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

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

In this study, adults with bimodal hearing will try two fitting maps for their cochlear implant: an anatomy-based map and the standard default map. Researchers will measure speech understanding in quiet and in noise, as well as consonant/vowel discrimination and pitch/timbre perception, in an acute setting. The trial compares the two approaches to see which provides better auditory performance for bimodal users. Participants must have an MED-EL implant, a compatible processor, and at least six months of CI experience.

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
* 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

Where it's running

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

Similar studies

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

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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.