Actively Recruiting
Anatomy-based Fitting in Cochear Implant Users
Led by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz · Updated on 2025-08-12
30
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
Sponsors
F
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Lead Sponsor
M
MED-EL Elektromedizinische Geräte GesmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 to compare outcomes.
CONDITIONS
Official Title
Anatomy-based Fitting in Cochear Implant Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- Post-operative CT scan of the cochlear implant electrode available
- Implanted with MED-EL cochlear implant(s)
- Received a Flex28 or FlexSoft electrode
- Planned to receive a SONNET 2 or RONDO3 audio processor on the newly implanted side
- Audio processor not yet activated on the newly implanted side
- The most apical active electrode contact inserted at least 450 degrees
- Minimum of 10 active channels can be activated
- Fluent in Spanish
- Signed and dated informed consent form before any study procedure
- For bilateral CI users: bilateral implantation with SONNET 2/RONDO3 audio processor on first implanted ear
- 40% speech recognition on monosyllabic word test in quiet at 65 dB SPL on already implanted side
- 40% speech recognition in sentence test in noise (10 dB SNR) on already implanted side
- First activation of already implanted side between 3 and 12 months prior to inclusion
- For unilateral CI users: unilateral implantation with contralateral hearing threshold of 60 dB or better (PTA at 500,1000,2000,4000 Hz)
- For single-sided deafness (SSD) CI users: unilateral implantation with contralateral hearing threshold 30 dB or better (PTA at 500,1000,2000,4000 Hz)
- Interaural threshold gap of 40 dB or more
- For bimodal CI users: unilateral implantation with contralateral ear fitted with hearing aid
- Contralateral hearing threshold 30 dB or better (PTA at 500,1000,2000,4000 Hz)
- Contralateral hearing threshold 55 dB or better (PTA at 500,1000,2000,4000 Hz)
- Interaural threshold gap 15 dB or less
You will not qualify if you...
- Failure to meet any inclusion criteria
- Use of an EAS audio processor
- Implanted with C40+, C40X, or C40C devices
- Implanted with an auditory brainstem implant (ABI) or split electrode array
- Known allergic reactions to components of the medical device
- Any condition that increases risk or prevents full compliance or completion of the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario de La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
Research Team
L
Luis Lassaletta, PhD
CONTACT
M
Miryam Calvino, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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