Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Default CI fitting, Anatomy-based CI fitting.
- Who it may be relevant to
- Registry conditions: Cochlear Implants, Sensorineural Hearing Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Default CI fitting
Programming of cochlear implant speech processor according to standard clinical care - Device Anatomy-based CI fitting
Programming of cochlear implant speech processor with anatomy-based fitting
Primary outcome measures
- Speech recognition test in quiet (S0): percentage correctly identified phonemes [Time frame: 3 months post-activation]
- Speech recognition test in quiet (S0): percentage correctly identified phonemes [Time frame: 6 months post-activation]
- Speech recognition test in quiet (S0): percentage correctly identified phonemes [Time frame: 12 months post-activation]
- Speech recognition test in quiet (S0): percentage correctly identified phonemes [Time frame: 24 months post-activation]
Secondary outcome measures (12)
- Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR [Time frame: 3 months post-activation]
- Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR [Time frame: 6 months post-activation]
- Result of the pitch matching test: frequency difference in semitones [Time frame: 3 months post-activation]
- Result of the pitch matching test: frequency differences in semitones [Time frame: 6 months post-activation]
- Result of the perception of timbre test: Score on Visual Analog Scale (VAS) [Time frame: 3 months post-activation]
- Result of the perception of timbre test: Score on Visual Analog Scale (VAS) [Time frame: 6 months post-activation]
- Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure [Time frame: 3 months post-activation]
- Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure [Time frame: 6 months post-activation]
- Result of the speech contrast discrimination test: Psychometric function of phoneme categorization [Time frame: 3 months post-activation]
- Result of the speech contrast discrimination test: Psychometric function of phoneme categorization [Time frame: 6 months post-activation]
- 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)]
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit [Time frame: 3 months post-activation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 2 centers
- University Hospital Brussels — Brussels
- Antwerp University Hopsital — Antwerp
Identifiers
NCT: NCT05451628 · EC-2021-437