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
529–552 of 1367
Cleared Aug 09, 1990
CE-8 CUSTOM IN-THE-EAR HEARING AIDS
K901833
Starkey Laboratories, Inc.
Ear, Nose, Throat · 107d
Cleared Jul 27, 1990
REXTON RX12 POWER PLUS W/DUAL RECEIVER
K901341
Rexton, Inc.
Ear, Nose, Throat · 127d
Cleared Jul 20, 1990
INTRA III AND INTRA IV HEARING AIDS
K901860
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Jul 09, 1990
CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
K902559
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODELS C AND M
K902351
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODEL: H
K902352
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODELS F AND L
K902353
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared May 29, 1990
AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.
K901745
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZD (XT)
K901746
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
K901747
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
K901783
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 23, 1990
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
K897033
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
K897035
Miracle-Ear, Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
K900675
Phonak, Inc.
Ear, Nose, Throat · 100d
Cleared May 23, 1990
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
K900829
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
K900830
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
BTE PICO SCD, PICO SC
K900831
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
MODEL 366 HEARING AID
K900846
Telex Communications, Inc.
Ear, Nose, Throat · 90d
Cleared May 23, 1990
WIDEX HEARING AID MODEL THE DISCOVERY
K901642
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 44d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-L
K893573
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-AGC
K893574
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 283 ASP
K893575
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP
K893576
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared Apr 27, 1990
SEARS MODEL 9094 ITE HEARING AID
K901350
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d