Profound Hearing LosseSRTNCT06051006
The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping
An observational study of Profound Hearing Loss and Cochlear Implants, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Profound Hearing Loss, Cochlear Implants
- What is being tested?
- ESR and ECAP measurements, Device setting and Speech audiometry
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2023to 7 Jan 2026
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor patients from 8 years with cochlear implants for at least 1 year and followed by a physician at Hôpital Necker-Enfants malades.
Who may be able to join
- 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
Who cannot join
- 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)
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
Paris, 75015
Nara Vaez-Leppin, 0187892914 ext. +33, Nara.vaez-leppin@aphp.fr
Sabrina Bouzaid
About this study
Official title: The Value of Electrical Stapedial Reflex Thresholds (eSRTs) in Determining Upper Stimulation Levels in Cochlear Implant Maps
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.
Read the detailed description
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).
For these patients, the adjustment is often based on the dynamic range recommended by the manufacturer in relation to the threshold (lower stimulation level) and/or on the discomfort level (upper stimulation level).
Objective measures such as ECAPs (Electric compound action potentials) are commonly used to estimate upper stimulation levels.
These measurements are useful for confirming electrode function and neuronal response, and some research has shown that these measures are correlated with the upper stimulation level. However, other studies suggest that ECAPs are poor predictors of high (and low) stimulation levels and can show variability between electrodes and between subjects.
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 patient settings are known as the MAP, where the upper and lower levels of stimulation are defined.
MAPs using eSRTs to set upper stimulation levels (C-eSRT) have been shown equal or better speech recognition results compared to behavior-based MAPs (intensity scale). Additionally, eSRT-based MAPs have been shown to result in equal sound intensity across all electrodes, and patients tend to prefer eSRT-based MAPs over behavioral MAPs.
The main objective of this study is investigate there is a link between subjective comfort levels (C-subjective levels) and the eSRT.
- Conditions
- Profound Hearing Loss, Cochlear Implants
- Being tested
- ESR and ECAP measurements, Device setting, Speech audiometry, Intelligibility in noise test, Cochlear implant datalogging, speech audiometry test, FraSimat test
- Keywords
- Profound hearing loss, Cochlear implants, Cochlear implant programming, Stapedial reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESR and ECAP measurementsOther
Measurement of electrically evoked stapedial reflexes (ESRT) by stimulation via the cochlear implant. Measurement of the Electric compound action potentials (ECAPs) on the electrodes where the ESRT were performed.
The measurements and tests will be performed during a routine visit to the Necker hospital for the adjustment of the cochlear implant (visit 1).
Device settingOther
The adjustment will be made by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. The purpose of this setting is to modify the comfort thresholds using the ESR via a correction (according to the literature). The cochlear implant (CI) will therefore be set with the setting using the ESR (setting 2). The basic setting (setting 1) will be stored in memory in the CI. If ever the patient does not support setting 2, he/she will have the possibility of returning to the basic setting, without having to return to the Necker hospital for an additional setting.
The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1).
Speech audiometryOther
This examination is part of the usual care for a patient with a cochlear implant. Fournier's monosyllabic test will be used. The test will be carried out by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. The measurement will be performed under both setting conditions: setting 1 (current setting) and setting 2 (based on ESR). The order of administration will be randomized in order to overcome a training effect.
The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1).
Intelligibility in noise testOther
Also called FraSimat
The FraSimat is a measure of speech perception in noise. The test consists of 14 sentences of 3 words, recorded in the presence of background noise, which the child must listen to and repeat. The background noise remains fixed at 65dB HL and the speech intensity adapts according to the patient's responses. The measurement will be performed under two setting conditions: MAP 1 (current setting) and MAP 2 (setting based on ESR). The order of administration will be randomized in order to overcome a training effect.
The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1).
Cochlear implant datalogging, speech audiometry test, FraSimat testOther
The follow-up visit (visit 2) will take place 1 month after visit 1 only for patients with a comfort levels threshold (via the eSRT) different from the current threshold (C-subjective).
At the start of the visit, cochlear implant datalogging will be recorded to determine the use of both settings (setting 2, using the ESR and setting 1, basic setting) while wearing the cochlear implant.
The datalogging will be recorded by an audioprosthetist at the Center for Research in Audiology at Necker Hospital.
If the patient has worn the new program (setting 2), the speech audiometry test and the FraSimat test (Intelligibility in noise test) will be performed again with the setting based on ESR.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Minor patients from 8 years with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades. Receives: Other: ESR and ECAP measurements; Other: Device setting; Other: Speech audiometry; Other: Intelligibility in noise test; Other: Cochlear implant datalogging, speech audiometry test, FraSimat test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between the patient's current upper stimulation level (C-subjective) and the measured eSRT
Correlation between the patient's current upper stimulation level (C-subjective) and the measured eSRT measured at the visit 1.
Measured: Day 0
Secondary outcomes (5)
To determine the relationship between the difference between C-subjective and the eSRT and the speech recognition scores
Correlation between the difference between C-subjective and the eSRT measured at the visit 1 and the percent correct on the Fournier's monosyllabic word test.
Measured: Day 0
To determine the relationship between the ECAPs (electric compound action potentials) and the eSRT
Correlation between the patient's ECAPs (electric compound action potentials) and the measured eSRT measured at the visit 1.
Measured: Day 0
To evaluate the difference in speech performance in silence obtained using a C-subjective MAP and a C-eSRT MAP
Comparison of the percent correct on the Fournier's monosyllabic word test at the visit 1, using the C-subjective MAP and at the visit 2, using the C-eSRT MAP.
Measured: 1 month
To evaluate the difference in speech performance in noise obtained using a C-subjective MAP and a C-eSRT MAP
Comparison of the percent correct on the FraSimat speech in noise test at the visit 1, using the C-subjective MAP and at the visit 2, using the C-eSRT MAP.
Measured: 1 month
The difference in average daily use time of C-subjective MAP and a C-eSRT MAP
Comparison of the number of average daily hours of use time for the C-subjective MAP and the C-eSRT MAP at the visit 2.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start7 Dec 2023
- Primary completion7 Jan 2026 (estimated)
- Study completion7 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Profound Hearing LossStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 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
- Melissa MacAskill, Study director, Assistance Publique - Hôpitaux de ParisNara Vaez-Leppin, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051006
- Sponsor's protocol ID
- APHP230584
- Other IDs
- 2023-A00644-41
- Acronym
- eSRT
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allum JH, Greisiger R, Probst R. Relationship of intraoperative electrically evoked stapedius reflex thresholds to maximum comfortable loudness levels of children with cochlear implants. Int J Audiol. 2002 Mar;41(2):93-9. doi: 10.3109/14992020209090399.
PubMed 12212861Walkowiak A, Lorens A, Polak M, Kostek B, Skarzynski H, Szkielkowska A, Skarzynski PH. Evoked stapedius reflex and compound action potential thresholds versus most comfortable loudness level: assessment of their relation for charge-based fitting strategies in implant users. ORL J Otorhinolaryngol Relat Spec. 2011;73(4):189-95. doi: 10.1159/000326892. Epub 2011 Jun 10.
PubMed 21659787Geers A, Brenner C, Davidson L. Factors associated with development of speech perception skills in children implanted by age five. Ear Hear. 2003 Feb;24(1 Suppl):24S-35S. doi: 10.1097/01.AUD.0000051687.99218.0F.
PubMed 12612478Brown CJ, Abbas PJ, Gantz B. Electrically evoked whole-nerve action potentials: data from human cochlear implant users. J Acoust Soc Am. 1990 Sep;88(3):1385-91. doi: 10.1121/1.399716.
PubMed 2229673Brown CJ, Hughes ML, Luk B, Abbas PJ, Wolaver A, Gervais J. The relationship between EAP and EABR thresholds and levels used to program the nucleus 24 speech processor: data from adults. Ear Hear. 2000 Apr;21(2):151-63. doi: 10.1097/00003446-200004000-00009.
PubMed 10777022Gordon KA, Papsin BC, Harrison RV. Toward a battery of behavioral and objective measures to achieve optimal cochlear implant stimulation levels in children. Ear Hear. 2004 Oct;25(5):447-63. doi: 10.1097/01.aud.0000146178.84065.b3.
PubMed 15599192Hodges AV, Butts S, Dolan-Ash S, Balkany TJ. Using electrically evoked auditory reflex thresholds to fit the CLARION cochlear implant. Ann Otol Rhinol Laryngol Suppl. 1999 Apr;177:64-8. doi: 10.1177/00034894991080s413.
PubMed 10214804Hodges AV, Balkany TJ, Ruth RA, Lambert PR, Dolan-Ash S, Schloffman JJ. Electrical middle ear muscle reflex: use in cochlear implant programming. Otolaryngol Head Neck Surg. 1997 Sep;117(3 Pt 1):255-61. doi: 10.1016/s0194-5998(97)70183-9.
PubMed 9334774Lorens A, Walkowiak A, Piotrowska A, Skarzynski H, Anderson I. ESRT and MCL correlations in experienced paediatric cochlear implant users. Cochlear Implants Int. 2004 Mar;5(1):28-37. doi: 10.1002/cii.121.
PubMed 18792192Van Den Abbeele T, Noel-Petroff N, Akin I, Caner G, Olgun L, Guiraud J, Truy E, Attias J, Raveh E, Belgin E, Sennaroglu G, Basta D, Ernst A, Martini A, Rosignoli M, Levi H, Elidan J, Benghalem A, Amstutz-Montadert I, Lerosey Y, De Vel E, Dhooge I, Hildesheimer M, Kronenberg J, Arnold L. Multicentre investigation on electrically evoked compound action potential and stapedius reflex: how do these objective measures relate to implant programming parameters? Cochlear Implants Int. 2012 Feb;13(1):26-34. doi: 10.1179/1754762810Y.0000000001.
PubMed 22340749Brickley G, Boyd P, Wyllie F, O'Driscoll M, Webster D, Nopp P. Investigations into electrically evoked stapedius reflex measures and subjective loudness percepts in the MED-EL COMBI 40+ cochlear implant. Cochlear Implants Int. 2005 Mar;6(1):31-42. doi: 10.1002/cii.18.
PubMed 18792318Craddock L, Cooper H, van de Heyning P, Vermeire K, Davies M, Patel J, Cullington H, Ricaud R, Brunelli T, Knight M, Plant K, Dees DC, Murray B. Comparison between NRT-based MAPs and behaviourally measured MAPs at different stimulation rates--a multicentre investigation. Cochlear Implants Int. 2003 Dec;4(4):161-70. doi: 10.1179/cim.2003.4.4.161.
PubMed 18792149Franck KH, Norton SJ. Estimation of psychophysical levels using the electrically evoked compound action potential measured with the neural response telemetry capabilities of Cochlear Corporation's CI24M device. Ear Hear. 2001 Aug;22(4):289-99. doi: 10.1097/00003446-200108000-00004.
PubMed 11527036Jeon EK, Brown CJ, Etler CP, O'Brien S, Chiou LK, Abbas PJ. Comparison of electrically evoked compound action potential thresholds and loudness estimates for the stimuli used to program the Advanced Bionics cochlear implant. J Am Acad Audiol. 2010 Jan;21(1):16-27. doi: 10.3766/jaaa.21.1.3.
PubMed 20085196Joly CA, Pean V, Hermann R, Seldran F, Thai-Van H, Truy E. Using Electrically-evoked Compound Action Potentials to Estimate Perceptive Levels in Experienced Adult Cochlear Implant Users. Otol Neurotol. 2017 Oct;38(9):1278-1289. doi: 10.1097/MAO.0000000000001548.
PubMed 28834942
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Electrical Stapedial Reflex Thresholds (eSRTs) in Determining Upper Stimulation Levels in Cochlear Implant Maps
- ClinicalTrials.gov ID
- NCT06051006
- Acronym / sponsor ID
- eSRT / APHP230584
- Conditions
- Profound Hearing Loss, Cochlear Implants
- Keywords
- Profound hearing loss, Cochlear implants, Cochlear implant programming, Stapedial reflex
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 7 Jan 2026 (estimated)
- Study completion
- 7 Jan 2026 (estimated)
- First posted
- 22 Sep 2023 (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.
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.
Detailed description
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).
For these patients, the adjustment is often based on the dynamic range recommended by the manufacturer in relation to the threshold (lower stimulation level) and/or on the discomfort level (upper stimulation level).
Objective measures such as ECAPs (Electric compound action potentials) are commonly used to estimate upper stimulation levels.
These measurements are useful for confirming electrode function and neuronal response, and some research has shown that these measures are correlated with the upper stimulation level. However, other studies suggest that ECAPs are poor predictors of high (and low) stimulation levels and can show variability between electrodes and between subjects.
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 patient settings are known as the MAP, where the upper and lower levels of stimulation are defined.
MAPs using eSRTs to set upper stimulation levels (C-eSRT) have been shown equal or better speech recognition results compared to behavior-based MAPs (intensity scale). Additionally, eSRT-based MAPs have been shown to result in equal sound intensity across all electrodes, and patients tend to prefer eSRT-based MAPs over behavioral MAPs.
The main objective of this study is investigate there is a link between subjective comfort levels (C-subjective levels) and the eSRT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: ESR and ECAP measurements, Other: Device setting, Other: Speech audiometry, Other: Intelligibility in noise test, Other: Cochlear implant datalogging, speech audiometry test, FraSimat testMinor patients from 8 years with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor patients from 8 years with cochlear implants for at least 1 year and followed by a physician at Hôpital Necker-Enfants malades.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| ESR and ECAP measurementsMeasurement of electrically evoked stapedial reflexes (ESRT) by stimulation via the cochlear implant. Measurement of the Electric compound action potentials (ECAPs) on the electrodes where the ESRT were performed. The measurements and tests will be performed during a routine visit to the Necker hospital for the adjustment of the cochlear implant (visit 1). | Other | Patients |
| Device settingThe adjustment will be made by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. The purpose of this setting is to modify the comfort thresholds using the ESR via a correction (according to the literature). The cochlear implant (CI) will therefore be set with the setting using the ESR (setting 2). The basic setting (setting 1) will be stored in memory in the CI. If ever the patient does not support setting 2, he/she will have the possibility of returning to the basic setting, without having to return to the Necker hospital for an additional setting. The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1). | Other | Patients |
| Speech audiometryThis examination is part of the usual care for a patient with a cochlear implant. Fournier's monosyllabic test will be used. The test will be carried out by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. The measurement will be performed under both setting conditions: setting 1 (current setting) and setting 2 (based on ESR). The order of administration will be randomized in order to overcome a training effect. The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1). | Other | Patients |
| Intelligibility in noise testAlso: FraSimatThe FraSimat is a measure of speech perception in noise. The test consists of 14 sentences of 3 words, recorded in the presence of background noise, which the child must listen to and repeat. The background noise remains fixed at 65dB HL and the speech intensity adapts according to the patient's responses. The measurement will be performed under two setting conditions: MAP 1 (current setting) and MAP 2 (setting based on ESR). The order of administration will be randomized in order to overcome a training effect. The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1). | Other | Patients |
| Cochlear implant datalogging, speech audiometry test, FraSimat testThe follow-up visit (visit 2) will take place 1 month after visit 1 only for patients with a comfort levels threshold (via the eSRT) different from the current threshold (C-subjective). At the start of the visit, cochlear implant datalogging will be recorded to determine the use of both settings (setting 2, using the ESR and setting 1, basic setting) while wearing the cochlear implant. The datalogging will be recorded by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. If the patient has worn the new program (setting 2), the speech audiometry test and the FraSimat test (Intelligibility in noise test) will be performed again with the setting based on ESR. | Other | Patients |
Primary outcome
The relationship between the patient's current upper stimulation level (C-subjective) and the measured eSRT
Time frame: Day 0
Correlation between the patient's current upper stimulation level (C-subjective) and the measured eSRT measured at the visit 1.
5 secondary outcomes
To determine the relationship between the difference between C-subjective and the eSRT and the speech recognition scores
Time frame: Day 0
To determine the relationship between the ECAPs (electric compound action potentials) and the eSRT
Time frame: Day 0
To evaluate the difference in speech performance in silence obtained using a C-subjective MAP and a C-eSRT MAP
Time frame: 1 month
To evaluate the difference in speech performance in noise obtained using a C-subjective MAP and a C-eSRT MAP
Time frame: 1 month
The difference in average daily use time of C-subjective MAP and a C-eSRT MAP
Time frame: 1 month
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 12 Sep 2025.
- Background: PubMed 12212861Allum JH, Greisiger R, Probst R. Relationship of intraoperative electrically evoked stapedius reflex thresholds to maximum comfortable loudness levels of children with cochlear implants. Int J Audiol. 2002 Mar;41(2):93-9. doi: 10.3109/14992020209090399.
- Background: PubMed 21659787Walkowiak A, Lorens A, Polak M, Kostek B, Skarzynski H, Szkielkowska A, Skarzynski PH. Evoked stapedius reflex and compound action potential thresholds versus most comfortable loudness level: assessment of their relation for charge-based fitting strategies in implant users. ORL J Otorhinolaryngol Relat Spec. 2011;73(4):189-95. doi: 10.1159/000326892. Epub 2011 Jun 10.
- Background: PubMed 12612478Geers A, Brenner C, Davidson L. Factors associated with development of speech perception skills in children implanted by age five. Ear Hear. 2003 Feb;24(1 Suppl):24S-35S. doi: 10.1097/01.AUD.0000051687.99218.0F.
- Background: PubMed 2229673Brown CJ, Abbas PJ, Gantz B. Electrically evoked whole-nerve action potentials: data from human cochlear implant users. J Acoust Soc Am. 1990 Sep;88(3):1385-91. doi: 10.1121/1.399716.
- Background: PubMed 10777022Brown CJ, Hughes ML, Luk B, Abbas PJ, Wolaver A, Gervais J. The relationship between EAP and EABR thresholds and levels used to program the nucleus 24 speech processor: data from adults. Ear Hear. 2000 Apr;21(2):151-63. doi: 10.1097/00003446-200004000-00009.
- Background: PubMed 15599192Gordon KA, Papsin BC, Harrison RV. Toward a battery of behavioral and objective measures to achieve optimal cochlear implant stimulation levels in children. Ear Hear. 2004 Oct;25(5):447-63. doi: 10.1097/01.aud.0000146178.84065.b3.
- Background: PubMed 10214804Hodges AV, Butts S, Dolan-Ash S, Balkany TJ. Using electrically evoked auditory reflex thresholds to fit the CLARION cochlear implant. Ann Otol Rhinol Laryngol Suppl. 1999 Apr;177:64-8. doi: 10.1177/00034894991080s413.
- Background: PubMed 9334774Hodges AV, Balkany TJ, Ruth RA, Lambert PR, Dolan-Ash S, Schloffman JJ. Electrical middle ear muscle reflex: use in cochlear implant programming. Otolaryngol Head Neck Surg. 1997 Sep;117(3 Pt 1):255-61. doi: 10.1016/s0194-5998(97)70183-9.
- Background: PubMed 18792192Lorens A, Walkowiak A, Piotrowska A, Skarzynski H, Anderson I. ESRT and MCL correlations in experienced paediatric cochlear implant users. Cochlear Implants Int. 2004 Mar;5(1):28-37. doi: 10.1002/cii.121.
- Background: PubMed 22340749Van Den Abbeele T, Noel-Petroff N, Akin I, Caner G, Olgun L, Guiraud J, Truy E, Attias J, Raveh E, Belgin E, Sennaroglu G, Basta D, Ernst A, Martini A, Rosignoli M, Levi H, Elidan J, Benghalem A, Amstutz-Montadert I, Lerosey Y, De Vel E, Dhooge I, Hildesheimer M, Kronenberg J, Arnold L. Multicentre investigation on electrically evoked compound action potential and stapedius reflex: how do these objective measures relate to implant programming parameters? Cochlear Implants Int. 2012 Feb;13(1):26-34. doi: 10.1179/1754762810Y.0000000001.
- Background: PubMed 18792318Brickley G, Boyd P, Wyllie F, O'Driscoll M, Webster D, Nopp P. Investigations into electrically evoked stapedius reflex measures and subjective loudness percepts in the MED-EL COMBI 40+ cochlear implant. Cochlear Implants Int. 2005 Mar;6(1):31-42. doi: 10.1002/cii.18.
- Background: PubMed 18792149Craddock L, Cooper H, van de Heyning P, Vermeire K, Davies M, Patel J, Cullington H, Ricaud R, Brunelli T, Knight M, Plant K, Dees DC, Murray B. Comparison between NRT-based MAPs and behaviourally measured MAPs at different stimulation rates--a multicentre investigation. Cochlear Implants Int. 2003 Dec;4(4):161-70. doi: 10.1179/cim.2003.4.4.161.
- Individual participant dataSharing planned: No
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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.
Melissa MacAskill study director
Assistance Publique - Hôpitaux de Paris
Nara Vaez-Leppin principal investigator
Assistance Publique - Hôpitaux de Paris
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 Profound Hearing Loss and 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 6 inclusion and 4 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 12 Sep 2025. 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 Nara Vaez-Leppin (0187892914 ext. +33, nara.vaez-leppin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between the patient's current upper stimulation level (C-subjective) and the measured eSRT (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051006, which also lists 21 linked publications.
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 12 Sep 2025.