Starkey (Suzhou) Hearing Technology Co., Ltd.
Registered establishment in Guoxiang, Wuzhong District, Suzhou, Jiangsu, China. 3 device types.
Starkey (Suzhou) Hearing Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Masker, Tinnitus, Hearing Aid, Air-Conduction, Prescription and 1 other device type. Its earliest product listing with the FDA dates from 2007.
Registration
| Registered name | STARKEY (Suzhou) Hearing Technology Co, LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006544364 |
| FEI number | 3006544364 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 斯达克听力技术（苏州）有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Guoxiang, Wuzhong District, Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 1st Floor and East Unit of 2nd Floor |
| Postal code | 215124 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Class 2 | Audibel Invisibel Synergy, Starkey Evolv AI, Starkey Muse iQ, MicroTech esentia AI, Starkey SoundGear Phantom, Ampli-Mini E 7S and 54 more | 2013 | 29 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | Starkey Tour, MicroTech Signature Series, Starkey SoundLens Synergy, Afflelou Incognito GS AI, Starkey X Series, MicroTech Propel and 54 more | 2007 | 45 |
| Masker, Tinnitus | Class 2 | Afflelou Incognito OM AI+, NuEar NE Series AI, Miracle Ear Custom Tinnitus +, OuieZen GS AI, Miracle-Ear MEMINI, Starkey G Series AI and 14 more | 2013 | 4 |
Clearances
No clearance names Starkey (Suzhou) Hearing Technology Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K201370 | 2020-06-19 | KLW | Special | Starkey Laboratories, Inc. |
| K122876 | 2012-10-31 | KLW | Traditional | Starkey Laboratories, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Hearing aids, Omega AI series, G Series AI, Signature series, Rechargeable hearing aids |
|---|
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.
The manufacturer named here can complete this record.