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

NCT06930170 | Recruiting

• 2 other identifiers: APHP2206692023-A00003-42
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Unilateral Hearing Loss; Asymmetric Hearing Loss

Keywords

Cochlear implants; unilateral hearing loss; Asymmetric hearing loss

Outcome Measures

Primary Outcomes (1)

• French simplified matrix test (FraSimat) SAABAN condition at Month 18

  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.

  18 months after implantation or fitting

Secondary Outcomes (13)

• French simplified matrix test (FraSimat) SAABAN condition at Month 12

  12 months after implantation or fitting

• French simplified matrix test (FraSimat) S0B0 condition at Month 18

  18 months after implantation or fitting

• French simplified matrix test (FraSimat) S0B0 condition at Month 12

  12 months after implantation or fitting

• Sound localization test (ERKI) Month 12

  12 months after implantation or fitting

• Sound localization test (ERKI) Month 18

  18 months after implantation or fitting

Study Arms (2)

Cochlear implant

EXPERIMENTAL

Fitted with a cochlear implant

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

CROS or biCROS system

ACTIVE COMPARATOR

Fitted with a CROS or BiCROS system, depending on the type of hearing loss

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

Interventions

Cortical Auditory Evoked Potentials (PEAc) DIAGNOSTIC_TEST

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.

CROS or biCROS system; Cochlear implant

Speech, Spatial and Qualities of Hearing Scale (SSQ) OTHER

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.

CROS or biCROS system; Cochlear implant

Peabody Picture Vocabulary Scale (PPVT or EVIP in french) OTHER

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.

CROS or biCROS system; Cochlear implant

NEPSY-II (A Developmental Neuropsychological Assessment) OTHER

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.

CROS or biCROS system; Cochlear implant

Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS) OTHER

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.

CROS or biCROS system; Cochlear implant

Cochlear implantation DEVICE

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

CROS or biCROS system

CROS or BiCROS device fitting DEVICE

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

Cochlear implant

French simplified matrix test (FraSimat) DIAGNOSTIC_TEST

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.

CROS or biCROS system; Cochlear implant

Sound localization test (ERKI) DIAGNOSTIC_TEST

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.

CROS or biCROS system; Cochlear implant

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Unilateral

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Nathalie LOUNDON, MD, PHD

  Unité d'Audiophonologie et d'Implantation cochléaire - Service d'ORL et chirurgie cervico-faciale Hôpital Necker.

  STUDY CHAIR

Central Study Contacts

Nathalie LOUNDON, MD, PhD

CONTACT

01 71 39 67 82; natalie.loundon@aphp.fr

Laure CHOUPEAUX, Project manager

CONTACT

01 44 38 17 11; laure.choupeaux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 16, 2025
• Study Start: March 9, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)