Deafness; Sensoneural Single SidedNCT03086135
Clinical Performance of a New Implant System for Bone Conduction Hearing
A study testing Osia System in people with Deafness; Sensoneural Single Sided and Conductive Hearing Loss, run by Cochlear at 5 sites in 5 countries.
Trial summary
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- What is being tested?
- Osia System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 9 Mar 2017to 20 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects (18 years or older)
- Subject with 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 55 dB HL.
- OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
- Signed informed consent
- Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
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 for implantation of a BI300 Implant.
- Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
- 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.
- Participation in another clinical investigation with pharmaceutical and/or device.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Australia1 site
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, VIC 3002
Germany1 site
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Poland1 site
World Hearing Center Institute of Physiology and Pathology of Hearing
Kajetany, Nadarzyn, 05-830
About this study
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
- Being tested
- Osia System
- Medical subject headings
- Deafness, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osia SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Bone-conduction hearing device | Experimental | 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. Receives: Device: Osia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is <25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Measured: Baseline before surgery, 3 months after surgery
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment.
Measured: Baseline before surgery, 3 months after surgery
Secondary outcomes (22)
Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
The change of hearing performance from the unaided hearinhg situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 6 and 12 months, measured as free-field hearing test: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is <25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Measured: Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. This value gives a snapshot of an individual's hearing level. If PTA is <25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of the unaided hearing level expressed in dB and the hearing level aided with the Osia system at different time points. An unaided value should be higher than a aided if the hearing device is effective. A lower or more negative score is therefor more desirable and reflects a better ability to hear at the specified frequency.
Measured: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test Speech in quiet at 50, 65 and 80 dB SPL [% correctly perceived words at 50, 65 and 80 dB SPL] is presented. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.
Measured: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects a better hearing in a noisy environment.
Measured: Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
The change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months is presented. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problem and 100% indicates always problem. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 100 and the aided 0, the result is then 100. A positive value indicates an improvement, a negative value an impairment.
Measured: Baseline before surgery, 3 and 12 months after surgery
Health Utility Index (HUI) at 3 and 12 Months
The change of health status and health related quality of life from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the generic quality of life scale Health Utilities Index (HUI3) is presented. All subscales (comprehensive health state, vision, hearing, speech, ambulation, dexterity, emotion, pain, cognition) range from 0-1. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 0 and the aided 1, the result is then 1.0. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Measured: Baseline before surgery and 3 and 12 months after surgery
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
The change of speech, spatial and hearing experiences from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the SSQ scale is presented. All subscales (speech, spatial, quality) range from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". Total score is a average of the subscales. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Measured: Baseline before surgery and 3 and 12 months after surgery
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. The units reported for PTA4 are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Measured: Baseline before surgery, 4 weeks, 3, 6 and 12 months.
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry individual frequencies (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. The units reported are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Measured: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband measured as free-field hearing test; Speech in quiet [% correctly perceived words at 50, 65 and 80 dB SPL]. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.
Measured: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Adaptive Speech Recognition in Noise, With Reference Device BP110
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband;measured with free field hearing test Adaptive speech recognition in noise which was measured as signal to noise ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB. A positive SNR-value reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.
Measured: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Surgical Information: Time of Surgery
Surgery time in minutes between first incision and last suture
Measured: Visit 2, surgery
Soft Tissue Thickness
Surgical information: Soft tissue thickness was measured in mm
Measured: Visit 2, surgery
Soft Tissue Reduction
Surgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for "Yes" or "No".
Measured: Visit 2, surgery
Bone Polishing/Removal at Implant Site
Surgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked.
Measured: Visit 2, surgery
Type of Anaesthesia
Surgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked.
Measured: Visit 2, surgery
Location of BI300 Implant
Surgical information: where is the location of the BI300 implant, measured in two different ways:
Alternative 1 used for the first 6 subjects: Location from the ear channel in mm.
Alternative 2 used for the rest of the population 45 subjects, after an amendment: measured in mm horizontally and vertically from ear channel. and the distance in mm between the receiver and the coil.
Value 9.64 mm vertically from ear channel is correct.
Measured: Visit 2, surgery
Incision Type
Surgical information: a question was asked regarding what type of incision had been used; C-shaped flap, posterior based flap or other could be ticked.
Measured: Visit 2, surgery
Daily Usage Time of Sound Processor
Sound processor usage time measured as hours per day.
Measured: 6 weeks, 3, 6 and 12 months
Comfort
Comfort of sound processor measured with a visual analogue scale where 0% is defined as no comfort at all and 100% as most comfortable imaginable, i.e. minimum 0, maximum 100.
Measured: 6 weeks, 3, 6 and 12 months
Magnet Choice
Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest.
Measured: 4, 6 weeks, 3, 6 and 12 months
Softpad Use
A question was asked if the subjects used softpads; yes or no could be ticked.
Measured: 6 weeks, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start9 Mar 2017
- Primary completion30 Oct 2018
- Study completion20 Jun 2019
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 Deafness; Sensoneural Single SidedStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmanuel Mylanus, Prof., Principal investigator, Radboud Univerity Medical centreRobert Briggs, Prof., Principal investigator, The Royal Victorian Eye and Ear HospitaSusan Arndt, Prof., Principal investigator, University Hospital FreiburgPiotr Skarżyński, Ass.Prof., Principal investigator, Center of Hearing and SpeechHenry Alexander Arts, Prof., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086135
- Sponsor's protocol ID
- CBAS5539
- Status last verified
- Jan 2020
- First submitted
- 9 Mar 2017
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a New Implant System for Bone Conduction Hearing
- ClinicalTrials.gov ID
- NCT03086135
- Acronym / sponsor ID
- CBAS5539
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 5 Feb 2020
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 the new Bone conduction system in patients with conductive, mixed 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 |
|---|---|---|
| Bone-conduction hearing device | Experimental | Device: Osia SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects (18 years or older)
- Subject with 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 55 dB HL.
- OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
- Signed informed consent
- Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
Key exclusion criteria (7 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 for implantation of a BI300 Implant.
- Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
- 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 SystemAn 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. | Device | Bone-conduction hearing device |
Primary outcome
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
Time frame: Baseline before surgery, 3 months after surgery
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is <25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
Time frame: Baseline before surgery, 3 months after surgery
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment.
22 secondary outcomes
Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
Time frame: Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
Time frame: Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
Time frame: Baseline before surgery, 3 and 12 months after surgery
Health Utility Index (HUI) at 3 and 12 Months
Time frame: Baseline before surgery and 3 and 12 months after surgery
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
Time frame: Baseline before surgery and 3 and 12 months after surgery
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months.
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Adaptive Speech Recognition in Noise, With Reference Device BP110
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Surgical Information: Time of Surgery
Time frame: Visit 2, surgery
Soft Tissue Thickness
Time frame: Visit 2, surgery
Soft Tissue Reduction
Time frame: Visit 2, surgery
Bone Polishing/Removal at Implant Site
Time frame: Visit 2, surgery
Type of Anaesthesia
Time frame: Visit 2, surgery
Location of BI300 Implant
Time frame: Visit 2, surgery
Incision Type
Time frame: Visit 2, surgery
Daily Usage Time of Sound Processor
Time frame: 6 weeks, 3, 6 and 12 months
Comfort
Time frame: 6 weeks, 3, 6 and 12 months
Magnet Choice
Time frame: 4, 6 weeks, 3, 6 and 12 months
Softpad Use
Time frame: 6 weeks, 3, 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Recruiting
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Recruiting
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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.
Emmanuel Mylanus, Prof. principal investigator
Radboud Univerity Medical centre
Robert Briggs, Prof. principal investigator
The Royal Victorian Eye and Ear Hospita
Susan Arndt, Prof. principal investigator
University Hospital Freiburg
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osia System in people with Deafness; Sensoneural Single Sided and Conductive Hearing Loss, run by Cochlear at 5 sites in 5 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 5 inclusion and 7 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 14 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 5 sites in United States, Australia, Germany, Netherlands, Poland. 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 5 Feb 2020). 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?
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months (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?
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 14 Oct 2021.