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NCT Number: NCT07691853

Anatomy-Based Fitting in Bimodal Cochlear Implant Users

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.

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Key information

Conditions

Cochlear Implant Ear Diseases Hearing Aid Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Sensorineural Hearing Loss Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hopsital, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anatomy-based fitting

Device

Programming of cochlear implant speech processor with anatomy-based fitting

Default fitting

Device

Programming of cochlear implant speech processor according to standard clinical care

Primary outcomes

  1. Speech recognition test in quiet

    Time frame: Day 1 (single study visit), post intervention

    Percentage correctly identified phonemes

Secondary outcomes

  1. Speech recognition test in noise (S0N0, S0N90)

    Time frame: Day 1 (single study visit), post- intervention

    Speech reception threshold in dB SNR

  2. Vowel and consonant identification task (ASSE)

    Time frame: Day 1 (single study visit), post-intervention

    Number of correctly identified vowels and correctly identified consonants

  3. Pitch and timbre ranking

    Time frame: Day 1 (single study visit), post intervention

    Score on visual analog scale (VAS) with a range from 0 (duller than the reference) to 10 (brighter than the reference). The score of 5 means an exact match with the timbre or pitch of the hearing aid.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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