FDA product code EPF: Hearing Aid, Group And Auditory Trainer
EPF is the FDA product code for hearing aid, group and auditory trainer. It is a Class II device, regulated under 21 CFR 874.3320 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 32 510(k) submissions under EPF, from 12 different applicants. The average 510(k) review took 73 days (median 71).
Classification
| Field | Value |
|---|---|
| Device name | Hearing Aid, Group And Auditory Trainer |
| Device class | Class II |
| Regulation | 21 CFR 874.3320 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EPF clearance
Top EPF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phonic Ear, Inc. | 12 | 1998-02-25 |
| Telex Communications, Inc. | 7 | 1998-10-06 |
| Hc Electronics | 3 | 1981-03-04 |
| Williams Sound, LLC | 2 | 1997-05-02 |
| Hypersound Health, Inc. | 1 | 2014-02-12 |
7 more applicants have EPF clearances. See the full list in Caduvo.
Most recent EPF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133352 | Hypersound Health, Inc. | HYPERSOUND AUDIO SYSTEM (HSS) | 2014-02-12 | 104 |
| K982683 | Telex Communications, Inc. | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION | 1998-10-06 | 67 |
| K974658 | Phonic Ear, Inc. | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT | 1998-02-25 | 72 |
| K974287 | Phonic Ear, Inc. | FM RECEIVER - AUDITORY TRAINER | 1998-02-10 | 88 |
| K970687 | Williams Sound, LLC | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | 1997-05-02 | 67 |
Recalls for EPF devices
openFDA lists no recalls for product code EPF.
Frequently asked questions
What is FDA product code EPF?
EPF is the FDA product code for hearing aid, group and auditory trainer. It is a Class II device, regulated under 21 CFR 874.3320 and reviewed by the Ear, Nose and Throat panel.
What device class is EPF?
Class II, regulation 21 CFR 874.3320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EPF?
Across 32 cleared submissions the average was 73 days from receipt to decision (median 71).
Which companies have the most EPF clearances?
Phonic Ear, Inc. (12); Telex Communications, Inc. (7); Hc Electronics (3); Williams Sound, LLC (2); Hypersound Health, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EPF
- Run a recall and safety report across every EPF manufacturer
- Watch product code EPF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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