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NCT Number: NCT05451628

Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

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.

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Key information

Conditions

Cochlear Implants Ear Diseases 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

University Hospital Brussels, Brussels, Brussels Capital, 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
  • 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

Treatment and study plan

Default CI fitting

Device

Programming of cochlear implant speech processor according to standard clinical care

Anatomy-based CI fitting

Device

Programming of cochlear implant speech processor with anatomy-based fitting

Primary outcomes

  1. Speech recognition test in quiet (S0): percentage correctly identified phonemes

    Time frame: 3 months post-activation

  2. Speech recognition test in quiet (S0): percentage correctly identified phonemes

    Time frame: 6 months post-activation

  3. Speech recognition test in quiet (S0): percentage correctly identified phonemes

    Time frame: 12 months post-activation

  4. Speech recognition test in quiet (S0): percentage correctly identified phonemes

    Time frame: 24 months post-activation

Secondary outcomes

  1. Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

    Time frame: 3 months post-activation

  2. Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

    Time frame: 6 months post-activation

  3. Result of the pitch matching test: frequency difference in semitones

    Time frame: 3 months post-activation

  4. Result of the pitch matching test: frequency differences in semitones

    Time frame: 6 months post-activation

  5. Result of the perception of timbre test: Score on Visual Analog Scale (VAS)

    Time frame: 3 months post-activation

    Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.

  6. Result of the perception of timbre test: Score on Visual Analog Scale (VAS)

    Time frame: 6 months post-activation

    Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.

  7. Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure

    Time frame: 3 months post-activation

  8. Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure

    Time frame: 6 months post-activation

  9. Result of the speech contrast discrimination test: Psychometric function of phoneme categorization

    Time frame: 3 months post-activation

  10. Result of the speech contrast discrimination test: Psychometric function of phoneme categorization

    Time frame: 6 months post-activation

  11. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Time frame: 1 day visit (At the activation of the sound processor)

  12. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Time frame: 3 months post-activation

  13. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Time frame: 6 months post-activation

  14. Datalogging data: Average numbers of hours per day

    Time frame: 2 weeks post-activation

  15. Datalogging data: Average numbers of hours per day

    Time frame: 1 months post-activation

  16. Datalogging data: Average numbers of hours per day

    Time frame: 3 months post-activation

  17. Datalogging data: Average numbers of hours per day

    Time frame: 6 months post-activation

  18. Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

    Time frame: 12 months post-activation

  19. Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

    Time frame: 24 months post-activation

  20. Result of the pitch matching test: frequency differences in semitones

    Time frame: 12 months post-activation

  21. Result of the pitch matching test: frequency differences in semitones

    Time frame: 24 months post-activation

  22. Result of the perception of timbre test: Score on Visual Analog Scale (VAS)

    Time frame: 12 months post-activation

    Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.

  23. Result of the perception of timbre test: Score on Visual Analog Scale (VAS)

    Time frame: 24 months post-activation

    Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.

  24. Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure

    Time frame: 12 months post-activation

  25. Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure

    Time frame: 24 months post-activation

  26. Result of the speech contrast discrimination test: Psychometric function of phoneme categorization

    Time frame: 12 months post-activation

  27. Result of the speech contrast discrimination test: Psychometric function of phoneme categorization

    Time frame: 24 months post-activation

  28. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Time frame: 12 months post-activation

  29. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Time frame: 24 months post-activation

  30. Datalogging data: Average numbers of hours per day

    Time frame: 12 months post-activation

  31. Datalogging data: Average numbers of hours per day

    Time frame: 24 months post-activation

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Acronym: ABFmulti

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2022
Registry last updated
Jul 2, 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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