Relationship of intraoperative electrically evoked stapedius reflex thresholds to maximum comfortable loudness levels of children with cochlear implants.
J H J Allum, R Greisiger, R Probst
https://pubmed.ncbi.nlm.nih.gov/12212861Actively Recruiting
Age: 8Years - 17Years
All Genders
ID06051006
The Value of Electrical Stapedial Reflex Thresholds (eSRTs) in Determining Upper Stimulation Levels in Cochlear Implant Maps
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-12
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how electrical stapedial reflex thresholds (eSRTs) relate to subjective comfort levels (C-subjective) in programming cochlear implants, especially for young children or those with additional health conditions. Programming cochlear implants requires setting lower and upper stimulation levels for each electrode, but many patients find it hard to judge comfort levels using traditional loudness scales. eSRTs offer a more objective way to estimate comfortable upper stimulation levels and may improve implant programming. The study involves measuring electrically evoked stapedial reflexes and electric compound action potentials (ECAPs) in patients with cochlear implants. Audioprosthetists adjust the implant settings using eSRTs during routine hospital visits, creating a new MAP based on these thresholds. Speech audiometry and speech perception in noise tests are performed under both the current and eSRT-based settings, with the order randomized. A follow-up visit one month later evaluates speech performance and implant usage for those with different comfort thresholds between the two settings. Participants are children aged 8 to 17 years who have used cochlear implants for at least one year and communicate primarily in French. They attend two visits involving hearing tests, implant adjustment, and speech evaluations. Researchers collect data on comfort levels, speech recognition, and implant use to compare the eSRT-based and subjective programming methods. The main outcome is the relationship between measured eSRT and current upper stimulation levels, with additional measures of speech performance and device usage monitored over one month.
CONDITIONS
Brief Title
The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping
Who Can Participate
Age: 8Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients between 8 and 17 years old at the time of inclusion
- Have had a cochlear implant for at least 1 year and are followed at Hôpital Necker-Enfants malades
- Use oral French as their 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 30 dB HL
- Provide informed consent and non-opposition from parental authority and minor patients to participate in the study
You will not qualify if you...
- Have a severe neurological pathology before inclusion (identified by MRI or neuro-pediatric assessment)
- Have cognitive or psychiatric impairments or severe developmental delay at inclusion
- Are from a family that does not understand oral French
- Are patients under State Medical Aid (AME)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Observational Measurements and Device Setting
Duration - 1 day
Participants undergo measurement of electrically evoked stapedial reflexes (eSRT) and electric compound action potentials (ECAPs), and the cochlear implant settings are adjusted based on these measurements. Speech audiometry and intelligibility in noise tests are performed under both the current and eSRT-based settings during this usual care visit.
1 visit (in-person)
Follow-up Monitoring
Duration - 1 day
Participants with differences between comfort level thresholds based on eSRT and current settings return for a follow-up visit approximately 1 month later. At this visit, cochlear implant datalogging is recorded to assess use of each setting, and speech audiometry and intelligibility in noise tests are repeated if the eSRT-based setting was used.
1 visit (in-person) approximately 1 month after previous visit
Trial Site Locations
Total: 1 location
1
Hôpital Necker-Enfants Malades
Paris, France, 75015
Actively Recruiting
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Research Team
N
Nara Vaez-Leppin
H
Hélène Morel
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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C J Brown, P J Abbas, B Gantz
https://pubmed.ncbi.nlm.nih.gov/2229673The relationship between EAP and EABR thresholds and levels used to program the nucleus 24 speech processor: data from adults.
C J Brown, M L Hughes, B Luk...
https://pubmed.ncbi.nlm.nih.gov/10777022Toward a battery of behavioral and objective measures to achieve optimal cochlear implant stimulation levels in children.
Karen A Gordon, Blake C Papsin, Robert V Harrison
https://pubmed.ncbi.nlm.nih.gov/15599192Using electrically evoked auditory reflex thresholds to fit the CLARION cochlear implant.
A V Hodges, S Butts, S Dolan-Ash...
https://pubmed.ncbi.nlm.nih.gov/10214804Electrical middle ear muscle reflex: use in cochlear implant programming.
A V Hodges, T J Balkany, R A Ruth...
https://pubmed.ncbi.nlm.nih.gov/9334774ESRT and MCL correlations in experienced paediatric cochlear implant users.
Artur Lorens, Adam Walkowiak, Anna Piotrowska...
https://pubmed.ncbi.nlm.nih.gov/18792192Multicentre investigation on electrically evoked compound action potential and stapedius reflex: how do these objective measures relate to implant programming parameters?
Thierry Van Den Abbeele, Nathalie Noël-Petroff, Istemihan Akin...
https://pubmed.ncbi.nlm.nih.gov/22340749