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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 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Newsound | Huisheng ITE | FDA UDI | Class I | Active |
| Neosonic | Neosonic MX-Smart | FDA UDI | Class I | Active |
| Hionec | Hionec Fit | FDA UDI | Class II | Active |
| EarCentric | RIE 400 | FDA UDI | Class I | Active |
| Newsound | Neosonic Qt | FDA UDI | Class I | Active |
| Nano | First Ear Plus BTE | FDA UDI | Class I | Active |
| Imh | Legato 209 | FDA UDI | Class I | Active |
| Imh | Symphony Pro 400 | FDA UDI | Class I | Active |
| Newsound | RV4 | FDA UDI | Class I | Active |
| Newsound | SOUNDWEAR ULITE2000 R White | FDA UDI | Class II | Active |
| Newsound | Supertone I ITE | FDA UDI | Class I | Active |
| Newsound | Realtone I CIC | FDA UDI | Class I | Active |
| Newsound | EA40 | FDA UDI | Class II | Active |
| Newsound | Eartiva 500 P | FDA UDI | Class I | Active |
| Newsound | Aria 810 | FDA UDI | Class I | Active |
| Newsound | Wing 8 ITC WP | FDA UDI | Class I | Active |
| Imh | Forte 200 | FDA UDI | Class I | Active |
| Newsound | HC 206 Grey | FDA UDI | Class I | Active |
| NewSound | Primo R401 | FDA UDI | Class I | Active |
| Imh | Symphony 410 | FDA UDI | Class I | Active |
| Newsound | Poco MU803 | FDA UDI | Class II | Active |
| Newsound | POCO R101 L | FDA UDI | Class I | Active |
| Newsound | SAP40T | FDA UDI | Class I | Active |
| Newsound | SOUNDWEAR ROCEKR 202 | FDA UDI | Class I | Active |
| Newsound | Realtone | FDA UDI | Class I | Active |
| Newsound | HA-900 | FDA UDI | Class II | Active |
| Imh | Flute P ITE | FDA UDI | Class I | Active |
| Zdeer | Poco X403 | FDA UDI | Class II | Active |
| Imh | Flute S ITC | FDA UDI | Class I | Active |
| Newsound | LUX18 R(Primo R401 R) | FDA UDI | Class I | Active |
| Imh | Flute S ITE | FDA UDI | Class I | Active |
| Newsound | Primo RA801 L | FDA UDI | Class II | Active |
| Newsound | HC X Taupe | FDA UDI | Class I | Active |
| Imh | Flute H MCIC HD | FDA UDI | Class I | Active |
| Newsound | HA-302-4 Grey | FDA UDI | Class I | Active |
| Newsound | ROCKER 206D | FDA UDI | Class I | Active |
| Newsound | New TI 100 | FDA UDI | Class I | Active |
| Neosonic | Neosonic BT-Omni | FDA UDI | Class II | Active |
| Newsound | LX201 Silver | FDA UDI | Class I | Active |
| Newsound | Nano Sigma Silver | FDA UDI | Class II | Active |
| Newsound | Ulaif | FDA UDI | Class I | Active |
| Newsound | Legato 209 Beige | FDA UDI | Class I | Active |
| Newsound | Wing | FDA UDI | Class I | Active |
| Newsound | HC 206 Beige | FDA UDI | Class I | Active |
| Newsound | Primo R401 L | FDA UDI | Class I | Active |
| Newsound | Otofonix Encore Grey | FDA UDI | Class I | Active |
| Newsound | HC64 | FDA UDI | Class I | Active |
| Newsound | IRIS10S | FDA UDI | Class II | Active |
| Imh | Flute R ITC | FDA UDI | Class I | Active |
| Newsound | EU1061 | FDA UDI | Class I | Active |
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