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
313–336 of 1367
Cleared Apr 01, 1994
BELTONE ODE AND BELTONE ODE VX
K940103
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP)
K940177
Beltone Electronics Corp.
Ear, Nose, Throat · 80d
Cleared Mar 24, 1994
OTOSONIC MINI PAS
K940104
Beltone Electronics Corp.
Ear, Nose, Throat · 73d
Cleared Mar 22, 1994
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD
K935867
Unitron Industries, Inc.
Ear, Nose, Throat · 106d
Cleared Mar 21, 1994
AIR CONDUCTION HEARING AID: IKON PP
K936106
Unitron Industries, Inc.
Ear, Nose, Throat · 89d
Cleared Mar 21, 1994
RIONET HEARING AID HB-53CI
K936122
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 88d
Cleared Mar 21, 1994
MIRACLE-EAR CONFIDANTE
K940458
Miracle-Ear, Inc.
Ear, Nose, Throat · 48d
Cleared Mar 17, 1994
WIDEX R.C. 2 (REMOTE CONTROL)
K935424
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 127d
Cleared Mar 07, 1994
MIRACLE-EAR ENTRE
K934940
Miracle-Ear, Inc.
Ear, Nose, Throat · 140d
Cleared Jan 26, 1994
PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT
K935791
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jan 13, 1994
BINAURAL HEARING AID
K935366
Telex Communications, Inc.
Ear, Nose, Throat · 70d
Cleared Dec 22, 1993
PRO FIT-CYBER II OPTION
K935289
Qualitone
Ear, Nose, Throat · 49d
Cleared Dec 15, 1993
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
K935095
3M Company
Ear, Nose, Throat · 51d
Cleared Dec 15, 1993
MIRACLE EAR MODEL SHARP II CANAL
K935265
Miracle-Ear, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 15, 1993
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID
K935266
Miracle-Ear, Inc.
Ear, Nose, Throat · 43d
Cleared Nov 29, 1993
OMNI 2000 SERIES ITE HEARING AID
K934416
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 29, 1993
OMNI 2000 SERIES ITC HEARING AID
K934417
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 29, 1993
UNITRON MODEL IKON AGCO/ AOD
K934565
Unitron Industries, Inc.
Ear, Nose, Throat · 74d
Cleared Nov 19, 1993
RIONET HEARING AID HA-72
K934479
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 19, 1993
RIONET HEARING AID HA-73
K934480
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 19, 1993
PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID
K934586
Unitron Industries, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 19, 1993
CLARIFIER II CIRCUIT OPTION
K934597
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared Nov 19, 1993
OTOSONIC ADVANCED FULL SHIELD (AFS)
K934618
Beltone Electronics Corp.
Ear, Nose, Throat · 53d
Cleared Nov 03, 1993
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K931372
Resound Corp.
Ear, Nose, Throat · 231d