Clinical trial NCT05451628: Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
Official title: Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cochlear Implants
Sensorineural Hearing Loss
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Speech recognition test in quiet (S0): percentage correctly identified phonemes
timeFrame: 3 months post-activation
measure: Speech recognition test in quiet (S0): percentage correctly identified phonemes
timeFrame: 6 months post-activation
Secondary outcomes:
measure: Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
timeFrame: 3 months post-activation
measure: Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
timeFrame: 6 months post-activation
measure: Result of the pitch matching test: frequency difference in semitones
timeFrame: 3 months post-activation
measure: Result of the pitch matching test: frequency differences in semitones
timeFrame: 6 months post-activation
measure: Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
timeFrame: 3 months post-activation
measure: Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
timeFrame: 6 months post-activation
measure: Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
timeFrame: 3 months post-activation
measure: Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
timeFrame: 6 months post-activation
measure: Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
timeFrame: 3 months post-activation
measure: Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
timeFrame: 6 months post-activation
measure: Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
timeFrame: 1 day visit (At the activation of the sound processor)
measure: Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
timeFrame: 3 months post-activation
measure: Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
timeFrame: 6 months post-activation
measure: Datalogging data: Average numbers of hours per day
timeFrame: 2 weeks post-activation
measure: Datalogging data: Average numbers of hours per day
timeFrame: 1 months post-activation
measure: Datalogging data: Average numbers of hours per day
timeFrame: 3 months post-activation
measure: Datalogging data: Average numbers of hours per day
timeFrame: 6 months post-activation
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: UZB-VUB
name: Vedat Topsakal, Prof.
role: PRINCIPAL_INVESTIGATOR
References: