LZI · Device, Assistive Listening
Ear, Nose, Throat · 21 CFR 874.3320 · Class 2
Overview
| Product Code | LZI |
|---|---|
| Device Name | Device, Assistive Listening |
| 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K043090 | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS | Phonic Ear, Inc. | Dec 23, 2004 | SESE |
| K970974 | WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER | Williams Sound, LLC | May 2, 1997 | SESE |
| K970340 | AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER | Bellab | Mar 26, 1997 | SESE |
| K954748 | POCKETALKER PRO | Williams Sound, LLC | Nov 22, 1995 | SESE |
| K952057 | LISTENAIDER II | National Hearing Aid Dist., Inc. | Jun 21, 1995 | SESE |
| K934805 | HEARIT | Je Liss & Co., Inc. | Feb 7, 1994 | SESE |
| K904755 | ACOUSTIQ LISTENING DEVICE | Krueger Laboratories | Jan 29, 1991 | SESE |
Top Applicants
- Williams Sound, LLC — 2 clearances
- Phonic Ear, Inc. — 1 clearance
- National Hearing Aid Dist., Inc. — 1 clearance
- Krueger Laboratories — 1 clearance
- Je Liss & Co., Inc. — 1 clearance
