Hearing Loss Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 6
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Audiophonology Unit of the Ear, Nose and Throat (ENT) Department (Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale)
RECRUITING
Paris
Contact Information
Primary
Nathalie LOUNDON, MD, PhD
natalie.loundon@aphp.fr
01 71 39 67 82
Backup
Laure CHOUPEAUX, Project manager
laure.choupeaux@aphp.fr
01 44 38 17 11
Time Frame
Start Date: 2026-03-09
Estimated Completion Date: 2029-04
Participants
Target number of participants: 36
Treatments
Experimental: Cochlear implant
Fitted with a cochlear implant
Active_comparator: CROS or biCROS system
Fitted with a CROS or BiCROS system, depending on the type of hearing loss
Related Therapeutic Areas
Sponsors
Collaborators: URC-CIC Paris Descartes Necker Cochin
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov