| Eligibility |
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
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