Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side, Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis)
Conditions
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
Interventions
DEVICEOsseointegrated Steady State Implant
Bone anchored, bone conduction hearing system
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Bone Anchored Hearing Device (OSIA) | — |
|---|---|---|
| Age, Categorical <=18 years | 14 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
| Type of Hearing Loss Conductive | 9 Participants | — |
| Type of Hearing Loss Mixed Conductive | 2 Participants | — |
| Type of Hearing Loss Single-Sided-Deafness | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 10 / 14 |
| serious Total, serious adverse events | 1 / 14 |
Outcome results
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.
Time frame: Surgery to 12 months post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Redness at magnet site | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - some discomfort following surgery | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Ingrown hair near incision | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Red incision site with pus leaking | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Patient bumped magnet site in shower, pain and swelling | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Serious - Skin flap measurement >10mm prevented device connectio/activiation | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Pain and swelling at the tip of mastoid | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - magnetitis and soe discomfort with pin skin | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - right swelling at the tip of the mastoid | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Left side facial swelling at post-operative site | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Pain and swelling at surgical sight | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Post-operative nausea and vomitting | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - swelling post surgery | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - Sensitivity post surgery | 1 Participants |
| Bone Anchored Hearing Device (OSIA) | Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System | Not Serious - discomfort post surgery for one week | 1 Participants |