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Electrophysiological-based Estimation of Cochlear Implant Fitting

NCT02748915 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-12-19

No results posted yet for this study

Summary

The primary objective of this research is to evaluate the relationships between multiple data from cochlear implant (CI) adult users to and to estimate predictive models of their fitting parameters. In a group of patients, the Electrically-evoked Compound Action Potentials (ECAP) will be collected intra-operatively and the correlation with demographic data (deafness duration, age deafness onset, etiology, duration of cochlear implant use of CI), auditory performances and subjective measures used for implant fitting (hearing threshold and most comfortable level) will be calculated. In a second group of experienced users (more than 9months of use of their CI), ECAP and Electrically-evoked Auditory Brainstem Response (EABR) will be collected after 9 months of CI experience and after 12 months or more of use. Correlation analyzes with demographic data, performance and fitting parameters will be performed as well. Statistical predictive models for both fitting at the activation or in experienced users should be developed according to the correlation analysis.

The secondary objective is to evaluate the effects of simultaneous stimulation on hearing performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and compared in the different conditions.

Conditions

  • Cochlear Implants

Interventions

OTHER

Electrophysiological and psychoacoustic tests

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Eric TRUY, Professor · Hospices Civils de Lyon

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-26
Primary Completion
2020-06-04
Completion
2020-06-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02748915 on ClinicalTrials.gov