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
145–168 of 1367
Cleared Jan 30, 1995
MAICO IN-THE-EAR MODEL RD 201
K946253
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 38d
Cleared Jan 30, 1995
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
K946323
Unitron Industries, Inc.
Ear, Nose, Throat · 32d
Cleared Jan 26, 1995
UNITRON MODEL SOUNG F/S
K946264
Unitron Industries, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 26, 1995
PHONAK SONO-FORTE 332X-AZ
K946294
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Jan 24, 1995
3M MODEL 8233 HEARING INSTRUMENT
K943854
3M Company
Ear, Nose, Throat · 169d
Cleared Jan 19, 1995
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION
K934917
Resound Corp.
Ear, Nose, Throat · 463d
Cleared Jan 05, 1995
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
K943380
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 176d
Cleared Dec 27, 1994
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944174
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 123d
Cleared Dec 27, 1994
WIDEX MODEL LOGO 8S
K944518
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 102d
Cleared Dec 27, 1994
AIR CONDUCTION HEARING AID
K944520
Unitron Industries, Inc.
Ear, Nose, Throat · 102d
Cleared Dec 27, 1994
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944645
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 97d
Cleared Dec 23, 1994
BTP-A HEARING SYSTEM
K944043
Resound Corp.
Ear, Nose, Throat · 127d
Cleared Dec 23, 1994
WIDEX MODEL LOGO - L9
K945703
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 51d
Cleared Dec 21, 1994
IMAGE
K944161
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 117d
Cleared Dec 14, 1994
ADOBE C.I.C
K943016
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 173d
Cleared Nov 15, 1994
COMPASS SOFTWARE MODULE
K944097
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 85d
Cleared Oct 20, 1994
FEDELITY F495, VIENNATONE ALPP II
K943687
Starkey Laboratories, Inc.
Ear, Nose, Throat · 83d
Cleared Oct 20, 1994
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS
K943960
Miracle-Ear, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 20, 1994
BELTONE CONCERTO S
K944502
Beltone Electronics Corp.
Ear, Nose, Throat · 36d
Cleared Oct 20, 1994
WIDEX MODEL LX-ITE
K944838
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Sep 23, 1994
MIRACLE-EAR IMPRESSION MATERIAL KIT
K942523
Miracle-Ear, Inc.
Ear, Nose, Throat · 161d
Cleared Sep 23, 1994
MIRACLE-EAR MIRAGE
K943826
Miracle-Ear, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 21, 1994
RESOUND PERSONAL HEARING SYSTEM
K943788
Resound Corp.
Ear, Nose, Throat · 49d
Cleared Sep 21, 1994
MIRACLE EAR CONFIDANTE
K943825
Miracle-Ear, Inc.
Ear, Nose, Throat · 47d