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Anatomy-Based Fitting in Bimodal Cochlear Implant Users

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Subject implanted with MED-EL cochlear implant(s)

• Subject received a Flex28, FlexSoft or Standard electrode

• Subject uses a SONNET 2 or RONDO 3 audio processor

• Subject has experience of at least 6 months with cochlear implant

• The most apical active electrode contact has to be inserted at least 540°

• Minimum of 10 active channels are activated

• Subject wears an adequately fitted hearing aid on the contralateral side

• Fluent in the language of the test centre

• Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure

Locations
Other Locations
Belgium
Antwerp University Hopsital
RECRUITING
Antwerp
University Hospital Brussels
RECRUITING
Brussels
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 25
Treatments
Active_comparator: First default fitting, then anatomy-based fitting
Active_comparator: First anatomy-based fitting, then default fitting
Related Therapeutic Areas
Sponsors
Leads: Universitair Ziekenhuis Brussel
Collaborators: University Hospital, Antwerp

This content was sourced from clinicaltrials.gov