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
649–672 of 1367
Cleared Jul 16, 1987
HEARING AID 49 SERIES
K872554
Electone, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 16, 1987
HEARING AID M35/M36 SERIES
K872556
Electone, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 10, 1987
HEARING AID 47 SERIES
K872555
Electone, Inc.
Ear, Nose, Throat · 11d
Cleared Jun 08, 1987
BTE HEARING AID OTICON MODEL E30P
K872017
Oticon Corp.
Ear, Nose, Throat · 13d
Cleared May 19, 1987
DAHLBERG MODEL UL IN-THE-EAR HEARING AID
K871525
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 29d
Cleared May 08, 1987
DAHLBERG MODEL UH IN-THE-EAR HEARING AID
K871524
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 18d
Cleared Mar 30, 1987
3M INSTANT FIT CUSTOM EARMOLD
K870985
3M Company
Ear, Nose, Throat · 19d
Cleared Mar 13, 1987
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID
K870691
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 11, 1987
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS
K870434
Telex Communications, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 11, 1987
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID
K870435
Telex Communications, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 11, 1987
HEARING AID, UNITRON MODEL UM60
K870503
Unitron Industries, Inc.
Ear, Nose, Throat · 35d
Cleared Feb 20, 1987
PHONIC EAR MODELS PE 811CS AND PE 811CST
K864672
Phonic Ear, Inc.
Ear, Nose, Throat · 80d
Cleared Nov 13, 1986
MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID
K864028
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID
K864029
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID
K864030
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID
K864031
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 05, 1986
WIDEX HEARING AID MODEL ES2
K864097
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 15d
Cleared Oct 24, 1986
UNITRON MODEL UL21 HEARING AID
K863225
Unitron Industries, Inc.
Ear, Nose, Throat · 64d
Cleared Oct 15, 1986
OTICON I31 INITIALES HEARING AID
K862981
Oticon Corp.
Ear, Nose, Throat · 69d
Cleared Oct 14, 1986
PA EQUALIZER
K863787
Electone, Inc.
Ear, Nose, Throat · 18d
Cleared Aug 26, 1986
OTICON I31 CITE HEARING AID
K862980
Oticon Corp.
Ear, Nose, Throat · 19d
Cleared Aug 07, 1986
I81 INITIALES
K862623
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Aug 01, 1986
I22 CITE
K862622
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Jul 31, 1986
RIONET HEARING AID HB-35PT
K862670
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 17d