Medical Device Manufacturer · US , Mchenry , IL

Phonic Ear, Inc. - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 1982

Recent clearances: EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS, INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT, FM RECEIVER - AUDITORY TRAINER

31

Total

31

Cleared

0

Denied

FDA 510(k) Regulatory Record - Phonic Ear, Inc. Ear, Nose, Throat ✕

31 devices

1-12 of 31

Cleared Dec 23, 2004

EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS

Ear, Nose, Throat · 45d

Cleared Feb 25, 1998

INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN...

Ear, Nose, Throat · 72d

Cleared Feb 10, 1998

FM RECEIVER - AUDITORY TRAINER

Ear, Nose, Throat · 88d

Cleared Jun 30, 1995

GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)

Ear, Nose, Throat · 134d

Cleared Mar 22, 1994

Ear, Nose, Throat · 57d

Cleared Sep 29, 1992

PE 400IR, PE 400T, PE 400E

Ear, Nose, Throat · 90d

Cleared Aug 24, 1992

GROUP AUDITORY TRAINING SYSTEM

Ear, Nose, Throat · 80d

Cleared Aug 15, 1991

GROUP AUDITORY TRAINER,FM RECEIVER

Ear, Nose, Throat · 79d

Cleared Aug 21, 1989

AUDITORY TRAINER PE150R FM RECEIVER

Ear, Nose, Throat · 111d

Cleared Jul 05, 1988

PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER

Ear, Nose, Throat · 25d

Cleared Jun 07, 1988

PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER

Ear, Nose, Throat · 84d

Cleared Nov 20, 1987

PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL

Ear, Nose, Throat · 31d