Back to results

Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population (OSIA Pediatric)

Primary Purpose

Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Osseointegrated Steady State Implant

About this trial

This is an interventional treatment trial for Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis)

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals 5 through 18 years of age will be eligible for inclusion in the investigation if all of the criteria below are met:

Conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure-tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of less than or equal to 55 dB HL.

Subject does not benefit from or will not wear a conventional hearing aid.

Note: Candidates may include individuals seeking new implantation unilaterally (in one ear) or bilaterally (both ears) as well as individuals already implanted with a bone-anchored device seeking a second-side implant.

Single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure-tone average (PTA4; mean of 0.5, 1, 2, and 3 kHz) of less that equal to 20 dB HL in the good ear.

Subject does not benefit from or will not wear a conventional hearing aid

Exclusion Criteria:

Uncontrolled diabetes as judged by the investigator. Subject who has received radiotherapy in the area of implantation, or such radiotherapy is planned during the study period.

Current use of ototoxic drugs. Condition that could jeopardize osseointegration and/or wound healing or condition that may have an impact on the outcome of the investigation as judged by the investigator.

Insufficient bone quality and quantity for implantation of a BI300 Implant, as determined by the surgeon.

Unable to follow investigational procedures. Participation in another clinical investigation with pharmaceutical and/or device

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone Anchored Hearing Device (OSIA)

Arm Description

All subjects will receive the Bone Anchored Hearing Device (OSIA)

Outcomes

Primary Outcome Measures

Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System

Number, Type and Severity of Adverse Events will be tabulated and summarized.

Secondary Outcome Measures

Full Information

NCT ID

NCT03509974

First Posted

April 17, 2018

Last Updated

October 1, 2021

Sponsor

Cochlear

1. Study Identification

Unique Protocol Identification Number

NCT03509974

Brief Title

Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population

Acronym

OSIA Pediatric

Official Title

Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

April 18, 2018 (Actual)

Primary Completion Date

February 20, 2020 (Actual)

Study Completion Date

March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cochlear

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.

Detailed Description

Experimental: Bone-conduction hearing device The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet. Device: Osia System An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bone Anchored Hearing Device (OSIA)

Arm Type

Experimental

Arm Description

All subjects will receive the Bone Anchored Hearing Device (OSIA)

Intervention Type

Device

Intervention Name(s)

Osseointegrated Steady State Implant

Other Intervention Name(s)

Bone anchored, bone conduction hearing system

Intervention Description

Bone anchored, bone conduction hearing system

Primary Outcome Measure Information:

Title

Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System

Description

Number, Type and Severity of Adverse Events will be tabulated and summarized.

Time Frame

Surgery to 12 months post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals 5 through 18 years of age will be eligible for inclusion in the investigation if all of the criteria below are met: Conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure-tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of less than or equal to 55 dB HL. Subject does not benefit from or will not wear a conventional hearing aid. Note: Candidates may include individuals seeking new implantation unilaterally (in one ear) or bilaterally (both ears) as well as individuals already implanted with a bone-anchored device seeking a second-side implant. OR Single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure-tone average (PTA4; mean of 0.5, 1, 2, and 3 kHz) of less that equal to 20 dB HL in the good ear. Subject does not benefit from or will not wear a conventional hearing aid Exclusion Criteria: Uncontrolled diabetes as judged by the investigator. Subject who has received radiotherapy in the area of implantation, or such radiotherapy is planned during the study period. Current use of ototoxic drugs. Condition that could jeopardize osseointegration and/or wound healing or condition that may have an impact on the outcome of the investigation as judged by the investigator. Insufficient bone quality and quantity for implantation of a BI300 Implant, as determined by the surgeon. Unable to follow investigational procedures. Participation in another clinical investigation with pharmaceutical and/or device

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G1X8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population

We'll reach out to this number within 24 hrs