Anatomy-Based Fitting in Bimodal Cochlear Implant Users
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: Anatomy-based fitting, Default fitting.
- Who it may be relevant to
- Registry conditions: Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid. Basic parameters: from 18 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
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.
Interventions
- Device Anatomy-based fitting
Programming of cochlear implant speech processor with anatomy-based fitting - Device Default fitting
Programming of cochlear implant speech processor according to standard clinical care
Primary outcome measures
- Speech recognition test in quiet [Time frame: Day 1 (single study visit), post intervention]
Secondary outcome measures (3)
- Speech recognition test in noise (S0N0, S0N90) [Time frame: Day 1 (single study visit), post- intervention]
- Vowel and consonant identification task (ASSE) [Time frame: Day 1 (single study visit), post-intervention]
- Pitch and timbre ranking [Time frame: Day 1 (single study visit), post intervention]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- Post-operative Computed Tomography (CT) scan of the CI electrode available
- Subject implanted with MED-EL cochlear implant(s)
- Subject received a Flex28, FlexSoft or Standard electrode
- Subject uses a SONNET 2 or RONDO 3 audio processor
- Subject has experience of at least 6 months with cochlear implant
- The most apical active electrode contact has to be inserted at least 540°
- Minimum of 10 active channels are activated
- Subject wears an adequately fitted hearing aid on the contralateral side
- Fluent in the language of the test centre
- Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
Exclusion criteria
- Lack of compliance with any inclusion criteria
- Implanted with C40+, C40X and C40C
- Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
- Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 2 centers
- Antwerp University Hopsital — Antwerp
- University Hospital Brussels — Brussels
Identifiers
NCT: NCT07691853 · EC-2024-063