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Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

NCT ID: NCT05369598

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-02-28

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. This study will focus on patients that are already implanted with the HEARO robotic system.

Detailed Description

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Conditions

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Cochlear Implants Sensorineural Hearing Loss, Bilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ABF fitting followed by standard fitting

Group Type ACTIVE_COMPARATOR

Post-operative ABF followed by fitting according to clinical standard

Intervention Type DEVICE

Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months.

Standard fitting followed by ABF fitting

Group Type ACTIVE_COMPARATOR

Fitting according to clinical standard followed by post-operative ABF

Intervention Type DEVICE

Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months.

Interventions

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Post-operative ABF followed by fitting according to clinical standard

Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months.

Intervention Type DEVICE

Fitting according to clinical standard followed by post-operative ABF

Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months.

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)
* 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

* 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

Exclusion Criteria

* Subject is a Single-Sided Deafness (SSD) CI user
* Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
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: 024749772

Email: [email protected]

Facility Contacts

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Vedat Topsakal, Prof

Role: primary

Other Identifiers

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EC-2022-022

Identifier Type: -

Identifier Source: org_study_id