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

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.

Study Overview

• Status: Completed
• Conditions: Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis); Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
• Intervention / Treatment: Device: Osseointegrated Steady State Implant

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone Anchored Hearing Device (OSIA); All subjects will receive the Bone Anchored Hearing Device (OSIA)	Device: Osseointegrated Steady State Implant; Bone anchored, bone conduction hearing system; Other Names: Bone anchored, bone conduction hearing system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Surgery to 12 months post-operative

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Unilateral; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: CAM5706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No