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

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

December 7, 2023

Primary Completion Date

January 7, 2026

Study Completion Date

January 7, 2026

Conditions
Profound Hearing LossCochlear Implants
Interventions
OTHER

ESR and ECAP measurements

"Measurement of electrically evoked stapedial reflexes (ESRT) by stimulation via the cochlear implant. Measurement of the Electric compound action potentials (ECAPs) on the electrodes where the ESRT were performed.~The measurements and tests will be performed during a routine visit to the Necker hospital for the adjustment of the cochlear implant (visit 1)."

OTHER

Device setting

"The adjustment will be made by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. The purpose of this setting is to modify the comfort thresholds using the ESR via a correction (according to the literature). The cochlear implant (CI) will therefore be set with the setting using the ESR (setting 2). The basic setting (setting 1) will be stored in memory in the CI. If ever the patient does not support setting 2, he/she will have the possibility of returning to the basic setting, without having to return to the Necker hospital for an additional setting.~The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1)."

OTHER

Speech audiometry

"This examination is part of the usual care for a patient with a cochlear implant. Fournier's monosyllabic test will be used. The test will be carried out by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. The measurement will be performed under both setting conditions: setting 1 (current setting) and setting 2 (based on ESR). The order of administration will be randomized in order to overcome a training effect.~The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1)."

OTHER

Intelligibility in noise test

"The FraSimat is a measure of speech perception in noise. The test consists of 14 sentences of 3 words, recorded in the presence of background noise, which the child must listen to and repeat. The background noise remains fixed at 65dB HL and the speech intensity adapts according to the patient's responses. The measurement will be performed under two setting conditions: MAP 1 (current setting) and MAP 2 (setting based on ESR). The order of administration will be randomized in order to overcome a training effect.~The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1)."

OTHER

Cochlear implant datalogging, speech audiometry test, FraSimat test

"The follow-up visit (visit 2) will take place 1 month after visit 1 only for patients with a comfort levels threshold (via the eSRT) different from the current threshold (C-subjective).~At the start of the visit, cochlear implant datalogging will be recorded to determine the use of both settings (setting 2, using the ESR and setting 1, basic setting) while wearing the cochlear implant.~The datalogging will be recorded by an audioprosthetist at the Center for Research in Audiology at Necker Hospital.~If the patient has worn the new program (setting 2), the speech audiometry test and the FraSimat test (Intelligibility in noise test) will be performed again with the setting based on ESR."

Trial Locations (1)

75015

RECRUITING

Hôpital Necker-Enfants Malades, Paris

All Listed Sponsors
collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06051006 - The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping | Biotech Hunter | Biotech Hunter