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Sign in to claim this brandAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.
US
Last updated May 26, 2026
What Austar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd. makes
The company designs and manufactures air-conduction hearing aids in three form factors: behind-the-ear, in-the-ear, and receiver-in-the-ear models. These devices are intended for individuals with mild to severe hearing loss, providing customised amplification solutions.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with listings in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Austar Hearing Science & Technology (Xiamen) Co., Ltd. manufacture?
Austar Hearing Science & Technology (Xiamen) Co., Ltd. specialises in air-conduction hearing aids, which are devices designed to amplify sound for individuals with hearing loss. Their portfolio includes three primary form factors: behind-the-ear (BTE), in-the-ear (ITE), and receiver-in-the-ear (RITE) models. These devices are tailored to address mild to severe hearing impairments by delivering customised amplification solutions.
Where is Austar Hearing Science & Technology (Xiamen) Co., Ltd. based?
The company is based in the United States. This location is relevant for regulatory oversight and compliance, as it aligns with the FDA’s jurisdiction over medical devices marketed in the US.
Which regulatory registries list Austar Hearing Science & Technology (Xiamen) Co., Ltd.’s devices?
Austar’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a global standard for identifying medical devices, ensuring traceability and transparency in regulatory tracking. This listing helps healthcare providers and regulators verify the identity and classification of their hearing aids.
How are Austar Hearing Science & Technology (Xiamen) Co., Ltd.’s hearing aids classified under regulatory frameworks?
Austar’s hearing aids fall into two regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory controls, while Class II devices involve a higher level of risk and require premarket notification (510(k)) or other regulatory submissions to demonstrate safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and design complexity.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 547919154
Catalogue (179)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Austar | FHE409 | FDA UDI | Class I | Active |
| Austar | SU05 | FDA UDI | Class I | Active |
| Austar | FHE509-B | FDA UDI | Class II | Unknown |
| Austar | FH204-B | FDA UDI | Class II | Unknown |
| Austar | FH209-B | FDA UDI | Class II | Unknown |
| Austar | FH310-B | FDA UDI | Class II | Unknown |
| Austar | FH210 | FDA UDI | Class I | Active |
| Austar | FH211 | FDA UDI | Class I | Active |
| Austar | FH204 | FDA UDI | Class I | Active |
| Austar | FH207-B | FDA UDI | Class II | Unknown |
| Austar | FHE403 | FDA UDI | Class I | Active |
| Austar | FH303-B | FDA UDI | Class II | Unknown |
| Austar | FHE412-B | FDA UDI | Class II | Unknown |
| Austar | FHE409-B | FDA UDI | Class II | Unknown |
| Austar | FHE504 | FDA UDI | Class I | Active |
| Austar | FH305-B | FDA UDI | Class II | Unknown |
| Austar | FHE509 | FDA UDI | Class I | Active |
| Austar | FH209-B | FDA UDI | Class II | Unknown |
| Austar | FHE507 | FDA UDI | Class I | Active |
| Austar | FH307-B | FDA UDI | Class II | Unknown |
| Austar | FH212 | FDA UDI | Class I | Active |
| Austar | FHE507-B | FDA UDI | Class II | Unknown |
| Austar | FHE404 | FDA UDI | Class I | Active |
| Austar | FH308 | FDA UDI | Class I | Active |
| Austar | J307 | FDA UDI | Class I | Active |
| Austar | FH304 | FDA UDI | Class I | Active |
| Austar | FH306-B | FDA UDI | Class II | Unknown |
| Austar | FH212-B | FDA UDI | Class II | Unknown |
| Austar | RS13A | FDA UDI | Class I | Active |
| Austar | FHE407-B | FDA UDI | Class II | Unknown |
| Austar | FHE506-B | FDA UDI | Class II | Unknown |
| Austar | FHW120-W | FDA UDI | Class II | Active |
| Austar | FH311-B | FDA UDI | Class II | Unknown |
| Austar | FH209 | FDA UDI | Class I | Active |
| Austar | FHE510 | FDA UDI | Class I | Active |
| Austar | FH203-B | FDA UDI | Class II | Unknown |
| Austar | FHE412 | FDA UDI | Class I | Active |
| Austar | FH309 | FDA UDI | Class I | Active |
| Austar | FH212-B | FDA UDI | Class II | Unknown |
| Austar | FH306-B | FDA UDI | Class II | Unknown |
| Austar | FH309-B | FDA UDI | Class II | Unknown |
| Austar | FHE503 | FDA UDI | Class I | Active |
| Austar | FH211-B | FDA UDI | Class II | Unknown |
| Austar | FHE403-B | FDA UDI | Class II | Unknown |
| Austar | D-L-C2B | FDA UDI | Class I | Active |
| Austar | FHE506 | FDA UDI | Class I | Active |
| Austar | FHE406-B | FDA UDI | Class II | Unknown |
| Austar | FH303 | FDA UDI | Class I | Active |
| Austar | FHE403 | FDA UDI | Class I | Active |
| Austar | ALD-L1A | FDA UDI | Class I | Unknown |
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