Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results (ImplantHear3)

The objective of the study is to compare the responses recorded with automated cortical auditory evoked potentials, of children who had one or two cochlear implants for 3 years, and the results of the speech therapy assessment.

24 patients in the main ImplantHear3 study presented with disappointing language development or poor cortical responses. These patients will be followed up once a year, during a visit scheduled for the usual care, until 6 years post-implant, in order to make it possible to objectify the quality of the auditory rehabilitation received by the child.

Study Overview

• Status: Completed
• Conditions: Cochlear Implantation
• Intervention / Treatment: Other: Cortical auditory evoked potentials; Other: Additional exams

Detailed Description

Children with severe to profound deafness can benefit from cochlear rehabilitation, combined with a speech-language therapy. At present, 70 to 80% of children with congenital - profound deafness who are implanted at an early age will have a language level identical to their hearing peers. But 20 to 30% of them will be able to present linguistic difficulties.

The objective recording of the cortical activity in response to a sound stimulus gives a proof of the quality of the auditory stimulation that is perceived by the cortex, an essential condition for the further linguistic development of the child. By the use of complex stimuli of speeching type, all the channels involved in the auditory processing are analyzed.

The recording in routine clinical practice of the cortical auditory evoked potentials in response to a vocal stimulus makes it possible to objectify the quality of the auditory rehabilitation received by the child.

The implanted children all benefit from regular and prolonged speech therapy follow-up, with a complete evaluation every year. It is important to regularly monitor the linguistic evolution of young children who are implanted in order to identify children at risk of poorer linguistic development at an early age.

The objective of the study is to compare the responses recorded with automated cortical auditory evoked potentials, of children who had one or two cochlear implants for 3 years, and the results of the speech therapy assessment.

24 patients in the main ImplantHear3 study presented with disappointing language development or poor cortical responses. These patients will be followed up to 6 years post-implant by carrying out, during a visit scheduled for patient care, once a year for 3 years:

• Recording of automated cortical auditory evoked potentials in response to a vocal stimulus, as performed for the main study, but also :
• Recording of cortical auditory evoked potentials in response to a click
• Realization of electrical potentials via the implant And this in order to make it possible to objectify the quality of the auditory rehabilitation received by the child.

The objectives of the ancillary study are :

Comparison of the responses recorded to automated cortical auditory evoked potentials, of children who have had one or two cochlear implants for 4 years, with the results of speech therapy and up to 6 years post-implant.

Look for prognostic factors of poor linguistic development: correlate the electrophysiological results, the adjustment parameters, the modalities of hearing rehabilitation, the side of the cochlear implantation, and the audiometric thresholds with the results of the speech therapy assessment.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 13 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children implanted for 3 years, in unilateral or bilateral and followed in the pediatric otolaryngology department of the Necker-Enfants Malades Hospital in Paris.

Description

Inclusion Criteria:

• Patients aged 42 months to 17 years on the day of inclusion.
• Patient who has received one or two cochlear implants between August 1, 2016 and November 1, 2017 and after 3 years of follow-up for the first implant.
• Non-opposition of the holders of the parental authority and the patient.

Exclusion Criteria:

• Patients over 15 years of age at implantation.
• Patient relocated between August 1, 2016 and November 1, 2017.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Children implanted cochlear since 3 years in uni or bilateral and followed in the pediatric otolaryngology department of Necker-Enfants Malades Hospital.	Other: Cortical auditory evoked potentials; Recording of automated cortical auditory evoked potentials in response to a vocal stimulus.
Patients with disappointing language development or poor cortical responses; Children having participated in the main ImplantHear3 study and who present with disappointing language development or poor cortical responses.	Other: Additional exams; Cortical auditory evoked potentials Recording of automated cortical auditory evoked potentials in response to a vocal stimulus.; Recording of cortical auditory evoked potentials in response to a click; Realization of electrical potentials via the implant Followed up once a year during a visit scheduled for usual care, for 3 years, that to say up to 6 years post-implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Automated cortical auditory evoked potentials results	Latency and amplitude of the waves P1, N1, P2, N2.	Annual assessment performed during 3 years.
Speech therapy result	Percentage of recognition Open Set Words : cochlear implant 1,; cochlear implant 2,; 2 cochlear implants together,; cochlear implant and hearing aid together.	Annual assessment performed during 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of p (HearLab)	Analysis of the automatic validation by HearLab: value of p, for each vocal stimulus / m /, / g /, / t /, and / s / as a function of the intensity : 55, 65, 75 Db.	Annual assessment performed during 3 years.
Latencies P1, N1, P2, N2 (HearLab)	Study of the latencies P1, N1, P2, N2 by HearLab, as a function of the stimulus / m /, / g /, / t /, and / s /, intensity : 55, 65, 75 dB and age.	Annual assessment performed during 3 years.
Amplitudes P1, N1, P2, N2 (HearLab)	Study of the amplitudes P1, N1, P2, N2 by HearLab, as a function of the stimulus / m /, / g /, / t /, and / s /, intensity : 55, 65, 75 dB and age.	Annual assessment performed during 3 years.
Setting parameters	Active electrode number, minimum thresholds and comfort, dynamic, on each side, pulse width and frequency.	Annual assessment performed during 3 years.
Auditory rehabilitation	- Type of auditory rehabilitation : uni or bilateral cochlear implant : if bilateral cochlear implant : sequential or simultaneous, if unilateral cochlear implant : side, contralateral hearing aid (yes or no),; age at implantation (for each side if bilateral); cochlear implant Device; electrode; datalogging for each cochlear implant : never/ <6 hours/ 6-9hours/>10 hours,; hearing aid device.	Annual assessment performed during 3 years.
Residual hearing level	Auditory level without devices : right Ear : 250, 500, 1000, 2000, 4000 Hz, left Ear : 250, 500, 1000, 2000, 4000 Hz.	Annual assessment performed during the year of the 3 years following cochlear implantation.
Deafness characteristics	age at the diagnosis,; age at the beginning of deafness,; etiology of the deafness,; syndromic deafness or not.	Annual assessment performed during the year of the 3 years following cochlear implantation.
Latencies P1, N1, P2, N2	Study of the latencies P1, N1, P2, N2 by cortical auditory evoked potentials results (in response to click)	Annual assessment performed during 3 years.
Amplitudes P1, N1, P2, N2	Study of the amplitudes P1, N1, P2, N2 by cortical auditory evoked potentials results (in response to click)	Annual assessment performed during 3 years.
Latency study of the wave V	Electrical evoked potentials results via the implant	Annual assessment performed during 3 years.
Amplitude study of the wave V	Electrical evoked potentials results via the implant	Annual assessment performed during 3 years.
Stimulation level and pulse duration required to generate a wave V	Electrical evoked potentials results via the implant	Annual assessment performed during 3 years.

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Natalie Loundon, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Isabelle Rouillon, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): April 13, 2024
• Study Completion (Actual): April 13, 2024

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Children; Cochlear implantation; Automated cortical auditory evoked potentials; Speech-language therapy; Cortical auditory evoked potentials; Electrical potentials via the implant
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Communication Disorders
• Other Study ID Numbers: APHP190839; 2019-A02402-55 (Other Identifier: ID RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No