NCT07371299

Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation

Multimodal Objective Measures Help Cochlear Implant Programming: Cross-sectional and Prospective Study Focusing on the Correlations Between eSRT, Behavioural and Other Objective Responses (eABR, eCAP)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cochlear implants have been used for several decades, with major technological advances. However, adjustment can be difficult for patients who have to get used to a new sound that is electrical rather than acoustic. In general, adjustment is based on the patient's responses: the patient must inform the technician of their sensations in order to determine the sound level that is comfortable for them (MCL: maximum comfortable level). The adjustment therefore depends on a subjective assessment. The aim of the adjustments is to make the sound pleasant while increasing the stimulation level to the maximum tolerated level in order to achieve good listening dynamics. Objective indicators would therefore be useful in improving the accuracy of the adjustments. The objective measurements that can be taken are: * Electrical compound action potentials (eCAP) * Electrical auditory brainstem response (eABR) * Electrical stapedius reflex threshold (eSRT).

Detailed description

Observational study of adult patients who are going to receive or have received a cochlear implant. In fact, two groups of patients will be studied: Incident case cohort: patients included in the cohort will be followed for one year after surgery. Data will be collected at each postoperative follow-up visit (M1, M3, M6, M9, M12) to monitor their progress. Each objective measurement will be taken on at least three electrodes: on the left, right, and central electrodes. Data will be collected at each postoperative follow-up visit (M1, M3, M6, M9, M12) in order to monitor their progress. Each objective measurement will be taken on at least three electrodes: on the basal, median, and apical parts of the electrode array. Stimulation will be configured using the software normally used to adjust the implant. Responses are collected: * for eCAPs: via the same software * for eABRs: using an auditory evoked potential recording device synchronized with the implant stimulations * for eSRTs: using a tympanometer with the probe inserted into the external auditory canal on the same side or the opposite side to the stimulation. Cross-sectional sample of prevalent cases: The same measurements will be taken in patients who had a cochlear implant some time ago (evaluation more than one year after surgery). The measurements will be taken only once during their annual check-up. This population will enable us to compare data from patients who have recently had an implant with data from a population that already has a minimum of experience and adaptation to the implant.

Conditions

• Severe to Profound Sensorineural Hearing Loss

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Objective electrophysiological measures (eCAP, eABR, eSRT)	Non-invasive electrophysiological recordings obtained during/after routine cochlear-implant programming, using standard clinical equipment: eCAP via CI software, eABR via an evoked-potential system synchronized with the implant, and eSRT via tympanometry. No investigational device or randomization. Measurements are collected for observational correlations with behavioral levels. Schedule: incident cohort at M1, M3, M6, M9, M12; prevalent cohort single annual visit.

Timeline

• Start date: 2026-01-15
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2026-01-27
• Last updated: 2026-01-27