EPF · Class II · 21 CFR 874.3320

FDA Product Code EPF: Hearing Aid, Group And Auditory Trainer

Leading manufacturers include Phonic Ear, Inc., Telex Communications, Inc. and Resound Corp..

32
Total
32
Cleared
73d
Avg days
1977
Since

FDA 510(k) Cleared Hearing Aid, Group And Auditory Trainer Devices (Product Code EPF)

32 devices
1–24 of 32
Cleared Oct 06, 1998
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
K982683
Telex Communications, Inc.
Ear, Nose, Throat · 67d
Cleared Feb 25, 1998
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
K974658
Phonic Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 10, 1998
FM RECEIVER - AUDITORY TRAINER
K974287
Phonic Ear, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 30, 1995
GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
K950730
Phonic Ear, Inc.
Ear, Nose, Throat · 134d
Cleared Jun 24, 1994
PHONAK MICROVOX RESONAL FM SYSTEM
K941768
Phonak, Inc.
Ear, Nose, Throat · 74d
Cleared Mar 22, 1994
PHONIC EAR
K940313
Phonic Ear, Inc.
Ear, Nose, Throat · 57d
Cleared Sep 29, 1992
PE 400IR, PE 400T, PE 400E
K923234
Phonic Ear, Inc.
Ear, Nose, Throat · 90d
Cleared Aug 24, 1992
GROUP AUDITORY TRAINING SYSTEM
K922720
Phonic Ear, Inc.
Ear, Nose, Throat · 80d
Cleared Aug 06, 1992
RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1
K922570
Resound Corp.
Ear, Nose, Throat · 66d
Cleared Jan 17, 1992
TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915383
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915384
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER
K915397
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER
K915398
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Nov 01, 1991
TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC
K913494
Telex Communications, Inc.
Ear, Nose, Throat · 87d
Cleared Nov 01, 1991
TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC
K913495
Telex Communications, Inc.
Ear, Nose, Throat · 87d
Cleared Aug 15, 1991
GROUP AUDITORY TRAINER,FM RECEIVER
K912356
Phonic Ear, Inc.
Ear, Nose, Throat · 79d
Cleared Aug 21, 1989
AUDITORY TRAINER PE150R FM RECEIVER
K893431
Phonic Ear, Inc.
Ear, Nose, Throat · 111d
Cleared Jul 05, 1988
PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
K882409
Phonic Ear, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 07, 1988
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER
K881099
Phonic Ear, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 09, 1986
PHONIC EAR, MODEL PE475R
K862773
Phonic Ear, Inc.
Ear, Nose, Throat · 79d
Cleared Aug 01, 1983
PHONIC EAR PE 467R-PE 461T
K832080
Phonic Ear, Inc.
Ear, Nose, Throat · 34d

About Product Code EPF - Regulatory Context