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Sign in to claim this brandXiamen New Sound Technology Co., Ltd.
US
Last updated May 23, 2026
What Xiamen New Sound Technology Co., Ltd. makes
Xiamen New Sound Technology Co., Ltd. manufactures air-conduction hearing aids in behind-the-ear, in-the-ear, and wearable case designs, as well as audiometer testing systems. These devices are intended for hearing assessment and amplification, including models branded as Newsound and IMH. The company also produces accessories and additional hearing aid components under the AHA Technologies brand.
The company’s products are regulated under the FDA’s Unique Device Identification (UDI) system, with devices classified as Class I and Class II. These devices are listed in the FDA’s UDI database, adhering to U.S. medical device regulations. The manufacturer 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 Xiamen New Sound Technology Co., Ltd. manufacture?
Xiamen New Sound Technology Co., Ltd. specializes in air-conduction hearing aids, which come in three primary designs: behind-the-ear, in-the-ear, and wearable cases. They also produce audiometer testing systems, which are used for hearing assessment. These devices are branded under names like Newsound and IMH, with additional hearing aid components and accessories under the AHA Technologies brand.
Where is Xiamen New Sound Technology Co., Ltd. based?
The company is based in the United States. While the name suggests an origin in China, the operational headquarters and regulatory presence are established within the U.S., aligning with its device listings and compliance requirements.
Which regulatory registries or databases list Xiamen New Sound Technology Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations, where individual devices are classified and tracked accordingly.
How are Xiamen New Sound Technology Co., Ltd.’s devices classified under U.S. regulations?
The company’s devices fall under two classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require specific controls to ensure safety and effectiveness. The classification is determined by factors like intended use, potential harm, and the duration of use.
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
- 528181200
Catalogue (219)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Newsound | LUX18 L(Primo R401 L) | FDA UDI | Class I | Active |
| Newsound | VIVE 20 | FDA UDI | Class I | Active |
| Newsound | RV4B | FDA UDI | Class I | Active |
| Newsound | POCO R101 R | FDA UDI | Class I | Active |
| Newsound | HCZ3 Taupe | FDA UDI | Class I | Active |
| Metiko | elclear 9106 | FDA UDI | Class II | Active |
| Nano | First Ear Plus ITE | FDA UDI | Class I | Active |
| Imh | Harp pro | FDA UDI | Class I | Active |
| Newsound | VIVO 202 | FDA UDI | Class I | Active |
| Newsound | LX201 Beige | FDA UDI | Class I | Active |
| Newsound | HC X Beige | FDA UDI | Class I | Active |
| Imh | Flute R ITE | FDA UDI | Class I | Active |
| Vivtone | Smart | FDA UDI | Class I | Active |
| Newsound | TactEar 801 | FDA UDI | Class I | Active |
| Imh | Symphony Pro 201 | FDA UDI | Class I | Active |
| Imh | Symphony 210 | FDA UDI | Class I | Active |
| Newsound | ARIA 206 R Pearl Gray | FDA UDI | Class I | Active |
| Newsound | EU1080 | FDA UDI | Class I | Active |
| Newsound | HA-802 Beige | FDA UDI | Class I | Active |
| Newsound | DX400 | FDA UDI | Class I | Active |
| Newsound | HCR3 Beige | FDA UDI | Class I | Active |
| Newsound | Lucid30 | FDA UDI | Class I | Active |
| Newsound | Realtone I ITE | FDA UDI | Class I | Active |
| Newsound | HCR3 Grey | FDA UDI | Class I | Active |
| Newsound | Primo SA401 | FDA UDI | Class II | Active |
| Newsound | POCO ZA401 | FDA UDI | Class II | Active |
| Newsound | Tweak Lite | FDA UDI | Class I | Active |
| Newsound | Wing 8 CIC WP | FDA UDI | Class I | Active |
| Newsound | IRIS 20 L | FDA UDI | Class II | Active |
| Imh | Dolce III 800 | FDA UDI | Class I | Active |
| Imh | Dolce III 400 | FDA UDI | Class I | Active |
| Neosonic | Poco X405 | FDA UDI | Class II | Active |
| Newsound | POCO X401 | FDA UDI | Class II | Active |
| Newsound | Neosonic MX-RIC | FDA UDI | Class I | Active |
| Newsound | Neosonic SF | FDA UDI | Class II | Active |
| Newsound | LUX14 | FDA UDI | Class I | Active |
| Newsound | ARIA 206 L Pearl Gray | FDA UDI | Class I | Active |
| Newsound | Primo S401 | FDA UDI | Class I | Active |
| Imh | Flute H ITC | FDA UDI | Class I | Active |
| Newsound | SOUNDWEAR ULITE2000 L White | FDA UDI | Class II | Active |
| Newsound | Forte SA201 | FDA UDI | Class II | Active |
| Imh | Symphony Pro 600 | FDA UDI | Class I | Active |
| Newsound | MA41T | FDA UDI | Class I | Active |
| Nano | First Ear Pro BTE | FDA UDI | Class I | Active |
| Imh | Flute W ITC WP | FDA UDI | Class I | Active |
| Newsound | Nexus HD | FDA UDI | Class II | Active |
| Newsound | Helix | FDA UDI | Class I | Active |
| Newsound | Poco X406 | FDA UDI | Class II | Active |
| Newsound | ReFocus | FDA UDI | Class I | Active |
| Newsound | Class D | FDA UDI | Class I | Active |
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