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 May 12, 1995
RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C)
K951067
Resound Corp.
Ear, Nose, Throat · 65d
Cleared May 12, 1995
RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M)
K951068
Resound Corp.
Ear, Nose, Throat · 65d
Cleared Apr 27, 1995
RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION
K951378
Resound Corp.
Ear, Nose, Throat · 31d
Cleared Apr 27, 1995
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION
K951379
Resound Corp.
Ear, Nose, Throat · 31d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BT2/S-E
K951374
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM ED3/S-E
K951375
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION
K951376
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION
K951377
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 13, 1995
BELTONE COMPARAFIT
K946340
Beltone Electronics Corp.
Ear, Nose, Throat · 105d
Cleared Mar 31, 1995
SILVER ULTRA MINI CANAL
K950458
Electone, Inc.
Ear, Nose, Throat · 56d
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID
K950691
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID
K950692
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID
K950693
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 31, 1995
UNITRON MODEL ESTEEM
K950759
Unitron Industries, Inc.
Ear, Nose, Throat · 42d
Cleared Mar 24, 1995
GOLD K AMP ULTRA MINI CANAL
K950459
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 24, 1995
GOLD CD ULTRA MINI CANAL
K950460
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 21, 1995
M-29 PP-PC, M-29 PP-O/PC
K950451
Rexton, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 21, 1995
MAICO IN-THE-EAR MODEL RD-312 CIC
K950637
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 21, 1995
DYNA 231X
K950758
Phonak, Inc.
Ear, Nose, Throat · 32d
Cleared Mar 07, 1995
RESOUND(R) RESOURCE(TM)
K945750
Resound Corp.
Ear, Nose, Throat · 104d
Cleared Feb 22, 1995
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC
K944851
Rexton, Inc.
Ear, Nose, Throat · 145d
Cleared Feb 08, 1995
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE
K950319
Resound Corp.
Ear, Nose, Throat · 13d
Cleared Jan 30, 1995
LX-ITC
K946071
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 119d
Cleared Jan 30, 1995
MAICO IN-THE-EAR MODEL RD 201
K946253
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 38d