Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Study Overview
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Brief Summary
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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.

Official Title
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Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Conditions
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Cochlear Implants, Sensorineural Hearing Loss

Intervention / Treatment
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* Device: Default CI fitting
* Device: Anatomy-based CI fitting


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Default CI fitting<br>Programming of cochlear implant speech processor according to standard clinical care | Device: Default CI fitting<br>* Programming of cochlear implant speech processor according to standard clinical care<br>|
| Active Comparator: Anatomy-based CI fitting<br>Programming of cochlear implant speech processor with anatomy-based fitting | Device: Anatomy-based CI fitting<br>* Programming of cochlear implant speech processor with anatomy-based fitting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 3 months post-activation | 
| Result of the perception of timbre test: Score on Visual Analog Scale (VAS) | 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 months post-activation | 
| 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 |