Single Sided Sensorineural DeafnessNCT02722330
Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
A study testing Baha 5 SuperPower on Baha Attract System in people with Single Sided Sensorineural Deafness and Mixed Hearing Loss, Unilateral, run by Cochlear Bone Anchored Solutions at 4 sites in 4 countries.
Trial summary
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single Sided Sensorineural Deafness, Mixed Hearing Loss, Unilateral
- What is being tested?
- Baha 5 SuperPower on Baha Attract System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2016to Dec 2016
- 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
- Adult subjects ≥ 18 years of age
- Mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4, Mean of 0.5, 1, 2 and 4kHz) of 30-55 dBHL or
- Single-sided sensorineural deafness: Bone conduction thresholds with a pure tone average [PTA4, Mean of 0.5, 1, 2 and 4 kHz] of lower or 30 dBHL in the best ear. Subjects who have, for some reason, experienced no or limited benefit from other sound processors when tested on a Baha Softband.
- Subjects suitable for surgery according to the recommended surgical procedure for Cochlear Baha 5 SuperPower with no previous implant on the side to be investigated.
- Signed inform consent.
Who cannot join
- Subject scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Investigational device (however, bilateral hearing loss is not an exclusion criterion).
- Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
- Less than 3 mm soft tissue thickness at the planned implant site. (Intra-operative exclusion criteria judged by the surgeon at Visit 1 or Visit 2 according to local practice).
- Subjects that have received radiation therapy at the same side of the skull where the Investigational device will be positioned.
- Uncontrolled diabetes as judged by the investigator.
- Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis and long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation 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
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Evaluation of Audiological Outcomes and Subjective Benefits of Cochlear Baha® 5 SuperPower Sound Processor on the Baha® Attract™ System
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.
Read the detailed description
The Cochlear Baha bone conduction hearing implant offers two alternative ways to transmit vibrations from the external sound processor to the osseointegrated implant: The Baha Connect System uses a skin-penetrating abutment and allows direct bone conduction. The Baha Attract System uses a magnetic connection through intact skin. Magnetic bone conduction hearing implants have the advantage over skin-penetrating systems of eliminating the daily cleaning of the site and are perceived as a more cosmetically appealing by some subjects. With modern sound processor technology, it is possible to obtain good sound transmission despite the soft tissue attenuation that is inherent to magnetic bone conduction hearing implants. Clinical investigations have shown that the Baha Attract System, when used in combination with existing head-worn sound processors within the Premium (e.g. BP100, Baha 4 Sound Processors) and Power (BP110 Sound processor) segments, provides good hearing outcomes in subjects with conductive and mild mixed hearing loss.
The Cochlear Baha 5 SuperPower Sound Processor is the first head-worn sound processor within the Super Power segment and has a fitting range of 65 dBHL. It is CE marked and is intended for subjects with mixed hearing loss or single-sided sensorineural deafness (SSD). It can be used with the Baha Connect and Baha Attract Systems and with a Baha Softband. When used in combination with the Baha Attract System, it will be able to compensate for a larger sensorineural component than the current Premium and Power sound processors and, hence, will allow more subjects to benefit from the Baha Attract System. The combination Baha Attract System with Baha 5 SuperPower Sound Processor is the most powerful non-skin penetrating bone conduction hearing implant solution available today.
The Baha 5 SuperPower Sound Processor includes discreet design, advanced signal processing and improved connectivity to external sound sources. The new sound processor supports Cochlear's 2.4 GHz wireless protocol and is programmable with a new version of the Baha 5 Fitting Software.
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.
- Being tested
- Baha 5 SuperPower on Baha Attract System
- Medical subject headings
- Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baha 5 SuperPower on Baha Attract SystemDevice
The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
| Study group | Role | What they receive |
|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Experimental | The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling. Receives: Device: Baha 5 SuperPower on Baha Attract System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided
Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Measured: 12 weeks
Secondary outcomes (21)
Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.
The APHAB is a 24-item self-assessment questionnaire evaluating the benefit experienced by the subject when using hearing amplification compared to the unaided situation. It comprises of four subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). The Global score is the mean of the subscales. All subscales are scored in the same way.
The scores show how frequently (%) clients experience performance problems and varies between 0-100, 0 indicates no problems, 100 indicates always problem. Benefit is then calculated by subtracting the aided average from the unaided average. The theoretical benefit score could vary between -100 to + 100. The higher the score the better benefit and positive score indicates an improvement, a negative value an impairment.
Measured: 12 weeks
Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks.
The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item.
The change from unaided to aided hearing is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
Measured: 12 weeks
Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided
Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Measured: 4 weeks
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Measured: 4 weeks
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Measured: 12 weeks
Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Measured: 4 weeks
Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Measured: 12 weeks
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Measured: 4 weeks
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Measured: 12 weeks
Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband
Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 4 weeks
Measured: 4 weeks
Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband
Change of hearing performance PTA4 from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 12 weeks
Measured: 12 weeks
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from the situation with same sound processor on a Baha softband with the Investigational device on the attract system at 4 weeks
Measured: 4 weeks
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from the same sound processor on a Baha softband with the Investigational device on the attract system at 12 weeks
Measured: 12 weeks
Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 4 weeks
Measured: 4 weeks
Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 12 weeks
Measured: 12 weeks
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 4 weeks
Measured: 4 weeks
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 12 weeks
Measured: 12 weeks
Sound Processor Magnet Selection at 4 Weeks
Information about sound processor magnet selection, type of SP magnet
Measured: 4 weeks
Sound Processor Magnet Selection at 6 Weeks
Information about sound processor magnet selection, type of SP magnet
Measured: 6 weeks
Sound Processor Magnet Selection at 12 Weeks
Information about sound processor magnet selection, type of SP magnet
Measured: 12 weeks
Daily Use of Sound Processor (Average Daily Use During the Last Week)
Average daily use (hours/day) of the sound processor during the last week of the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionDec 2016
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 Single Sided Sensorineural DeafnessStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear Bone Anchored Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaydip Ray, Professor, Principal investigator, Royal Hallamshire HospitalCésar Orús, Dr, Principal investigator, Hospital de Sant PauPaul Van de Heyning, Professor, Principal investigator, University Hospital, AntwerpJesper Schmidt, Dr, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722330
- Sponsor's protocol ID
- CBAS5619
- Status last verified
- Feb 2019
- First submitted
- 17 Feb 2016
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Audiological Outcomes and Subjective Benefits of Cochlear Baha® 5 SuperPower Sound Processor on the Baha® Attract™ System
- ClinicalTrials.gov ID
- NCT02722330
- Acronym / sponsor ID
- CBAS5619
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cochlear Bone Anchored SolutionsIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 3 Jun 2019
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 evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.
Detailed description
The Cochlear Baha bone conduction hearing implant offers two alternative ways to transmit vibrations from the external sound processor to the osseointegrated implant: The Baha Connect System uses a skin-penetrating abutment and allows direct bone conduction. The Baha Attract System uses a magnetic connection through intact skin. Magnetic bone conduction hearing implants have the advantage over skin-penetrating systems of eliminating the daily cleaning of the site and are perceived as a more cosmetically appealing by some subjects. With modern sound processor technology, it is possible to obtain good sound transmission despite the soft tissue attenuation that is inherent to magnetic bone conduction hearing implants. Clinical investigations have shown that the Baha Attract System, when used in combination with existing head-worn sound processors within the Premium (e.g. BP100, Baha 4 Sound Processors) and Power (BP110 Sound processor) segments, provides good hearing outcomes in subjects with conductive and mild mixed hearing loss.
The Cochlear Baha 5 SuperPower Sound Processor is the first head-worn sound processor within the Super Power segment and has a fitting range of 65 dBHL. It is CE marked and is intended for subjects with mixed hearing loss or single-sided sensorineural deafness (SSD). It can be used with the Baha Connect and Baha Attract Systems and with a Baha Softband. When used in combination with the Baha Attract System, it will be able to compensate for a larger sensorineural component than the current Premium and Power sound processors and, hence, will allow more subjects to benefit from the Baha Attract System. The combination Baha Attract System with Baha 5 SuperPower Sound Processor is the most powerful non-skin penetrating bone conduction hearing implant solution available today.
The Baha 5 SuperPower Sound Processor includes discreet design, advanced signal processing and improved connectivity to external sound sources. The new sound processor supports Cochlear's 2.4 GHz wireless protocol and is programmable with a new version of the Baha 5 Fitting Software.
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Experimental | Device: Baha 5 SuperPower on Baha Attract SystemThe device involves the following parts: The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects ≥ 18 years of age
- Mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4, Mean of 0.5, 1, 2 and 4kHz) of 30-55 dBHL or
- Single-sided sensorineural deafness: Bone conduction thresholds with a pure tone average [PTA4, Mean of 0.5, 1, 2 and 4 kHz] of lower or 30 dBHL in the best ear. Subjects who have, for some reason, experienced no or limited benefit from other sound processors when tested on a Baha Softband.
- Subjects suitable for surgery according to the recommended surgical procedure for Cochlear Baha 5 SuperPower with no previous implant on the side to be investigated.
- Signed inform consent.
Key exclusion criteria (8 listed)
- Subject scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Investigational device (however, bilateral hearing loss is not an exclusion criterion).
- Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
- Less than 3 mm soft tissue thickness at the planned implant site. (Intra-operative exclusion criteria judged by the surgeon at Visit 1 or Visit 2 according to local practice).
- Subjects that have received radiation therapy at the same side of the skull where the Investigational device will be positioned.
- Uncontrolled diabetes 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 |
|---|---|---|
| Baha 5 SuperPower on Baha Attract SystemThe Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling. | Device | Baha 5 SuperPower on Baha Attract System |
Primary outcome
Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided
Time frame: 12 weeks
Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
21 secondary outcomes
Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.
Time frame: 12 weeks
Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks.
Time frame: 12 weeks
Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided
Time frame: 4 weeks
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
Time frame: 4 weeks
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
Time frame: 12 weeks
Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
Time frame: 4 weeks
Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
Time frame: 12 weeks
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Time frame: 4 weeks
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Time frame: 12 weeks
Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband
Time frame: 4 weeks
Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband
Time frame: 12 weeks
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
Time frame: 4 weeks
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
Time frame: 12 weeks
Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
Time frame: 4 weeks
Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
Time frame: 12 weeks
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Time frame: 4 weeks
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Time frame: 12 weeks
Sound Processor Magnet Selection at 4 Weeks
Time frame: 4 weeks
Sound Processor Magnet Selection at 6 Weeks
Time frame: 6 weeks
Sound Processor Magnet Selection at 12 Weeks
Time frame: 12 weeks
Daily Use of Sound Processor (Average Daily Use During the Last Week)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Jaydip Ray, Professor principal investigator
Royal Hallamshire Hospital
César Orús, Dr principal investigator
Hospital de Sant Pau
Paul Van de Heyning, Professor principal investigator
University Hospital, Antwerp
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baha 5 SuperPower on Baha Attract System in people with Single Sided Sensorineural Deafness and Mixed Hearing Loss, Unilateral, run by Cochlear Bone Anchored Solutions at 4 sites in 4 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 8 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 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Denmark, Spain, United Kingdom. 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 3 Jun 2019). 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?
Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided (time frame: 12 weeks). 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 3 Jun 2019.