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
193–216 of 1367
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 28, 1995
HEARING AID
K952658
Philips Hearing Instruments Co.
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 Jul 06, 1995
WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
K952450
Argosy Electronics
Ear, Nose, Throat · 42d
Cleared Jul 06, 1995
CLASS D LINEAR WITH ACTIVE TONE CONTROL
K952451
Argosy Electronics
Ear, Nose, Throat · 42d
Cleared Jul 06, 1995
OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL
K952452
Argosy Electronics
Ear, Nose, Throat · 42d
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 21, 1995
INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL
K952453
Argosy Electronics
Ear, Nose, Throat · 27d
Cleared Jun 21, 1995
EXPANDER WITH ACTIVE TONE CONTROL
K952454
Argosy Electronics
Ear, Nose, Throat · 27d
Cleared Jun 21, 1995
IMPROVED MANHATTAN II
K952455
Argosy Electronics
Ear, Nose, Throat · 27d
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
Cleared Jun 02, 1995
RIONET HEARING AID HM-02
K951677
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 52d
Cleared May 30, 1995
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951896
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared May 15, 1995
THE MODEL ACAPPELLA IN THE EAR HEARING AID
K943961
Telex Communications, Inc.
Ear, Nose, Throat · 273d