Bose SoundControl Hearing Aid
A self-fitting wireless air conduction hearing aid.
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
Record
| Listed by | Bose Corporation, United States |
|---|---|
| FDA product code | QDD |
| Device type | Self-Fitting Air-Conduction Hearing Aid, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3325 |
| Record published | 2021-05-18 |
| Record revised | 2022-10-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature 0 to 45 °C |
| Packaging | Pack of 6 |
| Distribution end date | 2022-10-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BMD0012 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Hearing | GN Hearing A/S | 17 |
| Sony | WS Audiology USA, Inc. | 3 |
| Eargo RX | Eargo Inc | 2 |
| Lexie Hearing | Hearx SA | 2 |
| Lexie B1, Powered by Bose | Hearx SA | 1 |
| Lexie B2, Powered by Bose | Hearx SA | 1 |
| Braun | KAZ USA, Inc. | 1 |
| Bose Hear App | Bose Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211008 | 2021-05-05 |
| DEN180026 | 2018-10-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.