Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Recruiting now · Not applicable

Conditions studied: Cochlear Implants, Sensorineural Hearing Loss

In brief

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.

Key facts

Study ID

NCT05451628

Run by

Universitair Ziekenhuis Brussel

People needed

40

Starts

2022-03-30

Expected to finish

2027-01-01

Last updated by the study team

2026-07-02

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
• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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