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
697–720 of 1367
Cleared Dec 18, 1985
INT'L MODEL XG BEHIND-THE-EAR HEARING AID
K853941
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 18, 1985
INT'L MODEL XE BEHIND-THE-EAR HEARING AID
K853942
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 02, 1985
WIDEX MODEL M1
K853793
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 82d
Cleared Nov 07, 1985
UNITRON MODEL UM60-D
K853780
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 07, 1985
UNITRON MODEL UM60-PP
K853781
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 01, 1985
PERSONAL AMPLIFIER SLIMLINE III
K853605
Electone, Inc.
Ear, Nose, Throat · 65d
Cleared Oct 17, 1985
INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI
K853172
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 79d
Cleared Oct 04, 1985
INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID
K853170
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 01, 1985
INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A
K853171
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 23, 1985
HEARING AID MODEL 337D
K853264
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 23, 1985
DAHLBERG EA BEHING-THE-EAR HEARING AID
K853323
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 23, 1985
DAHLBERG EB BEHING-THE-EAR HEARING AID
K853324
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 23, 1985
DAHLBERG EC BEHIND-THE-EAR HEARING AID
K853325
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 23, 1985
PERSONAL AMPLIFIER COMMUNICATOR PREMIUM
K853606
Electone, Inc.
Ear, Nose, Throat · 26d
Cleared Sep 23, 1985
RIONET HEARING AID HI-06
K853636
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 23, 1985
RIONET HEARING AID HI-07
K853637
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 23, 1985
RIONET HEARING AID
K853638
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 06, 1985
INTERNATION MODEL SS STOCK CANAL IN THE EAR H.A.
K853173
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 38d
Cleared Aug 22, 1985
RIONET HEARING AID HB-69HT
K852453
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 73d
Cleared Aug 22, 1985
DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID
K852486
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 22, 1985
MODEL 372L HEARING AID
K853108
Telex Communications, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 21, 1985
RIONET HEARING AID HB-34HT
K852451
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 21, 1985
RIONET HEARING AID HB-71P
K852452
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 16, 1985
DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID
K852098
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 93d