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
193–216 of 1367
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 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
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