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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Default CI fitting | Active Comparator | Programming of cochlear implant speech processor according to standard clinical care |
|
| Anatomy-based CI fitting | Active Comparator | Programming of cochlear implant speech processor with anatomy-based fitting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Default CI fitting | Device | Programming of cochlear implant speech processor according to standard clinical care |
|
| 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 | |
| Speech recognition test in quiet (S0): percentage correctly identified phonemes | 12 months post-activation | |
| Speech recognition test in quiet (S0): percentage correctly identified phonemes | 24 months post-activation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brussels | Recruiting | Brussels | Brussels Capital | 1090 | Belgium |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Anatomy-based CI fitting | Device | Programming of cochlear implant speech processor with anatomy-based fitting |
|
| 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 |
| Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR | 12 months post-activation |
| Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR | 24 months post-activation |
| Result of the pitch matching test: frequency differences in semitones | 12 months post-activation |
| Result of the pitch matching test: frequency differences in semitones | 24 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. | 12 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. | 24 months post-activation |
| Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure | 12 months post-activation |
| Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure | 24 months post-activation |
| Result of the speech contrast discrimination test: Psychometric function of phoneme categorization | 12 months post-activation |
| Result of the speech contrast discrimination test: Psychometric function of phoneme categorization | 24 months post-activation |
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit | 12 months post-activation |
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit | 24 months post-activation |
| Datalogging data: Average numbers of hours per day | 12 months post-activation |
| Datalogging data: Average numbers of hours per day | 24 months post-activation |
| Antwerp University Hopsital | Recruiting | Antwerp | 2650 | Belgium |
|
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |