Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement.
- Who it may be relevant to
- Registry conditions: Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants. Basic parameters: 0 Days — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Cochlear implant programming relies on determining the patient's auditory dynamic range. This corresponds to identifying, for each electrode, the threshold of first perception (T-level) and the most comfortable level of stimulation (C-level or MCL), which defines the functional stimulation range. Different implant manufacturers (Advanced Bionics, Cochlear, Med-El, Oticon Medical) provide specific recommendations for estimating these upper stimulation levels.
Programming can be performed using behavioral measures or objective measures. Behavioral methods, based on patient responses, are widely used in adults. In children and in patients with associated pathologies, behavioral measures are often difficult due to limited auditory experience and potential confusion between loudness and pitch perception.
Therefore, objective measures are recommended in pediatric populations to assist in programming. ECAP/EAP measures are commonly used but show variable performance depending on the measure and implant manufacturer
Another objective measure, the electrically evoked stapedius reflex threshold (eSRT), shows a strong relationship with comfort levels (C-level/MCL) in both adults and children. eSRT appears to be a relevant tool for guiding programming, especially when subjective measures are limited. Recent studies have optimized the protocol (probe frequencies, reproducibility criteria) and confirmed its feasibility , including in pediatric populations using high-frequency probes (Palani et al., 2022) and normative data in children (Aini, 2022). Combined approaches using ECAP and eSRT to estimate C-levels/MCL are also emerging in pediatric programming .
Functionally, better estimation of the comfort level improves auditory accessibility, which is associated with enhanced speech perception and vocal performance. Over the long term, this supports faster language development in children implanted early.
Our previous eSRT study in children over 8 years old demonstrated a strong correlation between C-subjective and C-eSRT thresholds, and improved speech intelligibility (particularly in noise, FraSiMat) with eSRT-guided maps. These findings support the integration of eSRT into routine programming for pediatric populations.
Interventions
- Other 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
Primary outcome measures
- 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 [Time frame: 3, 6, and 12 months post-implantation]
Secondary outcome measures (3)
- 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 [Time frame: 3, 6, and 12 months post-implantation]
- To study the correlation between CeSRT and free-field tonal thresholds; association with speech performance (pediatric lists: Boorsmaa <4 years; Lafon ≥4 years - adjusted to the child's abilities; at the audiologist's discretion) [Time frame: 3, 6, and 12 months post-implantation]
- To document the burden of integrating eSRT into routine clinical practice [Time frame: 3, 6, and 12 months post-implantation]
Eligibility criteria
Inclusion criteria
- Child aged 0 to 7 years
- Unilateral or bilateral cochlear implant
- Normal tympanogram
- No objection from either parent or legal guardian
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Necker Enfants Malades - Service d'ORL et chirurgie cervico-faciale — Paris
Identifiers
NCT: NCT07417956 · APHP251668 · IDRCB