Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Not Applicable

Recruiting

• Conditions: Sensorineural Hearing Loss; Cochlear Implants
• Interventions: Device: Default CI fitting; Device: Anatomy-based CI fitting

• Registration Number: NCT05451628
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-30
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Default CI fitting	Default CI fitting	Programming of cochlear implant speech processor according to standard clinical care
Anatomy-based CI fitting	Anatomy-based CI fitting	Programming of cochlear implant speech processor with anatomy-based fitting

Primary Outcome Measures

Name	Time	Method
Speech recognition test in quiet (S0): percentage correctly identified phonemes	6 months post-activation

Secondary Outcome Measures

Name	Time	Method
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)	6 months post-activation	Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure	6 months post-activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit	6 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 speech contrast discrimination test: Psychometric function of phoneme categorization	6 months post-activation
Datalogging data: Average numbers of hours per day	6 months post-activation

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussel, Belgium