Anatomy-based fitting for cochlear implant users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a new fitting strategy for cochlear implants (CIs) that uses post-operative CT scans to create a personalized frequency-band distribution for sound perception. Currently, most CI recipients are fitted using a default map that does not consider individual cochlear anatomy. By aligning the fitting more closely with the natural frequency distribution of a normal hearing cochlea, the study aims to improve auditory outcomes for patients with severe to profound hearing loss. Participants will be randomly assigned to receive either the standard fitting or the new anatomy-based fitting approach.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Brussels
  Brussels, Brussels Capital, Belgium Recruiting
• Antwerp University Hopsital
  Antwerp, Belgium Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Anatomy-based fitting for single-sided deaf CI users

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• Anatomy-Based Fitting for People with a Cochlear Implant and Hearing Aid

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.