Hearing Loss in Children With Unilateral or Bilateral Cochlear ImplantseSRT2NCT07417956
Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
An observational study of Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 7 years
- Conditions the study is for
- Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants
- What is being tested?
- Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2026to 15 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: The target population is pediatric children aged 0 to 7 years followed at a specialized center (Necker Hospital, Paris). In children under 7, cooperation with behavioral testing is often limited, making the use of robust objective markers crucial (Gordon et al., 2004). Pediatric data suggest that eSRT can be measured in the majority of children and corresponds closely to the C-level (Lorens et al., 2004; Bresnihan et al., 2001; Aini, 2022), with recently optimized protocols (Palani et al., 2022; Wolfe et al., 2017). The study includes children with unilateral or bilateral cochlear implants, across all implant manufacturers, reflecting real-world practice. Exclusion of children with unstable middle ear pathology reduces the risk of false-negative eSRT results related to tympano-ossicular transmission.
Who may be able to join
- Child aged 0 to 7 years
- Unilateral or bilateral cochlear implant
- Normal tympanogram
- No objection from either parent or legal guardian
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker Enfants Malades - Service d'ORL et chirurgie cervico-faciale
Paris, Île-de-France Region, 75015
About this study
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.
Read the 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.
- Being tested
- Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement
- Keywords
- Unilateral or bilateral cochlear implants, electrically evoked stapedius reflex threshold (eSRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrically Evoked Stapedius Reflex Threshold (eSRT) MeasurementOther
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 group | Role | What they receive |
|---|---|---|
| eSRT | All enrolled children (0-7 years) with unilateral or bilateral cochlear implants will undergo electrically evoked stapedius reflex threshold (eSRT) measurements during routine post-operative programming sessions at 3, 6, and 12 months. The eSRT measurement is complementary to standard programming procedures and does not replace any routine clinical care. Receives: Other: Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 3, 6, and 12 months post-implantation
Secondary outcomes (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
The variability of eSRT values must be < 5 machine units (MU) between each pair of visits (3↔6, 6↔12, and 3↔12 months).
Measured: 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)
Correlation between CeSRT and free-field tonal thresholds will be evaluated. Associations with speech performance will be assessed using pediatric lists: Boorsmaa for children <4 years and Lafon for children ≥4 years, adjusted to the child's abilities and at the audiologist's discretion.
Measured: 3, 6, and 12 months post-implantation
To document the burden of integrating eSRT into routine clinical practice
eSRT measurement time will be recorded from probe placement to the last usable measurement. Success and failure rates per session will be documented, along with the types of failure causes (non-cooperative child, artifacts, middle ear pathology, equipment/logistics issues).
Measured: 3, 6, and 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Jun 2026
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss in Children With Unilateral or Bilateral Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sabrina BOUZAID, Principal investigator, Hôpital Universitaire Necker - Enfants Malades - Service d'ORL et chirurgie cervico-faciale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417956
- Sponsor's protocol ID
- APHP251668
- Other IDs
- IDRCB
- Acronym
- eSRT2
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
- ClinicalTrials.gov ID
- NCT07417956
- Acronym / sponsor ID
- eSRT2 / APHP251668
- Keywords
- Unilateral or bilateral cochlear implants, electrically evoked stapedius reflex threshold (eSRT)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eSRT | – | Other: Electrically Evoked Stapedius Reflex Threshold (eSRT) MeasurementAll enrolled children (0-7 years) with unilateral or bilateral cochlear implants will undergo electrically evoked stapedius reflex threshold (eSRT) measurements during routine post-operative programming sessions at 3, 6, and 12 months. The eSRT measurement is complementary to standard programming procedures and does not replace any routine clinical care. |
Who may qualify
- Ages
- 0 days to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The target population is pediatric children aged 0 to 7 years followed at a specialized center (Necker Hospital, Paris). In children under 7, cooperation with behavioral testing is often limited, making the use of robust objective markers crucial (Gordon et al., 2004). Pediatric data suggest that eSRT can be measured in the majority of children and corresponds closely to the C-level (Lorens et al., 2004; Bresnihan et al., 2001; Aini, 2022), with recently optimized protocols (Palani et al., 2022; Wolfe et al., 2017). The study includes children with unilateral or bilateral cochlear implants, across all implant manufacturers, reflecting real-world practice. Exclusion of children with unstable middle ear pathology reduces the risk of false-negative eSRT results related to tympano-ossicular transmission.
Key inclusion criteria (4 listed)
- Child aged 0 to 7 years
- Unilateral or bilateral cochlear implant
- Normal tympanogram
- No objection from either parent or legal guardian
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrically Evoked Stapedius Reflex Threshold (eSRT) MeasurementDuring 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 | Other | eSRT |
Primary outcome
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
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).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabrina BOUZAID principal investigator
Hôpital Universitaire Necker - Enfants Malades - Service d'ORL et chirurgie cervico-faciale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina BOUZAID (01 87 89 29 14 ext. +33, sabrina.bouzaid-ext@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.