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
817–840 of 1367
Cleared Apr 09, 1982
RIONET HEARING AID HA-57
K820656
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 31d
Cleared Mar 02, 1982
DAHLBERG HEARING AID MODEL AL
K820398
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 19d
Cleared Mar 01, 1982
RIONET HEARING AID HB-69AS
K820348
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
RIONET HEARING AID HB-71H
K820349
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
RIONET HEARING AID HB-71S
K820350
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Feb 24, 1982
PHONIC EAR MODEL PE 810S
K820172
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
Cleared Feb 23, 1982
MODEL 343 HEARING AID
K820148
Telex Communications, Inc.
Ear, Nose, Throat · 35d
Cleared Jan 12, 1982
RIONET HEARING AID HI-62
K813546
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 12, 1982
PHONIC EAR MODEL PE805CD
K813583
Phonic Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Dec 08, 1981
HEARING AID MODEL UE9-R
K813229
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Nov 06, 1981
BEHIND-THE-EAR MODEL 115
K812937
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 06, 1981
IN-THE-EAR MODEL 821
K812938
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 06, 1981
IN-THE-EAR MODEL 101M
K812939
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Oct 02, 1981
ELEGANCE
K812578
Qualitone
Ear, Nose, Throat · 23d
Cleared Jul 28, 1981
EAGLE I HEARING AID
K811988
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jul 01, 1981
DAHLBERG MODEL AP HEARING AID
K811578
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jun 26, 1981
RIONET HEARING AID HB-69S
K811529
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
RIONET HEARING AID HB 69 T
K811530
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
RIONET HEARING AID HB-69
K811531
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 16, 1981
HEARING AID MODEL E1-P
K811285
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 16, 1981
HEARING AID MODEL E1-PL
K811286
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 16, 1981
BEHIND-THE-EAR HEARING AID
K811344
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared May 13, 1981
HEARING AID, UNITRON MODEL C5-H
K811174
Unitron Industries, Inc.
Ear, Nose, Throat · 15d
Cleared May 13, 1981
DAHLBERG MODEL AM
K811226
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 9d