Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
ABFmulti
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2022
CompletedFirst Submitted
Initial submission to the registry
June 2, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedDecember 12, 2023
December 1, 2023
2.8 years
June 2, 2022
December 11, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (17)
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
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)
3 months post-activation
- +12 more secondary outcomes
Study Arms (2)
Default CI fitting
ACTIVE COMPARATORProgramming of cochlear implant speech processor according to standard clinical care
Anatomy-based CI fitting
ACTIVE COMPARATORProgramming of cochlear implant speech processor with anatomy-based fitting
Interventions
Programming of cochlear implant speech processor according to standard clinical care
Programming of cochlear implant speech processor with anatomy-based fitting
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Brussel
Brussels, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vedat Topsakal, Prof.
UZB-VUB
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2022
First Posted
July 11, 2022
Study Start
March 30, 2022
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share