Tranquil I OTE
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer…
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from 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) | K061459 |
| Record published | 2016-09-28 |
| 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 |
|---|---|---|
| Tranquil I,OTE,10A,Digital,Black,Left | In distribution | |
| Tranquil I,OTE,10A,Digital,Beige,Pair | In distribution | |
| Tranquil I,OTE,10A,Digital,Beige,Right | In distribution | |
| Tranquil I,OTE,10A,Digital,Grey,Pair | In distribution | |
| Tranquil I,OTE,10A,Digital,Grey,Left | In distribution | |
| Tranquil I,OTE,10A,Digital,Brown,Pair | In distribution | |
| Tranquil I,OTE,10A,Digital,Black,Right | In distribution | |
| Tranquil I,OTE,10A,Digital,Black,Pair | In distribution | |
| Tranquil I,OTE,10A,Digital,Brown,Left | In distribution | |
| Tranquil I,OTE,10A,Digital,Beige,Left | In distribution | |
| Tranquil I,OTE,10A,Digital,Grey,Right | In distribution | |
| Tranquil I,OTE,10A,Digital,Brown,Right | 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.