Clinical Performance of a New Implant System for Bone Conduction Hearing

Inclusion Criteria: * Adult subjects (18 years or older) * Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL. OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal). * Signed informed consent * Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband) Exclusion Criteria: * Uncontrolled diabetes as judged by the investigator. * Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator. * Insufficient bone quality and quantity for implantation of a BI300 Implant. * Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period * Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator * Unable to follow investigational procedures, e.g. to complete quality o…