Ceretone
OTC Hearing Aids, Color:Silver grey
4manufacturers in China registered for this device type
1catalogue number
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 | Audicon Corporation, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K221052 |
| Record published | 2024-09-04 |
| Record revised | 2025-11-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Inner pack of 2, case of 20, case of 40, pallet of 495 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Beacon | In distribution |
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 |
| Lexie Hearing | Hearx SA | 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 |
Showing 12 of 28. All products under Self-Fitting Air-Conduction Hearing Aid, Over The Counter
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.