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New treatment option for Cochlear Implant
Official title Anatomy-based Fitting in Cochear Implant Users
ClinicalTrials.gov ID: NCT05360212
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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)
- people received a Flex28 or FlexSoft electrode
You likely can't join if
- 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...
See the full eligibility 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)
- people 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 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.