numerous studies on this population have demonstrated its impact on speech and language development, as well as academic progress. Monaural hearing increases the risk of listening fatigue and causes considerable difficulty in sound localization and speech perception in noisy environments, as these abilities rely on binaural hearing.

Recent research has also indicated that in children with unilateral deafness, the better ear may be affected by sensory deprivation in the impaired ear. Despite these substantial effects, treatment options for these children remain limited. Traditional hearing aids are insufficient to restore functional hearing in cases of profound deafness. The only routinely available options are a Bone-Anchored Hearing Aid (BAHA) or a Contralateral Routing of Sound (CROS) system. While these devices allow the signal from the affected side to be transmitted to the better ear, they do not restore binaural hearing, unlike cochlear implants (CIs).

A growing body of evidence has demonstrated the benefits of cochlear implantation on speech perception in noise and sound localization in adults. However, in France, CIs are currently indicated only for cases of severe to profound unilateral deafness associated with debilitating tinnitus, and only when alternative treatments-such as CROS systems and osseointegrated hearing aids-have failed in children. While studies suggest that children may achieve similar outcomes, no clinical research has been conducted. This study aims to evaluate functional performance and neurological correlates in unilaterally implanted children with unilateral hearing loss, in comparison with their hearing-aided peers

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-04-15
• Study First Posted: 2025-04-16
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Study Start: 2025-06
• Primary Completion: 2029-01
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Child aged 4 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
French simplified matrix test (FraSimat) SAABAN condition at Month 12	12 months after implantation or fitting	Evolution of FraSimat score in Signal to Noise Ratio at 12 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.
French simplified matrix test (FraSimat) S0B0 condition at Month 18	18 months after implantation or fitting	Evolution of FraSimat score in Signal to Noise Ratio at 18 months compared with the value at the pre-intervention visit. It is assessed in the S0B0 condition, i.e. signal and noise at 0° to the head (in front).
French simplified matrix test (FraSimat) S0B0 condition at Month 12	12 months after implantation or fitting	Evolution of FraSimat score in Signal to Noise Ratio at 12 months compared with the value at the pre-intervention visit. It is assessed in the S0B0 condition, i.e. signal and noise at 0° to the head (in front).
Sound localization test (ERKI) Month 12	12 months after implantation or fitting	Evolution of RMSE (root-mean-square deviation) in the ERKI (Assessment of directional hearing for children) test between the pre-intervention visit and Month 12
Sound localization test (ERKI) Month 18	18 months after implantation or fitting	Evolution of RMSE (root-mean-square deviation) in the ERKI (Assessment of directional hearing for children) test between the pre-intervention visit and Month18
Questionnaire Speech, Spatial and Qualities of Hearing Scale (SSQ, version parent)	18 months after implantation or fitting	Evolution of SSQ total score and sub-scores between the pre-intervention visit and Month 18.
Peabody Picture Vocabulary Scale (PPVT or EVIP in french)	18 months after implantation or fitting	Change in standardized PPVT/EVIP score from pre-intervention visit to Month 18
NEuroPSYchological assessment NEPSY-II	18 months after implantation or fitting	Change in NEPSY-II score between pre-intervention visit and Month 18 in patients aged 5 and over at inclusion.
Cortical Auditory Evoked Potentials (PEAc) Month 12	12 months after implantation or fitting	Evolution of latencies and amplitudes between the pre-intervention visit and Month12 for waves P1, N1, P2, N2.; Evolution of the interaural difference in P1 latency between the pre-intervention visit and Month 12 (experimental group only).
Cortical Auditory Evoked Potentials (PEAc) Month 18	18 months after implantation or fitting	Evolution of latencies and amplitudes between the pre-intervention visit and Month18 for waves P1, N1, P2, N2.; Evolution of the interaural difference in P1 latency between the pre-intervention visit and Month 18 (experimental group only).
Quality of life : Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS)	18 months after implantation or fitting	Evolution of the PedsQL MFS total score and sub-scores between the pre-intervention visit and Month18.
Device satisfaction	Up to 18 months after implantation or fitting	Duration of device use via datalogging of implant cochlear or hearing system
Number of adverse events	Up to 18 months after implantation or fitting	Expected implant-related adverse events may include Facial paralysis or paresis, Dizziness, Meningitis, Skin complications, Implant failure The presence of one or more of these effects will be evaluated at each ENT (ear nose throat) assessment.

Trial Locations

Locations (1)

Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale"); 🇫🇷 Paris, France