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.
Who can participate
Age range18 Years
SexALL
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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 an…
What they're measuring
1
Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided