Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cochlear Implants
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
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
Outcomes
Primary Outcomes
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Time Frame: 8 months post-activation
Secondary Outcomes
- Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)(8 months post- activation)
- Speech recognition in quiet: Percentage correctly identified phonemes(8 months post-activation)
- Speech discrimination: Number of correctly discriminated pairs of phonemes(8 months post- activation)
- Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain(8 months post- activation)
- Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain(8 months post- activation)
- Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain(6 months post- activation)
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit(8 months post- activation)