Atlas FDA

EPF

32 FDA 510(k) clearances · Product code

72 daysmedian time to decision
104 days90th percentile
32clearances measured

FDA profile

Official device name
Hearing Aid, Group And Auditory Trainer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3320
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HYPERSOUND AUDIO SYSTEM (HSS) (K133352)Hypersound Health, Inc.2014-02-12
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (K982683)Telex Communications, Inc.1998-10-06
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT (K974658)Phonic Ear, Inc.1998-02-25
FM RECEIVER - AUDITORY TRAINER (K974287)Phonic Ear, Inc.1998-02-10
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (K970687)Williams Sound, LLC1997-05-02
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (K970665)Williams Sound, LLC1997-05-02
HF MEGA EAR (K960567)Maxi-Aids, Inc.1996-10-16
GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (K950730)Phonic Ear, Inc.1995-06-30
PHONAK MICROVOX RESONAL FM SYSTEM (K941768)Phonak, Inc.1994-06-24
PHONIC EAR (K940313)Phonic Ear, Inc.1994-03-22
PE 400IR, PE 400T, PE 400E (K923234)Phonic Ear, Inc.1992-09-29
GROUP AUDITORY TRAINING SYSTEM (K922720)Phonic Ear, Inc.1992-08-24
RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 (K922570)Resound Corp.1992-08-06
TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER (K915383)Telex Communications, Inc.1992-01-17
TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER (K915384)Telex Communications, Inc.1992-01-17
TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER (K915397)Telex Communications, Inc.1992-01-17
TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER (K915398)Telex Communications, Inc.1992-01-17
TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC (K913495)Telex Communications, Inc.1991-11-01
TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC (K913494)Telex Communications, Inc.1991-11-01
GROUP AUDITORY TRAINER,FM RECEIVER (K912356)Phonic Ear, Inc.1991-08-15
AUDITORY TRAINER PE150R FM RECEIVER (K893431)Phonic Ear, Inc.1989-08-21
PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER (K882409)Phonic Ear, Inc.1988-07-05
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER (K881099)Phonic Ear, Inc.1988-06-07
PHONIC EAR, MODEL PE475R (K862773)Phonic Ear, Inc.1986-10-09
METAVOX MV-1000 AUDITORY TRAINER (K832190)Metavox, Inc.1983-09-12
PHONIC EAR PE 467R-PE 461T (K832080)Phonic Ear, Inc.1983-08-01
STIMRITE (K821691)Biotone International, Inc.1982-08-25
POWERED MUSCLE STIMULATOR (K821511)High Country Ent.1982-08-16
STEREO AUDITORY TRAINER (MODEL PM228) (K810031)Hc Electronics1981-03-04
PHONIC EAR (K780936)Hc Electronics1978-06-22
AUDITORY TRAINER (K771671)Accutone, Inc.1977-09-12
GROUP AUDITORY TRAINER HC 431R (K771357)Hc Electronics1977-07-29

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Every clearance here is in the API, with alerts when new ones post.