Brief Title
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)
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.
Study Type
Interventional
Primary Outcome
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Secondary Outcome
Speech recognition in quiet: Percentage correctly identified phonemes
Condition
Cochlear Implants
Intervention
Post-operative ABF followed by fitting according to clinical standard
Study Arms / Comparison Groups
Arm 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
March 1, 2022
Completion Date
March 2025
Primary Completion Date
March 2025
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Vedat Topsakal, Prof., 024749772, [email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT05369598
Organization ID
EC-2022-022
Responsible Party
Sponsor
Study Sponsor
Universitair Ziekenhuis Brussel
Study Sponsor
Vedat Topsakal, Prof., Principal Investigator, UZB-VUB
Verification Date
May 2022