Osia 2 Pediatric Expansion Study (NCT05000931) | Clinical Trial Compass
CompletedNot Applicable
Osia 2 Pediatric Expansion Study
United States50 participantsStarted 2022-01-26
Plain-language summary
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Thus the objective of this study is to examine the safety and effectiveness of the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the indications for use.
Who can participate
Age range5 Years – 11 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects aged 5 to 11 years of age with the following audiometric criterion:
✓. Prior experience with amplified sound through properly fitted amplification device such as a hearing aid, a CROS device, or a bone conduction device on a softband or sound arc.
✓. Parent or legal guardian who is willing and able to provide written informed consent for the study participant.
Exclusion criteria
✕. Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant.
✕. Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by the investigator.
✕. Abnormally progressive hearing loss.
✕. Evidence that hearing loss is bilateral retro cochlear or bilateral central origin.
✕. Evidence of conditions that would prevent speech recognition improvement as determined by the investigator.
What they're measuring
1
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Timeframe: From implantation to 6 months post-surgery
. Skin or scalp conditions that may preclude attachment of the Sound Processor or that may interfere with the use of the Sound Processor.
✕. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
✕. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.