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

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.

Study Overview

• Status: Recruiting
• Conditions: Sensorineural Hearing Loss; Cochlear Implants
• Intervention / Treatment: Device: Default CI fitting; Device: Anatomy-based CI fitting

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie Heuninck; Phone Number: +3224749772; Email: emilie.heuninck@uzbrussel.be

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Vedat Topsakal, Prof
    • Contact: Emilie Heuninck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Default CI fitting; Programming of cochlear implant speech processor according to standard clinical care	Device: Default CI fitting; Programming of cochlear implant speech processor according to standard clinical care
Active Comparator: Anatomy-based CI fitting; Programming of cochlear implant speech processor with anatomy-based fitting	Device: Anatomy-based CI fitting; Programming of cochlear implant speech processor with anatomy-based fitting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	3 months post-activation
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)	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.	6 months post-activation
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure		3 months post-activation
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure		6 months post-activation
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization		3 months post-activation
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization		6 months post-activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit		1 day visit (At the activation of the sound processor)
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit		3 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
Datalogging data: Average numbers of hours per day		2 weeks post-activation
Datalogging data: Average numbers of hours per day		1 months post-activation
Datalogging data: Average numbers of hours per day		3 months post-activation
Datalogging data: Average numbers of hours per day		6 months post-activation

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Vedat Topsakal, Prof., UZB-VUB

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: EC-2021-437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No