Clinical trial NCT05369598: Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
Official title: Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cochlear Implants
Sensorineural Hearing Loss, Bilateral
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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. This study will focus on patients that are already implanted with the HEARO robotic system.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
* Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
* Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage
* Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side
* Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid)
* Pre- operative and post-operative CT scan of the temporal bone available
* Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
* Audio processor not yet activated on the newly implanted side
* Minimum of 10 active channels can be activated
* Fluent in the language of the test centre (Dutch or French)
* Signed and dated ICF before the start of any study-specific procedure

Exclusion Criteria:

* Subject is a Single-Sided Deafness (SSD) CI user
* Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
* Lack of compliance with any inclusion criteria
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Primary outcomes:
measure: Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
timeFrame: 3 months post- activation
measure: Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
timeFrame: 6 months post- activation
measure: Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
timeFrame: 8 months post-activation
Secondary outcomes:
measure: Speech recognition in quiet: Percentage correctly identified phonemes
timeFrame: 3 months post-activation
measure: Speech recognition in quiet: Percentage correctly identified phonemes
timeFrame: 6 months post-activation
measure: Speech recognition in quiet: Percentage correctly identified phonemes
timeFrame: 8 months post-activation
measure: Speech discrimination: Number of correctly discriminated pairs of phonemes
timeFrame: 3 months post- activation
measure: Speech discrimination: Number of correctly discriminated pairs of phonemes
timeFrame: 6 months post- activation
measure: Speech discrimination: Number of correctly discriminated pairs of phonemes
timeFrame: 8 months post- activation
measure: Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
timeFrame: 1 month post- activation
measure: Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
timeFrame: 3 month post- activation
measure: Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
timeFrame: 6 months post- activation
measure: Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
timeFrame: 8 months post- activation
measure: Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
timeFrame: Baseline at activation
measure: Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
timeFrame: 3 months post- activation
measure: Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
timeFrame: 6 months post- activation
measure: Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
timeFrame: 8 months post- activation
measure: Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
timeFrame: Baseline at activation
measure: Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
timeFrame: 3 months post- activation
measure: Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
timeFrame: 6 months post- activation
measure: Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
timeFrame: 8 months post- activation
measure: Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
timeFrame: Baseline at activation
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: Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
timeFrame: 8 months post- activation
Other outcomes:
measure: Evaluation of electrode contact location: Degrees of deviation
timeFrame: 8th months post activation
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: UZB-VUB
name: Vedat Topsakal, Prof.
role: PRINCIPAL_INVESTIGATOR
References: