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
25–48 of 1367
Cleared Oct 28, 1997
AM SERIES HEARING AID
K973579
A & M Hearing, Ltd.
Ear, Nose, Throat · 39d
Cleared Oct 28, 1997
DUALINE 100 BTE
K973948
Bernafon-Maico, Inc.
Ear, Nose, Throat · 12d
Cleared Oct 27, 1997
MODEL C-1 HEARING AID
K973043
Better Hearing, Inc.
Ear, Nose, Throat · 73d
Cleared Oct 17, 1997
D72 DIGITAL
K972818
Philips Hearing Instruments Co.
Ear, Nose, Throat · 80d
Cleared Oct 14, 1997
LORI/LORI, LORI-S (LORI STOCK AID)
K973376
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Sep 23, 1997
Z DEQ-II
K973266
Electone, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 08, 1997
DRY & STORE
K972776
Ear Technology Corp.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
PRISMA
K972998
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 25, 1997
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
K972039
Nu-Sound
Ear, Nose, Throat · 84d
Cleared Aug 15, 1997
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
K971845
Sound Hearing Instruments, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 15, 1997
AIR CONDUCTION HAEARING AIDS
K971852
Beltone Electronics Corp.
Ear, Nose, Throat · 87d
Cleared Aug 15, 1997
LORIPRO, LORIPRO II
K972058
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 74d
Cleared Aug 15, 1997
PHONAK NOVO FORTE E3
K972106
Phonak, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 07, 1997
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
K971807
Hear-Right, Inc.
Ear, Nose, Throat · 84d
Cleared Aug 05, 1997
V-12 LONG LIFE 675 HEARING AID
K972755
Vista Labs
Ear, Nose, Throat · 14d
Cleared Aug 01, 1997
PHONAK EPICA
K972105
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Jul 31, 1997
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
K972550
Trutone
Ear, Nose, Throat · 31d
Cleared Jul 30, 1997
PHONAK MICROZOOM P 2
K972097
Phonak, Inc.
Ear, Nose, Throat · 56d
Cleared Jul 30, 1997
AUDIFON H20 PC/AUDIFON H32 PP
K972552
Trutone
Ear, Nose, Throat · 30d
Cleared Jul 29, 1997
OVATION HDP
K972373
Orsonique, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 23, 1997
BETTER HEARING, INC. MODEL L-1 HEARING AID
K971298
Better Hearing, Inc.
Ear, Nose, Throat · 107d
Cleared Jul 23, 1997
MIRACLE-EAR DIGITAL BTE
K972344
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
DAHLBERG/MIRACLE-EAR
K972345
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 23, 1997
MIRACLE-EAR ITE DIGITAL
K972346
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d