The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping

NCT06051006 | Recruiting

• 2 other identifiers: APHP2305842023-A00644-41
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Profound Hearing Loss; Cochlear Implants

Keywords

Profound hearing loss; Cochlear implants; Cochlear implant programming; Stapedial reflex

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0

Secondary Outcomes (5)

• To determine the relationship between the difference between C-subjective and the eSRT and the speech recognition scores

  Day 0

• To determine the relationship between the ECAPs (electric compound action potentials) and the eSRT

  Day 0

• To evaluate the difference in speech performance in silence obtained using a C-subjective MAP and a C-eSRT MAP

  1 month

• To evaluate the difference in speech performance in noise obtained using a C-subjective MAP and a C-eSRT MAP

  1 month

• The difference in average daily use time of C-subjective MAP and a C-eSRT MAP

  1 month

Study Arms (1)

Patients

Minor patients from 8 years with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades.

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

Interventions

ESR and ECAP measurements OTHER

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).

Patients

Device setting OTHER

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).

Patients

Speech audiometry OTHER

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).

Patients

Intelligibility in noise test OTHER

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).

Also known as: FraSimat

Patients

Cochlear implant datalogging, speech audiometry test, FraSimat test OTHER

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.

Patients

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Be part of a family that does not understand oral French
• Patients under AME (State Medical Aid)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

Related Publications (21)

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  PMID: 12212861 BACKGROUND

• Walkowiak 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.

  PMID: 21659787 BACKGROUND

• Geers 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.

  PMID: 12612478 BACKGROUND

• Brown 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.

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• Gordon 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.

  PMID: 15599192 BACKGROUND

• Hodges 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.

  PMID: 10214804 BACKGROUND

• Hodges 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.

  PMID: 9334774 BACKGROUND

• Lorens 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.

  PMID: 18792192 BACKGROUND

• Van 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.

  PMID: 22340749 BACKGROUND

• Brickley 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.

  PMID: 18792318 BACKGROUND

• Craddock 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.

  PMID: 18792149 BACKGROUND

• Franck 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.

  PMID: 11527036 BACKGROUND

• Jeon 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.

  PMID: 20085196 BACKGROUND

• Joly 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.

  PMID: 28834942 BACKGROUND

• Smoorenburg GF, Willeboer C, van Dijk JE. Speech perception in nucleus CI24M cochlear implant users with processor settings based on electrically evoked compound action potential thresholds. Audiol Neurootol. 2002 Nov-Dec;7(6):335-47. doi: 10.1159/000066154.

  PMID: 12401965 BACKGROUND

• Wolfe J, Kasulis H. Relationships among objective measures and speech perception in adult users of the HiResolution Bionic Ear. Cochlear Implants Int. 2008 Jun;9(2):70-81. doi: 10.1179/cim.2008.9.2.70.

  PMID: 18680210 BACKGROUND

• Bresnihan M, Norman G, Scott F, Viani L. Measurement of comfort levels by means of electrical stapedial reflex in children. Arch Otolaryngol Head Neck Surg. 2001 Aug;127(8):963-6. doi: 10.1001/archotol.127.8.963.

  PMID: 11493206 BACKGROUND

• Polak M, Hodges AV, King JE, Payne SL, Balkany TJ. Objective methods in postlingually and prelingually deafened adults for programming cochlear implants: ESR and NRT. Cochlear Implants Int. 2006 Sep;7(3):125-41. doi: 10.1179/cim.2006.7.3.125.

  PMID: 18792380 BACKGROUND

• Holder JT, Holcomb MA, Snapp H, Labadie RF, Vroegop J, Rocca C, Elgandy MS, Dunn C, Gifford RH. Guidelines for Best Practice in the Audiological Management of Adults Using Bimodal Hearing Configurations. Otol Neurotol Open. 2022 Jun;2(2):e011. doi: 10.1097/ONO.0000000000000011. Epub 2022 Jun 24.

  PMID: 36274668 BACKGROUND

• Palani S, Alexander A, Sreenivasan A. Evaluation of the Electrically-Evoked Stapedial Reflex Threshold in Pediatric Cochlear Implant Users with High-Frequency Probe Tones. Int Arch Otorhinolaryngol. 2022 Feb 8;26(4):e566-e573. doi: 10.1055/s-0042-1742332. eCollection 2022 Oct.

  PMID: 36405469 BACKGROUND

Study Officials

• Melissa MacAskill

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Nara Vaez-Leppin

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nara Vaez-Leppin

CONTACT

0187892914; nara.vaez-leppin@aphp.fr

Hélène Morel

CONTACT

0171196346; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: September 22, 2023
• Study Start: December 7, 2023
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)