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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Anchored Hearing Device (OSIA) | Experimental | All subjects will receive the Bone Anchored Hearing Device (OSIA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osseointegrated Steady State Implant | Device | Bone anchored, bone conduction hearing system |
|
| 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 |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone Anchored Hearing Device (OSIA) | All subjects will receive the Bone Anchored Hearing Device (OSIA) Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2017 | Jan 10, 2021 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bone Anchored Hearing Device (OSIA) | All subjects will receive the Bone Anchored Hearing Device (OSIA) Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Type of Hearing Loss | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Surgery to 12 months post-operative |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bone Anchored Hearing Device (OSIA) | All subjects will receive the Bone Anchored Hearing Device (OSIA) Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system | 0 | 14 | 1 | 14 | 10 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prevention of Device Connection/Activation | Ear and labyrinth disorders | Systematic Assessment | Skin flap easurement greater than 10mm prevented device connection/activation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ingrown hair near incision site | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Red incision site with some pus leaking | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pain and swelling at magnet site | Product Issues | Systematic Assessment | Patient bumped magnet site leadig to pain and swelling |
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| Pain and swelling at the tip of mastoid | Product Issues | Systematic Assessment |
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| Magnetitis and discomfort | Product Issues | Systematic Assessment | Very mild magnetitis causing pink skin |
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| Right swelling at the tip of the mastoid | Product Issues | Systematic Assessment |
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| Left-side facial swelling at post-operation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Redness at magnet site | Product Issues | Systematic Assessment |
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| Some discomfort following surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pain and swelling at surgical site | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-operation nausea and vomitting | Injury, poisoning and procedural complications | Systematic Assessment |
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| Swelling post surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| Sensitivity post surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| Discomfort post-surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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Principal Investigators and Team at Sick Kids preparing a publication for peer review with sponsor coordination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Cire | Cochlear | +13038855440 | gcire@cochlear.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D004194 | Disease |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| >=65 years |
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| Single-Sided-Deafness |
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| Serious - Skin flap measurement >10mm prevented device connectio/activiation |
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| Not Serious - Pain and swelling at the tip of mastoid |
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| Not Serious - magnetitis and soe discomfort with pin skin |
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| Not Serious - right swelling at the tip of the mastoid |
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| Not Serious - Left side facial swelling at post-operative site |
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| Not Serious - Redness at magnet site |
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| Not Serious - some discomfort following surgery |
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| Not Serious - Pain and swelling at surgical sight |
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| Not Serious - Post-operative nausea and vomitting |
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| Not Serious - swelling post surgery |
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| Not Serious - Sensitivity post surgery |
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| Not Serious - discomfort post surgery for one week |
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