NCT05451628 Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
| NCT ID | NCT05451628 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Cochlear Implants |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-03-30 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-03-30 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 * 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 Criteria: * Lack of compliance with any inclusion criteria * Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor) * 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
Frequently Asked Questions
Who can join the NCT05451628 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cochlear Implants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05451628 currently recruiting?
Yes, NCT05451628 is actively recruiting participants. Visit ClinicalTrials.gov or contact Universitair Ziekenhuis Brussel to inquire about joining.
Where is the NCT05451628 trial being conducted?
This trial is being conducted at Brussels, Belgium, Antwerp, Belgium.
Who is sponsoring the NCT05451628 clinical trial?
NCT05451628 is sponsored by Universitair Ziekenhuis Brussel. The trial plans to enroll 40 participants.