Anatomy-Based Fitting in Bimodal Cochlear Implant Users

Recruiting now · Not applicable

Conditions studied: Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid

In brief

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.

Key facts

Study ID

NCT07691853

Run by

Universitair Ziekenhuis Brussel

People needed

25

Starts

2024-07-01

Expected to finish

2026-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Antwerp University Hopsital — Antwerp, Belgium (enrolling)
• University Hospital Brussels — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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