ALL American
38 catalogue numbers from PRIDE 2400 BTE 312, listed by Starkey Laboratories, Inc., United States, under Masker, Tinnitus. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
38catalogue numbers in this listing
10510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (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 |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Starkey Laboratories, Inc., United States |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Manufacturer |
| Record published | 2016-10-07 |
| Record revised | 2025-08-20 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 60 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRIDE 2400 BTE 312 | In distribution | |
| PRIDE I2400 HALF SHELL | In distribution | |
| PRIDE 1200 HALF SHELL | In distribution | |
| PRIDE 2400 BTE 312 | In distribution | |
| PRIDE 1000 ITC | In distribution | |
| PRIDE I2000 BTE 312 | In distribution | |
| PRIDE 1200 MRIC 312 | In distribution | |
| PRIDE 1000 CIC | In distribution | |
| PRIDE 2400 MRIC 312 | In distribution | |
| PRIDE 2400 HALF SHELL | In distribution | |
| PRIDE I2400 ITE | In distribution | |
| PRIDE I2400 MRIC 312 | In distribution | |
| HONOR I1600 RIC 13 | In distribution | |
| PRIDE 2000 MRIC 312 | In distribution | |
| PRIDE I2400 ITC | In distribution | |
| PRIDE I1600 ITC | In distribution | |
| PRIDE 2400 CIC | In distribution | |
| PRIDE I2400 HALF SHELL | In distribution | |
| PRIDE I2400 CIC | In distribution | |
| PRIDE 1600 ITE | In distribution | |
| PRIDE CROSBICROS MRIC 312 | In distribution | |
| PRIDE I1600 IIC | In distribution | |
| PRIDE 2000 IIC | In distribution | |
| PRIDE 2000 CIC | In distribution | |
| PRIDE I1000 MRIC 312 | In distribution | |
| PRIDE 1200 CIC | In distribution | |
| PRIDE 1600 CIC | In distribution | |
| PRIDE I2400 BTE 312 | In distribution | |
| PRIDE 1600 CIC | In distribution | |
| PRIDE I1200 HALF SHELL | In distribution | |
| PRIDE 1000 ITE | In distribution | |
| PRIDE 1200 ITC | In distribution | |
| PRIDE I1600 CIC | In distribution | |
| PRIDE I1200 BTE 312 | In distribution | |
| PRIDE 2400 IIC | In distribution | |
| HONOR I2400 RIC 13 | In distribution | |
| PRIDE I1000 CIC | In distribution | |
| HONOR I2000 RIC 13 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Phonak | Sonova AG | 448 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Audibel | Starkey Laboratories, Inc. | 318 |
| Unitron | Unitron Hearing Division | 292 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
Showing 12 of 86. All products under Masker, Tinnitus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201370 | 2020-06-19 |
| K122876 | 2012-10-31 |
| K030180 | 2003-09-17 |
| K964216 | 1996-12-06 |
| K963838 | 1996-11-26 |
| K963995 | 1996-11-26 |
| K791790 | 1979-10-26 |
| K791142 | 1979-09-28 |
| K791071 | 1979-07-03 |
| K781798 | 1978-11-03 |
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.