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New treatment option for Cochlear Implants
Official title Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
ClinicalTrials.gov ID: NCT05451628
What this study is testing
- What it's testing
- Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit.
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
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-operative Computed Tomography (CT) scan of the CI electrode available
- Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
- Subject implanted with MED-EL cochlear implant(s)
You likely can't join if
- Lack of compliance with any inclusion criteria
- Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
- 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...
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-operative Computed Tomography (CT) scan of the CI electrode available
- Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
- Subject implanted with MED-EL cochlear implant(s)
- people received a Flex28, FlexSoft or Standard electrode
- Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 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 the language of the test centre
- Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
- Lack of compliance with any inclusion criteria
- Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Brussels Capital, Belgium
- Antwerp, Belgium
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Brussels Capital, Belgium; Antwerp, Belgium. Enter your location above to see the nearest site and check your eligibility.
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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.