Medical Device Manufacturer · US , Casselberry , FL

Audina Hearing Instrument

8 submissions · 8 cleared · Since 1982

Total

Cleared

Denied

Audina Hearing Instrument — FDA 510(k) Submissions

Audina Hearing Instrument has submitted 8 FDA 510(k) premarket notifications since 1982, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription, Face Plate Hearing Aid . Use the specialty filter in the sidebar to narrow results.

8 devices

1–8 of 8

AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR

K964816 · ESD Hearing Aid,... · Ear, Nose, Throat

Jan 1997 49d

HEARING AID (ALL-IN-THE-EAR)

K953960 · ESD Hearing Aid,... · Ear, Nose, Throat

Sep 1995 21d

AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)

K942236 · LRB Face Plate Hearing Aid · Ear, Nose, Throat

Jun 1994 39d

BEHIND THE EAR HEARING AID