The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents With Mixed/Conductive Hearing Loss and Single Sided Deafness
Oticon Medical
Summary
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).
Eligibility
- Age range
- 12–18 years
- Sex
- All
- Healthy volunteers
- No
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…
Location
- Atlanta Institute for ENTAtlanta, Georgia