Lexie B2, Powered by Bose
Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
2manufacturers in China registered for this device type
1catalogue number
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 | Hearx SA, South Africa |
|---|---|
| FDA product code | QDD |
| Device type | Self-Fitting Air-Conduction Hearing Aid, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3325 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K211008 |
| Record published | 2022-09-09 |
| Record revised | 2023-10-06 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Special storage condition: Storage and handling temperature between 0 and 45 degrees Celsius |
| Distribution end date | 2022-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LB2001 | Withdrawn |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 |
| Braun | KAZ USA, Inc. | 1 |
| Bose Hear App | Bose Corporation | 1 |
| Bose SoundControl Hearing Aid | Bose Corporation | 1 |
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.