Device, Assistive Listening
The Assistive Listening Device (product code LZI) is an electronic device designed to improve the ability of individuals with hearing loss to hear in specific listening environments by amplifying or transmitting sound directly to the listener, supplementing or substituting for a conventional hearing aid. Regulated under 21 CFR 874.3320 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the Ear, Nose, and Throat specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- LZI
- Device Class
- FDA class 2
- Regulation Number
- 874.3320
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K043090 | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS | Dec 23, 2004 | Substantially Equivalent | Phonic Ear, Inc. |
| K970974 | WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER | May 02, 1997 | Substantially Equivalent | Williams Sound, LLC |
| K970340 | AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER | Mar 26, 1997 | Substantially Equivalent | Bellab |
| K954748 | POCKETALKER PRO | Nov 22, 1995 | Substantially Equivalent | Williams Sound, LLC |
| K952057 | LISTENAIDER II | Jun 21, 1995 | Substantially Equivalent | National Hearing Aid Dist., Inc. |
| K934805 | HEARIT | Feb 07, 1994 | Substantially Equivalent | Je Liss & Co., Inc. |
| K904755 | ACOUSTIQ LISTENING DEVICE | Jan 29, 1991 | Substantially Equivalent | Krueger Laboratories |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.