- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05000931
Osia 2 Pediatric Expansion Study
March 22, 2024 updated by: Cochlear
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older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system.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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system.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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kari Kovac
- Phone Number: 303 264 2154
- Email: kkovac@cochlear.com
Study Contact Backup
- Name: Laura Temple
- Phone Number: 303 827 8786
- Email: ltemple@cochlear.com
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurological Institute
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-
California
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Palo Alto, California, United States, 94304
- Stanford University
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San Diego, California, United States, 92123
- Rady Children's Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Minnesota
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 11 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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).
- 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.
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:
- 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.
- 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.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- 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.
- Individuals undergoing simultaneous single-stage aural atresia or microtia repair due to the increased risk of skin complications associated with ear reconstruction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.
|
Osia 2 System in a pediatric population aged 5 - 11 years by quantifying the type, frequency and severity of adverse events.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of adverse events quantified by type, frequency, and severity between surgery and 6-months post-surgery.
Time Frame: 6 months post-surgery
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6 months post-surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to 6-month post-surgery in parental questionnaires.
Time Frame: Baseline before surgery, 6 months post-surgery
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Baseline before surgery, 6 months post-surgery
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Change from baseline to 4-weeks post-surgery in unaided bone conduction thresholds.
Time Frame: Baseline before surgery, 4 weeks post-surgery
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Baseline before surgery, 4 weeks post-surgery
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Change in word recognition using CNC words presented in quiet from baseline to 6-months post-surgery.
Time Frame: Baseline before surgery, 6 months post-surgery
|
Baseline before surgery, 6 months post-surgery
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Change in sentence recognition in noise using the BKB-SIN from baseline to 6-months post-surgery.
Time Frame: Baseline before surgery, 6 months post-surgery
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Baseline before surgery, 6 months post-surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lori O'Neill, Cochlear
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2022
Primary Completion (Actual)
September 22, 2023
Study Completion (Actual)
March 14, 2024
Study Registration Dates
First Submitted
July 23, 2021
First Submitted That Met QC Criteria
August 4, 2021
First Posted (Actual)
August 11, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAM 5766
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Cochlear do not have an approved platform for public sharing of IPD collected in this study.
Data may be provided to individual researchers on request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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