Taking people in FranceNo phase

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

Key facts

Who runs it: Assistance Publique - Hôpitaux de Paris
Where: Paris, FranceSee the site
Trial code: NCT06051006
Status: Recruiting
People taking part: 30 people, planned
Started: 7 Dec 2023
Planned end: 7 Jan 2026
Type of study: Observational
Treatments tested: ESR and ECAP measurements
Device setting
Speech audiometry
Intelligibility in noise test
Cochlear implant datalogging, speech audiometry test, FraSimat test
Record updated: 12 September 2025

Who can take part

Age: 8 years to 17 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 8 and 17 years old?

Where in France

Hopital Necker Enfants MaladesParis, FranceContact: Nara Vaez-LeppinTaking people

About the trial

What the trial wants to find out

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 (= C-Subjective). Currently, to define this C-Subjective level, patients are presented with a loudness scale and must indicate whether the sound stimulus, sent via the implant, is soft, comfortable, or loud. The lower and upper stimulation levels must be determined for each electrode in order to program the implant. For many patients this can be difficult due to a lack of auditory experience and confusion between the sensation of sound intensity (weak or loud) and frequency (low or high).

Read full original descriptionShow less

A less commonly used but more objective approach to programming upper stimulation levels involves the use of the electrical stapedial reflex threshold (eSRTs) value. eSRTs are a promising measure, given the demonstrated correlation between the threshold that generates a stapedial reflex and the C-subjective level. Furthermore, eSRTs can be recorded in the majority of patients, and can typically be evoked at a comfortable stimulation level i.e. inferior to the uncomfortable level.

The main objective of this study is investigate the link between subjective comfort levels (C-subjective levels) and the eSRT.

The group in the trial

Patients
Minor patients from 8 years with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades.
Treatment: ESR and ECAP measurements, Device setting, Speech audiometry, Intelligibility in noise test, and Cochlear implant datalogging, speech audiometry test, FraSimat test