Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Sensorineural Hearing Loss Clinical Trial

— ABFmulti  

Official title:

Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451628
• Other study ID #: EC-2021-437
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Emilie Heuninck
• Phone: +3224749772
• Email: emilie.heuninck[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implants
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• Default CI fitting
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

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech recognition test in quiet (S0): percentage correctly identified phonemes		3 months post-activation
Primary	Speech recognition test in quiet (S0): percentage correctly identified phonemes		6 months post-activation
Secondary	Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR		3 months post-activation
Secondary	Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR		6 months post-activation
Secondary	Result of the pitch matching test: frequency difference in semitones		3 months post-activation
Secondary	Result of the pitch matching test: frequency differences in semitones		6 months post-activation
Secondary	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
Secondary	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
Secondary	Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure		3 months post-activation
Secondary	Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure		6 months post-activation
Secondary	Result of the speech contrast discrimination test: Psychometric function of phoneme categorization		3 months post-activation
Secondary	Result of the speech contrast discrimination test: Psychometric function of phoneme categorization		6 months post-activation
Secondary	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)
Secondary	Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit		3 months post-activation
Secondary	Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit		6 months post-activation
Secondary	Datalogging data: Average numbers of hours per day		2 weeks post-activation
Secondary	Datalogging data: Average numbers of hours per day		1 months post-activation
Secondary	Datalogging data: Average numbers of hours per day		3 months post-activation
Secondary	Datalogging data: Average numbers of hours per day		6 months post-activation