Oticon Medical
This study is a post-market, multicentre, prospective, single arm investigation aimed to systematically collect safety and performance data on the Sentio system, when used as intended for adolescents (12-17 years inclusive).
Inclusion Criteria: * Subjects must meet the following criteria to be eligible for participation in the investigation: 1. Signed Informed Consent Form (signed by parent or legal guardian and child). 2. Subjects aged 12 to 17 years of age (inclusive) 3. Subjects with the following audiometric criteria consistent with the current and approved labeling of the device: 3.1 Conductive or mixed hearing loss with a pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) of the indicated ear better than or equal to 45 dB HL. 3.2 OR subjects with a p…
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