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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 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Newsound | SOUNDWEAR VIVO108 | FDA UDI | Class I | Active |
| Imh | Flute W CIC WP | FDA UDI | Class I | Active |
| Newsound | BW51 | FDA UDI | Class I | Active |
| Imh | Flute P ITC P | FDA UDI | Class I | Active |
| Newsound | Asana pro 200 | FDA UDI | Class I | Active |
| Newsound | HC X Grey | FDA UDI | Class I | Active |
| Newsound | POCO SA801 R | FDA UDI | Class II | Active |
| Newsound | Primo RA801 R | FDA UDI | Class II | Active |
| Imh | Flute R CIC HD | FDA UDI | Class I | Active |
| Newsound | Otofonix Encore Beige | FDA UDI | Class I | Active |
| Newsound | Nano-SIGMA-Plus-B | FDA UDI | Class II | Active |
| Newsound | HearIQ 4 | FDA UDI | Class II | Active |
| Newsound | HCZ3 Beige | FDA UDI | Class I | Active |
| Newsound | Van 401 | FDA UDI | Class I | Active |
| Newsound | LUX 10 | FDA UDI | Class I | Active |
| Newsound | EU1080P | FDA UDI | Class I | Active |
| Newsound | POCO SA801 L | FDA UDI | Class II | Active |
| Newsound | EON | FDA UDI | Class II | Active |
| Imh | Flute R CIC | FDA UDI | Class I | Active |
| Newsound | Bee 100 | FDA UDI | Class I | Active |
| Newsound | Primo P200 | FDA UDI | Class I | Active |
| Imh | Flute H CIC | FDA UDI | Class I | Active |
| Newsound | EUBW21 | FDA UDI | Class I | Active |
| Newsound | Supertone I ITC | FDA UDI | Class I | Active |
| Newsound | Aria 200 | FDA UDI | Class I | Active |
| Newsound | Clarity10 | FDA UDI | Class I | Active |
| NewSound | Poco XA601 | FDA UDI | Class II | Active |
| Newsound | HCGO Beige | FDA UDI | Class I | Active |
| Newsound | Forte MA801 | FDA UDI | Class II | Active |
| Newsound | DX800 | FDA UDI | Class I | Active |
| Newsound | Poco X808 | FDA UDI | Class II | Active |
| Newsound | Medley RC600 | FDA UDI | Class I | Active |
| Newsound | Realtone I ITC HD | FDA UDI | Class I | Active |
| Newsound | EU1021 | FDA UDI | Class I | Active |
| Imh | Symphony 810 | FDA UDI | Class I | Active |
| Vivtone | Xpure | FDA UDI | Class I | Active |
| Newsound | SOUNDWEAR PRIMO U600 | FDA UDI | Class I | Active |
| Newsound | LUX 12 L | FDA UDI | Class I | Active |
| Newsound | Poco Z401 | FDA UDI | Class I | Active |
| Newsound | Supertone | FDA UDI | Class I | Active |
| Newsound | Huisheng ITC | FDA UDI | Class I | Active |
| Newsound | Aria 800 | FDA UDI | Class I | Active |
| Imh | Dolce III 101 | FDA UDI | Class I | Active |
| Newsound | Nano Sigma Beige | FDA UDI | Class I | Active |
| Newsound | Poco X405 | FDA UDI | Class II | Active |
| Imh | Forte 400 | FDA UDI | Class I | Active |
| Newsound | HCRD Beige | FDA UDI | Class I | Active |
| Newsound | LUX 12 R | FDA UDI | Class I | Active |
| Newsound | Classic-RIC02 | FDA UDI | Class I | Active |
| Newsound | EX2 | FDA UDI | Class I | Active |
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