Status:

RECRUITING

The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

URC-CIC Paris Descartes Necker Cochin

Conditions:

Profound Hearing Loss

Cochlear Implants

Eligibility:

All Genders

8-17 years

Brief Summary

One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (...

Detailed Description

One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (...

Eligibility Criteria

Inclusion

  • Patients between the ages of 8-17 years at the time of inclusion with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades
  • Use oral French as the main mode of communication
  • Have a tonal threshold with the cochlear implant of 40 dB or more
  • Have a normal tympanogram
  • Have a voice threshold of less than 70% at 30dB HL
  • Information and non-opposition of holders of parental authority and minor patients to participate in the study

Exclusion

  • Present a severe neurological pathology before inclusion (which can be identified by an MRI +/- a neuro-pediatric assessment)
  • Present, on inclusion, a cognitive or psychiatric impairment or severe developmental delay
  • Be part of a family that does not understand oral French
  • Patients under AME (State Medical Aid)

Key Trial Info

Start Date :

December 7 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 7 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06051006

Start Date

December 7 2023

End Date

January 7 2026

Last Update

September 12 2025

Active Locations (1)

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Hôpital Necker-Enfants Malades

Paris, France, 75015