Trial Outcomes & Findings for Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System) (NCT NCT01822119)
NCT ID: NCT01822119
Last Updated: 2017-02-06
Results Overview
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.
COMPLETED
NA
27 participants
Baseline before surgery and 12 weeks after surgery
2017-02-06
Participant Flow
Participant milestones
| Measure |
Baha Attract System
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 Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
Baseline characteristics by cohort
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Gender
Female
|
15 Participants
n=5 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
5 participants
n=5 Participants
|
|
Type of hearing loss
Conductive hearing loss
|
17 participants
n=5 Participants
|
|
Type of hearing loss
Single-sided sensorineural deafness
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline before surgery and 12 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, PTA4 at 12 Weeks
|
-18.4 dB
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryThe 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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, PTA4 at 36 Weeks
|
-18.4 dB
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, Individual Frequencies
Change in hearing level at 500HZ
|
-20.2 dB
Standard Deviation 14.4
|
|
Hearing Performance, Individual Frequencies
Change in hearing level at 1000HZ
|
-25.2 dB
Standard Deviation 8.4
|
|
Hearing Performance, Individual Frequencies
Change in hearing level at 2000HZ
|
-18.3 dB
Standard Deviation 9.5
|
|
Hearing Performance, Individual Frequencies
Change in hearing level at 3000HZ
|
-18.7 dB
Standard Deviation 14.7
|
|
Hearing Performance, Individual Frequencies
Change in hearing level at 4000HZ
|
-9.8 dB
Standard Deviation 10.8
|
|
Hearing Performance, Individual Frequencies
Change in hearing level at 6000HZ
|
-5.0 dB
Standard Deviation 12.3
|
|
Hearing Performance, Individual Frequencies
Change in hearing level at 8000HZ
|
-4.2 dB
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryPopulation: Intention-to-Treat population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
|
0.926 dB
Standard Deviation 5.553
|
SECONDARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
500Hz
|
-0.741 dB
Standard Deviation 13.637
|
|
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
1000Hz
|
-1.67 dB
Standard Deviation 7.34
|
|
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
2000Hz
|
1.67 dB
Standard Deviation 7.07
|
|
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
3000Hz
|
-0.37 dB
Standard Deviation 8.077
|
|
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
4000Hz
|
4.44 dB
Standard Deviation 9.64
|
|
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
6000Hz
|
6.92 dB
Standard Deviation 12.34
|
|
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
8000
|
3.80 dB
Standard Deviation 12.10
|
SECONDARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
Change at 50dB presentation level
|
50 % perception of presented words
Standard Deviation 23.7
|
|
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
Change at 65dB presentation level
|
46.4 % perception of presented words
Standard Deviation 31.7
|
|
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
Change at 80dB presentation level
|
24.2 % perception of presented words
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Change at 50dB presentation level
|
2.83 % perception of presented words
Standard Deviation 23.80
|
|
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Change at 65dB presentation level
|
0.98 % perception of presented words
Standard Deviation 13.49
|
|
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Change at 80dB presentation level
|
1.71 % perception of presented words
Standard Deviation 7.80
|
SECONDARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
|
-15.0 Signal to noise ratio
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
|
-3.79 Signal to noise ratio
Standard Deviation 6.96
|
SECONDARY outcome
Timeframe: Baseline before surgery and 36 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Aversiveness
|
-4.04 units on a scale
Standard Deviation 36.03
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Ease of communication
|
4.23 units on a scale
Standard Deviation 52.16
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Reverberation
|
5.10 units on a scale
Standard Deviation 42.78
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Background noise
|
8.92 units on a scale
Standard Deviation 48.07
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Global score
|
6.76 units on a scale
Standard Deviation 45.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2 (surgery)Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Time to Perform Surgery
|
45.0 minutes
Standard Deviation 14.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2 (surgery)Population: Intention-to-Treat population, includes all patients who received surgical intervention.
Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Tissue Reduction Performed During Surgery
No tissue reduction
|
24 participants
|
|
Tissue Reduction Performed During Surgery
Tissue reduction
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2 (surgery)Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Implant Stability
|
75.7 units on a scale
Standard Deviation 8.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Type of sound processors BP100 and BP110 attached to a soft band (subject preference)
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Choice of Sound Processor
BP100
|
6 participants
|
|
Choice of Sound Processor
BP110
|
21 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline before surgery and 12 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Feedback Measurement, BP100
400Hz
|
-13.2 dB
Standard Deviation 7.8
|
|
Feedback Measurement, BP100
500Hz
|
-6.54 dB
Standard Deviation 3.98
|
|
Feedback Measurement, BP100
630Hz
|
-4.29 dB
Standard Deviation 8.56
|
|
Feedback Measurement, BP100
800Hz
|
-7.11 dB
Standard Deviation 6.84
|
|
Feedback Measurement, BP100
1000Hz
|
-7.85 dB
Standard Deviation 4.59
|
|
Feedback Measurement, BP100
1250Hz
|
-10.1 dB
Standard Deviation 2.4
|
|
Feedback Measurement, BP100
1600Hz
|
-7.44 dB
Standard Deviation 2.88
|
|
Feedback Measurement, BP100
2000Hz
|
-2.82 dB
Standard Deviation 1.59
|
|
Feedback Measurement, BP100
2500Hz
|
-2.91 dB
Standard Deviation 3.64
|
|
Feedback Measurement, BP100
3150Hz
|
-1.21 dB
Standard Deviation 3.66
|
|
Feedback Measurement, BP100
4000Hz
|
1.83 dB
Standard Deviation 3.42
|
|
Feedback Measurement, BP100
5000Hz
|
0.17 dB
Standard Deviation 4.37
|
|
Feedback Measurement, BP100
6300Hz
|
7.28 dB
Standard Deviation 7.62
|
|
Feedback Measurement, BP100
8000Hz
|
3.95 dB
Standard Deviation 3.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline before surgery and 12 weeks after surgeryPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Feedback Measurement, BP110
400Hz
|
-3.50 dB
Standard Deviation 8.36
|
|
Feedback Measurement, BP110
500Hz
|
-3.86 dB
Standard Deviation 8.46
|
|
Feedback Measurement, BP110
630Hz
|
-4.20 dB
Standard Deviation 10.59
|
|
Feedback Measurement, BP110
800Hz
|
-3.39 dB
Standard Deviation 9.16
|
|
Feedback Measurement, BP110
1000Hz
|
-5.03 dB
Standard Deviation 7.17
|
|
Feedback Measurement, BP110
1250Hz
|
-8.10 dB
Standard Deviation 7.87
|
|
Feedback Measurement, BP110
1600Hz
|
-8.85 dB
Standard Deviation 6.51
|
|
Feedback Measurement, BP110
2000Hz
|
-4.73 dB
Standard Deviation 4.65
|
|
Feedback Measurement, BP110
2500Hz
|
-3.08 dB
Standard Deviation 4.10
|
|
Feedback Measurement, BP110
3150Hz
|
-3.00 dB
Standard Deviation 3.30
|
|
Feedback Measurement, BP110
4000Hz
|
0.69 dB
Standard Deviation 4.86
|
|
Feedback Measurement, BP110
5000Hz
|
6.58 dB
Standard Deviation 6.24
|
|
Feedback Measurement, BP110
6300Hz
|
10.3 dB
Standard Deviation 4.7
|
|
Feedback Measurement, BP110
8000Hz
|
12.2 dB
Standard Deviation 9.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 4, 6, 12 and 36Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
To investigate if the magnetic force required for sound processor magnet retention will change over time
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Magnetic Force
4 weeks
|
0.97 Newton
Standard Deviation 0.30
|
|
Magnetic Force
6 weeks
|
1.05 Newton
Standard Deviation 0.37
|
|
Magnetic Force
12 weeks
|
0.98 Newton
Standard Deviation 0.29
|
|
Magnetic Force
36 weeks
|
0.97 Newton
Standard Deviation 0.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeksPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Safety; Skin Evaluation
Overall opinion observer
|
1.52 units on a scale
Standard Deviation 0.93
|
|
Safety; Skin Evaluation
Overall opinion patient
|
1.81 units on a scale
Standard Deviation 1.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeksPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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).
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Safety; Pain
Neuropathic pain
|
1.19 units on a scale
Standard Deviation 0.79
|
|
Safety; Pain
Pain in the scar
|
1.15 units on a scale
Standard Deviation 0.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeksPopulation: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
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.
Outcome measures
| Measure |
Baha Attract System
n=27 Participants
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
|
|---|---|
|
Safety; Numbness
No numbness
|
21 participants
|
|
Safety; Numbness
Numbness within 2 cm
|
1 participants
|
|
Safety; Numbness
Numbness within 2 cm and beyond
|
5 participants
|
Adverse Events
Baha Attract System
Serious adverse events
| Measure |
Baha Attract System
n=27 participants at risk
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
|
|---|---|
|
Infections and infestations
Postoperative wound infection
|
7.4%
2/27 • Number of events 2 • 36 weeks
|
|
Injury, poisoning and procedural complications
Post procedural heamatoma
|
3.7%
1/27 • Number of events 1 • 36 weeks
|
Other adverse events
| Measure |
Baha Attract System
n=27 participants at risk
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
|
|---|---|
|
General disorders
Application site pain
|
14.8%
4/27 • Number of events 4 • 36 weeks
|
|
General disorders
Implant site erythema
|
14.8%
4/27 • Number of events 4 • 36 weeks
|
Additional Information
Professor Robert Cowan
The HEARing CRC & Hearworks, Audiology Hearing and Speech Science, Melbourne, Australia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60