FDA product code LRB: Face Plate Hearing Aid
LRB is the FDA product code for face plate hearing aid. It is a Class I device, regulated under 21 CFR 874.3300 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 24 510(k) submissions under LRB, from 11 different applicants. The average 510(k) review took 105 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Face Plate Hearing Aid |
| Device class | Class I |
| Regulation | 21 CFR 874.3300 |
| 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 LRB clearance
Top LRB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electone, Inc. | 9 | 1994-09-06 |
| Telex Communications, Inc. | 3 | 1994-02-09 |
| Audina Hearing Instrument | 2 | 1994-06-17 |
| Richards Medical Co., Inc. | 2 | 1987-12-08 |
| Maico Hearing Instruments, Inc. | 2 | 1986-08-13 |
6 more applicants have LRB clearances. See the full list in Caduvo.
Most recent LRB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974219 | Finetone Hearing Instruments | FACEPLATE ASSEMBLY | 1998-02-20 | 102 |
| K961593 | Segi Hearing Aid Co. | INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS | 1996-11-07 | 197 |
| K942722 | Electone, Inc. | MODULE PROGRAM | 1994-09-06 | 89 |
| K942236 | Audina Hearing Instrument | AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) | 1994-06-17 | 39 |
| K935048 | Telex Communications, Inc. | ARTISAN PROGRAMMER & HEARING AID | 1994-02-09 | 111 |
Recalls for LRB devices
openFDA lists no recalls for product code LRB.
Frequently asked questions
What is FDA product code LRB?
LRB is the FDA product code for face plate hearing aid. It is a Class I device, regulated under 21 CFR 874.3300 and reviewed by the Ear, Nose and Throat panel.
What device class is LRB?
Class I, regulation 21 CFR 874.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRB?
Across 24 cleared submissions the average was 105 days from receipt to decision (median 96).
Which companies have the most LRB clearances?
Electone, Inc. (9); Telex Communications, Inc. (3); Audina Hearing Instrument (2); Richards Medical Co., Inc. (2); Maico Hearing Instruments, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LRB
- Run a recall and safety report across every LRB manufacturer
- Watch product code LRB 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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