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
289–312 of 1367
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
155 PP AGC-I
K940608
Danavox, Inc.
Ear, Nose, Throat · 79d
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
Cleared May 04, 1994
BELTON MERIT (HEARING AID)
K941395
Beltone Electronics Corp.
Ear, Nose, Throat · 43d
Cleared May 04, 1994
WIDEX S-21
K941508
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 36d
Cleared May 04, 1994
INTRA S, INTRA SH
K941635
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 04, 1994
MINI PAK
K941636
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 03, 1994
COMPLETELY IN THE CANAL
K940116
Argosy Electronics
Ear, Nose, Throat · 113d
Cleared Apr 01, 1994
OTOSONIC (OSI) LPS D
K940099
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
PROFILE IC
K940100
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
OTOSONIC ACS II D WITH SRR
K940101
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
BELTONE OPERA/OPERA MHP/OPERA MAX
K940102
Beltone Electronics Corp.
Ear, Nose, Throat · 81d