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
673–696 of 1367
Cleared Jul 31, 1986
HEARING AID, UNITRON MODEL UF11
K862760
Unitron Industries, Inc.
Ear, Nose, Throat · 9d
Cleared Jul 22, 1986
ALPHA ALL-IN-THE-EAR HEARING AID
K862169
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 43d
Cleared Jul 22, 1986
PHONIC EAR PE 602 PPCS
K862229
Phonic Ear, Inc.
Ear, Nose, Throat · 41d
Cleared Jun 23, 1986
DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID
K862099
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL ED BEHIND-THE-EAR HEARING AID
K862100
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UM IN-THE-CANAL HEARING AID
K862101
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL KM IN-THE-CANAL HEARING AID
K862102
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UC IN-THE-CANAL HEARING AID
K862103
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UC SPECTRUM IN-THE-CANAL HEARING AID
K862104
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 05, 1986
RX-33S INTRA MINI CANAL MODULE
K861532
Rexton, Inc.
Ear, Nose, Throat · 42d
Cleared Jun 02, 1986
BEHING-THE-EAR HEARING AID SERIES SP
K861597
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared May 27, 1986
RIONET HEARING AID
K861728
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 11, 1986
DAHLBERG MODEL UT IN-THE-EAR HEARING AID
K860670
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Apr 03, 1986
DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID
K860671
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 38d
Cleared Mar 17, 1986
MODEL 353C HEARING AID
K860035
Telex Communications, Inc.
Ear, Nose, Throat · 70d
Cleared Mar 12, 1986
AM 12, HEARING AID
K860007
Electone, Inc.
Ear, Nose, Throat · 68d
Cleared Mar 12, 1986
AM 31, HEARING AID
K860008
Electone, Inc.
Ear, Nose, Throat · 68d
Cleared Mar 12, 1986
A & M DISCREET - HEARING AID
K860190
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 12, 1986
PA PRESIDENTIAL II - HEARING AID
K860191
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 12, 1986
A & M 150 PP (HEARING AID)
K860244
Electone, Inc.
Ear, Nose, Throat · 47d
Cleared Mar 04, 1986
DAHLBERG MODEL KC IN-THE-EAR HEARING AID
K854834
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 91d
Cleared Feb 24, 1986
THE ANSWER HEARING AID
K854438
Electone, Inc.
Ear, Nose, Throat · 111d
Cleared Feb 20, 1986
OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE
K854742
Oticon Corp.
Ear, Nose, Throat · 87d
Cleared Dec 31, 1985
CERTI-FORM
K854001
Beltone Electronics Corp.
Ear, Nose, Throat · 92d