Trial Outcomes & Findings for Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System) (NCT NCT02022085)
NCT ID: NCT02022085
Last Updated: 2018-10-12
Results Overview
The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
Results posted on
2018-10-12
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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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|---|---|
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Overall Study
STARTED
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54
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Overall Study
COMPLETED
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53
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
Baseline characteristics by cohort
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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|---|---|
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Age, Continuous
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42.1 years
STANDARD_DEVIATION 13.6 • n=93 Participants
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Sex: Female, Male
Female
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33 Participants
n=93 Participants
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Sex: Female, Male
Male
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21 Participants
n=93 Participants
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Region of Enrollment
Netherlands
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23 participants
n=93 Participants
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Region of Enrollment
United States
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1 participants
n=93 Participants
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Region of Enrollment
Poland
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14 participants
n=93 Participants
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Region of Enrollment
United Kingdom
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16 participants
n=93 Participants
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Type of hearing loss
Conductive hearing loss
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39 participants
n=93 Participants
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Type of hearing loss
Single-sided sensorineural deafness
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15 participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline (unaided) before surgery, 6, 12 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.
The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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|---|---|
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Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
PTA4 6 months, Baha Attract vs Unaided
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-21.0 dB
Standard Deviation 10.4
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Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
PTA4 12 months, Baha Attract vs Baha Attract
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-20.9 dB
Standard Deviation 10.4
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Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
PTA4 24 months, Baha Attract vs Unaided
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-21.5 dB
Standard Deviation 8.3
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PRIMARY outcome
Timeframe: Baseline (unaided) before surgery, 24 months after surgeryPopulation: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Outcome measures
| Measure |
Baha Attract System
n=46 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 250 Hz
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-19.9 dB
Standard Deviation 11.0
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 500 Hz
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-25.3 dB
Standard Deviation 9.6
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 1000 Hz
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-28.0 dB
Standard Deviation 12.4
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 2000 Hz
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-19.6 dB
Standard Deviation 11.8
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 3000 Hz
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-18.4 dB
Standard Deviation 10.9
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 4000 Hz
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13.2 dB
Standard Deviation 12.0
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 6000 Hz
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-8.67 dB
Standard Deviation 8.88
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PRIMARY outcome
Timeframe: Baseline (unaided) before surgery, 12 months after surgeryPopulation: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz). The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Outcome measures
| Measure |
Baha Attract System
n=51 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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|---|---|
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 4000 Hz
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-12.5 dB
Standard Deviation 12.2
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 250 Hz
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-18.5 dB
Standard Deviation 14.3
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 500 Hz
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-26.0 dB
Standard Deviation 13.0
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 1000 Hz
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-26.5 dB
Standard Deviation 14.2
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 2000 Hz
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-18.5 dB
Standard Deviation 13.5
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 3000 Hz
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-16.3 dB
Standard Deviation 13.2
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 6000 Hz
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-7.25 dB
Standard Deviation 11.19
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PRIMARY outcome
Timeframe: Baseline (unaided) before surgery, 6 months after surgeryPopulation: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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|---|---|
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 250 Hz
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-16.9 dB
Standard Deviation 12.9
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 500 Hz
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-26.6 dB
Standard Deviation 12.8
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 1000 Hz
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-26.4 dB
Standard Deviation 14.1
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 2000 Hz
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-18.7 dB
Standard Deviation 12.1
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 3000 Hz
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-16.9 dB
Standard Deviation 12.7
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 4000 Hz
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-12.3 dB
Standard Deviation 10.6
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Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Change of Threshold value at 6000 Hz
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-7.04 dB
Standard Deviation 8.61
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SECONDARY outcome
Timeframe: Baseline (unaided) before surgery, 6, 12 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention. Adaptive Speech in Noise analysis excluded subjects from Birmingham and Manchester clinics due to incorrect set up.
The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. Manchester and Birmingham are excluded from this analysis due to incorrect set up.
Outcome measures
| Measure |
Baha Attract System
n=36 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract
SNR 6 months, Baha Attract vs Unaided
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-4.30 dB
Standard Deviation 5.64
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Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract
SNR 12 months, Baha Attract vs Unaided
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4.79 dB
Standard Deviation 6.17
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Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract
SNR 24 months, Baha Attract vs Unaided
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-4.47 dB
Standard Deviation 6.11
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SECONDARY outcome
Timeframe: Baseline before surgery, 6, 12 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
The change of hearing performance with the Baha Attract System at 6, 12 and 24 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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Speech in Quiet, Baha Attract Versus Unaided
6 months: Speech in quiet at 50dB
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52.1 Change of % correct words at the dB leve
Standard Deviation 29.2
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Speech in Quiet, Baha Attract Versus Unaided
6 months: Speech in quiet at 65dB
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43.4 Change of % correct words at the dB leve
Standard Deviation 31.5
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Speech in Quiet, Baha Attract Versus Unaided
6 months: Speech in quiet at 80dB
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13.3 Change of % correct words at the dB leve
Standard Deviation 20.6
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Speech in Quiet, Baha Attract Versus Unaided
12 months: Speech in quiet at 50dB
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50.7 Change of % correct words at the dB leve
Standard Deviation 30.2
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Speech in Quiet, Baha Attract Versus Unaided
12 months: Speech in quiet at 65dB
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45.5 Change of % correct words at the dB leve
Standard Deviation 31.4
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Speech in Quiet, Baha Attract Versus Unaided
12 months: Speech in quiet at 80dB
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13.9 Change of % correct words at the dB leve
Standard Deviation 21.2
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Speech in Quiet, Baha Attract Versus Unaided
24 months: Speech in quiet at 50dB
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40.4 Change of % correct words at the dB leve
Standard Deviation 33.3
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Speech in Quiet, Baha Attract Versus Unaided
24 months: Speech in quiet at 65dB
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43.3 Change of % correct words at the dB leve
Standard Deviation 29.9
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Speech in Quiet, Baha Attract Versus Unaided
24 months: Speech in quiet at 80dB
|
14.0 Change of % correct words at the dB leve
Standard Deviation 20.7
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SECONDARY outcome
Timeframe: Baseline before surgery, 6, 12 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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|---|---|
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Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract
6 months vs Softband: PTA4
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-0.62 dB
Standard Deviation 5.138
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Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract
12 months vs Softband: PTA4
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0.196 dB
Standard Deviation 6.719
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Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract
24 months vs Softband: PTA4
|
-0.136 dB
Standard Deviation 6.472
|
SECONDARY outcome
Timeframe: Baseline (aided) before surgery, 6 months after surgeryPopulation: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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|---|---|
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Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
6 months: Change of Threshold value at 250 Hz
|
-1.30 dB
Standard Deviation 9.77
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Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
6 months: Change of Threshold value at 500 Hz
|
-4.17 dB
Standard Deviation 7.99
|
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Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
6 months: Change of Threshold value at 1000 Hz
|
-1.11 dB
Standard Deviation 6.49
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Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
6 months: Change of Threshold value at 2000 Hz
|
-0.463 dB
Standard Deviation 7.022
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Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
6 months: Change of Threshold value at 3000 Hz
|
2.69 dB
Standard Deviation 9.40
|
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Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
6 months: Change of Threshold value at 4000 Hz
|
3.24 dB
Standard Deviation 9.07
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Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
6 months: Change of Threshold value at 6000 Hz
|
5.56 dB
Standard Deviation 9.60
|
SECONDARY outcome
Timeframe: Baseline (aided) before surgery, 12 months after surgeryPopulation: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Outcome measures
| Measure |
Baha Attract System
n=51 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
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|---|---|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
12 months: Change of Threshold value at 250 Hz
|
-2.55 dB
Standard Deviation 11.15
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
12 months: Change of Threshold value at 500 Hz
|
-2.84 dB
Standard Deviation 10.74
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
12 months: Change of Threshold value at 1000 Hz
|
-0.392 dB
Standard Deviation 6.989
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
12 months: Change of Threshold value at 2000 Hz
|
0.392 dB
Standard Deviation 9.265
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
12 months: Change of Threshold value at 3000 Hz
|
4.02 dB
Standard Deviation 11.53
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
12 months: Change of Threshold value at 4000 Hz
|
3.63 dB
Standard Deviation 11.84
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
12 months: Change of Threshold value at 6000 Hz
|
5.59 dB
Standard Deviation 11.52
|
SECONDARY outcome
Timeframe: Baseline (aided) before surgery, 24 months after surgeryPopulation: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Outcome measures
| Measure |
Baha Attract System
n=46 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
24 months: Change of Threshold value at 2000 Hz
|
-0.761 dB
Standard Deviation 8.690
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
24 months: Change of Threshold value at 3000 Hz
|
2.61 dB
Standard Deviation 9.23
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
24 months: Change of Threshold value at 4000 Hz
|
3.15 dB
Standard Deviation 11.17
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
24 months: Change of Threshold value at 6000 Hz
|
5.22 dB
Standard Deviation 11.72
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
24 months: Change of Threshold value at 250 Hz
|
-3.67 dB
Standard Deviation 8.35
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
24 months: Change of Threshold value at 500 Hz
|
-1.74 dB
Standard Deviation 10.23
|
|
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
24 months: Change of Threshold value at 1000 Hz
|
-1.20 dB
Standard Deviation 6.34
|
SECONDARY outcome
Timeframe: Baseline (aided) before surgery, 6, 12 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention. Speech in Noise analysis excludes patients from Birmingham and Manchester due to incorrect set up.
The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive Speech recognition in Noise measured as signal to noise ratio. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB.
Outcome measures
| Measure |
Baha Attract System
n=38 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband
6 months: Speech in Noise
|
-0.508 change in SNR dB
Standard Deviation 4.173
|
|
Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband
12 months: Speech in Noise
|
-1.05 change in SNR dB
Standard Deviation 4.75
|
|
Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband
24 months: Speech in Noise
|
-0.739 change in SNR dB
Standard Deviation 4.106
|
SECONDARY outcome
Timeframe: Baseline (aided) before surgery, 6, 12 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
6 months: Speech in quiet at 50dB
|
2.74 Change of % correct words at the dB leve
Standard Deviation 29.94
|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
6 months: Speech in quiet at 65dB
|
-2.11 Change of % correct words at the dB leve
Standard Deviation 10.62
|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
6 months: Speech in quiet at 80dB
|
-0.33 Change of % correct words at the dB leve
Standard Deviation 5.00
|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
12 months: Speech in quiet at 50dB
|
0.373 Change of % correct words at the dB leve
Standard Deviation 27.201
|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
12 months: Speech in quiet at 65dB
|
-2.69 Change of % correct words at the dB leve
Standard Deviation 11.16
|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
12 months: Speech in quiet at 80dB
|
-0.961 Change of % correct words at the dB leve
Standard Deviation 8.457
|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
24 months: Speech in quiet at 50dB
|
-11.6 Change of % correct words at the dB leve
Standard Deviation 32.6
|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
24 months: Speech in quiet at 65dB
|
-5.67 Change of % correct words at the dB leve
Standard Deviation 16.48
|
|
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
24 months: Speech in quiet at 80dB
|
-0.696 Change of % correct words at the dB leve
Standard Deviation 8.178
|
SECONDARY outcome
Timeframe: Baseline (unaided) before surgery, 6 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.
Outcome measures
| Measure |
Baha Attract System
n=53 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Health Utility Index (HUI)
6 months: Vision
|
-0.003 units on a scale
Standard Deviation 0.033
|
|
Health Utility Index (HUI)
6 months: Comprehensive health state
|
0.063 units on a scale
Standard Deviation 0.249
|
|
Health Utility Index (HUI)
6 months: Hearing
|
0.111 units on a scale
Standard Deviation 0.321
|
|
Health Utility Index (HUI)
6 months: Speech
|
0.045 units on a scale
Standard Deviation 0.153
|
|
Health Utility Index (HUI)
6 months: Ambulation
|
-0.016 units on a scale
Standard Deviation 0.067
|
|
Health Utility Index (HUI)
6 months: Dexterity
|
-0.021 units on a scale
Standard Deviation 0.108
|
|
Health Utility Index (HUI)
6 months: Emotion
|
0.017 units on a scale
Standard Deviation 0.152
|
|
Health Utility Index (HUI)
6 months: Cognition
|
0.005 units on a scale
Standard Deviation 0.158
|
|
Health Utility Index (HUI)
6 months: Pain
|
0.020 units on a scale
Standard Deviation 0.123
|
|
Health Utility Index (HUI)
24 months: Comprehensive health state
|
0.069 units on a scale
Standard Deviation 0.240
|
|
Health Utility Index (HUI)
24 months: Vision
|
0.002 units on a scale
Standard Deviation 0.015
|
|
Health Utility Index (HUI)
24 months: Hearing
|
0.119 units on a scale
Standard Deviation 0.358
|
|
Health Utility Index (HUI)
24 months: Speech
|
0.051 units on a scale
Standard Deviation 0.135
|
|
Health Utility Index (HUI)
24 months: Ambulation
|
-0.015 units on a scale
Standard Deviation 0.076
|
|
Health Utility Index (HUI)
24 months: Dexterity
|
-0.025 units on a scale
Standard Deviation 0.151
|
|
Health Utility Index (HUI)
24 months: Emotion
|
0.014 units on a scale
Standard Deviation 0.089
|
|
Health Utility Index (HUI)
24 months: Cognition
|
0.003 units on a scale
Standard Deviation 0.134
|
|
Health Utility Index (HUI)
24 months: Pain
|
0.040 units on a scale
Standard Deviation 0.117
|
SECONDARY outcome
Timeframe: Baseline before surgery, 6 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.
Outcome measures
| Measure |
Baha Attract System
n=53 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
6 months: Ease of communication
|
20.4 units on scale
Standard Deviation 24.9
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
6 months: Background noise
|
26.3 units on scale
Standard Deviation 20.6
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
6 months: Reverberation
|
22.0 units on scale
Standard Deviation 19.0
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
6 months: Aversiveness
|
1.32 units on scale
Standard Deviation 23.45
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
6 months: Global
|
22.9 units on scale
Standard Deviation 18.1
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
24 months: Ease of communication
|
18.7 units on scale
Standard Deviation 26.3
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
24 months: Background noise
|
23.7 units on scale
Standard Deviation 20.4
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
24 months: Reverberation
|
20.8 units on scale
Standard Deviation 19.9
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
24 months: Aversiveness
|
-0.596 units on scale
Standard Deviation 19.646
|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
24 months: Global
|
21.1 units on scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Baseline before surgery, 6 and 24 months after surgeryPopulation: Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.
Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pre-operative unaided situation. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Outcome measures
| Measure |
Baha Attract System
n=53 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Speech: Change from pre-op to 6 months
|
2.49 units on scale
Standard Deviation 1.67
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Spatial: Change from pre-op to 6 months
|
1.87 units on scale
Standard Deviation 1.90
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Qualities: Change from pre-op to 6 months
|
1.68 units on scale
Standard Deviation 1.36
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Speech: Change from pre-op to 24 months
|
2.07 units on scale
Standard Deviation 1.57
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Spatial: Change from pre-op to 24 months
|
1.36 units on scale
Standard Deviation 1.74
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Qualities: Change from pre-op to 24 months
|
1.30 units on scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Visit 2 (Surgery)Population: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
Time of first incision to time of last suture
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Time to Perform Surgery
|
38.7 Minutes
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Visit 2 (surgery)Population: Intention-to-Treat (ITT) population; 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=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Tissue Reduction Performed During Surgery
Tissue thinning
|
12 participants
|
|
Tissue Reduction Performed During Surgery
No tissue thinning
|
42 participants
|
SECONDARY 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=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Implant Stability
|
77.3 units on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 4, 6, 12 weeks, 6, 12 and 24 monthsPopulation: 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=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Magnetic Force
4 weeks
|
1.01 Newton
Standard Deviation 0.40
|
|
Magnetic Force
6 weeks
|
1.07 Newton
Standard Deviation 0.33
|
|
Magnetic Force
12 weeks
|
1.15 Newton
Standard Deviation 0.41
|
|
Magnetic Force
6 months
|
1.16 Newton
Standard Deviation 0.42
|
|
Magnetic Force
12 months
|
1.15 Newton
Standard Deviation 0.38
|
|
Magnetic Force
24 months
|
1.09 Newton
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: 4, 6, 12 weeks, 6, 12 and 24 monthsPopulation: Intention-to-Treat (ITT) population; includes all patients who received surgical intervention at week 4. At week 6, 12 and month 6, 12 and 24 one patient had left the study.
To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Sound Processor Magnet Choice
Week 4 · SPM 6
|
19 Participants
|
|
Sound Processor Magnet Choice
Week 4 · SPM 5
|
19 Participants
|
|
Sound Processor Magnet Choice
Week 4 · SPM 4
|
9 Participants
|
|
Sound Processor Magnet Choice
Week 4 · SPM 3
|
6 Participants
|
|
Sound Processor Magnet Choice
Week 4 · SPM 2
|
1 Participants
|
|
Sound Processor Magnet Choice
Week 4 · SPM 1
|
0 Participants
|
|
Sound Processor Magnet Choice
Week 6 · SPM 6
|
11 Participants
|
|
Sound Processor Magnet Choice
Week 6 · SPM 5
|
10 Participants
|
|
Sound Processor Magnet Choice
Week 6 · SPM 4
|
16 Participants
|
|
Sound Processor Magnet Choice
Week 6 · SPM 3
|
13 Participants
|
|
Sound Processor Magnet Choice
Week 6 · SPM 2
|
2 Participants
|
|
Sound Processor Magnet Choice
Week 6 · SPM 1
|
1 Participants
|
|
Sound Processor Magnet Choice
Week 12 · SPM 6
|
6 Participants
|
|
Sound Processor Magnet Choice
Week 12 · SPM 5
|
12 Participants
|
|
Sound Processor Magnet Choice
Week 12 · SPM 4
|
11 Participants
|
|
Sound Processor Magnet Choice
Week 12 · SPM 3
|
15 Participants
|
|
Sound Processor Magnet Choice
Week 12 · SPM 2
|
9 Participants
|
|
Sound Processor Magnet Choice
Week 12 · SPM 1
|
0 Participants
|
|
Sound Processor Magnet Choice
Month 6 · SPM 6
|
5 Participants
|
|
Sound Processor Magnet Choice
Month 6 · SPM 5
|
9 Participants
|
|
Sound Processor Magnet Choice
Month 6 · SPM 4
|
12 Participants
|
|
Sound Processor Magnet Choice
Month 6 · SPM 3
|
18 Participants
|
|
Sound Processor Magnet Choice
Month 6 · SPM 2
|
9 Participants
|
|
Sound Processor Magnet Choice
Month 6 · SPM 1
|
0 Participants
|
|
Sound Processor Magnet Choice
Month 12 · SPM 6
|
6 Participants
|
|
Sound Processor Magnet Choice
Month 12 · SPM 5
|
11 Participants
|
|
Sound Processor Magnet Choice
Month 12 · SPM 4
|
12 Participants
|
|
Sound Processor Magnet Choice
Month 12 · SPM 3
|
14 Participants
|
|
Sound Processor Magnet Choice
Month 12 · SPM 2
|
8 Participants
|
|
Sound Processor Magnet Choice
Month 12 · SPM 1
|
1 Participants
|
|
Sound Processor Magnet Choice
Month 24 · SPM 6
|
5 Participants
|
|
Sound Processor Magnet Choice
Month 24 · SPM 5
|
8 Participants
|
|
Sound Processor Magnet Choice
Month 24 · SPM 4
|
5 Participants
|
|
Sound Processor Magnet Choice
Month 24 · SPM 3
|
17 Participants
|
|
Sound Processor Magnet Choice
Month 24 · SPM 2
|
9 Participants
|
|
Sound Processor Magnet Choice
Month 24 · SPM 1
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 6, Week 12, Month 6, Month 12, Month 24Population: Safety population; includes all patients who received the surgical intervention.
Degree of pain and discomfort.
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Pain & Discomfort
Month 24 · Excessive Discomfort or Pain
|
0 Participants
|
|
Pain & Discomfort
Week 6 · No Discomfort or Pain
|
21 Participants
|
|
Pain & Discomfort
Week 6 · Slight Discomfort or Pain
|
15 Participants
|
|
Pain & Discomfort
Week 6 · Discomfort or Pain
|
15 Participants
|
|
Pain & Discomfort
Week 6 · Excessive Discomfort or Pain
|
2 Participants
|
|
Pain & Discomfort
Week 12 · No Discomfort or Pain
|
24 Participants
|
|
Pain & Discomfort
Week 12 · Slight Discomfort or Pain
|
16 Participants
|
|
Pain & Discomfort
Week 12 · Discomfort or Pain
|
11 Participants
|
|
Pain & Discomfort
Week 12 · Excessive Discomfort or Pain
|
2 Participants
|
|
Pain & Discomfort
Month 6 · No Discomfort or Pain
|
33 Participants
|
|
Pain & Discomfort
Month 6 · Slight Discomfort or Pain
|
15 Participants
|
|
Pain & Discomfort
Month 6 · Discomfort or Pain
|
5 Participants
|
|
Pain & Discomfort
Month 6 · Excessive Discomfort or Pain
|
0 Participants
|
|
Pain & Discomfort
Month 12 · No Discomfort or Pain
|
37 Participants
|
|
Pain & Discomfort
Month 12 · Slight Discomfort or Pain
|
11 Participants
|
|
Pain & Discomfort
Month 12 · Discomfort or Pain
|
4 Participants
|
|
Pain & Discomfort
Month 12 · Excessive Discomfort or Pain
|
0 Participants
|
|
Pain & Discomfort
Month 24 · No Discomfort or Pain
|
40 Participants
|
|
Pain & Discomfort
Month 24 · Slight Discomfort or Pain
|
4 Participants
|
|
Pain & Discomfort
Month 24 · Discomfort or Pain
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24Population: Safety population; includes all patients who received the surgical intervention.
Degree of numbness when tested with a pin
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Numbness When Tested With a Pin
Day 10: Numbness tested with a Pin · No Numbness
|
12 Participants
|
|
Numbness When Tested With a Pin
Day 10: Numbness tested with a Pin · Numbness within 2cm of Implant
|
9 Participants
|
|
Numbness When Tested With a Pin
Day 10: Numbness tested with a Pin · Numbness within & beyond 2cm from Implant
|
33 Participants
|
|
Numbness When Tested With a Pin
Week 4: Numbness tested with a pin · No Numbness
|
15 Participants
|
|
Numbness When Tested With a Pin
Week 4: Numbness tested with a pin · Numbness within 2cm of Implant
|
7 Participants
|
|
Numbness When Tested With a Pin
Week 4: Numbness tested with a pin · Numbness within & beyond 2cm from Implant
|
32 Participants
|
|
Numbness When Tested With a Pin
Week 6: Numbness tested with a pin · No Numbness
|
21 Participants
|
|
Numbness When Tested With a Pin
Week 6: Numbness tested with a pin · Numbness within 2cm of Implant
|
3 Participants
|
|
Numbness When Tested With a Pin
Week 6: Numbness tested with a pin · Numbness within & beyond 2cm from Implant
|
29 Participants
|
|
Numbness When Tested With a Pin
Week 12: Numbness tested with a pin · No Numbness
|
33 Participants
|
|
Numbness When Tested With a Pin
Week 12: Numbness tested with a pin · Numbness within 2cm of Implant
|
5 Participants
|
|
Numbness When Tested With a Pin
Week 12: Numbness tested with a pin · Numbness within & beyond 2cm from Implant
|
15 Participants
|
|
Numbness When Tested With a Pin
Month 6: Numbness tested with a Pin · No Numbness
|
42 Participants
|
|
Numbness When Tested With a Pin
Month 6: Numbness tested with a Pin · Numbness within 2cm of Implant
|
3 Participants
|
|
Numbness When Tested With a Pin
Month 6: Numbness tested with a Pin · Numbness within & beyond 2cm from Implant
|
7 Participants
|
|
Numbness When Tested With a Pin
Month 12: Numbness tested with a Pin · No Numbness
|
45 Participants
|
|
Numbness When Tested With a Pin
Month 12: Numbness tested with a Pin · Numbness within 2cm of Implant
|
3 Participants
|
|
Numbness When Tested With a Pin
Month 12: Numbness tested with a Pin · Numbness within & beyond 2cm from Implant
|
4 Participants
|
|
Numbness When Tested With a Pin
Month 24: Numbness tested with a Pin · No Numbness
|
45 Participants
|
|
Numbness When Tested With a Pin
Month 24: Numbness tested with a Pin · Numbness within 2cm of Implant
|
0 Participants
|
|
Numbness When Tested With a Pin
Month 24: Numbness tested with a Pin · Numbness within & beyond 2cm from Implant
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24Population: Safety population; includes all patients who received the surgical intervention.
Degree of numbness when tested with a Cotton Swab
Outcome measures
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Numbness When Tested With a Cotton Swab
Week 4: Numbness tested with a Cotton Swab · No Numbness
|
18 Participants
|
|
Numbness When Tested With a Cotton Swab
Day 10: Numbness tested with a Cotton Swab · No Numbness
|
13 Participants
|
|
Numbness When Tested With a Cotton Swab
Day 10: Numbness tested with a Cotton Swab · Numbness within 2 cm from implant
|
9 Participants
|
|
Numbness When Tested With a Cotton Swab
Day 10: Numbness tested with a Cotton Swab · Numbness within & beyond 2cm from Implant
|
32 Participants
|
|
Numbness When Tested With a Cotton Swab
Week 4: Numbness tested with a Cotton Swab · Numbness within 2 cm from implant
|
6 Participants
|
|
Numbness When Tested With a Cotton Swab
Week 4: Numbness tested with a Cotton Swab · Numbness within & beyond 2cm from Implant
|
30 Participants
|
|
Numbness When Tested With a Cotton Swab
Week 6: Numbness tested with a Cotton Swab · No Numbness
|
23 Participants
|
|
Numbness When Tested With a Cotton Swab
Week 6: Numbness tested with a Cotton Swab · Numbness within 2 cm from implant
|
2 Participants
|
|
Numbness When Tested With a Cotton Swab
Week 6: Numbness tested with a Cotton Swab · Numbness within & beyond 2cm from Implant
|
28 Participants
|
|
Numbness When Tested With a Cotton Swab
Week 12: Numbness tested with a Cotton Swab · No Numbness
|
31 Participants
|
|
Numbness When Tested With a Cotton Swab
Week 12: Numbness tested with a Cotton Swab · Numbness within 2 cm from implant
|
6 Participants
|
|
Numbness When Tested With a Cotton Swab
Week 12: Numbness tested with a Cotton Swab · Numbness within & beyond 2cm from Implant
|
16 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 6: Numbness tested with a Cotton Swab · No Numbness
|
43 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 6: Numbness tested with a Cotton Swab · Numbness within 2 cm from implant
|
2 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 6: Numbness tested with a Cotton Swab · Numbness within & beyond 2cm from Implant
|
7 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 12: Numbness tested with a Cotton Swab · No Numbness
|
44 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 12: Numbness tested with a Cotton Swab · Numbness within 2 cm from implant
|
3 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 12: Numbness tested with a Cotton Swab · Numbness within & beyond 2cm from Implant
|
5 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 24: Numbness tested with a Cotton Swab · No Numbness
|
42 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 24: Numbness tested with a Cotton Swab · Numbness within 2 cm from implant
|
3 Participants
|
|
Numbness When Tested With a Cotton Swab
Month 24: Numbness tested with a Cotton Swab · Numbness within & beyond 2cm from Implant
|
1 Participants
|
Adverse Events
Baha Attract System
Serious events: 13 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Infections and infestations
Infection
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
General disorders
Increase in instability of knee prosthesis
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Blood and lymphatic system disorders
Embolisation of the Splenic Artery from pancreatitis
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Ear and labyrinth disorders
Increase of Meniere Attacks
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Ear and labyrinth disorders
Progression of Hearing Loss
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Hepatobiliary disorders
Decompensated Alcoholic Liver Disease
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Injury, poisoning and procedural complications
Broken Ankle
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Injury, poisoning and procedural complications
Pain/Discomfort
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Surgical and medical procedures
Surgery for Baha Attract on other ear
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Vascular disorders
Increase in Occlusive Arterial Disease
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Musculoskeletal and connective tissue disorders
Dequervian
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Pregnancy, puerperium and perinatal conditions
Patient was addmitted to the hospital due to childbirth
|
1.9%
1/54 • Number of events 1 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
Other adverse events
| Measure |
Baha Attract System
n=54 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: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
|
|---|---|
|
Ear and labyrinth disorders
Ear and Labyrinth Disorders
|
11.1%
6/54 • Number of events 9 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
7.4%
4/54 • Number of events 5 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
General disorders
General Disorders and Administration Site Conditions
|
18.5%
10/54 • Number of events 10 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Infections and infestations
Infections and Infestation
|
25.9%
14/54 • Number of events 21 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Infections and infestations
Injury, Poisoning and Procedural Complications
|
9.3%
5/54 • Number of events 5 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
7.4%
4/54 • Number of events 4 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Nervous system disorders
Nervous System Disorders
|
9.3%
5/54 • Number of events 5 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
5.6%
3/54 • Number of events 3 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders
|
13.0%
7/54 • Number of events 7 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Vascular disorders
Vascular Disorders
|
5.6%
3/54 • Number of events 3 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Skin and subcutaneous tissue disorders
Predefined event: Pressure related Skin Complications
|
11.1%
6/54 • Number of events 6 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
|
Skin and subcutaneous tissue disorders
Predefined event: Pain/Discomfort
|
44.4%
24/54 • Number of events 37 • 24 months
The AEs were encoded according to the CTCAE dictionary and only to the SOC term.
|
Additional Information
Professor Emmanuel Mylanus
Radboud University Medical Centre, Nijmegen, The Netherlands
Phone: +31 24 361 1111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60