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

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Device: Osseointegrated Steady State Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |