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

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

Interventions

DEVICE

Cochlear implantation

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

DEVICE

CROS or BiCROS device fitting

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Nathalie LOUNDON, MD, PHD · Unité d'Audiophonologie et d'Implantation cochléaire - Service d'ORL et chirurgie cervico-faciale Hôpital Necker.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-09

Primary Completion

2029-01-31

Completion

2029-04-30

Countries

• France

Study Locations