Anatomy-based Fitting in Cochear Implant Users

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO LA PAZ · Apr 28, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well cochlear implants (CIs) perform over time in different groups of people who have recently received them. Researchers want to compare two methods of adjusting the CIs: one based on standard sound frequencies and another based on the individual's ear anatomy. The goal is to understand how these different fitting methods affect overall hearing outcomes and quality of life for CI users.

To participate in this study, individuals need to be at least 18 years old and have a specific type of hearing loss in one or both ears. They must be using a MED-EL cochlear implant and have a certain type of electrode. Participants should also be fluent in Spanish and must sign a consent form before joining. Those who enroll can expect ongoing evaluations to track their hearing progress and quality of life as they adapt to their new cochlear implants. It's an exciting opportunity to contribute to research that could help improve hearing for many people in the future!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
• • Post-OP CT scan of the CI electrode available
• • Subject implanted with MED-EL cochlear implant(s)
• • Subjects received a Flex28 or FlexSoft electrode
• • Subject planned to receive a SONNET 2 /RONDO3 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 Spanish
• • Signed and dated ICF before the start of any study-specific procedure
• • Specific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2/RONDO3 audio processor on the first ear implanted
• • 40% speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side
• • 40% speech recognition in a sentence test in noise (10 dB SNR) on the already implanted side First activation of the already implanted side between 3 and 12 months prior to study inclusion
• • • Unilateral CI users: Unilateral CI implantation CI user with contralateral hearing ≥ 60 dB (PTA measured at 500, 1000, 2000, and 4000 Hz)
• • • SSD CI users: Unilateral CI implantation CI user with contralateral hearing ≤30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥40 dB
• • • Bimodal CI users: Unilateral CI implantation Contralateral ear adequately fitted with a hearing aid CI user with contralateral hearing ≥30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) CI user with contralateral hearing ≤55 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥15 dB
• Exclusion Criteria:
• • Lack of compliance with any inclusion criteria
• • EAS user (user of an EAS audio processor)
• • Implanted with C40+, C40X and C40C
• • Implanted with an ABI or Split electrode array
• • Known allergic reactions to components of the investigational medical device
• • 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