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Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

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ClinicalTrials.gov Identifier: NCT01822119
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Deafness
Hearing Loss
Hearing Loss, Conductive
Intervention Device: Baha Attract System
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Baha Attract System
Hide Arm/Group Description

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)

Baha Attract System

Period Title: Overall Study
Started 27
Completed 27
Not Completed 0
Arm/Group Title Baha Attract System
Hide Arm/Group Description

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)

Baha Attract System

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
45.7  (13.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
15
  55.6%
Male
12
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
Hong Kong 8
Israel 6
Australia 8
Chile 5
Type of hearing loss  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
Conductive hearing loss 17
Single-sided sensorineural deafness 10
1.Primary Outcome
Title Hearing Performance, PTA4 at 12 Weeks
Hide Description 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.
Time Frame Baseline before surgery and 12 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: dB
-18.4  (6.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher’s non-parametric permutation
Comments [Not Specified]
2.Primary Outcome
Title Hearing Performance, PTA4 at 36 Weeks
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: dB
-18.4  (6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher’s non-parametric permutation
Comments [Not Specified]
3.Secondary Outcome
Title Hearing Performance, Individual Frequencies
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: dB
Change in hearing level at 500HZ -20.2  (14.4)
Change in hearing level at 1000HZ -25.2  (8.4)
Change in hearing level at 2000HZ -18.3  (9.5)
Change in hearing level at 3000HZ -18.7  (14.7)
Change in hearing level at 4000HZ -9.8  (10.8)
Change in hearing level at 6000HZ -5.0  (12.3)
Change in hearing level at 8000HZ -4.2  (10.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Statistically significant changes with the same value at 500 to 4000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Change at 6000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0499
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Change at 8000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0632
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
4.Secondary Outcome
Title Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: dB
0.926  (5.553)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
5.Secondary Outcome
Title Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: dB
500Hz -0.741  (13.637)
1000Hz -1.67  (7.34)
2000Hz 1.67  (7.07)
3000Hz -0.37  (8.077)
4000Hz 4.44  (9.64)
6000Hz 6.92  (12.34)
8000 3.80  (12.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 500Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 1000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 2000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 3000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 4000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 6000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0085
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 8000Hz
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
6.Secondary Outcome
Title Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: % perception of presented words
Change at 50dB presentation level 50  (23.7)
Change at 65dB presentation level 46.4  (31.7)
Change at 80dB presentation level 24.2  (25.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Statistically significant improvement with the same value at all presentation levels.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
7.Secondary Outcome
Title Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: % perception of presented words
Change at 50dB presentation level 2.83  (23.80)
Change at 65dB presentation level 0.98  (13.49)
Change at 80dB presentation level 1.71  (7.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 50dB
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 60dB
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments 80dB
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
8.Secondary Outcome
Title Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: Signal to noise ratio
-15.0  (12.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
9.Secondary Outcome
Title Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: Signal to noise ratio
-3.79  (6.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0092
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
10.Secondary Outcome
Title Abbreviated Profile of Hearing Aid Benefit (APHAB)
Hide Description 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.
Time Frame Baseline before surgery and 36 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aversiveness -4.04  (36.03)
Ease of communication 4.23  (52.16)
Reverberation 5.10  (42.78)
Background noise 8.92  (48.07)
Global score 6.76  (45.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Aversiveness
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Ease of Communication
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Reverberation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Background noise
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Baha Attract System
Comments Global score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Fisher’s non-parametric permutation test
Comments [Not Specified]
11.Other Pre-specified Outcome
Title Time to Perform Surgery
Hide Description [Not Specified]
Time Frame Visit 2 (surgery)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: minutes
45.0  (14.6)
12.Other Pre-specified Outcome
Title Tissue Reduction Performed During Surgery
Hide Description Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.
Time Frame Visit 2 (surgery)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
No tissue reduction 24
Tissue reduction 3
13.Other Pre-specified Outcome
Title Implant Stability
Hide Description Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.
Time Frame Visit 2 (surgery)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
75.7  (8.8)
14.Other Pre-specified Outcome
Title Choice of Sound Processor
Hide Description Type of sound processors BP100 and BP110 attached to a soft band (subject preference)
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
BP100 6
BP110 21
15.Other Pre-specified Outcome
Title Feedback Measurement, BP100
Hide Description 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.
Time Frame Baseline before surgery and 12 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: dB
400Hz -13.2  (7.8)
500Hz -6.54  (3.98)
630Hz -4.29  (8.56)
800Hz -7.11  (6.84)
1000Hz -7.85  (4.59)
1250Hz -10.1  (2.4)
1600Hz -7.44  (2.88)
2000Hz -2.82  (1.59)
2500Hz -2.91  (3.64)
3150Hz -1.21  (3.66)
4000Hz 1.83  (3.42)
5000Hz 0.17  (4.37)
6300Hz 7.28  (7.62)
8000Hz 3.95  (3.26)
16.Other Pre-specified Outcome
Title Feedback Measurement, BP110
Hide Description 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.
Time Frame Baseline before surgery and 12 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: dB
400Hz -3.50  (8.36)
500Hz -3.86  (8.46)
630Hz -4.20  (10.59)
800Hz -3.39  (9.16)
1000Hz -5.03  (7.17)
1250Hz -8.10  (7.87)
1600Hz -8.85  (6.51)
2000Hz -4.73  (4.65)
2500Hz -3.08  (4.10)
3150Hz -3.00  (3.30)
4000Hz 0.69  (4.86)
5000Hz 6.58  (6.24)
6300Hz 10.3  (4.7)
8000Hz 12.2  (9.7)
17.Other Pre-specified Outcome
Title Magnetic Force
Hide Description To investigate if the magnetic force required for sound processor magnet retention will change over time
Time Frame Week 4, 6, 12 and 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: Newton
4 weeks 0.97  (0.30)
6 weeks 1.05  (0.37)
12 weeks 0.98  (0.29)
36 weeks 0.97  (0.28)
18.Other Pre-specified Outcome
Title Safety; Skin Evaluation
Hide Description Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall opinion observer 1.52  (0.93)
Overall opinion patient 1.81  (1.21)
19.Other Pre-specified Outcome
Title Safety; Pain
Hide Description 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).
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Neuropathic pain 1.19  (0.79)
Pain in the scar 1.15  (0.77)
20.Other Pre-specified Outcome
Title Safety; Numbness
Hide Description 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.
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Arm/Group Title Baha Attract System
Hide Arm/Group Description:

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)

Baha Attract System

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
No numbness 21
Numbness within 2 cm 1
Numbness within 2 cm and beyond 5
Time Frame 36 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baha Attract System
Hide Arm/Group Description

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)

Baha Attract System

All-Cause Mortality
Baha Attract System
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Baha Attract System
Affected / at Risk (%) # Events
Total   2/27 (7.41%)    
Infections and infestations   
Postoperative wound infection  1  2/27 (7.41%)  2
Injury, poisoning and procedural complications   
Post procedural heamatoma  1  1/27 (3.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baha Attract System
Affected / at Risk (%) # Events
Total   8/27 (29.63%)    
General disorders   
Application site pain  1  4/27 (14.81%)  4
Implant site erythema  1  4/27 (14.81%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Professor Robert Cowan
Organization: The HEARing CRC & Hearworks, Audiology Hearing and Speech Science, Melbourne, Australia
Phone: +61 3 9035 5346
Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT01822119     History of Changes
Other Study ID Numbers: CBAS5484
First Submitted: March 19, 2013
First Posted: April 2, 2013
Results First Submitted: August 24, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017