Trial Outcomes & Findings for Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System (NCT NCT02722330)
NCT ID: NCT02722330
Last Updated: 2019-06-03
Results Overview
Change of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
Baha 5 SuperPower on Baha Attract System
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 8.9 • n=23 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=23 Participants
|
|
Region of Enrollment
Belgium
|
10 participants
n=23 Participants
|
|
Region of Enrollment
Denmark
|
2 participants
n=23 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=23 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=23 Participants
|
|
Type of hearing loss in treatment ear
Mixed hearing loss
|
23 Participants
n=23 Participants
|
|
Type of hearing loss in treatment ear
Single-sided sensorineural deafness
|
0 Participants
n=23 Participants
|
|
Treatmen ear
Right
|
13 Participants
n=23 Participants
|
|
Treatmen ear
Left
|
10 Participants
n=23 Participants
|
|
Does the subject use a hearing aid in the treament ear
Yes
|
10 Participants
n=23 Participants
|
|
Does the subject use a hearing aid in the treament ear
No
|
13 Participants
n=23 Participants
|
|
Does the subject use a hearing aid in the non-treament ear
Yes
|
9 Participants
n=23 Participants
|
|
Does the subject use a hearing aid in the non-treament ear
No
|
14 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 12 weeksChange of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided
|
-27.7 dB HL
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 12 weeksThe APHAB is a 24-item self-assessment questionnaire evaluating the benefit experienced by the subject when using hearing amplification compared to the unaided situation. It comprises of four subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). The Global score is the mean of the subscales. All subscales are scored in the same way. The scores show how frequently (%) clients experience performance problems and varies between 0-100, 0 indicates no problems, 100 indicates always problem. Benefit is then calculated by subtracting the aided average from the unaided average. The theoretical benefit score could vary between -100 to + 100. The higher the score the better benefit and positive score indicates an improvement, a negative value an impairment.
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.
Reverberation
|
31.5 score on a scale
Standard Deviation 23.8
|
|
Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.
Ease of communication
|
44.8 score on a scale
Standard Deviation 33.1
|
|
Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.
Background noise
|
37.7 score on a scale
Standard Deviation 25.1
|
|
Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.
Aversiveness
|
-16.6 score on a scale
Standard Deviation 27.3
|
|
Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.
Global score
|
38.0 score on a scale
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: 12 weeksThe SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from unaided to aided hearing is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks.
Speech scale
|
3.59 score on a scale
Standard Deviation 1.9
|
|
Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks.
Spatial scale
|
2.37 score on a scale
Standard Deviation 2.08
|
|
Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks.
Qualities scale
|
3.51 score on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: 4 weeksChange of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided
|
-27.0 dB HL
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 4 weeksChange of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
250 Hz
|
-20.7 dB HL
Standard Deviation 13.3
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
500 Hz
|
-27.6 dB HL
Standard Deviation 11.8
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
750 Hz
|
-33.0 dB HL
Standard Deviation 13.5
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
1000 Hz
|
-31.5 dB HL
Standard Deviation 11.0
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
1500 Hz
|
-35.9 dB HL
Standard Deviation 11.1
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
2000 Hz
|
-30.0 dB HL
Standard Deviation 10.9
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
3000Hz
|
-20.9 dB HL
Standard Deviation 16.1
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
4000 Hz
|
-18.9 dB HL
Standard Deviation 16.0
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
6000 Hz
|
-19.5 dB HL
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 12 weeksChange of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
250 Hz
|
-24.3 dB HL
Standard Deviation 11.3
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
500 Hz
|
-27.6 dB HL
Standard Deviation 12.0
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
750 Hz
|
-33.0 dB HL
Standard Deviation 13.8
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
1000 Hz
|
-32.2 dB HL
Standard Deviation 11.2
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
1500 Hz
|
-35.9 dB HL
Standard Deviation 11.1
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
2000 Hz
|
-32.4 dB HL
Standard Deviation 10.1
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
3000 Hz
|
-23.9 dB HL
Standard Deviation 12.3
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
4000 Hz
|
-18.5 dB HL
Standard Deviation 13.7
|
|
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
6000 Hz
|
-23.4 dB HL
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 4 weeksChange of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=17 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
|
-8.56 dB
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: 12 weeksChange of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=17 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
|
-8.41 dB
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: 4 weeksChange of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Speech Presentation Level 50 dB
|
34.1 Percentage (%) correct words
Standard Deviation 31.4
|
|
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Speech Presentation Level 65 dB
|
43.3 Percentage (%) correct words
Standard Deviation 27.6
|
|
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Speech Presentation Level 80 dB
|
34.5 Percentage (%) correct words
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: 12 weeksChange of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Speech Presentation Level 50 dB
|
35.7 Percentage (%) correct words
Standard Deviation 29.6
|
|
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Speech Presentation Level 65 dB
|
49.0 Percentage (%) correct words
Standard Deviation 29.5
|
|
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Speech Presentation Level 80 dB
|
39.2 Percentage (%) correct words
Standard Deviation 32.9
|
SECONDARY outcome
Timeframe: 4 weeksChange of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 4 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband
|
2.55 dB HL
Standard Deviation 5.87
|
SECONDARY outcome
Timeframe: 12 weeksChange of hearing performance PTA4 from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 12 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband
|
1.9 dB HL
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: 4 weeksChange of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from the situation with same sound processor on a Baha softband with the Investigational device on the attract system at 4 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
250 Hz
|
1.3 dB HL
Standard Deviation 7.42
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
500 Hz
|
-2.61 dB HL
Standard Deviation 7.52
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
750 Hz
|
1.09 dB HL
Standard Deviation 7.38
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
1000 Hz
|
3.04 dB HL
Standard Deviation 6.70
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
1500 Hz
|
1.52 dB HL
Standard Deviation 6.47
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
2000 Hz
|
4.57 dB HL
Standard Deviation 8.25
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
3000 Hz
|
5.65 dB HL
Standard Deviation 10.90
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
4000 Hz
|
5.22 dB HL
Standard Deviation 12.29
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
6000 Hz
|
7.62 dB HL
Standard Deviation 11.47
|
SECONDARY outcome
Timeframe: 12 weeksChange of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from the same sound processor on a Baha softband with the Investigational device on the attract system at 12 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
1500 Hz
|
1.52 dB HL
Standard Deviation 7.30
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
2000 Hz
|
2.17 dB HL
Standard Deviation 6.54
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
250 Hz
|
-2.39 dB HL
Standard Deviation 7.52
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
500 Hz
|
-2.61 dB HL
Standard Deviation 6.01
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
750 Hz
|
1.09 dB HL
Standard Deviation 6.21
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
1000 Hz
|
2.39 dB HL
Standard Deviation 6.89
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
3000 Hz
|
2.61 dB HL
Standard Deviation 11.66
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
4000 Hz
|
5.65 dB HL
Standard Deviation 10.69
|
|
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
6000 Hz
|
2.50 dB HL
Standard Deviation 18.31
|
SECONDARY outcome
Timeframe: 4 weeksChange of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 4 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=17 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
|
1.19 dB
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: 12 weeksChange of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 12 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=17 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
|
1.42 dB
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: 4 weeksChange of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 4 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Speech Presentation Level 50 dB
|
-10.5 Percentage (%) correct words
Standard Deviation 25.7
|
|
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Speech Presentation Level 65 dB
|
-6.78 Percentage (%) correct words
Standard Deviation 18.37
|
|
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Speech Presentation Level 80 dB
|
-1.86 Percentage (%) correct words
Standard Deviation 17.39
|
SECONDARY outcome
Timeframe: 12 weeksChange of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 12 weeks
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=17 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Speech Presentation Level 50 dB
|
-9.00 dB
Standard Deviation 19.80
|
|
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Speech Presentation Level 65 dB
|
-1.17 dB
Standard Deviation 16.52
|
|
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Speech Presentation Level 80 dB
|
2.82 dB
Standard Deviation 18.11
|
SECONDARY outcome
Timeframe: 4 weeksInformation about sound processor magnet selection, type of SP magnet
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Sound Processor Magnet Selection at 4 Weeks
SPM3
|
3 Participants
|
|
Sound Processor Magnet Selection at 4 Weeks
SPM4
|
11 Participants
|
|
Sound Processor Magnet Selection at 4 Weeks
SPM1
|
0 Participants
|
|
Sound Processor Magnet Selection at 4 Weeks
SPM2
|
2 Participants
|
|
Sound Processor Magnet Selection at 4 Weeks
SPM5
|
5 Participants
|
|
Sound Processor Magnet Selection at 4 Weeks
SPM6
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 weeksInformation about sound processor magnet selection, type of SP magnet
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Sound Processor Magnet Selection at 6 Weeks
SPM1
|
0 Participants
|
|
Sound Processor Magnet Selection at 6 Weeks
SPM2
|
5 Participants
|
|
Sound Processor Magnet Selection at 6 Weeks
SPM3
|
8 Participants
|
|
Sound Processor Magnet Selection at 6 Weeks
SPM4
|
7 Participants
|
|
Sound Processor Magnet Selection at 6 Weeks
SPM5
|
2 Participants
|
|
Sound Processor Magnet Selection at 6 Weeks
SPM6
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksInformation about sound processor magnet selection, type of SP magnet
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Sound Processor Magnet Selection at 12 Weeks
SPM1
|
2 Participants
|
|
Sound Processor Magnet Selection at 12 Weeks
SPM2
|
3 Participants
|
|
Sound Processor Magnet Selection at 12 Weeks
SPM3
|
8 Participants
|
|
Sound Processor Magnet Selection at 12 Weeks
SPM4
|
10 Participants
|
|
Sound Processor Magnet Selection at 12 Weeks
SPM5
|
0 Participants
|
|
Sound Processor Magnet Selection at 12 Weeks
SPM6
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksAverage daily use (hours/day) of the sound processor during the last week of the study
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Daily Use of Sound Processor (Average Daily Use During the Last Week)
|
9.39 hours/day
Standard Deviation 3.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksNumber of adverse events related to the treatment during the 12 weeks treatment period
Outcome measures
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 Participants
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
Number of Adverse Events Related to the Treatment
|
3 events
|
Adverse Events
Baha 5 SuperPower on Baha Attract System
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baha 5 SuperPower on Baha Attract System
n=23 participants at risk
The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
|
|---|---|
|
General disorders
Pain/discomfort
|
4.3%
1/23 • Number of events 2 • 12 weeks
|
|
Renal and urinary disorders
Other
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Presssure related skin complications
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
Additional Information
Professor Jaydip Ray
ENT Department, Royal Hallamshire Hospital, Sheffield
Phone: +44 (0)114 271 1900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60