FDA product code LZI: Device, Assistive Listening
LZI is the FDA product code for device, assistive listening. It is a Class II device, regulated under 21 CFR 874.3320 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 7 510(k) submissions under LZI, from 6 different applicants. The average 510(k) review took 66 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Device, Assistive Listening |
| 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 LZI clearance
Top LZI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Williams Sound, LLC | 2 | 1997-05-02 |
| Phonic Ear, Inc. | 1 | 2004-12-23 |
| Bellab | 1 | 1997-03-26 |
| National Hearing Aid Dist., Inc. | 1 | 1995-06-21 |
| Je Liss & Co., Inc. | 1 | 1994-02-07 |
1 more applicants have LZI clearances. See the full list in Caduvo.
Most recent LZI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K043090 | Phonic Ear, Inc. | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS | 2004-12-23 | 45 |
| K970974 | Williams Sound, LLC | WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER | 1997-05-02 | 46 |
| K970340 | Bellab | AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER | 1997-03-26 | 56 |
| K954748 | Williams Sound, LLC | POCKETALKER PRO | 1995-11-22 | 37 |
| K952057 | National Hearing Aid Dist., Inc. | LISTENAIDER II | 1995-06-21 | 50 |
Recalls for LZI devices
openFDA lists no recalls for product code LZI.
Frequently asked questions
What is FDA product code LZI?
LZI is the FDA product code for device, assistive listening. 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 LZI?
Class II, regulation 21 CFR 874.3320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LZI?
Across 7 cleared submissions the average was 66 days from receipt to decision (median 50).
Which companies have the most LZI clearances?
Williams Sound, LLC (2); Phonic Ear, Inc. (1); Bellab (1); National Hearing Aid Dist., Inc. (1); Je Liss & Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LZI
- Run a recall and safety report across every LZI manufacturer
- Watch product code LZI 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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