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
97–120 of 1367
Cleared Sep 28, 1995
MAICO PRODIGY CIC SERIES
K954054
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 28, 1995
3M MODEL 8295
K954067
3M Company
Ear, Nose, Throat · 29d
Cleared Sep 18, 1995
PHONAK 9900 CIC
K953921
Phonak, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 28, 1995
UNITRON MODEL IKON AOHPL
K953646
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 23, 1995
PHONAK PICONET 232X-AZ HEARING INSTRUMENT
K945439
Phonak, Inc.
Ear, Nose, Throat · 299d
Cleared Aug 23, 1995
3M MODEL 8200P MULTIPRO BTE
K953543
3M Company
Ear, Nose, Throat · 26d
Cleared Aug 22, 1995
Z20
K953047
Electone, Inc.
Ear, Nose, Throat · 53d
Cleared Aug 22, 1995
Z33
K953050
Electone, Inc.
Ear, Nose, Throat · 53d
Cleared Aug 15, 1995
Z22
K953048
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
Z24
K953049
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
Z35
K953051
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
AM 260 K-AMP
K953052
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
AM 260 PP
K953053
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
AM 260 OHM
K953054
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Jul 26, 1995
PERSONAL PROGRAMMER 2000
K952940
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 30d
Cleared Jul 26, 1995
RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION
K953266
Resound Corp.
Ear, Nose, Throat · 13d
Cleared Jul 11, 1995
GOLD CD ULTRA MINI CANAL - MODULE
K951642
Electone, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 30, 1995
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K
K951587
Beltone Electronics Corp.
Ear, Nose, Throat · 85d
Cleared Jun 30, 1995
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951828
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 71d
Cleared Jun 28, 1995
BELTONE COMPOSER 2000
K950868
Beltone Electronics Corp.
Ear, Nose, Throat · 121d
Cleared Jun 28, 1995
OTOSONIC (OSI) CF 10-K, 10-D
K952097
Beltone Electronics Corp.
Ear, Nose, Throat · 55d
Cleared Jun 19, 1995
WIDEX MODEL LOGO 32 (L32)
K952229
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 38d
Cleared Jun 05, 1995
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
K952228
Resound Corp.
Ear, Nose, Throat · 25d
Cleared Jun 05, 1995
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
K952263
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d