Post-market clinical follow-up of a magnetic bone conduction implant (Cochlear Baha® Attract System)

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

• Adult subject, i.e. >= 18 years of age
• Conductive or mixed hearing loss in the ear to be implanted:
Bone conduction thresholds with a pure tone average PTA4 of < 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz).
OR
Single-sided sensorineural deafness (SSD):
o European sites: Bone conduction thresholds with a pure tone average PTA4 of < 30dB hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear.
o US sites: Air conduction thresholds with a pure tone average PTA4 of <= 20 dB hearing level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for an AC CROS but*for some reason*cannot or will not use an AC CROS.
• No previous bone conduction implant on the side of the skull to be implanted.
• Signed informed consent.

Exclusion Criteria

• Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Baha Attract System (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.
• Subjects that have received radiation therapy at the same side of the skull where the Baha Attract System will be positioned.
• Condition that could jeopardise osseointegration and/or wound healing as judged by the investigator (e.g. osteoporosis, psoriasis, use of corticosteroids).
• Uncontrolled diabetes as judged by the investigator.
• 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 investigation with pharmaceuticals and/or medical device.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the hearing performance with the Baha Attract System (aided) and the<br /><br>unaided hearing performance.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>•To compare the hearing performance with the Baha Attract System and the<br /><br>hearing performance with the same sound processor on a Baha Softband.<br /><br>•To compare health status and health-related quality of life and utility<br /><br>scores before and after use of the Baha Attract System.<br /><br>•To compare self-reported assessment of hearing aid outcome before and after<br /><br>use of the Baha Attract System.<br /><br>•To collect surgical information.<br /><br>•To investigate if the Sound Processor Magnet strength and magnetic force<br /><br>required for retention changes over time.<br /><br>•To collect information regarding pain, discomfort, numbness and soft tissue<br /><br>status.<br /><br>•To monitor implant survival.<br /><br>•To collect Adverse Events and device deficiencies.</p><br>