FDA product code LRA: Hearing Aid, Tactile
LRA is the FDA product code for hearing aid, tactile. It is a Unclassified device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 8 510(k) submissions under LRA, from 8 different applicants. The average 510(k) review took 65 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Hearing Aid, Tactile |
| Device class | Unclassified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LRA clearance
Top LRA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sevrain-Tech, Inc. | 1 | 1988-11-17 |
| Institute of Logopedics | 1 | 1986-09-12 |
| Medecon | 1 | 1985-06-27 |
| Monargue Intl. | 1 | 1985-06-20 |
| Spectro Industries, Inc. | 1 | 1984-11-14 |
3 more applicants have LRA clearances. See the full list in Caduvo.
Most recent LRA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883853 | Sevrain-Tech, Inc. | ETA | 1988-11-17 | 65 |
| K862471 | Institute of Logopedics | WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER | 1986-09-12 | 74 |
| K851441 | Medecon | TACTICON 1600 | 1985-06-27 | 78 |
| K851655 | Monargue Intl. | TEACHER TM | 1985-06-20 | 59 |
| K843433 | Spectro Industries, Inc. | KANIEVSKI SENSORY AID OR DEVICE | 1984-11-14 | 71 |
Recalls for LRA devices
openFDA lists no recalls for product code LRA.
Frequently asked questions
What is FDA product code LRA?
LRA is the FDA product code for hearing aid, tactile. It is a Unclassified device, reviewed by the Ear, Nose and Throat panel.
What device class is LRA?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LRA?
Across 8 cleared submissions the average was 65 days from receipt to decision (median 68).
Which companies have the most LRA clearances?
Sevrain-Tech, Inc. (1); Institute of Logopedics (1); Medecon (1); Monargue Intl. (1); Spectro Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LRA
- Run a recall and safety report across every LRA manufacturer
- Watch product code LRA 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times