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
721–744 of 1367
Cleared Jul 31, 1985
HEARING AID, UNITRON MODEL UM60-H
K852690
Unitron Industries, Inc.
Ear, Nose, Throat · 36d
Cleared Jul 05, 1985
MODEL DA BEHIND-THE-EAR HEARING AID
K851810
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 70d
Cleared Jul 05, 1985
DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AID
K851866
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 67d
Cleared Jul 05, 1985
DAHLBERG MODEL DD BEHING-THE-EAR HEARING AID
K851867
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 67d
Cleared Jul 05, 1985
DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AID
K851869
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 67d
Cleared Jul 01, 1985
DAHLBERT MODEL DE BEHING-THE-EAR HEARING AID
K851868
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 63d
Cleared Jun 19, 1985
CRESTLINE CL IN-THE-EAR HEARING AID
K850980
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 100d
Cleared Jun 05, 1985
HEARING AID, UNITRON MODEL UC
K850914
Unitron Industries, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 05, 1985
BODY TYPE HEARING AID 107S
K851069
Danavox, Inc.
Ear, Nose, Throat · 79d
Cleared Jun 04, 1985
QUALITONE STOCK CANAL AID
K851970
Qualitone
Ear, Nose, Throat · 28d
Cleared May 31, 1985
CRESTLINE CB BEHIND-THE-EAR HEARING AID
K850981
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 81d
Cleared May 29, 1985
EARETTE HEARING AID(BEHIND THE EAR OTICON E35F
K851429
Oticon Corp.
Ear, Nose, Throat · 49d
Cleared May 29, 1985
EARETTE HEARING AID(BEHIND THE EAR OTICON E37F
K851430
Oticon Corp.
Ear, Nose, Throat · 49d
Cleared Apr 09, 1985
BOSCH IN THE EAR HEARING AID SUPERSTAR
K850188
Robert Bosch Corp.
Ear, Nose, Throat · 81d
Cleared Apr 08, 1985
POST-AURICULAR HEARING AID MODEL PE 600PPCH
K844862
Phonic Ear, Inc.
Ear, Nose, Throat · 115d
Cleared Mar 28, 1985
POST-AURICULAR HEARING AID MODEL PE 600 PPC
K844859
Phonic Ear, Inc.
Ear, Nose, Throat · 104d
Cleared Mar 28, 1985
POST-SURICULAR HEARING AID PE 600CD
K844863
Phonic Ear, Inc.
Ear, Nose, Throat · 104d
Cleared Mar 27, 1985
POST-AURICULAR HEARING AID MODEL PE 600CHD
K844860
Phonic Ear, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 27, 1985
POST-AURICULAR HEARING AID MODEL PE 600PPCL
K844861
Phonic Ear, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 25, 1985
BODY HEARING AIDS MT 80 SP
K850185
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
BOSCH STARR 66PP -HEARING AIDS
K850187
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
BOSCH STAR 66PP-S HEARING AID
K850189
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
STAR 66F-AGC-I HEARING AID
K850190
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
HEARING AID 365
K850243
Telex Communications, Inc.
Ear, Nose, Throat · 62d