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
553–576 of 1367
Cleared Apr 27, 1990
SEARS MODEL 9098 ITE HEARING AID
K901351
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 18, 1990
AUDIOTONE MODEL FFI ITE HEARING AID
K901556
Miracle-Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 18, 1990
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
K901569
Unitron Industries, Inc.
Ear, Nose, Throat · 14d
Cleared Apr 16, 1990
SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
K901387
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT
K901388
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT
K901389
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT
K901469
Miracle-Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Apr 16, 1990
SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT
K901470
Miracle-Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Apr 13, 1990
DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT
K900862
Miracle-Ear, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 13, 1990
SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT
K901386
Miracle-Ear, Inc.
Ear, Nose, Throat · 18d
Cleared Apr 10, 1990
OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
K901292
Oticon Corp.
Ear, Nose, Throat · 21d
Cleared Apr 10, 1990
WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL
K901316
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Apr 10, 1990
WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL
K901317
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Apr 04, 1990
DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
K900861
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Mar 27, 1990
REXTON PP 142, PP 142-L
K900636
Rexton, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 15, 1990
WIDEX HEARING AID MODELS ES9T AND ES9H
K895981
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 154d
Cleared Mar 15, 1990
WIDEX HEARING AID MODEL ES 10 ASP T
K895982
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 154d
Cleared Mar 14, 1990
MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID
K900050
Miracle-Ear, Inc.
Ear, Nose, Throat · 70d
Cleared Mar 14, 1990
DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT
K900692
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Feb 22, 1990
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
K900237
Miracle-Ear, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 22, 1990
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
K900238
Miracle-Ear, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 08, 1990
RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
K896463
Resound Corp.
Ear, Nose, Throat · 87d
Cleared Jan 22, 1990
DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID
K896157
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1990
DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID
K896158
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d