The following data is part of a De Novo classification by Bose Corporation with the FDA for Bose Hearing Aid.
| DeNovo ID | DEN180026 |
| Device Name: | Bose Hearing Aid |
| Classification | Self-fitting Air-conduction Hearing Aid |
| Applicant | Bose Corporation the Mountain Framingham, MA 01701 |
| Contact | James Yeagle |
| Product Code | QDD |
| CFR Regulation Number | 874.3325 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ear Nose & Throat |
| Classification Advisory | Ear Nose & Throat |
| Type | Direct |
| Date Received | 2018-05-11 |
| Decision Date | 2018-10-05 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |