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New treatment option for Unilateral Hearing Loss
Official title Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
ClinicalTrials.gov ID: NCT06930170
What this study is testing
- What it's testing
- Today, unilateral hearing loss must be assessed and managed just as bilateral hearing loss is. It is recommended to consider the auditory difficulties caused by the loss of stereophonic hearing and to offer auditory rehabilitation as early as possible.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 6
You may be able to join if
- Child aged 4 to 6 years at the time of inclusion
- Using spoken French as the primary mode of communication
- Diagnosed with unilateral or asymmetric hearing loss : Unilateral is defined by severe to profound hearing loss in the affected ear (thresholds \> 70...
- Written informed consent from both legal guardians (or the sole guardian, if applicable)
- Affiliated with a health insurance system or entitled to coverage
You likely can't join if
- Severe neurological disorder, identified by MRI and/or a neuro-pediatric assessment
- Severe cognitive, child psychiatric, or developmental delay
- Severe cochleo-vestibular malformation
- Severe cochlear nerve malformation
- Social circumstances preventing long-term follow-up
- Family not proficient in spoken French
See the full eligibility criteria
- Child aged 4 to 6 years at the time of inclusion
- Using spoken French as the primary mode of communication
- Diagnosed with unilateral or asymmetric hearing loss : Unilateral is defined by severe to profound hearing loss in the affected ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and normal...
- Written informed consent from both legal guardians (or the sole guardian, if applicable)
- Affiliated with a health insurance system or entitled to coverage
- Severe neurological disorder, identified by MRI and/or a neuro-pediatric assessment
- Severe cognitive, child psychiatric, or developmental delay
- Severe cochleo-vestibular malformation
- Severe cochlear nerve malformation
- Social circumstances preventing long-term follow-up
- Family not proficient in spoken French
- Patient fitted with a CROS or BiCROS system
- Patient with a contraindication to implantation surgery or anesthesia (including lack of meningitis/pneumococcal vaccination)
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
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, 4 years to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. 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.