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
457–480 of 1367
Cleared Oct 21, 1991
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
K914477
Miracle-Ear, Inc.
Ear, Nose, Throat · 13d
Cleared Oct 18, 1991
MODEL 80 HEARING AID DISPENSING SYSTEM
K913245
3M Company
Ear, Nose, Throat · 88d
Cleared Oct 11, 1991
SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION
K914333
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 14d
Cleared Sep 23, 1991
UC312, ULTRA MINIATURE ITC HEARING AID
K914017
Qualitone
Ear, Nose, Throat · 14d
Cleared Sep 18, 1991
QUALITONE 46PP-AGC-I
K913592
Qualitone
Ear, Nose, Throat · 37d
Cleared Sep 18, 1991
ELEGANCE - KED, BEHIND THE EAR HEARING AID
K913771
Qualitone
Ear, Nose, Throat · 27d
Cleared Sep 18, 1991
QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID
K913781
Qualitone
Ear, Nose, Throat · 34d
Cleared Sep 06, 1991
PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT
K913502
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 06, 1991
PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT
K913503
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 26, 1991
PHILIPS S1594 OTB HEARING AID
K913389
Philips Hearing Instruments Co.
Ear, Nose, Throat · 28d
Cleared Aug 26, 1991
M32 IN-THE-EAR HEARING AID
K913390
Philips Hearing Instruments Co.
Ear, Nose, Throat · 28d
Cleared Jul 31, 1991
HEARING AID, UNITRON MODEL UIK
K912870
Unitron Industries, Inc.
Ear, Nose, Throat · 33d
Cleared Jul 24, 1991
SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID
K912665
Resound Corp.
Ear, Nose, Throat · 36d
Cleared Jun 26, 1991
SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID
K911810
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 26, 1991
SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
K911811
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 26, 1991
PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
K912570
Phonak, Inc.
Ear, Nose, Throat · 15d
Cleared Jun 26, 1991
PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT
K912571
Phonak, Inc.
Ear, Nose, Throat · 15d
Cleared Jun 20, 1991
TELEX MODEL TLP, IN-THE-EAR
K912204
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Jun 17, 1991
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
K912153
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 17, 1991
QUALITONE MODEL 48 C-WR-BEHIND THE EAR
K912154
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 07, 1991
PHILIPS M30 IN-THE-EAR HEARING AID
K912339
Philips Hearing Instruments Co.
Ear, Nose, Throat · 14d
Cleared May 28, 1991
WIDEX MODEL QX IN-THE-EAR HEARING AID
K912169
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 12d
Cleared May 17, 1991
CHAMPION, BEHIND-THE-EAR HEARING AID
K911705
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL 800, BEHIND-THE-EAR HEARING AID
K911706
Electone, Inc.
Ear, Nose, Throat · 31d