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

Recruiting now

Conditions studied: Profound Hearing Loss, Cochlear Implants

In brief

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.

Key facts

Study ID: NCT06051006
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 30
Starts: 2023-12-07
Expected to finish: 2026-01-07
Last updated by the study team: 2025-09-12

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Hôpital Necker-Enfants Malades — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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