Product Code: EPF
FDA class 2
21 CFR 874.3320
Hearing Aid, Group And Auditory Trainer
Ear, Nose, Throat
The group hearing aid and auditory trainer is a sound amplification system designed for use in group settings such as classrooms, intended to assist individuals with hearing impairment by amplifying sound and improving signal-to-noise ratio. It is classified as FDA Class 2, representing moderate risk, and requires 510(k) premarket clearance. The product code is EPF, regulated under 21 CFR 874.3320 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
510(k)s
32
FEI Numbers
2
Registration Numbers
2
Unique Applicants
12
Years Active
37
Basic Information
- Product Code
- EPF
- Device Class
- FDA class 2
- Regulation Number
- 874.3320
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 32 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K133352 | HYPERSOUND AUDIO SYSTEM (HSS) | Feb 12, 2014 | Substantially Equivalent | Hypersound Health, Inc. |
| K982683 | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION | Oct 06, 1998 | Substantially Equivalent | Telex Communications, Inc. |
| K974658 | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT | Feb 25, 1998 | Substantially Equivalent | Phonic Ear, Inc. |
| K974287 | FM RECEIVER - AUDITORY TRAINER | Feb 10, 1998 | Substantially Equivalent | Phonic Ear, Inc. |
| K970687 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | May 02, 1997 | Substantially Equivalent | Williams Sound, LLC |
| K970665 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | May 02, 1997 | Substantially Equivalent | Williams Sound, LLC |
| K960567 | HF MEGA EAR | Oct 16, 1996 | Substantially Equivalent | Maxi-Aids, Inc. |
| K950730 | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) | Jun 30, 1995 | Substantially Equivalent | Phonic Ear, Inc. |
| K941768 | PHONAK MICROVOX RESONAL FM SYSTEM | Jun 24, 1994 | Substantially Equivalent | Phonak, Inc. |
| K940313 | PHONIC EAR | Mar 22, 1994 | Substantially Equivalent | Phonic Ear, Inc. |
| K923234 | PE 400IR, PE 400T, PE 400E | Sep 29, 1992 | Substantially Equivalent | Phonic Ear, Inc. |
| K922720 | GROUP AUDITORY TRAINING SYSTEM | Aug 24, 1992 | Substantially Equivalent | Phonic Ear, Inc. |
| K922570 | RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 | Aug 06, 1992 | Substantially Equivalent | Resound Corp. |
| K915398 | TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER | Jan 17, 1992 | Substantially Equivalent | Telex Communications, Inc. |
| K915397 | TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER | Jan 17, 1992 | Substantially Equivalent | Telex Communications, Inc. |
| K915384 | TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER | Jan 17, 1992 | Substantially Equivalent | Telex Communications, Inc. |
| K915383 | TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER | Jan 17, 1992 | Substantially Equivalent | Telex Communications, Inc. |
| K913495 | TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC | Nov 01, 1991 | Substantially Equivalent | Telex Communications, Inc. |
| K913494 | TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC | Nov 01, 1991 | Substantially Equivalent | Telex Communications, Inc. |
| K912356 | GROUP AUDITORY TRAINER,FM RECEIVER | Aug 15, 1991 | Substantially Equivalent | Phonic Ear, Inc. |
| K893431 | AUDITORY TRAINER PE150R FM RECEIVER | Aug 21, 1989 | Substantially Equivalent | Phonic Ear, Inc. |
| K882409 | PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER | Jul 05, 1988 | Substantially Equivalent | Phonic Ear, Inc. |
| K881099 | PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER | Jun 07, 1988 | Substantially Equivalent | Phonic Ear, Inc. |
| K862773 | PHONIC EAR, MODEL PE475R | Oct 09, 1986 | Substantially Equivalent | Phonic Ear, Inc. |
| K832190 | METAVOX MV-1000 AUDITORY TRAINER | Sep 12, 1983 | Substantially Equivalent | Metavox, Inc. |
| K832080 | PHONIC EAR PE 467R-PE 461T | Aug 01, 1983 | Substantially Equivalent | Phonic Ear, Inc. |
| K821691 | STIMRITE | Aug 25, 1982 | Substantially Equivalent | Biotone International, Inc. |
| K821511 | POWERED MUSCLE STIMULATOR | Aug 16, 1982 | Substantially Equivalent | High Country Ent. |
| K810031 | STEREO AUDITORY TRAINER (MODEL PM228) | Mar 04, 1981 | Substantially Equivalent | Hc Electronics |
| K780936 | PHONIC EAR | Jun 22, 1978 | Substantially Equivalent | Hc Electronics |
| K771671 | AUDITORY TRAINER | Sep 12, 1977 | Substantially Equivalent | Accutone, Inc. |
| K771357 | GROUP AUDITORY TRAINER HC 431R | Jul 29, 1977 | Substantially Equivalent | Hc Electronics |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.