Anatomy-Based Fitting in Unexperienced Cochlear Implant Users (ABFmulti)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Cochlear Implants; Sensorineural Hearing Loss

Treatments: Device: Anatomy-based CI fitting; Device: Default CI fitting

Study type: Interventional

Funder types: Other

Identifiers

NCT05451628

EC-2021-437

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Default CI fitting

Active Comparator group

Description:

Programming of cochlear implant speech processor according to standard clinical care

Treatment:

Device: Default CI fitting

Anatomy-based CI fitting

Active Comparator group

Description:

Programming of cochlear implant speech processor with anatomy-based fitting

Treatment:

Device: Anatomy-based CI fitting