Deafness, Hearing Loss, Hearing Loss, Conductive
Conditions
Brief summary
The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery: * To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband * Which sound processor to select, i.e. BP100 vs BP110 * Improve the fitting process for the sound processor * Selection of sound processor magnet at time of fitting and over time
Interventions
DEVICEBaha Attract System
Sponsors
Cochlear Bone Anchored Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz \<30 decibel (dB) hearing level (HL) * Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz \<30 dB hearing level (HL) in the best ear * Signed informed consent
Exclusion criteria
* Uncontrolled diabetes as judged by the investigator * Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids * Unable to follow investigational procedures, e.g. to complete quality of life scales * Less than 4mm of soft tissue pre-operatively * Participation in another investigation with pharmaceuticals and/or device * Condition that may have an impact on the outcome of the investigation as judged by the investigator * Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned * Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Performance, PTA4 at 12 Weeks | Baseline before surgery and 12 weeks after surgery | The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12. |
| Hearing Performance, PTA4 at 36 Weeks | Baseline before surgery and 36 weeks after surgery | The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Performance, Individual Frequencies | Baseline before surgery and 36 weeks after surgery | The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36. |
| Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks | Baseline before surgery and 36 weeks after surgery | The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36. |
| Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks | Baseline before surgery and 36 weeks after surgery | The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36. |
| Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks | Baseline before surgery and 36 weeks after surgery | The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36. |
| Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks | Baseline before surgery and 36 weeks after surgery | The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36. |
| Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks | Baseline before surgery and 36 weeks after surgery | The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36. |
| Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks | Baseline before surgery and 36 weeks after surgery | The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36. |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline before surgery and 36 weeks after surgery | Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Perform Surgery | Visit 2 (surgery) | — |
| Tissue Reduction Performed During Surgery | Visit 2 (surgery) | Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm. |
| Implant Stability | Visit 2 (surgery) | Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability. |
| Choice of Sound Processor | Baseline | Type of sound processors BP100 and BP110 attached to a soft band (subject preference) |
| Feedback Measurement, BP100 | Baseline before surgery and 12 weeks after surgery | Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback. |
| Feedback Measurement, BP110 | Baseline before surgery and 12 weeks after surgery | Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback. |
| Magnetic Force | Week 4, 6, 12 and 36 | To investigate if the magnetic force required for sound processor magnet retention will change over time |
| Safety; Skin Evaluation | 36 weeks | Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable). |
| Safety; Pain | 36 weeks | Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much). |
| Safety; Numbness | 36 weeks | Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet. |
Countries
Australia, Chile, Hong Kong, Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Baha Attract System |
|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 13.8 |
| Gender Female | 15 Participants |
| Gender Male | 12 Participants |
| Region of Enrollment Australia | 8 participants |
| Region of Enrollment Chile | 5 participants |
| Region of Enrollment Hong Kong | 8 participants |
| Region of Enrollment Israel | 6 participants |
| Type of hearing loss Conductive hearing loss | 17 participants |
| Type of hearing loss Single-sided sensorineural deafness | 10 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 27 |
| serious Total, serious adverse events | 2 / 27 |
Outcome results
Primary
Hearing Performance, PTA4 at 12 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.
Time frame: Baseline before surgery and 12 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Hearing Performance, PTA4 at 12 Weeks | -18.4 dB | Standard Deviation 6.7 |
p-value: <0.0001Fisher's non-parametric permutation
Primary
Hearing Performance, PTA4 at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Hearing Performance, PTA4 at 36 Weeks | -18.4 dB | Standard Deviation 6.9 |
p-value: <0.0001Fisher's non-parametric permutation
Secondary
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.
Time frame: Baseline before surgery and 36 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Aversiveness | -4.04 units on a scale | Standard Deviation 36.03 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Ease of communication | 4.23 units on a scale | Standard Deviation 52.16 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Reverberation | 5.10 units on a scale | Standard Deviation 42.78 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Background noise | 8.92 units on a scale | Standard Deviation 48.07 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Global score | 6.76 units on a scale | Standard Deviation 45.92 |
Comparison: Aversivenessp-value: 0.59Fisher's non-parametric permutation test
Comparison: Ease of Communicationp-value: 0.71Fisher's non-parametric permutation test
Comparison: Reverberationp-value: 0.59Fisher's non-parametric permutation test
Comparison: Background noisep-value: 0.4Fisher's non-parametric permutation test
Comparison: Global scorep-value: 0.5Fisher's non-parametric permutation test
Secondary
Hearing Performance, Individual Frequencies
The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance, Individual Frequencies | Change in hearing level at 500HZ | -20.2 dB | Standard Deviation 14.4 |
| Baha Attract System | Hearing Performance, Individual Frequencies | Change in hearing level at 1000HZ | -25.2 dB | Standard Deviation 8.4 |
| Baha Attract System | Hearing Performance, Individual Frequencies | Change in hearing level at 2000HZ | -18.3 dB | Standard Deviation 9.5 |
| Baha Attract System | Hearing Performance, Individual Frequencies | Change in hearing level at 3000HZ | -18.7 dB | Standard Deviation 14.7 |
| Baha Attract System | Hearing Performance, Individual Frequencies | Change in hearing level at 4000HZ | -9.8 dB | Standard Deviation 10.8 |
| Baha Attract System | Hearing Performance, Individual Frequencies | Change in hearing level at 6000HZ | -5.0 dB | Standard Deviation 12.3 |
| Baha Attract System | Hearing Performance, Individual Frequencies | Change in hearing level at 8000HZ | -4.2 dB | Standard Deviation 10.7 |
Comparison: Statistically significant changes with the same value at 500 to 4000Hzp-value: <0.0001Fisher's non-parametric permutation test
Comparison: Change at 6000Hzp-value: 0.0499Fisher's non-parametric permutation test
Comparison: Change at 8000Hzp-value: 0.0632Fisher's non-parametric permutation test
Secondary
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks | 500Hz | -0.741 dB | Standard Deviation 13.637 |
| Baha Attract System | Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks | 1000Hz | -1.67 dB | Standard Deviation 7.34 |
| Baha Attract System | Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks | 2000Hz | 1.67 dB | Standard Deviation 7.07 |
| Baha Attract System | Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks | 3000Hz | -0.37 dB | Standard Deviation 8.077 |
| Baha Attract System | Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks | 4000Hz | 4.44 dB | Standard Deviation 9.64 |
| Baha Attract System | Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks | 6000Hz | 6.92 dB | Standard Deviation 12.34 |
| Baha Attract System | Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks | 8000 | 3.80 dB | Standard Deviation 12.1 |
Comparison: 500Hzp-value: 0.79Fisher's non-parametric permutation test
Comparison: 1000Hzp-value: 0.26Fisher's non-parametric permutation test
Comparison: 2000Hzp-value: 0.24Fisher's non-parametric permutation test
Comparison: 3000Hzp-value: 0.83Fisher's non-parametric permutation test
Comparison: 4000Hzp-value: 0.026Fisher's non-parametric permutation test
Comparison: 6000Hzp-value: 0.0085Fisher's non-parametric permutation test
Comparison: 8000Hzp-value: 0.13Fisher's non-parametric permutation test
Secondary
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Population: Intention-to-Treat population, includes all patients who received surgical intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks | 0.926 dB | Standard Deviation 5.553 |
p-value: 0.39Fisher's non-parametric permutation test
Secondary
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks | -3.79 Signal to noise ratio | Standard Deviation 6.96 |
p-value: 0.0092Fisher's non-parametric permutation test
Secondary
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks | -15.0 Signal to noise ratio | Standard Deviation 12.8 |
p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks | Change at 50dB presentation level | 2.83 % perception of presented words | Standard Deviation 23.8 |
| Baha Attract System | Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks | Change at 65dB presentation level | 0.98 % perception of presented words | Standard Deviation 13.49 |
| Baha Attract System | Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks | Change at 80dB presentation level | 1.71 % perception of presented words | Standard Deviation 7.8 |
Comparison: 50dBp-value: 0.55Fisher's non-parametric permutation test
Comparison: 60dBp-value: 0.72Fisher's non-parametric permutation test
Comparison: 80dBp-value: 0.28Fisher's non-parametric permutation test
Secondary
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks | Change at 50dB presentation level | 50 % perception of presented words | Standard Deviation 23.7 |
| Baha Attract System | Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks | Change at 65dB presentation level | 46.4 % perception of presented words | Standard Deviation 31.7 |
| Baha Attract System | Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks | Change at 80dB presentation level | 24.2 % perception of presented words | Standard Deviation 25.6 |
Comparison: Statistically significant improvement with the same value at all presentation levels.p-value: <0.0001Fisher's non-parametric permutation test
Other Pre-specified
Choice of Sound Processor
Type of sound processors BP100 and BP110 attached to a soft band (subject preference)
Time frame: Baseline
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baha Attract System | Choice of Sound Processor | BP100 | 6 participants |
| Baha Attract System | Choice of Sound Processor | BP110 | 21 participants |
Other Pre-specified
Feedback Measurement, BP100
Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.
Time frame: Baseline before surgery and 12 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Feedback Measurement, BP100 | 1250Hz | -10.1 dB | Standard Deviation 2.4 |
| Baha Attract System | Feedback Measurement, BP100 | 400Hz | -13.2 dB | Standard Deviation 7.8 |
| Baha Attract System | Feedback Measurement, BP100 | 500Hz | -6.54 dB | Standard Deviation 3.98 |
| Baha Attract System | Feedback Measurement, BP100 | 630Hz | -4.29 dB | Standard Deviation 8.56 |
| Baha Attract System | Feedback Measurement, BP100 | 800Hz | -7.11 dB | Standard Deviation 6.84 |
| Baha Attract System | Feedback Measurement, BP100 | 1000Hz | -7.85 dB | Standard Deviation 4.59 |
| Baha Attract System | Feedback Measurement, BP100 | 1600Hz | -7.44 dB | Standard Deviation 2.88 |
| Baha Attract System | Feedback Measurement, BP100 | 2000Hz | -2.82 dB | Standard Deviation 1.59 |
| Baha Attract System | Feedback Measurement, BP100 | 2500Hz | -2.91 dB | Standard Deviation 3.64 |
| Baha Attract System | Feedback Measurement, BP100 | 3150Hz | -1.21 dB | Standard Deviation 3.66 |
| Baha Attract System | Feedback Measurement, BP100 | 4000Hz | 1.83 dB | Standard Deviation 3.42 |
| Baha Attract System | Feedback Measurement, BP100 | 5000Hz | 0.17 dB | Standard Deviation 4.37 |
| Baha Attract System | Feedback Measurement, BP100 | 6300Hz | 7.28 dB | Standard Deviation 7.62 |
| Baha Attract System | Feedback Measurement, BP100 | 8000Hz | 3.95 dB | Standard Deviation 3.26 |
Other Pre-specified
Feedback Measurement, BP110
Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.
Time frame: Baseline before surgery and 12 weeks after surgery
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Feedback Measurement, BP110 | 400Hz | -3.50 dB | Standard Deviation 8.36 |
| Baha Attract System | Feedback Measurement, BP110 | 500Hz | -3.86 dB | Standard Deviation 8.46 |
| Baha Attract System | Feedback Measurement, BP110 | 630Hz | -4.20 dB | Standard Deviation 10.59 |
| Baha Attract System | Feedback Measurement, BP110 | 800Hz | -3.39 dB | Standard Deviation 9.16 |
| Baha Attract System | Feedback Measurement, BP110 | 1000Hz | -5.03 dB | Standard Deviation 7.17 |
| Baha Attract System | Feedback Measurement, BP110 | 1250Hz | -8.10 dB | Standard Deviation 7.87 |
| Baha Attract System | Feedback Measurement, BP110 | 1600Hz | -8.85 dB | Standard Deviation 6.51 |
| Baha Attract System | Feedback Measurement, BP110 | 2000Hz | -4.73 dB | Standard Deviation 4.65 |
| Baha Attract System | Feedback Measurement, BP110 | 2500Hz | -3.08 dB | Standard Deviation 4.1 |
| Baha Attract System | Feedback Measurement, BP110 | 3150Hz | -3.00 dB | Standard Deviation 3.3 |
| Baha Attract System | Feedback Measurement, BP110 | 4000Hz | 0.69 dB | Standard Deviation 4.86 |
| Baha Attract System | Feedback Measurement, BP110 | 5000Hz | 6.58 dB | Standard Deviation 6.24 |
| Baha Attract System | Feedback Measurement, BP110 | 6300Hz | 10.3 dB | Standard Deviation 4.7 |
| Baha Attract System | Feedback Measurement, BP110 | 8000Hz | 12.2 dB | Standard Deviation 9.7 |
Other Pre-specified
Implant Stability
Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.
Time frame: Visit 2 (surgery)
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Implant Stability | 75.7 units on a scale | Standard Deviation 8.8 |
Other Pre-specified
Magnetic Force
To investigate if the magnetic force required for sound processor magnet retention will change over time
Time frame: Week 4, 6, 12 and 36
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Magnetic Force | 4 weeks | 0.97 Newton | Standard Deviation 0.3 |
| Baha Attract System | Magnetic Force | 6 weeks | 1.05 Newton | Standard Deviation 0.37 |
| Baha Attract System | Magnetic Force | 12 weeks | 0.98 Newton | Standard Deviation 0.29 |
| Baha Attract System | Magnetic Force | 36 weeks | 0.97 Newton | Standard Deviation 0.28 |
Other Pre-specified
Safety; Numbness
Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet.
Time frame: 36 weeks
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baha Attract System | Safety; Numbness | No numbness | 21 participants |
| Baha Attract System | Safety; Numbness | Numbness within 2 cm | 1 participants |
| Baha Attract System | Safety; Numbness | Numbness within 2 cm and beyond | 5 participants |
Other Pre-specified
Safety; Pain
Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much).
Time frame: 36 weeks
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Safety; Pain | Neuropathic pain | 1.19 units on a scale | Standard Deviation 0.79 |
| Baha Attract System | Safety; Pain | Pain in the scar | 1.15 units on a scale | Standard Deviation 0.77 |
Other Pre-specified
Safety; Skin Evaluation
Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).
Time frame: 36 weeks
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Safety; Skin Evaluation | Overall opinion observer | 1.52 units on a scale | Standard Deviation 0.93 |
| Baha Attract System | Safety; Skin Evaluation | Overall opinion patient | 1.81 units on a scale | Standard Deviation 1.21 |
Other Pre-specified
Time to Perform Surgery
Time frame: Visit 2 (surgery)
Population: Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Time to Perform Surgery | 45.0 minutes | Standard Deviation 14.6 |
Other Pre-specified
Tissue Reduction Performed During Surgery
Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.
Time frame: Visit 2 (surgery)
Population: Intention-to-Treat population, includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baha Attract System | Tissue Reduction Performed During Surgery | No tissue reduction | 24 participants |
| Baha Attract System | Tissue Reduction Performed During Surgery | Tissue reduction | 3 participants |