Lexie Hearing
Lexie Hearing Club (Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Bundle)
4manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Luxshare Electronic Technology (Kunshan) Ltd. | Kunshan | Jiangsu | Contract manufacturer | 1 |
| Maintek Computer (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Hearx SA, South Africa |
|---|---|
| FDA product code | QUH |
| Device type | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3325 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K211008 |
| Record published | 2023-06-28 |
| Record revised | 2023-10-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-02-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Lexie Lumen Duo Beige | In distribution | |
| Lexie Lumen Duo Light Gray | In distribution | |
| Lexie Lumen Duo Gray | In distribution | |
| Lexie Lumen Duo Silver | In distribution | |
| Lexie B2 Powered by Bose (AARP Bundle) | In distribution | |
| Refurbished Lexie B2 Plus Powered by Bose | In distribution | |
| Lexie Lumen Duo Bronze | In distribution | |
| Lexie Lumen Duo Metalic Black | In distribution | |
| Refurbished Lexie B1 Powered by Bose | In distribution | |
| Refurbished Lexie B2 Powered by Bose | In distribution | |
| Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eargo SE | Eargo Inc | 16 |
| Soundwave Hearing | Soundwave Hearing, LLC | 14 |
| GN Hearing | GN Hearing A/S | 13 |
| Sontro Self-Fitting OTC Hearing Aids | Soundwave Hearing, LLC | 12 |
| Eargo 5 | Eargo Inc | 12 |
| Eargo 8 | Eargo Inc | 11 |
| Sony | WS Audiology USA, Inc. | 5 |
| Eargo 6 | Eargo Inc | 3 |
| Eargo 7 | Eargo Inc | 3 |
| Sonova Brand (multiple brand) | Sonova AG | 3 |
| Audialnet | Huizhou Jinghao Medical Technology Co., Ltd. | 2 |
| hear.com | WS Audiology USA, Inc. | 2 |
Showing 12 of 28. All products under Self-Fitting Air-Conduction Hearing Aid, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223137 | 2023-03-14 |
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.