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
241–264 of 1367
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
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
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-AI
K930999
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-AI-D
K931000
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Apr 07, 1993
RIONET HEARING AID HB-53S
K930721
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 55d
Cleared Mar 18, 1993
OTOSONIC FSD, IN-THE-EAR HEARING AID
K930598
Beltone Electronics Corp.
Ear, Nose, Throat · 41d
Cleared Mar 18, 1993
WIDEX MODEL DX HEARING AID
K930715
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 35d