Hearing LossNCT04754477
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
A study testing Active Osseointegrated Steady-State Implant System (OSI) in people with Hearing Loss, run by Cochlear at 3 sites in 2 countries.
Trial summary
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Active Osseointegrated Steady-State Implant System (OSI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 May 2021to 21 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
- Willing and able to provide written informed consent
Who cannot join
- Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
HEARnet Clinical studies
Carlton, Victoria, 3053
SCIC / NextSense
Gladesville, New South Wales, 2111
Hong Kong1 site
Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong
Hong Kong
About this study
Official title: A Multicentre, Open, Long-term Clinical Investigation Evaluating Safety, Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness.
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.
- Conditions
- Hearing Loss
- Being tested
- Active Osseointegrated Steady-State Implant System (OSI)
- Keywords
- Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, sensorineural single-sided
- Medical subject headings
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Osseointegrated Steady-State Implant System (OSI)Device
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process
| Study group | Role | What they receive |
|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Experimental | Not described Receives: Device: Active Osseointegrated Steady-State Implant System (OSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Type of Reported Adverse Events
The adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system
Measured: 6 months post-surgery to 24 months post-surgery
Number and Type of Reported Device Deficiencies
The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship
Measured: 6 months post-surgery to 24 months post-surgery
Concomitant Medication Used
Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)
Measured: 6 months post-surgery to 24 months post-surgery
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Measured: 12 months post-surgery
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Measured: 24 months post-surgery
Change in Audiometric Thresholds With the Active Osseointegrated Steady-State Implant System at 12 Months Post-surgery and 24 Months Post-surgery Compared to Preoperative Thresholds Via an Audiogram
Bone- and air conduction thresholds, masked and unmasked
Measured: Baseline before surgery, 12 months and 24 months post-surgery
Secondary outcomes (22)
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 Months and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds
Sound-field (Pure Tone Average 4, mean of 0.5, 1, 2 and 4 kHz)
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds
Sound-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Adaptive Speech Recognition in Noise
Speech-to-noise ratio, 50% speech understanding
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Bone Conduction (BC) Direct
BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Difference in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Assessed via Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. APHAB produces a global score and scores for four subscales: Ease of Communication, Reverberation, Background Noise, and Aversiveness. Global score is the average of all subscales. All scales range from 0-100%, where 0% indicates no problem and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The difference in scores will be presented. A positive value indicates an improvement, a negative value an impairment.
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Assessed via the Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire. Measuring change of speech, spatial and hearing experiences with the Active Osseointegrated Steady-State Implant System. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10 is used, where 0 represents "can not hear at all", and 10 "hear perfectly". An increase of an SSQ value reflects an improvement. The change in scores will be presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Health-related Quality of Life With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Assessed via the Health Utilities Index (HUI) questionnaire. Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index when wearing the Active Osseointegrated Steady-State Implant System. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores will be presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better.
Measured: 12 months post-surgery
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy.
Measured: 12 months post-surgery
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied.
Measured: 12 months post-surgery
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Measured: 12 months post-surgery
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better.
Measured: 24 months post-surgery
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy.
Measured: 24 months post-surgery
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied.
Measured: 24 months post-surgery
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Measured: 24 months post-surgery
Daily Use of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Average hours of daily use during the last week before each follow up visit
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Daily Streaming Time of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Average hours of daily streaming during the last week before each follow up visit
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Battery Lifetime of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Average hours of battery lifetime for a single battery during the last week before each follow up visit
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Magnet Choice of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Magnet strength ranging from 1 to 4, strength 1 being the weakest and 4 the strongest. If the magnet strength has been changed the reason for change is captured in free text
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Use of SoftWear Pad for the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
SoftWear pad usage: Yes or No
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Retention of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention.
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Wearing Comfort of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort.
Measured: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start6 May 2021
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statistiska Konsultgruppen
- Responsible party
- Sponsor
- Investigators
- Karin Ganlöv, MD, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754477
- Sponsor's protocol ID
- CBAS5793
- Status last verified
- Jan 2024
- First submitted
- 10 Feb 2021
- Last updated
- 10 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
Publications
Cowan R, Lewis AT, Hallberg C, Tong MCF, Birman CS, Ng IH, Briggs R. Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):683-691. doi: 10.1007/s00405-023-08133-3. Epub 2023 Aug 8.
PubMed 37552281
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open, Long-term Clinical Investigation Evaluating Safety, Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness.
- ClinicalTrials.gov ID
- NCT04754477
- Acronym / sponsor ID
- CBAS5793
- Conditions
- Hearing Loss
- Keywords
- Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, sensorineural single-sided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- Statistiska Konsultgruppen
- Study start
- 6 May 2021 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Posted 10 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Experimental | Device: Active Osseointegrated Steady-State Implant System (OSI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
- Willing and able to provide written informed consent
Key exclusion criteria (2 listed)
- Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
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 |
|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI)System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process | Device | Active Osseointegrated Steady-State Implant System (OSI) |
Primary outcome
Number and Type of Reported Adverse Events
Time frame: 6 months post-surgery to 24 months post-surgery
The adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system
Number and Type of Reported Device Deficiencies
Time frame: 6 months post-surgery to 24 months post-surgery
The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship
Concomitant Medication Used
Time frame: 6 months post-surgery to 24 months post-surgery
Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Time frame: 12 months post-surgery
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Time frame: 24 months post-surgery
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Change in Audiometric Thresholds With the Active Osseointegrated Steady-State Implant System at 12 Months Post-surgery and 24 Months Post-surgery Compared to Preoperative Thresholds Via an Audiogram
Time frame: Baseline before surgery, 12 months and 24 months post-surgery
Bone- and air conduction thresholds, masked and unmasked
22 secondary outcomes
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 Months and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Adaptive Speech Recognition in Noise
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Bone Conduction (BC) Direct
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Difference in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Change in Health-related Quality of Life With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Time frame: 12 months post-surgery
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Time frame: 12 months post-surgery
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Time frame: 12 months post-surgery
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Time frame: 12 months post-surgery
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Time frame: 24 months post-surgery
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Time frame: 24 months post-surgery
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Time frame: 24 months post-surgery
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Time frame: 24 months post-surgery
Daily Use of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Daily Streaming Time of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Battery Lifetime of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Magnet Choice of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Use of SoftWear Pad for the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Retention of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Wearing Comfort of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37552281Cowan R, Lewis AT, Hallberg C, Tong MCF, Birman CS, Ng IH, Briggs R. Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):683-691. doi: 10.1007/s00405-023-08133-3. Epub 2023 Aug 8.
- Individual participant dataSharing planned: No. Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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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.
Karin Ganlöv, MD study director
Cochlear
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Osseointegrated Steady-State Implant System (OSI) in people with Hearing Loss, run by Cochlear at 3 sites in 2 countries.
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 2 inclusion and 2 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Hong Kong. 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 10 Jun 2024). 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 and Type of Reported Adverse Events (time frame: 6 months post-surgery to 24 months post-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754477, which also lists 1 linked publication.
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 10 Jun 2024.