Mixed Hearing Loss, Unilateral, Single Sided Sensorineural Deafness
Conditions
Brief summary
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.
Detailed description
The Cochlear Baha bone conduction hearing implant offers two alternative ways to transmit vibrations from the external sound processor to the osseointegrated implant: The Baha Connect System uses a skin-penetrating abutment and allows direct bone conduction. The Baha Attract System uses a magnetic connection through intact skin. Magnetic bone conduction hearing implants have the advantage over skin-penetrating systems of eliminating the daily cleaning of the site and are perceived as a more cosmetically appealing by some subjects. With modern sound processor technology, it is possible to obtain good sound transmission despite the soft tissue attenuation that is inherent to magnetic bone conduction hearing implants. Clinical investigations have shown that the Baha Attract System, when used in combination with existing head-worn sound processors within the Premium (e.g. BP100, Baha 4 Sound Processors) and Power (BP110 Sound processor) segments, provides good hearing outcomes in subjects with conductive and mild mixed hearing loss. The Cochlear Baha 5 SuperPower Sound Processor is the first head-worn sound processor within the Super Power segment and has a fitting range of 65 dBHL. It is CE marked and is intended for subjects with mixed hearing loss or single-sided sensorineural deafness (SSD). It can be used with the Baha Connect and Baha Attract Systems and with a Baha Softband. When used in combination with the Baha Attract System, it will be able to compensate for a larger sensorineural component than the current Premium and Power sound processors and, hence, will allow more subjects to benefit from the Baha Attract System. The combination Baha Attract System with Baha 5 SuperPower Sound Processor is the most powerful non-skin penetrating bone conduction hearing implant solution available today. The Baha 5 SuperPower Sound Processor includes discreet design, advanced signal processing and improved connectivity to external sound sources. The new sound processor supports Cochlear's 2.4 GHz wireless protocol and is programmable with a new version of the Baha 5 Fitting Software. The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.
Interventions
DEVICEBaha 5 SuperPower on Baha Attract System
The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
Sponsors
Cochlear Bone Anchored Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects ≥ 18 years of age * Mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4, Mean of 0.5, 1, 2 and 4kHz) of 30-55 dBHL or * Single-sided sensorineural deafness: Bone conduction thresholds with a pure tone average \[PTA4, Mean of 0.5, 1, 2 and 4 kHz\] of lower or 30 dBHL in the best ear. Subjects who have, for some reason, experienced no or limited benefit from other sound processors when tested on a Baha Softband. * Subjects suitable for surgery according to the recommended surgical procedure for Cochlear Baha 5 SuperPower with no previous implant on the side to be investigated. * Signed inform consent.
Exclusion criteria
* Subject scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Investigational device (however, bilateral hearing loss is not an exclusion criterion). * Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness * Less than 3 mm soft tissue thickness at the planned implant site. (Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided | 12 weeks | Change of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks. | 12 weeks | The APHAB is a 24-item self-assessment questionnaire evaluating the benefit experienced by the subject when using hearing amplification compared to the unaided situation. It comprises of four subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). The Global score is the mean of the subscales. All subscales are scored in the same way. The scores show how frequently (%) clients experience performance problems and varies between 0-100, 0 indicates no problems, 100 indicates always problem. Benefit is then calculated by subtracting the aided average from the unaided average. The theoretical benefit score could vary between -100 to + 100. The higher the score the better benefit and positive score indicates an improvement, a negative value an impairment. |
| Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks. | 12 weeks | The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from unaided to aided hearing is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing. |
| Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided | 4 weeks | Change of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks |
| Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 4 weeks | Change of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks |
| Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided | 4 weeks | Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks |
| Free Field; - Speech Recognition in Quiet, Unaided vs Aided | 4 weeks | Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks |
| Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband | 4 weeks | Change of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 4 weeks |
| Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 4 weeks | Change of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from the situation with same sound processor on a Baha softband with the Investigational device on the attract system at 4 weeks |
| Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband | 4 weeks | Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 4 weeks |
| Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | 4 weeks | Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 4 weeks |
| Sound Processor Magnet Selection at 4 Weeks | 4 weeks | Information about sound processor magnet selection, type of SP magnet |
| Sound Processor Magnet Selection at 6 Weeks | 6 weeks | Information about sound processor magnet selection, type of SP magnet |
| Sound Processor Magnet Selection at 12 Weeks | 12 weeks | Information about sound processor magnet selection, type of SP magnet |
| Daily Use of Sound Processor (Average Daily Use During the Last Week) | 12 weeks | Average daily use (hours/day) of the sound processor during the last week of the study |
| Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband | 12 weeks | Change of hearing performance PTA4 from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 12 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Related to the Treatment | 12 weeks | Number of adverse events related to the treatment during the 12 weeks treatment period |
Countries
Belgium, Denmark, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baha 5 SuperPower on Baha Attract System The device involves the following parts:
The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.
Baha 5 SuperPower on Baha Attract System: The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Baha 5 SuperPower on Baha Attract System | — |
|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 8.9 | — |
| Does the subject use a hearing aid in the non-treament ear No | 14 Participants | — |
| Does the subject use a hearing aid in the non-treament ear Yes | 9 Participants | — |
| Does the subject use a hearing aid in the treament ear No | 13 Participants | — |
| Does the subject use a hearing aid in the treament ear Yes | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 10 participants | — |
| Region of Enrollment Denmark | 2 participants | — |
| Region of Enrollment Spain | 5 participants | — |
| Region of Enrollment United Kingdom | 6 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
| Treatmen ear Left | 10 Participants | — |
| Treatmen ear Right | 13 Participants | — |
| Type of hearing loss in treatment ear Mixed hearing loss | 23 Participants | — |
| Type of hearing loss in treatment ear Single-sided sensorineural deafness | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided
Change of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided | -27.7 dB HL | Standard Deviation 9 |
p-value: <0.0001Wilcoxon Signed Rank test
Secondary
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
Change of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from the same sound processor on a Baha softband with the Investigational device on the attract system at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 250 Hz | -2.39 dB HL | Standard Deviation 7.52 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 500 Hz | -2.61 dB HL | Standard Deviation 6.01 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 750 Hz | 1.09 dB HL | Standard Deviation 6.21 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 1000 Hz | 2.39 dB HL | Standard Deviation 6.89 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 1500 Hz | 1.52 dB HL | Standard Deviation 7.3 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 2000 Hz | 2.17 dB HL | Standard Deviation 6.54 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 3000 Hz | 2.61 dB HL | Standard Deviation 11.66 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 4000 Hz | 5.65 dB HL | Standard Deviation 10.69 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 6000 Hz | 2.50 dB HL | Standard Deviation 18.31 |
Comparison: 250 Hzp-value: 0.12Wilcoxon Signed Rank test
Comparison: 500 Hzp-value: 0.072Wilcoxon Signed Rank test
Comparison: 750 Hzp-value: 0.56Wilcoxon Signed Rank test
Comparison: 1000 Hzp-value: 0.16Wilcoxon Signed Rank test
Comparison: 1500 Hzp-value: 0.39Wilcoxon Signed Rank test
Comparison: 2000 Hzp-value: 0.11Wilcoxon Signed Rank test
Comparison: 3000 Hzp-value: 0.38Wilcoxon Signed Rank test
Comparison: 4000 Hzp-value: 0.014Wilcoxon Signed Rank test
Comparison: 6000 Hzp-value: 0.71Wilcoxon Signed Rank test
Secondary
Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
Change of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from the situation with same sound processor on a Baha softband with the Investigational device on the attract system at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 250 Hz | 1.3 dB HL | Standard Deviation 7.42 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 500 Hz | -2.61 dB HL | Standard Deviation 7.52 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 750 Hz | 1.09 dB HL | Standard Deviation 7.38 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 1000 Hz | 3.04 dB HL | Standard Deviation 6.7 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 1500 Hz | 1.52 dB HL | Standard Deviation 6.47 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 2000 Hz | 4.57 dB HL | Standard Deviation 8.25 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 3000 Hz | 5.65 dB HL | Standard Deviation 10.9 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 4000 Hz | 5.22 dB HL | Standard Deviation 12.29 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | 6000 Hz | 7.62 dB HL | Standard Deviation 11.47 |
Comparison: 250 Hzp-value: 0.47Wilcoxon Signed Rank test
Comparison: 500 Hzp-value: 0.16Wilcoxon Signed Rank test
Comparison: 750 Hzp-value: 0.59Wilcoxon Signed Rank test
Comparison: 1000 Hzp-value: 0.034Wilcoxon Signed Rank test
Comparison: 1500 Hzp-value: 0.25Wilcoxon Signed Rank test
Comparison: 2000 Hzp-value: 0.023Wilcoxon Signed Rank test
Comparison: 3000 Hzp-value: 0.028Wilcoxon Signed Rank test
Comparison: 4000 Hzp-value: 0.0075Wilcoxon Signed Rank test
Comparison: 6000 Hzp-value: 0.0035Wilcoxon Signed Rank test
Secondary
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
Change of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 750 Hz | -33.0 dB HL | Standard Deviation 13.8 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 250 Hz | -24.3 dB HL | Standard Deviation 11.3 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 500 Hz | -27.6 dB HL | Standard Deviation 12 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 1000 Hz | -32.2 dB HL | Standard Deviation 11.2 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 1500 Hz | -35.9 dB HL | Standard Deviation 11.1 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 2000 Hz | -32.4 dB HL | Standard Deviation 10.1 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 3000 Hz | -23.9 dB HL | Standard Deviation 12.3 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 4000 Hz | -18.5 dB HL | Standard Deviation 13.7 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 6000 Hz | -23.4 dB HL | Standard Deviation 14.8 |
Comparison: 250 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 500 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 750 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 1000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 1500 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 2000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 3000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 4000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 6000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Secondary
Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
Change of hearing performance free field tresholds per frequency \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz\] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 250 Hz | -20.7 dB HL | Standard Deviation 13.3 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 500 Hz | -27.6 dB HL | Standard Deviation 11.8 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 750 Hz | -33.0 dB HL | Standard Deviation 13.5 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 1000 Hz | -31.5 dB HL | Standard Deviation 11 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 1500 Hz | -35.9 dB HL | Standard Deviation 11.1 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 2000 Hz | -30.0 dB HL | Standard Deviation 10.9 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 3000Hz | -20.9 dB HL | Standard Deviation 16.1 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 4000 Hz | -18.9 dB HL | Standard Deviation 16 |
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | 6000 Hz | -19.5 dB HL | Standard Deviation 13.9 |
Comparison: 250 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 500 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 750 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 1000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 1500 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 2000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 3000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 4000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Comparison: 6000 Hzp-value: <0.0001Wilcoxon Signed Rank test
Secondary
Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband
Change of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband | 2.55 dB HL | Standard Deviation 5.87 |
p-value: 0.036Wilcoxon Signed Rank test
Secondary
Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband
Change of hearing performance PTA4 from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband | 1.9 dB HL | Standard Deviation 4.31 |
p-value: 0.065Wilcoxon Signed Rank test
Secondary
Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided
Change of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided | -27.0 dB HL | Standard Deviation 9.7 |
p-value: <0.0001Wilcoxon Signed Rank test
Secondary
Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.
The APHAB is a 24-item self-assessment questionnaire evaluating the benefit experienced by the subject when using hearing amplification compared to the unaided situation. It comprises of four subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). The Global score is the mean of the subscales. All subscales are scored in the same way. The scores show how frequently (%) clients experience performance problems and varies between 0-100, 0 indicates no problems, 100 indicates always problem. Benefit is then calculated by subtracting the aided average from the unaided average. The theoretical benefit score could vary between -100 to + 100. The higher the score the better benefit and positive score indicates an improvement, a negative value an impairment.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks. | Ease of communication | 44.8 score on a scale | Standard Deviation 33.1 |
| Baha 5 SuperPower on Baha Attract System | Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks. | Reverberation | 31.5 score on a scale | Standard Deviation 23.8 |
| Baha 5 SuperPower on Baha Attract System | Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks. | Background noise | 37.7 score on a scale | Standard Deviation 25.1 |
| Baha 5 SuperPower on Baha Attract System | Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks. | Aversiveness | -16.6 score on a scale | Standard Deviation 27.3 |
| Baha 5 SuperPower on Baha Attract System | Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks. | Global score | 38.0 score on a scale | Standard Deviation 24.2 |
Comparison: Ease of communicationp-value: <0.0001Wilcoxon Signed Rank test
Comparison: Reverberationp-value: <0.0001Wilcoxon Signed rank Test
Comparison: Background noisep-value: <0.0001Wilcoxon Signed rank Test
Comparison: Aversivenessp-value: 0.0004Wilcoxon Signed rank Test
Comparison: Global scorep-value: <0.0001Wilcoxon Signed rank Test
Secondary
Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks.
The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from unaided to aided hearing is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks. | Speech scale | 3.59 score on a scale | Standard Deviation 1.9 |
| Baha 5 SuperPower on Baha Attract System | Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks. | Spatial scale | 2.37 score on a scale | Standard Deviation 2.08 |
| Baha 5 SuperPower on Baha Attract System | Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks. | Qualities scale | 3.51 score on a scale | Standard Deviation 2.16 |
Comparison: Speech scalep-value: <0.0001Wilcoxon Signed Rank test
Comparison: Spatial scalep-value: <0.0001Wilcoxon Signed Rank test
Comparison: Qualities scalep-value: <0.0001Wilcoxon Signed Rank test
Secondary
Daily Use of Sound Processor (Average Daily Use During the Last Week)
Average daily use (hours/day) of the sound processor during the last week of the study
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Daily Use of Sound Processor (Average Daily Use During the Last Week) | 9.39 hours/day | Standard Deviation 3.54 |
Secondary
Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband | 1.19 dB | Standard Deviation 4.45 |
p-value: 0.48Wilcoxon Signed Rank test
Secondary
Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband | 1.42 dB | Standard Deviation 3.27 |
p-value: 0.11Wilcoxon Signed Rank test
Secondary
Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided | -8.56 dB | Standard Deviation 6.22 |
p-value: 0.002Wilcoxon Signed Rank test
Secondary
Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided | -8.41 dB | Standard Deviation 5.13 |
p-value: 0.0024Wilcoxon Signed Rank test
Secondary
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | Speech Presentation Level 50 dB | -10.5 Percentage (%) correct words | Standard Deviation 25.7 |
| Baha 5 SuperPower on Baha Attract System | Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | Speech Presentation Level 65 dB | -6.78 Percentage (%) correct words | Standard Deviation 18.37 |
| Baha 5 SuperPower on Baha Attract System | Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | Speech Presentation Level 80 dB | -1.86 Percentage (%) correct words | Standard Deviation 17.39 |
Comparison: SPL 50 dBp-value: 0.017Wilcoxon Signed Rank test
Comparison: SPL 65 dBp-value: 0.095Wilcoxon Signed Rank test
Comparison: SPL 80 dBp-value: 0.57Wilcoxon Signed Rank test
Secondary
Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | Speech Presentation Level 50 dB | -9.00 dB | Standard Deviation 19.8 |
| Baha 5 SuperPower on Baha Attract System | Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | Speech Presentation Level 65 dB | -1.17 dB | Standard Deviation 16.52 |
| Baha 5 SuperPower on Baha Attract System | Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | Speech Presentation Level 80 dB | 2.82 dB | Standard Deviation 18.11 |
Comparison: SPL 50 dBp-value: 0.096Wilcoxon Signed Rank test
Comparison: SPL 65 dBp-value: 1Wilcoxon Signed Rank test
Comparison: SPL 80 dBp-value: 0.41Wilcoxon Signed Rank test
Secondary
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Free Field; - Speech Recognition in Quiet, Unaided vs Aided | Speech Presentation Level 50 dB | 35.7 Percentage (%) correct words | Standard Deviation 29.6 |
| Baha 5 SuperPower on Baha Attract System | Free Field; - Speech Recognition in Quiet, Unaided vs Aided | Speech Presentation Level 65 dB | 49.0 Percentage (%) correct words | Standard Deviation 29.5 |
| Baha 5 SuperPower on Baha Attract System | Free Field; - Speech Recognition in Quiet, Unaided vs Aided | Speech Presentation Level 80 dB | 39.2 Percentage (%) correct words | Standard Deviation 32.9 |
Comparison: Speech Presentation Level 50 dBp-value: <0.0001Wolcoxon Signed rank test
Comparison: Speech Presentation Level 65 dBp-value: <0.0001Wilcoxon Signed Rank test
Comparison: Speech Presentation Level 80 dBp-value: <0.0001Wilcoxon Signed Rank test
Secondary
Free Field; - Speech Recognition in Quiet, Unaided vs Aided
Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Free Field; - Speech Recognition in Quiet, Unaided vs Aided | Speech Presentation Level 50 dB | 34.1 Percentage (%) correct words | Standard Deviation 31.4 |
| Baha 5 SuperPower on Baha Attract System | Free Field; - Speech Recognition in Quiet, Unaided vs Aided | Speech Presentation Level 65 dB | 43.3 Percentage (%) correct words | Standard Deviation 27.6 |
| Baha 5 SuperPower on Baha Attract System | Free Field; - Speech Recognition in Quiet, Unaided vs Aided | Speech Presentation Level 80 dB | 34.5 Percentage (%) correct words | Standard Deviation 33.1 |
Comparison: Speech Presentation Level 50 dBp-value: <0.0001Wilcoxon Signed Rank test
Comparison: Speech Presentation Level 65 dBp-value: <0.0001Wilcoxon Signed Rank test
Comparison: Speech Presentation Level 80 dBp-value: <0.0001Wilcoxon Signed Rank test
Secondary
Sound Processor Magnet Selection at 12 Weeks
Information about sound processor magnet selection, type of SP magnet
Time frame: 12 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 12 Weeks | SPM1 | 2 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 12 Weeks | SPM2 | 3 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 12 Weeks | SPM3 | 8 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 12 Weeks | SPM4 | 10 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 12 Weeks | SPM5 | 0 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 12 Weeks | SPM6 | 0 Participants |
Secondary
Sound Processor Magnet Selection at 4 Weeks
Information about sound processor magnet selection, type of SP magnet
Time frame: 4 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 4 Weeks | SPM1 | 0 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 4 Weeks | SPM2 | 2 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 4 Weeks | SPM3 | 3 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 4 Weeks | SPM4 | 11 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 4 Weeks | SPM5 | 5 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 4 Weeks | SPM6 | 2 Participants |
Secondary
Sound Processor Magnet Selection at 6 Weeks
Information about sound processor magnet selection, type of SP magnet
Time frame: 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 6 Weeks | SPM1 | 0 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 6 Weeks | SPM2 | 5 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 6 Weeks | SPM3 | 8 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 6 Weeks | SPM4 | 7 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 6 Weeks | SPM5 | 2 Participants |
| Baha 5 SuperPower on Baha Attract System | Sound Processor Magnet Selection at 6 Weeks | SPM6 | 1 Participants |
Other Pre-specified
Number of Adverse Events Related to the Treatment
Number of adverse events related to the treatment during the 12 weeks treatment period
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baha 5 SuperPower on Baha Attract System | Number of Adverse Events Related to the Treatment | 3 events |