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Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

NCT ID: NCT05451628

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2025-01-31

Brief Summary

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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

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Conditions

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Cochlear Implants Sensorineural Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Default CI fitting

Programming of cochlear implant speech processor according to standard clinical care

Group Type ACTIVE_COMPARATOR

Default CI fitting

Intervention Type DEVICE

Programming of cochlear implant speech processor according to standard clinical care

Anatomy-based CI fitting

Programming of cochlear implant speech processor with anatomy-based fitting

Group Type ACTIVE_COMPARATOR

Anatomy-based CI fitting

Intervention Type DEVICE

Programming of cochlear implant speech processor with anatomy-based fitting

Interventions

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Default CI fitting

Programming of cochlear implant speech processor according to standard clinical care

Intervention Type DEVICE

Anatomy-based CI fitting

Programming of cochlear implant speech processor with anatomy-based fitting

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vedat Topsakal, Prof.

Role: PRINCIPAL_INVESTIGATOR

UZB-VUB

Locations

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UZ Brussel

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Emilie Heuninck

Role: CONTACT

Phone: +3224749772

Email: [email protected]

Facility Contacts

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Vedat Topsakal, Prof

Role: primary

Emilie Heuninck

Role: backup

Other Identifiers

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EC-2021-437

Identifier Type: -

Identifier Source: org_study_id