Is this your brand? Sign in to claim ownership.
Sign in to claim this brandZhongshan Tianle Hearing Technology Co., Ltd.
US
Last updated May 23, 2026
What Zhongshan Tianle Hearing Technology Co., Ltd. makes
The company manufactures air-conduction hearing aids designed for different ear placements, including canal, behind-the-ear, in-the-ear, and wearable case styles. It also produces wireless hearing aid accessories, such as neck induction loops for improved audio input.
These devices are classified under FDA regulations as Class I and Class II, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates with a presence 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 Zhongshan Tianle Hearing Technology Co., Ltd. manufacture?
Zhongshan Tianle Hearing Technology Co., Ltd. specializes in air-conduction hearing aids, which are designed to amplify sound for individuals with hearing loss. Their product range includes canal, behind-the-ear, in-the-ear, and wearable case hearing aids, as well as wireless accessories like neck induction loops. These devices are tailored to different ear placements and audio input needs.
Where is Zhongshan Tianle Hearing Technology Co., Ltd. based?
The company has a presence in the United States, though its primary manufacturing operations are likely based in China (as inferred from the company name). The U.S. presence suggests it may serve the American market directly or through distributors.
Which regulatory registries list devices from Zhongshan Tianle Hearing Technology Co., Ltd.?
Devices from Zhongshan Tianle Hearing Technology Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory requirements.
How are the hearing aids manufactured by Zhongshan Tianle Hearing Technology Co., Ltd. classified under FDA regulations?
The company’s hearing aids fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may have fewer regulatory controls, while Class II devices require stricter oversight due to moderate risk. The classification depends on factors like the device’s intended use and potential health impact.
What distinguishes the wireless accessories produced by Zhongshan Tianle Hearing Technology Co., Ltd.?
The wireless accessories, such as neck induction loops, are designed to enhance audio input for hearing aids by transmitting sound wirelessly. These devices improve accessibility for users by reducing reliance on direct sound conduction, making them particularly useful in environments where traditional audio sources (like microphones) are present.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 546790267
Catalogue (584)
Page 11 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tianle | TL-119M | FDA UDI | Class II | Active |
| Tianle | TL-616 | FDA UDI | Class I | Active |
| Tianle | TL-518M | FDA UDI | Class II | Active |
| Tianle | TL-008AG | FDA UDI | Class II | Active |
| Tianle | TL-612F | FDA UDI | Class I | Active |
| Tianle | TW-811M | FDA UDI | Class II | Active |
| Tianle | TF-955 | FDA UDI | Class I | Active |
| Tianle | TF-960 | FDA UDI | Class I | Active |
| Tianle | TF-965F | FDA UDI | Class I | Active |
| Tianle | TL-116F | FDA UDI | Class I | Active |
| Tianle | TL-516M | FDA UDI | Class II | Active |
| Tianle | HA-93F | FDA UDI | Class I | Active |
| Tianle | TY-8009G | FDA UDI | Class II | Active |
| Tianle | TL-212M | FDA UDI | Class II | Active |
| Tianle | TL-628M | FDA UDI | Class II | Active |
| Tianle | TF-963F | FDA UDI | Class I | Active |
| Tianle | TY-8011 | FDA UDI | Class I | Active |
| Tianle | TY-8010M | FDA UDI | Class II | Active |
| Tianle | TW-919G | FDA UDI | Class II | Active |
| Tianle | TL-317F | FDA UDI | Class I | Active |
| Tianle | TL-628F | FDA UDI | Class I | Active |
| Tianle | TS-6119M | FDA UDI | Class II | Active |
| Tianle | TL-219M | FDA UDI | Class II | Active |
| Tianle | HA-98M | FDA UDI | Class II | Active |
| Tianle | TL-317G | FDA UDI | Class II | Active |
| Tianle | HA-9813F | FDA UDI | Class I | Active |
| Tianle | TE-008G | FDA UDI | Class II | Active |
| Tianle | TY-8005 | FDA UDI | Class I | Active |
| Tianle | TS-6112M | FDA UDI | Class II | Active |
| Tianle | TE-200M | FDA UDI | Class II | Active |
| Tianle | TL-113F | FDA UDI | Class I | Active |
| Tianle | TL-638M | FDA UDI | Class II | Active |
| Tianle | TY-8002G | FDA UDI | Class II | Active |
| Tianle | HA-9828F | FDA UDI | Class I | Active |
| Tianle | TW-811F | FDA UDI | Class I | Active |
| Tianle | HA-9826G | FDA UDI | Class II | Active |
| Tianle | TS-6116 | FDA UDI | Class I | Active |
| Tianle | TS-6215G | FDA UDI | Class II | Active |
| Tianle | TE-005M | FDA UDI | Class II | Active |
| Tianle | TW-912G | FDA UDI | Class II | Active |
| Tianle | TS-6212M | FDA UDI | Class II | Active |
| Tianle | HA-95M | FDA UDI | Class II | Active |
| Tianle | TF-963G | FDA UDI | Class II | Active |
| Tianle | TE-200G | FDA UDI | Class II | Active |
| Tianle | HA-93M | FDA UDI | Class II | Active |
| Tianle | TL-638G | FDA UDI | Class II | Active |
| Tianle | TL-219F | FDA UDI | Class I | Active |
| Tianle | TE-009 | FDA UDI | Class I | Active |
| Tianle | TF-953G | FDA UDI | Class II | Active |
| Tianle | TL-621M | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Zhongshan Tianle Hearing Technology Co., Ltd Zhongshan Guangdong · CN FEI 3037001880