OSIA Pediatric: Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System [Surgery to 12 months post-operative]
Number, Type and Severity of Adverse Events will be tabulated and summarized.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5G1X8 |
Sponsors and Collaborators
- Cochlear
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- CAM5706
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bone Anchored Hearing Device (OSIA) |
|---|---|
| Arm/Group Description | All subjects will receive the Bone Anchored Hearing Device (OSIA) Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system |
| Period Title: Overall Study | |
| STARTED | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Bone Anchored Hearing Device (OSIA) |
|---|---|
| Arm/Group Description | All subjects will receive the Bone Anchored Hearing Device (OSIA) Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system |
| Overall Participants | 14 |
| Age (Count of Participants) | |
| <=18 years |
14
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
50%
|
| Male |
7
50%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Type of Hearing Loss (Count of Participants) | |
| Conductive |
9
64.3%
|
| Mixed Conductive |
2
14.3%
|
| Single-Sided-Deafness |
3
21.4%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bone Anchored Hearing Device (OSIA) |
|---|---|
| Arm/Group Description | All subjects will receive the Bone Anchored Hearing Device (OSIA) Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system |
| Measure Participants | 14 |
| Not Serious - Ingrown hair near incision |
1
7.1%
|
| Not Serious - Red incision site with pus leaking |
1
7.1%
|
| Not Serious - Patient bumped magnet site in shower, pain and swelling |
1
7.1%
|
| Serious - Skin flap measurement >10mm prevented device connectio/activiation |
1
7.1%
|
| Not Serious - Pain and swelling at the tip of mastoid |
1
7.1%
|
| Not Serious - magnetitis and soe discomfort with pin skin |
1
7.1%
|
| Not Serious - right swelling at the tip of the mastoid |
1
7.1%
|
| Not Serious - Left side facial swelling at post-operative site |
1
7.1%
|
| Not Serious - Redness at magnet site |
1
7.1%
|
| Not Serious - some discomfort following surgery |
1
7.1%
|
| Not Serious - Pain and swelling at surgical sight |
1
7.1%
|
| Not Serious - Post-operative nausea and vomitting |
1
7.1%
|
| Not Serious - swelling post surgery |
1
7.1%
|
| Not Serious - Sensitivity post surgery |
1
7.1%
|
| Not Serious - discomfort post surgery for one week |
1
7.1%
|
Adverse Events
| Time Frame | 12 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Bone Anchored Hearing Device (OSIA) | |
| Arm/Group Description | All subjects will receive the Bone Anchored Hearing Device (OSIA) Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system | |
All Cause Mortality |
||
| Bone Anchored Hearing Device (OSIA) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | |
Serious Adverse Events |
||
| Bone Anchored Hearing Device (OSIA) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/14 (7.1%) | |
| Ear and labyrinth disorders | ||
| Prevention of Device Connection/Activation | 1/14 (7.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Bone Anchored Hearing Device (OSIA) | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/14 (71.4%) | |
| Injury, poisoning and procedural complications | ||
| Ingrown hair near incision site | 1/14 (7.1%) | 1 |
| Red incision site with some pus leaking | 1/14 (7.1%) | 1 |
| Left-side facial swelling at post-operation | 1/14 (7.1%) | 1 |
| Some discomfort following surgery | 1/14 (7.1%) | 1 |
| Pain and swelling at surgical site | 1/14 (7.1%) | 1 |
| Post-operation nausea and vomitting | 1/14 (7.1%) | 1 |
| Swelling post surgery | 1/14 (7.1%) | 1 |
| Sensitivity post surgery | 1/14 (7.1%) | 1 |
| Discomfort post-surgery | 1/14 (7.1%) | 1 |
| Product Issues | ||
| Pain and swelling at magnet site | 1/14 (7.1%) | 1 |
| Pain and swelling at the tip of mastoid | 1/14 (7.1%) | 1 |
| Magnetitis and discomfort | 1/14 (7.1%) | 1 |
| Right swelling at the tip of the mastoid | 1/14 (7.1%) | 1 |
| Redness at magnet site | 1/14 (7.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Principal Investigators and Team at Sick Kids preparing a publication for peer review with sponsor coordination.
Results Point of Contact
| Name/Title | George Cire |
|---|---|
| Organization | Cochlear |
| Phone | +13038855440 |
| gcire@cochlear.com |
- CAM5706