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
841–864 of 1367
Cleared May 05, 1981
EARETTE HEARING AID OTICON #E25F
K810986
Oticon Corp.
Ear, Nose, Throat · 19d
Cleared May 05, 1981
EARETTE HEARING AID OTICON #E27F
K810987
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Mar 31, 1981
POWER SONIC
K810577
Qualitone
Ear, Nose, Throat · 28d
Cleared Mar 20, 1981
EARETTE HEARING AID OTICON #E27
K810610
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Mar 17, 1981
EARETTE HEARING AID(BEHING THE EAR)
K810576
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Mar 04, 1981
EARETTE HEARING AID SEARS MODEL 8053
K810389
Oticon Corp.
Ear, Nose, Throat · 15d
Cleared Dec 31, 1980
BEHIND-THE-EAR HEARING AID
K802859
Danavox, Inc.
Ear, Nose, Throat · 49d
Cleared Oct 23, 1980
DAHLBERG HEARING AID MODEL AI
K802510
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Sep 26, 1980
RIONET HEARING AID HB-69C
K802053
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 09, 1980
RIONET HEARING AID HB-70H
K801958
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 48d
Cleared Aug 14, 1980
RIONET HEARING AID AND/OR RION #HB-70
K801692
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Jul 28, 1980
RIONET HEARING AID HB-66
K801556
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared Jul 21, 1980
OTICON MODEL E17P EARETTE HEARING AID
K801448
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Jun 17, 1980
HEARING AID, UNITRON MODEL C4-55
K801230
Unitron Industries, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 04, 1980
BEHIND-THE-EAR HEARING AID SERIES G
K801062
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 29d
Cleared May 28, 1980
OTICON EARETTE HEARING AID #E17 HC
K801002
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared May 28, 1980
OTICON EARETTE HEARING AID #E17CF
K801003
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared May 28, 1980
DAHLBERG HEARING AID MODEL MEH
K801114
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared May 28, 1980
DAHLBERG HEARING AID MODEL MEL
K801115
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared Apr 24, 1980
RIONET &/OR RION HEARING AID MOD. HB-67S
K800738
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 24, 1980
RIONET &/OR RION HEARING AID MODEL HA-82
K800739
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149
K800446
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149HF
K800447
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d
Cleared Mar 20, 1980
DAHLBERG #AZ BEHIND THE EAR HEARING AID
K800571
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 6d