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 of life scales.

- Participation in another clinical investigation with pharmaceutical and/or device.