Trial comparing treatments for Cochlear Implants
Official title Clinical Trial to Compare Two Surgical Approaches to the Cochlea
ClinicalTrials.gov ID: NCT06453343
What this study is testing
- What it's testing
- This is a multinational control trial.
Which group you join is decided by chance.
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
- Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.
- CI candidate based on local or national reimbursement criteria.
- Cochlear implantation with a CI632.
- Preoperative 500 Hz pure-tone air conduction threshold \<80 dB hearing level (HL) in the ear to be implanted.
- Willing and able to provide written informed consent.
You likely can't join if
- Previous or existing CI recipient.
- Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.
- Abnormal cochlear nerve anatomy on preoperative CT or MRI.
- people who are unable to undergo CT or MRI.
- Deafness due to acoustic nerve or central auditory pathway lesions.
- Diagnosis of auditory neuropathy.
See the full eligibility criteria
- Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.
- CI candidate based on local or national reimbursement criteria.
- Cochlear implantation with a CI632.
- Preoperative 500 Hz pure-tone air conduction threshold \<80 dB hearing level (HL) in the ear to be implanted.
- Willing and able to provide written informed consent.
- Previous or existing CI recipient.
- Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.
- Abnormal cochlear nerve anatomy on preoperative CT or MRI.
- people who are unable to undergo CT or MRI.
- Deafness due to acoustic nerve or central auditory pathway lesions.
- Diagnosis of auditory neuropathy.
- Active middle ear infection.
- Additional handicaps that would prevent participation in study evaluations.
- Unrealistic expectations from the participant regarding the possible benefits, risks, and limitations inherent to the CI procedure and the investigation.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
The study team makes the final eligibility decision.
Where it is enrolling
- Nijmegen, Netherlands
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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, but 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?
This study is enrolling now at Nijmegen, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.