DeafnessNCT01822119
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
A study testing Baha Attract System in people with Deafness and Hearing Loss, run by Cochlear Bone Anchored Solutions at 4 sites in 4 countries.
Trial summary
The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery: To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness, Hearing Loss, Hearing Loss, Conductive
- What is being tested?
- Baha Attract System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Mar 2013to Feb 2014
- 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
- Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 decibel (dB) hearing level (HL)
- Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 dB hearing level (HL) in the best ear
- Signed informed consent
Who cannot join
- Uncontrolled diabetes as judged by the investigator
- Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
- Unable to follow investigational procedures, e.g. to complete quality of life scales
- Less than 4mm of soft tissue pre-operatively
- Participation in another investigation with pharmaceuticals and/or device
- Condition that may have an impact on the outcome of the investigation as judged by the investigator
- Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned
- Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Australia1 site
The HEARing CRC & HearWorks, University of Melbourne
Melbourne, Victoria, 3010
About this study
Official title: Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months Follow-up
The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery:
- To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband
- Which sound processor to select, i.e. BP100 vs BP110
- Improve the fitting process for the sound processor
- Selection of sound processor magnet at time of fitting and over time
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Being tested
- Baha Attract System
- Medical subject headings
- Deafness, Hearing Loss, Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baha Attract SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Baha Attract System | Experimental | This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
* One implant magnet
* One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Receives: Device: Baha Attract System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Performance, PTA4 at 12 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.
Measured: Baseline before surgery and 12 weeks after surgery
Hearing Performance, PTA4 at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Measured: Baseline before surgery and 36 weeks after surgery
Secondary outcomes (8)
Hearing Performance, Individual Frequencies
The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Measured: Baseline before surgery and 36 weeks after surgery
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.
Measured: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.
Measured: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Measured: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.
Measured: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Measured: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.
Measured: Baseline before surgery and 36 weeks after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.
Measured: Baseline before surgery and 36 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear Bone Anchored Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Cowan, A/Professor, Principal investigator, The HEARing CRC & HearWorks, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822119
- Sponsor's protocol ID
- CBAS5484
- Status last verified
- Dec 2016
- First submitted
- 19 Mar 2013
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Briggs R, Van Hasselt A, Luntz M, Goycoolea M, Wigren S, Weber P, Smeds H, Flynn M, Cowan R. Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol. 2015 Jun;36(5):834-41. doi: 10.1097/MAO.0000000000000712.
PubMed 25634465
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months Follow-up
- ClinicalTrials.gov ID
- NCT01822119
- Acronym / sponsor ID
- CBAS5484
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cochlear Bone Anchored SolutionsIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery:
- To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband
- Which sound processor to select, i.e. BP100 vs BP110
- Improve the fitting process for the sound processor
- Selection of sound processor magnet at time of fitting and over time
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baha Attract System | Experimental | Device: Baha Attract SystemThis transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; * One implant magnet * One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 decibel (dB) hearing level (HL)
- Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 dB hearing level (HL) in the best ear
- Signed informed consent
Key exclusion criteria (8 listed)
- Uncontrolled diabetes as judged by the investigator
- Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
- Unable to follow investigational procedures, e.g. to complete quality of life scales
- Less than 4mm of soft tissue pre-operatively
- Participation in another investigation with pharmaceuticals and/or device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baha Attract System | Device | Baha Attract System |
Primary outcome
Hearing Performance, PTA4 at 12 Weeks
Time frame: Baseline before surgery and 12 weeks after surgery
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.
Hearing Performance, PTA4 at 36 Weeks
Time frame: Baseline before surgery and 36 weeks after surgery
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
8 secondary outcomes
Hearing Performance, Individual Frequencies
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Time frame: Baseline before surgery and 36 weeks after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Baseline before surgery and 36 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25634465Briggs R, Van Hasselt A, Luntz M, Goycoolea M, Wigren S, Weber P, Smeds H, Flynn M, Cowan R. Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol. 2015 Jun;36(5):834-41. doi: 10.1097/MAO.0000000000000712.
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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.
Robert Cowan, A/Professor principal investigator
The HEARing CRC & HearWorks, University of Melbourne
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 Attract System in people with Deafness and Hearing Loss, 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 3 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 6 Feb 2017. 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 Australia, Chile, Hong Kong, Israel. 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 6 Feb 2017). 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, PTA4 at 12 Weeks (time frame: Baseline before surgery and 12 weeks 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 NCT01822119, 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 6 Feb 2017.