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