The following data is part of a De Novo classification by Auric Hearing Systems, Inc. with the FDA for Retrox.
| DeNovo ID | DEN020003 |
| Device Name: | RETROX |
| Classification | Hearing Aid, Air Conduction, Transcutaneous System |
| Applicant | AURIC HEARING SYSTEMS, INC. 8 Fenno Way Nahant, MA 01908 |
| Contact | David J Navaroli |
| Product Code | NIX |
| CFR Regulation Number | 874.3950 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K013298 |
| Review Advisory Board | Ear Nose & Throat |
| Classification Advisory | Ear Nose & Throat |
| Type | Post-NSE |
| Date Received | 2002-06-21 |
| Decision Date | 2002-08-20 |
| Reclassification Order: | Reclassification Order |