FDA product code LEZ: Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
LEZ is the FDA product code for aids, speech training for the hearing impaired (ac-powered and patient-contact). It is a Unclassified device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under LEZ, from 3 different applicants. The average 510(k) review took 57 days (median 67). FDA has posted 1 recall for LEZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact) |
| Device class | Unclassified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LEZ clearance
Top LEZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lsvt Global, LLC | 1 | 2009-08-20 |
| Rsq, LLC | 1 | 1998-09-14 |
| Kindel & Anderson | 1 | 1980-12-17 |
Most recent LEZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091682 | Lsvt Global, LLC | LSVT C OR LSVT COMPANION, MODEL V.1 | 2009-08-20 | 71 |
| K982396 | Rsq, LLC | VISIVOX, MODEL V-2 | 1998-09-14 | 67 |
| K802870 | Kindel & Anderson | RION ELECTRO-PALATOGRAPH MODEL DP-01 | 1980-12-17 | 33 |
Recalls for LEZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-07-01.
Frequently asked questions
What is FDA product code LEZ?
LEZ is the FDA product code for aids, speech training for the hearing impaired (ac-powered and patient-contact). It is a Unclassified device, reviewed by the Ear, Nose and Throat panel.
What device class is LEZ?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LEZ?
Across 3 cleared submissions the average was 57 days from receipt to decision (median 67).
Which companies have the most LEZ clearances?
Lsvt Global, LLC (1); Rsq, LLC (1); Kindel & Anderson (1).
Have LEZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code LEZ
- Run a recall and safety report across every LEZ manufacturer
- Watch product code LEZ 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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