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New treatment option for Hearing Loss, Sensorineural
Official title Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
ClinicalTrials.gov ID: NCT06664710
What this study is testing
- What it's testing
- Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Cochlear implant candidate in one or two ears per current FDA indications
- Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
- Cochlear implantation using the Advanced Bionics SlimJ electrode array
- 18 years of age or older at the time of enrollment
- Willingness to participate in and comply with all requirements of the protocol
You likely can't join if
- Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not...
- 4\. History of temporal bone fracture that involves the cochlea/internal auditory canal.
- 5\. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory...
- 6\. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
- 7\. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to...
- 8\. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
See the full eligibility criteria
- Cochlear implant candidate in one or two ears per current FDA indications
- Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
- Cochlear implantation using the Advanced Bionics SlimJ electrode array
- 18 years of age or older at the time of enrollment
- Willingness to participate in and comply with all requirements of the protocol
- Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any...
- 4\. History of temporal bone fracture that involves the cochlea/internal auditory canal.
- 5\. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).
- 6\. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
- 7\. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.
- 8\. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
- 9\. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.
- 10\. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. 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.