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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baha Attract System | Experimental | This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baha Attract System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline before surgery and 36 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline before surgery and 36 weeks after surgery |
| Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Perform Surgery | 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. | Visit 2 (surgery) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cowan, A/Professor | The HEARing CRC & HearWorks, University of Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The HEARing CRC & HearWorks, University of Melbourne | Melbourne | Victoria | 3010 | Australia | ||
| Clinica Las Condes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25634465 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baha Attract System | This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
Baha Attract System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baha Attract System | This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
Baha Attract System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | dB | Baseline before surgery and 12 weeks after surgery |
|
36 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baha Attract System | This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
Baha Attract System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Robert Cowan | The HEARing CRC & Hearworks, Audiology Hearing and Speech Science, Melbourne, Australia | +61 3 9035 5346 | r.cowan@unimelb.edu.au |
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| ID | Term |
|---|---|
| D003638 | Deafness |
| D034381 | Hearing Loss |
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline before surgery and 36 weeks after surgery |
| Implant Stability | Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability. | Visit 2 (surgery) |
| Choice of Sound Processor | Type of sound processors BP100 and BP110 attached to a soft band (subject preference) | Baseline |
| Feedback Measurement, BP100 | Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback. | Baseline before surgery and 12 weeks after surgery |
| Feedback Measurement, BP110 | Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback. | Baseline before surgery and 12 weeks after surgery |
| Magnetic Force | To investigate if the magnetic force required for sound processor magnet retention will change over time | Week 4, 6, 12 and 36 |
| Safety; Skin Evaluation | Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable). | 36 weeks |
| Safety; Pain | Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much). | 36 weeks |
| Safety; Numbness | Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet. | 36 weeks |
| Santiago |
| Chile |
| The Chinese University of Hong Kong | Hong Kong | Hong Kong |
| Bnai Zion MedicalCenter | Haifa | 31048 | Israel |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of hearing loss | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | dB | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Secondary | 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. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | dB | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Secondary | 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. | Intention-to-Treat population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | dB | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Secondary | 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. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | dB | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Secondary | 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. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | % perception of presented words | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Secondary | 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. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | % perception of presented words | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Secondary | 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. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | Signal to noise ratio | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Secondary | 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. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | Signal to noise ratio | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Secondary | 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. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | units on a scale | Baseline before surgery and 36 weeks after surgery |
|
|
|
|
| Other Pre-specified | Time to Perform Surgery | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | minutes | Visit 2 (surgery) |
|
|
|
| Other Pre-specified | Tissue Reduction Performed During Surgery | Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm. | Intention-to-Treat population, includes all patients who received surgical intervention. | Posted | Number | participants | Visit 2 (surgery) |
|
|
|
| Other Pre-specified | Implant Stability | Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | units on a scale | Visit 2 (surgery) |
|
|
|
| Other Pre-specified | Choice of Sound Processor | Type of sound processors BP100 and BP110 attached to a soft band (subject preference) | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Number | participants | Baseline |
|
|
|
| Other Pre-specified | Feedback Measurement, BP100 | Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | dB | Baseline before surgery and 12 weeks after surgery |
|
|
|
| Other Pre-specified | Feedback Measurement, BP110 | Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | dB | Baseline before surgery and 12 weeks after surgery |
|
|
|
| Other Pre-specified | Magnetic Force | To investigate if the magnetic force required for sound processor magnet retention will change over time | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | Newton | Week 4, 6, 12 and 36 |
|
|
|
| Other Pre-specified | Safety; Skin Evaluation | Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable). | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | units on a scale | 36 weeks |
|
|
|
| Other Pre-specified | Safety; Pain | Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much). | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Mean | Standard Deviation | units on a scale | 36 weeks |
|
|
|
| Other Pre-specified | Safety; Numbness | Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet. | Intention-to-Treat (ITT) population, includes all patients who received surgical intervention. | Posted | Number | participants | 36 weeks |
|
|
|
| 2 |
| 27 |
| 8 |
| 27 |
| Post procedural heamatoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Implant site erythema | General disorders | MedDRA | Systematic Assessment |
|
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Change in hearing level at 3000HZ |
|
| Change in hearing level at 4000HZ |
|
| Change in hearing level at 6000HZ |
|
| Change in hearing level at 8000HZ |
|
| 0.0499 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| Change at 8000Hz | Fisher's non-parametric permutation test | 0.0632 | 2-Sided | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 3000Hz |
|
| 4000Hz |
|
| 6000Hz |
|
| 8000 |
|
| 0.26 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| 2000Hz | Fisher's non-parametric permutation test | 0.24 | 2-Sided | 95 | No | Superiority or Other |
| 3000Hz | Fisher's non-parametric permutation test | 0.83 | 2-Sided | 95 | No | Superiority or Other |
| 4000Hz | Fisher's non-parametric permutation test | 0.026 | 2-Sided | 95 | No | Superiority or Other |
| 6000Hz | Fisher's non-parametric permutation test | 0.0085 | 2-Sided | 95 | No | Superiority or Other |
| 8000Hz | Fisher's non-parametric permutation test | 0.13 | 2-Sided | 95 | No | Superiority or Other |
|
|
| 0.72 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| 80dB | Fisher's non-parametric permutation test | 0.28 | 2-Sided | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Background noise |
|
| Global score |
|
| 0.71 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| Reverberation | Fisher's non-parametric permutation test | 0.59 | 2-Sided | 95 | No | Superiority or Other |
| Background noise | Fisher's non-parametric permutation test | 0.40 | 2-Sided | 95 | No | Superiority or Other |
| Global score | Fisher's non-parametric permutation test | 0.50 | 2-Sided | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 800Hz |
|
| 1000Hz |
|
| 1250Hz |
|
| 1600Hz |
|
| 2000Hz |
|
| 2500Hz |
|
| 3150Hz |
|
| 4000Hz |
|
| 5000Hz |
|
| 6300Hz |
|
| 8000Hz |
|
| Title | Measurements |
|---|---|
|
| 800Hz |
|
| 1000Hz |
|
| 1250Hz |
|
| 1600Hz |
|
| 2000Hz |
|
| 2500Hz |
|
| 3150Hz |
|
| 4000Hz |
|
| 5000Hz |
|
| 6300Hz |
|
| 8000Hz |
|
| Title | Measurements |
|---|---|
|
| 36 weeks |
|
| Title | Measurements |
|---|---|
|