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
217–240 of 1367
Cleared Nov 29, 1993
OMNI 2000 SERIES ITC HEARING AID
K934417
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 29, 1993
UNITRON MODEL IKON AGCO/ AOD
K934565
Unitron Industries, Inc.
Ear, Nose, Throat · 74d
Cleared Nov 19, 1993
RIONET HEARING AID HA-72
K934479
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 19, 1993
RIONET HEARING AID HA-73
K934480
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 19, 1993
PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID
K934586
Unitron Industries, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 19, 1993
CLARIFIER II CIRCUIT OPTION
K934597
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared Nov 19, 1993
OTOSONIC ADVANCED FULL SHIELD (AFS)
K934618
Beltone Electronics Corp.
Ear, Nose, Throat · 53d
Cleared Nov 03, 1993
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K931372
Resound Corp.
Ear, Nose, Throat · 231d
Cleared Oct 07, 1993
STARKEY TYMPANETTE HEARING AID
K933407
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Oct 07, 1993
BOSCH EUROSTAR
K933988
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1993
RESOLUTION ITC HEARING AID
K933989
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Sep 18, 1993
AS-90
K923006
Qualitone
Ear, Nose, Throat · 453d
Cleared Aug 23, 1993
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
K933291
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 48d
Cleared Aug 23, 1993
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
K933579
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 12 (L12)
K933640
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 6 (L6)
K933643
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 8 (L8)
K933644
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 19, 1993
BELTONE PRIMA 2000
K932703
Beltone Electronics Corp.
Ear, Nose, Throat · 77d
Cleared Aug 05, 1993
OTICON MF
K932670
Oticon Corp.
Ear, Nose, Throat · 64d
Cleared Aug 02, 1993
GOLD ASP MODULE, ITE
K933036
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER COMPRESSION MODULE, ITE
K933042
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Jul 27, 1993
PHONAK PICO-FORTE SC-2
K932734
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 27, 1993
PHONAK PICO-FORTE SC-D-2
K932735
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 27, 1993
STARKEY TRILOGY II PROGRAMMABLE HEARING AID
K933113
Starkey Laboratories, Inc.
Ear, Nose, Throat · 32d