ABFmulti: Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Default CI fitting Programming of cochlear implant speech processor according to standard clinical care |
Device: Default CI fitting
Programming of cochlear implant speech processor according to standard clinical care
|
| Active Comparator: Anatomy-based CI fitting Programming of cochlear implant speech processor with anatomy-based fitting |
Device: Anatomy-based CI fitting
Programming of cochlear implant speech processor with anatomy-based fitting
|
Outcome Measures
Primary Outcome Measures
- Speech recognition test in quiet (S0): percentage correctly identified phonemes [3 months post-activation]
- Speech recognition test in quiet (S0): percentage correctly identified phonemes [6 months post-activation]
Secondary Outcome Measures
- Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR [3 months post-activation]
- Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR [6 months post-activation]
- Result of the pitch matching test: frequency difference in semitones [3 months post-activation]
- Result of the pitch matching test: frequency differences in semitones [6 months post-activation]
- Result of the perception of timbre test: Score on Visual Analog Scale (VAS) [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.
- Result of the perception of timbre test: Score on Visual Analog Scale (VAS) [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.
- Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure [3 months post-activation]
- Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure [6 months post-activation]
- Result of the speech contrast discrimination test: Psychometric function of phoneme categorization [3 months post-activation]
- Result of the speech contrast discrimination test: Psychometric function of phoneme categorization [6 months post-activation]
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit [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 [3 months post-activation]
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit [6 months post-activation]
- Datalogging data: Average numbers of hours per day [2 weeks post-activation]
- Datalogging data: Average numbers of hours per day [1 months post-activation]
- Datalogging data: Average numbers of hours per day [3 months post-activation]
- Datalogging data: Average numbers of hours per day [6 months post-activation]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
-
Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
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Post-operative Computed Tomography (CT) scan of the CI electrode available
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Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
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Subject implanted with MED-EL cochlear implant(s)
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Subjects received a Flex28, FlexSoft or Standard electrode
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Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
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Audio processor not yet activated on the newly implanted side
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The most apical active electrode contact has to be inserted at least 450°
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Minimum of 10 active channels can be activated
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Fluent in the language of the test centre
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Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
Exclusion Criteria:
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Lack of compliance with any inclusion criteria
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Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
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Implanted with C40+, C40X and C40C
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Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Brussel | Brussel | Belgium | 1090 |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
- Principal Investigator: Vedat Topsakal, Prof., UZB-VUB
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EC-2021-437