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
145–168 of 1367
Cleared May 07, 1996
TECHNA TONE
K961082
Techna Tone
Ear, Nose, Throat · 50d
Cleared May 07, 1996
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
K961143
Telex Communications, Inc.
Ear, Nose, Throat · 47d
Cleared May 07, 1996
AUDIO 'D' INTIMA CIC
K961308
Hearing Solutions, Inc.
Ear, Nose, Throat · 33d
Cleared Apr 18, 1996
AM 400
K961084
Electone, Inc.
Ear, Nose, Throat · 30d
Cleared Apr 10, 1996
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1
K960680
Resound Corp.
Ear, Nose, Throat · 50d
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 Apr 04, 1996
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
K960410
Perfect Ear
Ear, Nose, Throat · 66d
Cleared Apr 03, 1996
AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL)
K960935
Hearing Solutions, Inc.
Ear, Nose, Throat · 26d
Cleared Mar 22, 1996
LONG LIFE RX-12
K960295
Rexton, Inc.
Ear, Nose, Throat · 60d
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 07, 1996
OTICON /PRIMOFOCUS (PF)
K960284
Oticon, Inc.
Ear, Nose, Throat · 48d
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
HEARING AID IMPRESSION MATERIAL
K955288
Crown Delta Corp.
Ear, Nose, Throat · 78d
Cleared Feb 02, 1996
FINETONE FSC,
K955692
Finetone Hearing Instruments
Ear, Nose, Throat · 50d
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