search
Back to results

Osia 2 Pediatric Expansion Study

Primary Purpose

Mixed Hearing Loss, Single-Sided Deafness, Conductive Hearing Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osia 2 System
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Hearing Loss

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barrow Neurological Institute
  • Stanford University
  • Rady Children's Hospital
  • Children's Minnesota
  • University Hospitals Cleveland Medical Center
  • Children's Hospital of Philadelphia
  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.

Arm Description

Outcomes

Primary Outcome Measures

Number of adverse events quantified by type, frequency, and severity between surgery and 6-months post-surgery.

Secondary Outcome Measures

Change from baseline to 6-month post-surgery in parental questionnaires.
Change from baseline to 4-weeks post-surgery in unaided bone conduction thresholds.
Change in word recognition using CNC words presented in quiet from baseline to 6-months post-surgery.
Change in sentence recognition in noise using the BKB-SIN from baseline to 6-months post-surgery.

Full Information

First Posted
July 23, 2021
Last Updated
October 16, 2023
Sponsor
Cochlear
Collaborators
R. P. Chiacchierini Consulting, LLC, Analytical Solutions Group, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05000931
Brief Title
Osia 2 Pediatric Expansion Study
Official Title
A Pivotal, Prospective, Multi-center, Open-label Study Evaluating the Safety and Effectiveness of the CochlearTM Osia® 2 System in a Pediatric Population.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
R. P. Chiacchierini Consulting, LLC, Analytical Solutions Group, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Hearing Loss, Single-Sided Deafness, Conductive Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Osia 2 System
Intervention Description
Osia 2 System in a pediatric population aged 5 - 11 years by quantifying the type, frequency and severity of adverse events.
Primary Outcome Measure Information:
Title
Number of adverse events quantified by type, frequency, and severity between surgery and 6-months post-surgery.
Time Frame
6 months post-surgery
Secondary Outcome Measure Information:
Title
Change from baseline to 6-month post-surgery in parental questionnaires.
Time Frame
Baseline before surgery, 6 months post-surgery
Title
Change from baseline to 4-weeks post-surgery in unaided bone conduction thresholds.
Time Frame
Baseline before surgery, 4 weeks post-surgery
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori O'Neill
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Children's Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Osia 2 Pediatric Expansion Study

We'll reach out to this number within 24 hrs