Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center

Recruiting now

Conditions studied: Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants

In brief

In children aged 0 to 7 years, behavioral evaluation during cochlear implant programming is often difficult or unreliable. Objective, reproducible, and rapid markers are therefore essential. While objective measures such as ECAP (electrically evoked compound action potentials) help guide safe programming, they can show inter-electrode and inter-subject variability. Electrically evoked stapedius reflex threshold (eSRT) has emerged as a relevant objective marker to approximate the comfort level of stimulation. Pediatric studies indicate that eSRT can be measured in the majority of children, closely corresponds to the comfort level, and is associated with improved speech outcomes when programming is guided by eSRT. In our previous single-center study in children aged 8 to 17 years (N=30; 44 implanted ears), eSRT was obtained in 83.3% of patients, with strong correlation between C-subjective and C-eSRT thresholds (r\>0.94; p\<0.001) across all electrodes. Tonal performance remained stable, and speech intelligibility, particularly in noise (FraSiMat), significantly improved with an eSRT-based program after one month of habituation. Daily device use remained stable, reflecting good clinical acceptability. These results support the relevance of systematic integration of eSRT in routine programming. The aim of the eSRT2 study is to evaluate the feasibility and reliability of eSRT measurement in real-world clinical care for children aged 0 to 7 years, and to monitor its stability during post-operative follow-up. Improved auditory accessibility and better-controlled acoustic comfort through eSRT are expected to accelerate speech development in children by enabling earlier improvements in vocal performance and intelligibility.

Key facts

Study ID

NCT07417956

Run by

Assistance Publique - Hôpitaux de Paris

People needed

48

Starts

2026-06-15

Expected to finish

2029-08-15

Last updated by the study team

2026-08-10

Who can join

Age: any, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Child aged 0 to 7 years
• Unilateral or bilateral cochlear implant
• Normal tympanogram
• No objection from either parent or legal guardian

You may not qualify if…

• Severe neurological disorder present before inclusion (identifiable by MRI and/or pediatric neurological assessment)
• Unstable middle ear pathology on the day of inclusion (e.g., acute serous otitis, tympanic membrane perforation)
• Documented abnormality or lesion of the facial nerve or stapedius muscle
• Severe cognitive, psychiatric, or developmental delay at the day of inclusion
• Family not fluent in oral French.

Where it is running

• Hôpital Necker Enfants Malades - Service d'ORL et chirurgie cervico-faciale — Paris, Île-de-France Region, France (enrolling)

Full record on ClinicalTrials.gov

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