EPF · Hearing Aid, Group And Auditory Trainer
Ear, Nose, Throat · 21 CFR 874.3320 · Class 2
Overview
| Product Code | EPF |
|---|---|
| Device Name | Hearing Aid, Group And Auditory Trainer |
| Regulation | 21 CFR 874.3320 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K133352 | HYPERSOUND AUDIO SYSTEM (HSS) | Hypersound Health, Inc. | Feb 12, 2014 | SESE |
| K982683 | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION | Telex Communications, Inc. | Oct 6, 1998 | SESE |
| K974658 | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT | Phonic Ear, Inc. | Feb 25, 1998 | SESE |
| K974287 | FM RECEIVER - AUDITORY TRAINER | Phonic Ear, Inc. | Feb 10, 1998 | SESE |
| K970687 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | Williams Sound, LLC | May 2, 1997 | SESE |
| K970665 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | Williams Sound, LLC | May 2, 1997 | SESE |
| K960567 | HF MEGA EAR | Maxi-Aids, Inc. | Oct 16, 1996 | SESE |
| K950730 | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) | Phonic Ear, Inc. | Jun 30, 1995 | SESE |
| K941768 | PHONAK MICROVOX RESONAL FM SYSTEM | Phonak, Inc. | Jun 24, 1994 | SESE |
| K940313 | PHONIC EAR | Phonic Ear, Inc. | Mar 22, 1994 | SESE |
| K923234 | PE 400IR, PE 400T, PE 400E | Phonic Ear, Inc. | Sep 29, 1992 | SESE |
| K922720 | GROUP AUDITORY TRAINING SYSTEM | Phonic Ear, Inc. | Aug 24, 1992 | SESE |
| K922570 | RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 | Resound Corp. | Aug 6, 1992 | SESE |
| K915398 | TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER | Telex Communications, Inc. | Jan 17, 1992 | SESE |
| K915397 | TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER | Telex Communications, Inc. | Jan 17, 1992 | SESE |
| K915384 | TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER | Telex Communications, Inc. | Jan 17, 1992 | SESE |
| K915383 | TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER | Telex Communications, Inc. | Jan 17, 1992 | SESE |
| K913495 | TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC | Telex Communications, Inc. | Nov 1, 1991 | SESE |
| K913494 | TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC | Telex Communications, Inc. | Nov 1, 1991 | SESE |
| K912356 | GROUP AUDITORY TRAINER,FM RECEIVER | Phonic Ear, Inc. | Aug 15, 1991 | SESE |
Top Applicants
- Phonic Ear, Inc. — 12 clearances
- Telex Communications, Inc. — 7 clearances
- Hc Electronics — 3 clearances
- Williams Sound, LLC — 2 clearances
- Resound Corp. — 1 clearance
