Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis)OSIA PediatricNCT03509974
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
A study testing Osseointegrated Steady State Implant in people with Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis) and Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side, run by Cochlear at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
- What is being tested?
- Osseointegrated Steady State Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2018to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
- Being tested
- Osseointegrated Steady State Implant
- Medical subject headings
- Hearing Loss, Sensorineural, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osseointegrated Steady State ImplantDevice
Also called Bone anchored, bone conduction hearing system
Bone anchored, bone conduction hearing system
| Study group | Role | What they receive |
|---|---|---|
| Bone Anchored Hearing Device (OSIA) | Experimental | All subjects will receive the Bone Anchored Hearing Device (OSIA) Receives: Device: Osseointegrated Steady State Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Surgery to 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start18 Apr 2018
- Primary completion20 Feb 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis)Studies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509974
- Sponsor's protocol ID
- CAM5706
- Acronym
- OSIA Pediatric
- Status last verified
- Oct 2021
- First submitted
- 17 Apr 2018
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
- ClinicalTrials.gov ID
- NCT03509974
- Acronym / sponsor ID
- OSIA Pediatric / CAM5706
- Conditions
- Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Anchored Hearing Device (OSIA) | Experimental | Device: Osseointegrated Steady State ImplantAll subjects will receive the Bone Anchored Hearing Device (OSIA) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osseointegrated Steady State ImplantAlso: Bone anchored, bone conduction hearing systemBone anchored, bone conduction hearing system | Device | Bone Anchored Hearing Device (OSIA) |
Primary outcome
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Time frame: Surgery to 12 months post-operative
Number, Type and Severity of Adverse Events will be tabulated and summarized.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osseointegrated Steady State Implant in people with Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis) and Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side, run by Cochlear at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System (time frame: Surgery to 12 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021; AzTrials last refreshed its copy on 4 Nov 2026.