Hearing LossNCT04041700
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
A study testing Osia 2 system 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 data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness. 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?
- Osia 2 system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Aug 2019to 24 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with conductive hearing loss 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 ≤ 55 dB sensorineural hearing loss.
- OR Subject with 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 ≤ 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.
- Adult subjects (18 years or older).
- Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband).
- Candidate is a fluent speaker in the language used to assess speech perception performance.
- Willing and able to provide written informed consent
Who cannot join
- Uncontrolled diabetes as judged by the investigator.
- Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
- Insufficient bone quality and quantity to support successful implant placement.
- Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged by the investigator.
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
- 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.
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- Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator.
- Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Sydney Cochlear Implant Centre
Gladesville
The Royal Victorian Eye and Ear Hospital
Melbourne
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 Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.
- Conditions
- Hearing Loss
- Being tested
- Osia 2 system
- 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.
Osia 2 systemDevice
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 processor.
| Study group | Role | What they receive |
|---|---|---|
| Osia 2 system | Experimental | Not described Receives: Device: Osia 2 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Measured: Baseline before surgery, 3 months after surgery
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Speech-to-noise ratio, 50% speech understanding
Measured: Baseline before surgery, 3 months after surgery
Secondary outcomes (30)
Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Measured: Baseline before surgery, 4 weeks and 6 months after surgery
Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Speech-to-noise ratio, 50% speech understanding
Measured: Baseline before surgery, 4 weeks and 6 months after surgery
Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]
Measured: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet
% correctly perceived words at 50dB, 65dB and 80dB SPL
Measured: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an impairment, a negative value an improvement.
Measured: Baseline before surgery, 3 months and 6 months after surgery
Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire
Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Measured: Baseline before surgery, 3 months and 6 months after surgery
Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire
Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Osia 2 System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Measured: Baseline before surgery, 3 months and 6 months after surgery
Surgical Information: Soft Tissue Thickness
Measured in mm
Measured: Baseline before surgery or at surgery
Surgical Information: Surgery Time
Time in minutes between first incision to last suture
Measured: At surgery
Surgical Information: Bone Polishing/Removal at the Actuator Site
Yes/No
Measured: At surgery
Surgical Information: BI300 Implant Length
3 mm/4 mm
Measured: At surgery
Surgical Information: Location of BI300 Implant
Measured in mm between the ear canal and the center of the actuator
Measured: At surgery
Surgical Information: Type of Anesthesia
General/local
Measured: At surgery
Surgical Information: Soft Tissue Reduction
Yes/No
Measured: At surgery
Surgical Information: Surgical Incision Type
Examples: C-shaped/S-shaped/straight
Measured: At surgery
Surgical Information: Location of the Surgical Incision in Relation to the Actuator
Anterior/posterior
Measured: At surgery
Surgical Information: Estimated Length of the Surgical Incision
Measured in mm
Measured: At surgery
Surgical Information: Placement of the Coil
Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)
Measured: At surgery
Usability Information: Magnet Choice
Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet.
Measured: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Usability Information: Sound Processor Retention
Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention
Measured: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Usability Information: Sound Processor Wearing Comfort
Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort
Measured: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Usability Information: Use of SoftWear Pad
Yes/No
Measured: At 6 weeks, 3 months and 6 months after surgery
Usability Information: Daily Use of Sound Processor
Average hours of daily use
Measured: At 6 weeks, 3 months and 6 months after surgery
Usability Information: Daily Streaming Time of Sound Processor
Average hours of daily streaming
Measured: At 6 weeks, 3 months and 6 months after surgery
Usability Information: Battery Lifetime of Sound Processor
Average hours of battery lifetime
Measured: At 6 weeks, 3 months and 6 months after surgery
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz].
Measured: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz].
Measured: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise
Signal-to-noise ratio, 50% speech understanding
Measured: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet
% correctly perceived words at 50dB, 65dB and 80dB SPL
Measured: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery 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: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start16 Aug 2019
- Primary completion19 Jun 2020
- Study completion24 Sep 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.
- Publications (2)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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statistiska Konsultgruppen
- Responsible party
- Sponsor
- Investigators
- Karin Ganlöv, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041700
- Sponsor's protocol ID
- CBAS5751
- Status last verified
- Jul 2021
- First submitted
- 30 Jul 2019
- Last updated
- 18 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37552281Briggs R, Birman CS, Baulderstone N, Lewis AT, Ng IHY, Ostblom A, Rousset A, Tari S, Tong MCF, Cowan R. Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2022 Aug 1;43(7):827-834. doi: 10.1097/MAO.0000000000003590.
PubMed 35878640
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
- ClinicalTrials.gov ID
- NCT04041700
- Acronym / sponsor ID
- CBAS5751
- Conditions
- Hearing Loss
- Keywords
- Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, sensorineural single-sided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- Statistiska Konsultgruppen
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 18 Aug 2021
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 data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osia 2 system | Experimental | Device: Osia 2 system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject with conductive hearing loss 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 ≤ 55 dB sensorineural hearing loss.
- OR Subject with 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 ≤ 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.
- Adult subjects (18 years or older).
- Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband).
- Candidate is a fluent speaker in the language used to assess speech perception performance.
Key exclusion criteria (11 listed)
- Uncontrolled diabetes as judged by the investigator.
- Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
- Insufficient bone quality and quantity to support successful implant placement.
- Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged 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 |
|---|---|---|
| Osia 2 systemSystem 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 processor. | Device | Osia 2 system |
Primary outcome
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
Time frame: Baseline before surgery, 3 months after surgery
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Time frame: Baseline before surgery, 3 months after surgery
Speech-to-noise ratio, 50% speech understanding
30 secondary outcomes
Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
Time frame: Baseline before surgery, 4 weeks and 6 months after surgery
Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Time frame: Baseline before surgery, 4 weeks and 6 months after surgery
Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Time frame: Baseline before surgery, 3 months and 6 months after surgery
Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire
Time frame: Baseline before surgery, 3 months and 6 months after surgery
Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire
Time frame: Baseline before surgery, 3 months and 6 months after surgery
Surgical Information: Soft Tissue Thickness
Time frame: Baseline before surgery or at surgery
Surgical Information: Surgery Time
Time frame: At surgery
Surgical Information: Bone Polishing/Removal at the Actuator Site
Time frame: At surgery
Surgical Information: BI300 Implant Length
Time frame: At surgery
Surgical Information: Location of BI300 Implant
Time frame: At surgery
Surgical Information: Type of Anesthesia
Time frame: At surgery
Surgical Information: Soft Tissue Reduction
Time frame: At surgery
Surgical Information: Surgical Incision Type
Time frame: At surgery
Surgical Information: Location of the Surgical Incision in Relation to the Actuator
Time frame: At surgery
Surgical Information: Estimated Length of the Surgical Incision
Time frame: At surgery
Surgical Information: Placement of the Coil
Time frame: At surgery
Usability Information: Magnet Choice
Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Usability Information: Sound Processor Retention
Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Usability Information: Sound Processor Wearing Comfort
Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Usability Information: Use of SoftWear Pad
Time frame: At 6 weeks, 3 months and 6 months after surgery
Usability Information: Daily Use of Sound Processor
Time frame: At 6 weeks, 3 months and 6 months after surgery
Usability Information: Daily Streaming Time of Sound Processor
Time frame: At 6 weeks, 3 months and 6 months after surgery
Usability Information: Battery Lifetime of Sound Processor
Time frame: At 6 weeks, 3 months and 6 months after surgery
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- 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.
- Derived from this study: PubMed 35878640Briggs R, Birman CS, Baulderstone N, Lewis AT, Ng IHY, Ostblom A, Rousset A, Tari S, Tong MCF, Cowan R. Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2022 Aug 1;43(7):827-834. doi: 10.1097/MAO.0000000000003590.
- Individual participant dataSharing planned: No
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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 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 Osia 2 system 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 6 inclusion and 11 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 18 Aug 2021. 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 18 Aug 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?
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds (time frame: Baseline before surgery, 3 months after surgery). The study lists 2 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 NCT04041700, which also lists 2 linked publications.
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 18 Aug 2021.