Triad Combonation Unit
The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or…
The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or Tinnitus.
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 | General Hearing Instrument, Inc. |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| 510(k) | K974751 |
| Record published | 2016-09-29 |
| Record revised | 2022-08-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Triad Combo,Custom,Left | In distribution | |
| Triad Combo,Custom,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Grey,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Beige,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Beige,Right | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Black,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Brown,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Grey,Left | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Grey,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Black,Right | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Black,Right | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Grey,Left | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Black,Left | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Beige,Left | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Grey,Right | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Grey,Right | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Brown,Right | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Beige,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Beige,Right | In distribution | |
| Triad Combo,Custom,Right | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Brown,Left | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Brown,Left | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Brown,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Black,Pair | In distribution | |
| Triad Combo,OTE,10A,Digital,Polytube,Brown,Right | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Beige,Left | In distribution | |
| Triad Combo,OTE,10A,Digital,RIC,Black,Left | 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
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.