Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

Study Overview
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Brief Summary
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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

Official Title
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Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months Follow-up

Conditions
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Deafness, Hearing Loss, Hearing Loss, Conductive

Intervention / Treatment
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* Device: Baha Attract System


Participation Criteria
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Eligibility Criteria
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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

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baha Attract System<br>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) | Device: Baha Attract System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline before surgery and 12 weeks after surgery | 
| 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. | Baseline before surgery and 36 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline before surgery and 36 weeks after surgery | 
| 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. | Baseline before surgery and 36 weeks after surgery | 
| 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. | Baseline before surgery and 36 weeks after surgery | 
| 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. | Baseline before surgery and 36 weeks after surgery | 
| 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. | Baseline before surgery and 36 weeks after surgery | 
| 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. | Baseline before surgery and 36 weeks after surgery | 
| 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. | Baseline before surgery and 36 weeks after surgery | 
| 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. | Baseline before surgery and 36 weeks after surgery |