Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07691853

Anatomy-Based Fitting in Bimodal Cochlear Implant Users

Conditions: Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Universitair Ziekenhuis Brussel

Location: Antwerp University Hopsital Antwerp

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 Criteria

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 * 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 Exclusion Criteria: * Lack of compliance with any inclusion criteria * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07691853). StuddyBuddy aggregates publicly available trial information.