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Status unknownNCT05684393Updated Jan 13, 2023

Anatomy-based Fitting in Unexperienced Cochlear Implant Users

An interventional study of frequency distribution type in Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures, sponsored by Dominik Riss. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-13.

Sponsored by Dominik Riss · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).

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Conditions studied

  • Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures

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03

In context

Seizures

881 studies on the registry are indexed under Seizures; 143 are open to participants now.

This study's planned enrollment of 60 is close to the median of 64 across 610 interventional studies indexed under Seizures.

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Lead sponsor

Dominik Riss is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
  • Post-OP CT scan of the CI electrode available
  • Subject implanted with MED-EL cochlear implant(s)
  • Subjects received a Flex28, FlexSoft and Standard electrode
  • Subject planned to receive a SONNET 2 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 ICF before the start of any study-specific procedure

Exclusion criteria

Exclusion Criteria:

  • Lack of compliance with any inclusion criteria
  • EAS user (user of an EAS audio processor)
  • Implanted with C40+, C40X and C40C
  • Implanted with an ABI or Split electrode array
  • Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Anatomy based fitting

    Other: frequency distribution type

  • Active comparator
    Standard fitting

    Other: frequency distribution type

Interventions

  • Otherfrequency distribution type

    One group is fitted using channel filterbank frequency distribution based on anatomy data extracted from post-OP CT measurements. The second (control) group is fitted with the standard frequency distribution used in MAESTRO 9 fitting software.

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What researchers measure

Primary outcomes

  1. Word recognition score (WRS)

    Percentage of correctly understood monosyllabic words from a list.

    Time frame: 6 months

Secondary outcomes

  1. Speech reception threshold (SRT)

    German matrix sentence test - speech to noise ratio in dB.

    Time frame: 6 months

  2. Pitch ranking

    Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear.

    Time frame: 6 months

  3. Perception of timbre

    Visual Analog Scale ratings describing the difference in timbre between the tested CI ear and the reference ear when listening to audio.

    Time frame: 6 months

  4. Phoneme categorization

    Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum.

    Time frame: 6 months

  5. Consonance/difference rating

    The degree of modulation of the pleasantness-score across the individual intervals.

    Time frame: 6 months

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Study locations

1 of 1 sites recruiting
  • Medical University of Vienna
    Vienna, 1180, Austria
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05684393
Lead sponsor
Dominik Riss
Responsible party
Dominik Riss (Assoc.-Prof. Priv.-Doz. Dr. med., Medical University of Vienna) — Sponsor-investigator
First posted
Jan 13, 2023
Start date
Feb 2023 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Jan 13, 2023

Study contacts

Dominik Riss, MD
Contact
dominik.riss@meduniwien.ac.at
+43 1 40400 33760

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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