Osia 2 Pediatric Expansion Study

A Pivotal, Prospective, Multi-center, Open-label Study Evaluating the Safety and Effectiveness of the CochlearTM Osia® 2 System in a Pediatric Population.

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older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system.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.

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 Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Due to the success of the Osia 2 system in the United States within the currently indicated patient population, clinical providers have since requested the ability to use the Osia 2 system in children aged 11 years and younger who meet the audiometric requirements. As the Osia 2 system is based on existing bone conduction and cochlear implant technologies which each possess a younger age of implantation requirement (5 years for bone conduction and 9 months for cochlear implantation), the current proposal is to align the age at implantation requirement with existing surgical bone conduction technology such as the Baha Connect and Baha Attract Systems to 5 years of age. Therefore, 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.

Inclusion Criteria:

1. Subjects aged 5 to 11 years of age with the following audiometric criterion:

   • A conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL. OR
   • A profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

2. 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.

3. Parent or legal guardian who is willing and able to provide written informed consent for the study participant.

Note: Subjects may include individuals seeking new implantation unilaterally (in one ear) or individuals already implanted with a bone-anchored device seeking a second-side implant (sequential bilateral)

Exclusion Criteria:

1. Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant.
2. Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by the investigator.
3. Abnormally progressive hearing loss.
4. Evidence that hearing loss is bilateral retro cochlear or bilateral central origin.
5. Evidence of conditions that would prevent speech recognition improvement as determined by the investigator.
6. Skin or scalp conditions that may preclude attachment of the Sound Processor or that may interfere with the use of the Sound Processor.
7. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
8. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
9. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
10. Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Osia 2 system as determined by the investigator.
11. Individuals undergoing simultaneous single-stage aural atresia or microtia repair due to the increased risk of skin complications associated with ear reconstruction.