General Hearing Instruments, Inc. - FDA 510(k) Cleared Devices
Recent clearances: TRANQUIL TRI-BTE, TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC, AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Hearing Instruments, Inc. Ear, Nose, Throat ✕
5 devices
Cleared
Jun 30, 2006
TRANQUIL TRI-BTE
Ear, Nose, Throat
35d
Cleared
Mar 06, 1998
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
Ear, Nose, Throat
77d
Cleared
Jun 13, 1997
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
Ear, Nose, Throat
59d
Cleared
Jul 20, 1994
AURIS CIC
Ear, Nose, Throat
21d
Cleared
Mar 21, 1985
IN-TH-EAR HEARING AID
Ear, Nose, Throat
66d