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
361–384 of 1367
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
Cleared Jul 26, 1993
351-AGCO BEHIND-THE-EAR HEARING AID
K933095
Telex Communications, Inc.
Ear, Nose, Throat · 32d
Cleared Jul 20, 1993
RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P
K931942
Resound Corp.
Ear, Nose, Throat · 92d
Cleared Jul 14, 1993
VINYL ADDITION SILICONE SYSTEM
K926150
Crown Delta Corp.
Ear, Nose, Throat · 219d
Cleared Jul 14, 1993
BELTONE OPERA/OPERA MHP/OPERA MAX
K932426
Beltone Electronics Corp.
Ear, Nose, Throat · 56d
Cleared Jul 08, 1993
PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT
K932175
Phonak, Inc.
Ear, Nose, Throat · 64d
Cleared Jul 02, 1993
IN THE CANAL AID OTOSONIC ACS II WITH SRR
K931881
Beltone Electronics Corp.
Ear, Nose, Throat · 79d
Cleared Jul 02, 1993
BELTONE OPTIMA 2000 ITE HEARING AID
K932058
Beltone Electronics Corp.
Ear, Nose, Throat · 65d
Cleared Jun 24, 1993
M30 IN THE EAR HEARING AID
K922501
Electone, Inc.
Ear, Nose, Throat · 393d
Cleared Jun 24, 1993
M32 IN THE EAR HEARING AID
K922502
Electone, Inc.
Ear, Nose, Throat · 393d
Cleared Jun 01, 1993
MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID
K931035
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 01, 1993
MT 80 SP
K931040
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 01, 1993
STAR 42 PP-SP, STAR 42 PP-SL (T100)
K931041
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 01, 1993
SERIES STAR 66 BEKHIND THE EAR HEARING AID
K931160
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jun 01, 1993
SERIES STAR 22 - BEHIND THE EAR HEARING AID
K931161
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared May 19, 1993
ITE MODEL ADOBE 100 FULL CUSTOM
K931590
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 49d
Cleared May 19, 1993
ITC MODEL ADOBE 100 CANAL
K931591
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 49d
Cleared Apr 14, 1993
BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP
K931134
Telex Communications, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 14, 1993
BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP
K931157
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Apr 14, 1993
MEMOREX MODEL 361-AGCO HEARING AID
K931158
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-GC
K930998
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d