DeafnessNCT02022085
Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
A study testing Baha Attract System in people with Deafness and Hearing Loss, run by Cochlear Bone Anchored Solutions at 6 sites in 4 countries.
Trial summary
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery: to evaluate the efficacy of the Baha Attract System in terms of hearing… 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
- 54 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Jun 2014to Nov 2017
- 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 subject, i.e. ≥ 18 years of age
- Conductive or mixed hearing loss in the ear to be implanted:
- Bone conduction thresholds with a pure tone average PTA4 of < 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz).
- OR
- Single-sided sensorineural deafness (SSD):
- European sites: Bone conduction thresholds with a pure tone average PTA4 of < 30dB hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear.
- US sites: Air conduction thresholds with a pure tone average PTA4 of 20 dB hearing level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS.
- No previous bone conduction implant on the side of the skull to be implanted. Signed informed consent.
Who cannot join
- Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Baha Attract System (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. Subjects that have received radiation therapy at the same side of the skull where the Baha Attract System will be positioned.
- Condition that could jeopardise osseointegration and/or wound healing as judged by the investigator (e.g. osteoporosis, psoriasis, use of corticosteroids).
- Uncontrolled diabetes as judged by the investigator. 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 investigation with pharmaceuticals and/or medical device.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States2 sites
Christina Runge
Milwaukee, Wisconsin, 53227
Dr. Doug Backhus
Seattle, Washington, 98122
United Kingdom2 sites
Peter Monksfield
Birmingham
Kevin Green
Manchester
Poland1 site
World Hearing Center Institute of Physiology and Pathology of Hearing
Kajetany, Nadarzyn, 05-830
About this study
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery:
- to evaluate the efficacy of the Baha Attract System in terms of hearing performance compared to the unaided situation and compared to a pre-operative test situation using the sound processor on a Baha Softband;
- to evaluate the mid- and long-term safety of the Baha Attract System.
Read the detailed description
This investigation was designed to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that were candidates for Baha surgery.
The investigation was performed in an open design since it was not possible to perform the investigation in a blinded fashion. The main evaluations of the investigation, i.e. free-field hearing tests, are standard audiological procedures that are routinely used in daily clinical practice at hospitals worldwide for evaluation of hearing performance in hearing impaired patients. The primary efficacy evaluation, audiometric thresholds, renders comparable results across different sites and countries as it is not a language-specific test. Language-specific audiological tests were performed as secondary efficacy evaluations; to enable comparison of data across sites, validated word lists were used at all sites and equivalent speaker configurations (speech from front, noise from behind) and test procedures (same noise and adaptive speech levels, etc) were used.
For the primary evaluation in the investigation, the Baha Attract System was compared to the pre-operative unaided situation, as the intended use of the system is to improve hearing performance in patients with conductive or mixed hearing loss or single-sided sensorineural deafness. Audiological test results with the Baha Attract System were also compared against results obtained with the same Sound Processor on a Baha Softband. Use of the Sound Processor on a Softband is a standard procedure that is routinely used as a pre-operative test prior to bone conduction hearing implant surgery. The Softband test allows the patient to pre-operatively experience hearing through the Sound Processor to get an indication of the post-operative hearing outcome and to choose a suitable Sound Processor.
The generic and hearing-specific quality of life questionnaires used in the investigation (HUI3, APHAB, SSQ) are validated scales that have been frequently used and reported in the literature.
- 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
The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
| 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: Threshold Audiometry PTA4: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).
The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Measured: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).
The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Measured: Baseline (unaided) before surgery, 24 months after surgery
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz).
The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Measured: Baseline (unaided) before surgery, 12 months after surgery
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests:
Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz.
The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Measured: Baseline (unaided) before surgery, 6 months after surgery
Secondary outcomes (19)
Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio
The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding.
A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB.
Manchester and Birmingham are excluded from this analysis due to incorrect set up.
Measured: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
Speech in Quiet, Baha Attract Versus Unaided
The change of hearing performance with the Baha Attract System at 6, 12 and 24 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB.
Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Measured: Baseline before surgery, 6, 12 and 24 months after surgery
Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)
The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Measured: Baseline before surgery, 6, 12 and 24 months after surgery
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:
Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.
The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Measured: Baseline (aided) before surgery, 6 months after surgery
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:
Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.
The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Measured: Baseline (aided) before surgery, 12 months after surgery
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:
Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.
The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Measured: Baseline (aided) before surgery, 24 months after surgery
Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive Speech recognition in Noise measured as signal to noise ratio.
A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB.
Measured: Baseline (aided) before surgery, 6, 12 and 24 months after surgery
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB.
Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Measured: Baseline (aided) before surgery, 6, 12 and 24 months after surgery
Health Utility Index (HUI)
Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract 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.
HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.
Measured: Baseline (unaided) before surgery, 6 and 24 months after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract 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 improvement, a negative value an impairment.
Measured: Baseline before surgery, 6 and 24 months after surgery
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pre-operative unaided situation. A scale from 0 to 10, 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, 6 and 24 months after surgery
Time to Perform Surgery
Time of first incision to time of last suture
Measured: Visit 2 (Surgery)
Tissue Reduction Performed During Surgery
Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm
Measured: Visit 2 (surgery)
Implant Stability
Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability
Measured: Visit 2 (surgery)
Magnetic Force
To investigate if the magnetic force required for sound processor magnet retention will change over time
Measured: 4, 6, 12 weeks, 6, 12 and 24 months
Sound Processor Magnet Choice
To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.
Measured: 4, 6, 12 weeks, 6, 12 and 24 months
Pain & Discomfort
Degree of pain and discomfort.
Measured: Week 6, Week 12, Month 6, Month 12, Month 24
Numbness When Tested With a Pin
Degree of numbness when tested with a pin
Measured: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24
Numbness When Tested With a Cotton Swab
Degree of numbness when tested with a Cotton Swab
Measured: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionNov 2017
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 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear Bone Anchored Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Blechert, M.Sc, Study director, Cochlear Bone Anchored Solutions AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022085
- Sponsor's protocol ID
- CBAS5477
- Status last verified
- Oct 2018
- First submitted
- 16 Dec 2013
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
- ClinicalTrials.gov ID
- NCT02022085
- Acronym / sponsor ID
- CBAS5477
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cochlear Bone Anchored SolutionsIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 9 Dec 2016
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 post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery:
- to evaluate the efficacy of the Baha Attract System in terms of hearing performance compared to the unaided situation and compared to a pre-operative test situation using the sound processor on a Baha Softband;
- to evaluate the mid- and long-term safety of the Baha Attract System.
Detailed description
This investigation was designed to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that were candidates for Baha surgery.
The investigation was performed in an open design since it was not possible to perform the investigation in a blinded fashion. The main evaluations of the investigation, i.e. free-field hearing tests, are standard audiological procedures that are routinely used in daily clinical practice at hospitals worldwide for evaluation of hearing performance in hearing impaired patients. The primary efficacy evaluation, audiometric thresholds, renders comparable results across different sites and countries as it is not a language-specific test. Language-specific audiological tests were performed as secondary efficacy evaluations; to enable comparison of data across sites, validated word lists were used at all sites and equivalent speaker configurations (speech from front, noise from behind) and test procedures (same noise and adaptive speech levels, etc) were used.
For the primary evaluation in the investigation, the Baha Attract System was compared to the pre-operative unaided situation, as the intended use of the system is to improve hearing performance in patients with conductive or mixed hearing loss or single-sided sensorineural deafness. Audiological test results with the Baha Attract System were also compared against results obtained with the same Sound Processor on a Baha Softband. Use of the Sound Processor on a Softband is a standard procedure that is routinely used as a pre-operative test prior to bone conduction hearing implant surgery. The Softband test allows the patient to pre-operatively experience hearing through the Sound Processor to get an indication of the post-operative hearing outcome and to choose a suitable Sound Processor.
The generic and hearing-specific quality of life questionnaires used in the investigation (HUI3, APHAB, SSQ) are validated scales that have been frequently used and reported in the literature.
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 (8 listed)
- Adult subject, i.e. ≥ 18 years of age
- Bone conduction thresholds with a pure tone average PTA4 of < 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz).
- OR
- European sites: Bone conduction thresholds with a pure tone average PTA4 of < 30dB hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear.
- US sites: Air conduction thresholds with a pure tone average PTA4 of 20 dB hearing level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS.
Key exclusion criteria (7 listed)
- Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Baha Attract System (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. Subjects that have received radiation therapy at the same side of the skull where the Baha Attract System will be positioned.
- Condition that could jeopardise osseointegration and/or wound healing as judged by the investigator (e.g. osteoporosis, psoriasis, use of corticosteroids).
- Uncontrolled diabetes as judged by the investigator. Condition that may have an impact on the outcome of the investigation 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 Attract SystemThe Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling. | Device | Baha Attract System |
Primary outcome
Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
Time frame: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Time frame: Baseline (unaided) before surgery, 24 months after surgery
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Time frame: Baseline (unaided) before surgery, 12 months after surgery
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz). The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Time frame: Baseline (unaided) before surgery, 6 months after surgery
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
19 secondary outcomes
Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract
Time frame: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
Speech in Quiet, Baha Attract Versus Unaided
Time frame: Baseline before surgery, 6, 12 and 24 months after surgery
Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract
Time frame: Baseline before surgery, 6, 12 and 24 months after surgery
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
Time frame: Baseline (aided) before surgery, 6 months after surgery
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
Time frame: Baseline (aided) before surgery, 12 months after surgery
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
Time frame: Baseline (aided) before surgery, 24 months after surgery
Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband
Time frame: Baseline (aided) before surgery, 6, 12 and 24 months after surgery
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
Time frame: Baseline (aided) before surgery, 6, 12 and 24 months after surgery
Health Utility Index (HUI)
Time frame: Baseline (unaided) before surgery, 6 and 24 months after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Baseline before surgery, 6 and 24 months after surgery
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Time frame: Baseline before surgery, 6 and 24 months after surgery
Time to Perform Surgery
Time frame: Visit 2 (Surgery)
Tissue Reduction Performed During Surgery
Time frame: Visit 2 (surgery)
Implant Stability
Time frame: Visit 2 (surgery)
Magnetic Force
Time frame: 4, 6, 12 weeks, 6, 12 and 24 months
Sound Processor Magnet Choice
Time frame: 4, 6, 12 weeks, 6, 12 and 24 months
Pain & Discomfort
Time frame: Week 6, Week 12, Month 6, Month 12, Month 24
Numbness When Tested With a Pin
Time frame: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24
Numbness When Tested With a Cotton Swab
Time frame: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Johan Blechert, M.Sc study director
Cochlear Bone Anchored Solutions AB
6 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 6 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 8 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, United Kingdom, 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 9 Dec 2016). 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 PTA4: Unaided Versus Baha Attract (time frame: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery). The study lists 4 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 12 Oct 2018.