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
73–96 of 1367
Cleared Apr 10, 1996
HEARING AID - AIR CONDUCTION
K960684
Resound Corp.
Ear, Nose, Throat · 50d
Cleared Apr 05, 1996
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
K960804
Miracle-Ear, Inc.
Ear, Nose, Throat · 37d
Cleared Mar 12, 1996
RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241
K960052
Resound Corp.
Ear, Nose, Throat · 68d
Cleared Mar 07, 1996
AUDIOFLEX 120
K960031
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 65d
Cleared Mar 07, 1996
UNITRON MODEL SOUND F/XP
K960155
Unitron Industries, Inc.
Ear, Nose, Throat · 56d
Cleared Mar 01, 1996
BELTONE COMPOSER 2000 BTE HP
K955930
Beltone Electronics Corp.
Ear, Nose, Throat · 71d
Cleared Mar 01, 1996
EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
K960494
Starkey Laboratories, Inc.
Ear, Nose, Throat · 31d
Cleared Feb 27, 1996
WIDEX MODEL SENSO DIGITAL (C16)
K955879
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 61d
Cleared Feb 22, 1996
SONATA U-01
K955702
Electone, Inc.
Ear, Nose, Throat · 69d
Cleared Feb 13, 1996
DYNAMEQ-II OPTION
K955466
Qualitone
Ear, Nose, Throat · 75d
Cleared Feb 12, 1996
WIDEX MODEL SENSO DIGITAL (C8)
K955878
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 46d
Cleared Feb 02, 1996
RESOUND PERSONAL HEARING SYSTEM BT247
K955867
Resound Corp.
Ear, Nose, Throat · 36d
Cleared Jan 24, 1996
MIRACLE EAR MIRAGE
K954119
Miracle-Ear, Inc.
Ear, Nose, Throat · 145d
Cleared Dec 22, 1995
MIRACLE EAR AND AUDIOTONE
K954941
Miracle-Ear, Inc.
Ear, Nose, Throat · 53d
Cleared Dec 22, 1995
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
K955574
Resound Corp.
Ear, Nose, Throat · 15d
Cleared Dec 19, 1995
CYBER III OPTION UM, UC312, UC10, UCIC
K955359
Qualitone
Ear, Nose, Throat · 27d
Cleared Dec 08, 1995
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
K954579
Telex Communications, Inc.
Ear, Nose, Throat · 67d
Cleared Dec 06, 1995
BELTONE ULTIMA 80 OTOSONIC POWER PAS
K954936
Beltone Electronics Corp.
Ear, Nose, Throat · 40d
Cleared Oct 18, 1995
WIDEX SENSO DIGITAL (PX)
K954526
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 19d
Cleared Oct 07, 1995
UNITRON MODEL IKON AOHPD
K953727
Unitron Industries, Inc.
Ear, Nose, Throat · 58d
Cleared Oct 07, 1995
UNITRON MODEL SOUND F/XD
K953932
Unitron Industries, Inc.
Ear, Nose, Throat · 61d
Cleared Oct 07, 1995
UNITRON MODEL SOUND F/X II
K954516
Unitron Industries, Inc.
Ear, Nose, Throat · 9d
Cleared Oct 07, 1995
MIRACLE - EAR MODEL PBP
K954528
Miracle-Ear, Inc.
Ear, Nose, Throat · 8d
Cleared Oct 06, 1995
UNITRON MODEL SOUND F/X
K954430
Unitron Industries, Inc.
Ear, Nose, Throat · 14d