BridgeMD
New treatment option for Hearing Loss, Sensorineural
Official title Hearing and Structure Preservation Via ECochG
ClinicalTrials.gov ID: NCT06268340
What this study is testing
- What it's testing
- The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.
- 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
- Aged 18 years of age or older
- Within cochlear implant by local regulations/guidelines at the time of implantation
- Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be...
- Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted
- Less than 15 years of severe to profound deafness on the implant ear prior to surgery
You likely can't join if
- Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted
- Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
- Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local...
- Diagnosis of auditory spectrum neuropathy disorder
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Deafened by meningitis
See the full eligibility criteria
- Aged 18 years of age or older
- Within cochlear implant by local regulations/guidelines at the time of implantation
- Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted
- Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted
- Less than 15 years of severe to profound deafness on the implant ear prior to surgery
- Post-lingually acquired hearing loss in the ear to be implanted
- Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted
- Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array
- Listed for cochlear implant surgery under general anaesthesia
- Fluent in local language
- Given informed consent to participate in the study
- Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted
- Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
- Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections
- Diagnosis of auditory spectrum neuropathy disorder
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Deafened by meningitis
- Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL)
- Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear \> 30 dB HL and ≤ 55 dB HL)
- History of previous cochlear implantation/re-implantation on either ear
- Any contraindications to computed tomography (CT) scans
- Concurrent participation in other cochlear implant related studies
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Gent, Belgium
- Tours, Tours, France
- Freiburg im Breisgau, Freiburg, Germany
- Torino, TO, Italy
- Warsaw, Nadarzyn, Poland
- Granada, Granada, Spain
- Cambridge, England, United Kingdom
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 Ghent, Gent, Belgium; Tours, Tours, France; Freiburg im Breisgau, Freiburg, Germany; Torino, TO, Italy; Warsaw, Nadarzyn, Poland; Granada, Granada, Spain and 1 more location(s). 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.