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

Condition(s) studied

Investigational drug(s) / intervention(s)

Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement: During routine post-operative programming sessions (at 3, 6, and 12 months), each child will undergo eSRT measurement using a tympanometer placed in the ear canal

Study summary

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.

Eligibility

Primary outcome measure(s)

• To study the stability of eSRT over time at 3, 6, and 12 months: quantifying intra-subject / intra-ear stability of eSRT thresholds throughout follow-up — 3, 6, and 12 months post-implantation
  Success (per session) is defined as obtaining at least 3 usable eSRT measurements distributed across apex, middle, and base (≥1 electrode per third of the array), with a normal tympanogram and meeting the reproducibility criterion (≤5 machine units \[MU\] variation between two attempts on the same electrode).

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France