Hearing Aid, Group And Auditory Trainer
FDA product code EPF · Class II (moderate risk) · 21 CFR 874.3320 · Ear, Nose, Throat
32510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133352 | Hypersound Audio System (HSS)EPF · Traditional | Hypersound Health, Inc. | 02/12/2014SE |
| K982683 | Telex Select 1-40 with Adaptive CompressionEPF · Traditional | Telex Communications, Inc. | 10/06/1998SE |
| K974658 | Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver…EPF · Traditional | Phonic Ear, Inc. | 02/25/1998SE |
| K974287 | FM Receiver - Auditory TrainerEPF · Traditional | Phonic Ear, Inc. | 02/10/1998SE |
| K970687 | Williams Sound, Personal FM, Hearing HelperEPF · Traditional | Williams Sound, LLC | 05/02/1997SE |
| K970665 | Williams Sound, Personal FM, Hearing HelperEPF · Traditional | Williams Sound, LLC | 05/02/1997SE |
| K960567 | HF Mega EarEPF · Traditional | Maxi-Aids, Inc. | 10/16/1996SE |
| K950730 | Group Auditory Trainer (Group Amplification System)EPF · Traditional | Phonic Ear, Inc. | 06/30/1995SE |
| K941768 | Phonak Microvox Resonal FM SystemEPF · Traditional | Phonak, Inc. | 06/24/1994SE |
| K940313 | Phonic EarEPF · Traditional | Phonic Ear, Inc. | 03/22/1994SE |
| K923234 | Pe 400IR, Pe 400T, Pe 400EEPF · Traditional | Phonic Ear, Inc. | 09/29/1992SE |
| K922720 | Group Auditory Training SystemEPF · Traditional | Phonic Ear, Inc. | 08/24/1992SE |
| K922570 | Resound Personal Hearing System SOUNDLINK-1EPF · Traditional | Resound Corp. | 08/06/1992SE |
| K915398 | TDR-5 Binaural Hearingaid/Wireles FM ReceiverEPF · Traditional | Telex Communications, Inc. | 01/17/1992SE |
| K915397 | TDR-7 Binaural Hearing Aid/Wireless FM RecieverEPF · Traditional | Telex Communications, Inc. | 01/17/1992SE |
| K915384 | TDR-4S Monaural Hearing Aid/Wireless FM ReceiverEPF · Traditional | Telex Communications, Inc. | 01/17/1992SE |
| K915383 | TDR-4 Monaural Hearing Aid/Wireless FM ReceiverEPF · Traditional | Telex Communications, Inc. | 01/17/1992SE |
| K913495 | Telex TDR-7AA Binaural Hear Aid/Wireless FM RecEPF · Traditional | Telex Communications, Inc. | 11/01/1991SE |
| K913494 | Telex TDR-4AA Monaural Hear Aid/Wireless FM RecEPF · Traditional | Telex Communications, Inc. | 11/01/1991SE |
| K912356 | Group Auditory Trainer,Fm ReceiverEPF · Traditional | Phonic Ear, Inc. | 08/15/1991SE |
| K893431 | Auditory Trainer PE150R FM ReceiverEPF · Traditional | Phonic Ear, Inc. | 08/21/1989SE |
| K882409 | PE100R FM Receiver Used W/PE100T FM TransmitterEPF · Traditional | Phonic Ear, Inc. | 07/05/1988SE |
| K881099 | PE485R FM Receiver Used W/PE481FST FM TransmitterEPF · Traditional | Phonic Ear, Inc. | 06/07/1988SE |
| K862773 | Phonic Ear, Model PE475REPF · Traditional | Phonic Ear, Inc. | 10/09/1986SE |
| K832190 | Metavox MV-1000 Auditory TrainerEPF · Traditional | Metavox, Inc. | 09/12/1983SE |
| K832080 | Phonic Ear Pe 467R-PE 461TEPF · Traditional | Phonic Ear, Inc. | 08/01/1983SE |
| K821691 | StimriteEPF · Traditional | Biotone International, Inc. | 08/25/1982SE |
| K821511 | Powered Muscle StimulatorEPF · Traditional | High Country Ent. | 08/16/1982SE |
| K810031 | Stereo Auditory Trainer (Model PM228)EPF · Traditional | Hc Electronics | 03/04/1981SE |
| K780936 | Phonic EarEPF · Traditional | Hc Electronics | 06/22/1978SE |
| K771671 | Auditory TrainerEPF · Traditional | Accutone, Inc. | 09/12/1977SE |
| K771357 | Group Auditory Trainer HC 431REPF · Traditional | Hc Electronics | 07/29/1977SE |