Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population

Experimental: Bone-conduction hearing device The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.

Device: Osia System An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea

Inclusion criteria

Individuals 5 through 18 years of age will be eligible for inclusion in the investigation if all of the criteria below are met:

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 less than or equal to 55 dB HL.

Subject does not benefit from or will not wear a conventional hearing aid.

Note: Candidates may include individuals seeking new implantation unilaterally (in one ear) or bilaterally (both ears) as well as individuals already implanted with a bone-anchored device seeking a second-side implant.

OR

Single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure-tone average (PTA4; mean of 0.5, 1, 2, and 3 kHz) of less that equal to 20 dB HL in the good ear.

Subject does not benefit from or will not wear a conventional hearing aid

Exclusion criteria

Uncontrolled diabetes as judged by the investigator. Subject who has received radiotherapy in the area of implantation, or such radiotherapy is planned during the study period.

Current use of ototoxic drugs. Condition that could jeopardize osseointegration and/or wound healing 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, as determined by the surgeon.

Unable to follow investigational procedures. Participation in another clinical investigation with pharmaceutical and/or device