ESD · Class I · 21 CFR 874.3300

FDA Product Code ESD: Hearing Aid, Air-conduction, Prescription

An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.

Leading manufacturers include Unitron Industries, Inc., Miracle-Ear, Inc. and Electone, Inc..

1367
Total
1367
Cleared
56d
Avg days
1976
Since
1367 devices
169–192 of 1367
Cleared Sep 07, 1994
SIEMENS MODEL 584 P-2
K934752
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 338d
Cleared Sep 07, 1994
INFINITY 252
K935019
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 322d
Cleared Aug 22, 1994
SIEMENS BTE HEARING AIDS
K942857
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 67d
Cleared Aug 22, 1994
AUDILENS LLK
K943706
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 21d
Cleared Aug 17, 1994
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
K943682
Starkey Laboratories, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 09, 1994
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
K940667
Starkey Laboratories, Inc.
Ear, Nose, Throat · 174d
Cleared Jul 05, 1994
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 24, 1994
EUROSTAR SUPER, EUROSTAR VFC
K942036
Starkey Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 17, 1994
SHARP II HELIX HEARING AID
K941295
Miracle-Ear, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 17, 1994
OPTIMA WITH DELTA AMP
K942213
Beltone Electronics Corp.
Ear, Nose, Throat · 42d
Cleared Jun 15, 1994
BELTONE INVISA
K940098
Beltone Electronics Corp.
Ear, Nose, Throat · 156d
Cleared May 13, 1994
PRO-CONNECT
K932269
Starkey Laboratories, Inc.
Ear, Nose, Throat · 367d
Cleared May 13, 1994
PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS
K941734
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared May 12, 1994
WAX GUARD OPTION
K941039
Miracle-Ear, Inc.
Ear, Nose, Throat · 70d
Cleared May 12, 1994
AUDIOTONE MODEL A-54
K941121
Miracle-Ear, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
AUDIOTONE MODEL A-54SR
K941122
Miracle-Ear, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
770-ATC
K941133
Electone, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
SHARP II FULL CONTOUR
K941292
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
SHARP II SEMI CONTOUR HEARING AID
K941293
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
SHARP II LOW PROFILE HEARING AID
K941294
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 04, 1994
MIRACLE-EAR WITH POWER CIRCUIT OPTION
K935962
Miracle-Ear, Inc.
Ear, Nose, Throat · 142d
Cleared May 04, 1994
STARKEY EUROLINE A SERIES
K940978
Starkey Laboratories, Inc.
Ear, Nose, Throat · 64d
Cleared May 04, 1994
RIONET HEARING AID HB-54
K941021
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 62d
Cleared May 04, 1994
RIONET HEARING AID HB-37T
K941140
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 55d