Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Audiological Outcomes and Subjective Benefits of Cochlear Baha® 5 SuperPower Sound Processor on the Baha® Attract™ System

Conditions
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Single Sided Sensorineural Deafness, Mixed Hearing Loss, Unilateral

Intervention / Treatment
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* Device: Baha 5 SuperPower on Baha Attract System


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria judged by the surgeon at Visit 1 or Visit 2 according to local practice). Subjects that have received radiation therapy at the same side of the skull where the Investigational device will be positioned. Uncontrolled diabetes as judged by the investigator. Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis and long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator. Unable to follow investigational procedures, e.g. to complete quality of life scales. Participation in another clinical investigation with pharmaceutical and/or device.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baha 5 SuperPower on Baha Attract System<br>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. | Device: Baha 5 SuperPower on Baha Attract System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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 | 4 weeks | 
| 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 | 4 weeks | 
| 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 | 12 weeks | 
| 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 | 4 weeks | 
| 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 | 12 weeks | 
| 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 | 4 weeks | 
| 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 | 12 weeks | 
| 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 | 4 weeks | 
| 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 | 12 weeks | 
| 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 | 4 weeks | 
| 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 | 12 weeks | 
| 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 | 4 weeks | 
| 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 | 12 weeks | 
| 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 | 4 weeks | 
| 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 | 12 weeks | 
| Sound Processor Magnet Selection at 4 Weeks | Information about sound processor magnet selection, type of SP magnet | 4 weeks | 
| Sound Processor Magnet Selection at 6 Weeks | Information about sound processor magnet selection, type of SP magnet | 6 weeks | 
| Sound Processor Magnet Selection at 12 Weeks | Information about sound processor magnet selection, type of SP magnet | 12 weeks | 
| 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 | 12 weeks |