Status:
RECRUITING
Anatomy-based Fitting in Cochear Implant Users
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Collaborating Sponsors:
MED-EL Elektromedizinische Geräte GesmbH
Conditions:
Cochlear Implant
Outcomes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used...
Detailed Description
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05360212
Start Date
March 11 2022
End Date
December 31 2026
Last Update
August 12 2025
Active Locations (1)
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1
Hospital Universitario de La Paz
Madrid, Madrid, Spain, 28046