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
49–72 of 1367
Cleared Jul 23, 1997
MERIDIAN DSP
K972431
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
JAZZ PP AGC-O, JAZZ PP
K972542
Trutone
Ear, Nose, Throat · 14d
Cleared Jul 23, 1997
TWIST PPAGC-1, TWIST PP
K972543
Trutone
Ear, Nose, Throat · 14d
Cleared Jul 03, 1997
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K971605
Resound Corp.
Ear, Nose, Throat · 63d
Cleared Jul 03, 1997
ARGOSY DYNAMEQ
K971699
Argosy Electronics
Ear, Nose, Throat · 56d
Cleared Jun 20, 1997
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
K971296
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 74d
Cleared Jun 17, 1997
AUDALLION III HEARING SYSTEM
K971031
Gn Danavox, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 17, 1997
DANAVOX MODELS 163/162 BTE
K971032
Gn Danavox, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 13, 1997
DUALINE 400 CIC
K971158
Bernafon-Maico, Inc.
Ear, Nose, Throat · 77d
Cleared Jun 13, 1997
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
K971399
General Hearing Instruments, Inc.
Ear, Nose, Throat · 59d
Cleared Jun 06, 1997
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
K970880
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 06, 1997
VISTA V-38 CIC
K970939
Vista Labs
Ear, Nose, Throat · 85d
Cleared Jun 06, 1997
SCIENTIFIC PLASTICS MODEL SP
K971299
Scientific Plastics, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 06, 1997
WIDEX SENSO DIGITAL (MINI CANAL)
K971535
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 39d
Cleared Jun 06, 1997
RIONET HB-79P
K971693
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 30d
Cleared Jun 06, 1997
PHILIPS S1694, S1695
K971804
Philips Hearing Instruments Co.
Ear, Nose, Throat · 23d
Cleared May 28, 1997
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
K970828
United Hearing Systems, Inc.
Ear, Nose, Throat · 83d
Cleared May 08, 1997
UNITRON MODEL SOUND F/X CIC
K970692
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared May 02, 1997
PRECISE IMPRESSION KIT
K970952
Starkey Laboratories, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 24, 1997
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
K970519
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared Apr 21, 1997
IN THE EAR HEARING AID
K964898
Keytone Hearing Laboratory
Ear, Nose, Throat · 136d
Cleared Mar 31, 1997
AUDALLION II HEARING SYSTEM
K970215
Resound Corp.
Ear, Nose, Throat · 69d
Cleared Mar 31, 1997
MULTI-CHANNEL COMPRESSION BTE (SD)
K970262
Miracle-Ear, Inc.
Ear, Nose, Throat · 67d
Cleared Mar 28, 1997
REXTON MODEL 48 AND 49PP
K970537
Rexton, Inc.
Ear, Nose, Throat · 44d