Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Universitair Ziekenhuis Brussel
- Trial code
- NCT05451628
- Record updated
- 2 July 2026
- Original description
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.Read full original descriptionShow less
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.
Inclusion: 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; Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available; Subject implanted with MED-EL cochlear implant(s); Subjects received a Flex28, FlexSoft or Standard electrode; Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side; Audio processor not yet activated on the newly implanted side; The most apical active electrode contact has to be inserted at least 450°; Minimum of 10 active channels can be activated; Fluent in the language of the test centre; Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure.
Exclusion: Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array; Lack of compliance with any inclusion criteria; Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor); Implanted with C40+, C40X and C40C; 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.