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

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

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

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