About this trial
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).
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Present a severe neurological pathology before inclusion (which can be identified by an MRI +/- a neuro-pediatric assessment)
Present, on inclusion, a cognitive or psychiatric impairment or severe developmental delay
Be part of a family that does not understand oral French
Patients under AME (State Medical Aid)
Trial design
Treatments tested in this trial
- ESR and ECAP measurements
- Device setting
- Speech audiometry
- Intelligibility in noise test
- Cochlear implant datalogging, speech audiometry test, FraSimat test
Treatment groups
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator