
Omni Hearing Systems
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BEHIND THE EAR HEARING AID OMNI #OS is an FDA 510(k)-cleared medical device (K830459) manufactured by Omni Hearing Systems. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 6, 1983. Regulation: 8.

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