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
625–648 of 1367
Cleared Jan 19, 1988
OTICON HEARING AID MODEL I52
K874651
Oticon Corp.
Ear, Nose, Throat · 67d
Cleared Dec 29, 1987
BTE HEARING AID OTICON MODEL E38P
K874380
Oticon Corp.
Ear, Nose, Throat · 64d
Cleared Dec 23, 1987
BTE HEARING AID OTICON MODEL E39PL
K874381
Oticon Corp.
Ear, Nose, Throat · 58d
Cleared Dec 11, 1987
POST AURICULAR HEARING AID 46PP-PC SUMMIT
K874707
Richards Medical Co., Inc.
Ear, Nose, Throat · 24d
Cleared Dec 10, 1987
OTICON MODEL I50 IN-THE-EAR HEARING AID
K874744
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Dec 08, 1987
NICOLET DIGITAL TWO PIECE HEARING AID
K873736
Nicolet Biomedical Instruments
Ear, Nose, Throat · 84d
Cleared Nov 20, 1987
PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL
K874304
Phonic Ear, Inc.
Ear, Nose, Throat · 31d
Cleared Oct 20, 1987
INTERNATIONAL MODEL XP BEHIND-THE-EAR
K873798
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d
Cleared Oct 20, 1987
INTERNATIONAL MODEL XL BEHIND-THE-EAR
K873799
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d
Cleared Oct 20, 1987
INTERNATIONAL MODEL XM BEHIND-THE-EAR
K873800
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d
Cleared Oct 14, 1987
U-IMPULSE TVC AIR CONDUCTION HEARING AID
K873559
Richards Medical Co., Inc.
Ear, Nose, Throat · 42d
Cleared Sep 29, 1987
CUSTOM IN-THE-EAR HEARING AID SERIES MCA20
K873468
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 29, 1987
U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID
K873560
Richards Medical Co., Inc.
Ear, Nose, Throat · 27d
Cleared Sep 16, 1987
DAHLBERG MODEL GH BODY AID
K873169
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 36d
Cleared Sep 14, 1987
MODEL SI AND SP BEHIND-THE-EAR HEARING AID
K873376
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 21d
Cleared Sep 14, 1987
DAHLBERG MODEL MH BEHIND-THE-EAR HEARING AID
K873397
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 26, 1987
INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR
K872647
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 50d
Cleared Aug 11, 1987
SIEMENS SILICONE IMPRESSION MATERIAL
K872152
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 68d
Cleared Jul 31, 1987
BEHIND-THE-EAR HEARING AID OTICON E40
K872372
Oticon Corp.
Ear, Nose, Throat · 42d
Cleared Jul 31, 1987
WIDEX HEARING AID MODEL ES1
K872374
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 42d
Cleared Jul 28, 1987
WIDEX HEARING AID MODEL ES6
K872375
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 39d
Cleared Jul 28, 1987
POST-AURICULAR HEARING AID MODEL PE 805CD2
K872473
Phonic Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 28, 1987
POST-AURICULAR HEARING AID MODEL PE 805 SCD2
K872474
Phonic Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 16, 1987
HEARING AID S45 SERIES
K872553
Electone, Inc.
Ear, Nose, Throat · 17d