Question 1

What types of medical devices does Zhongshan Tianle Hearing Technology Co., Ltd. manufacture?

Accepted Answer

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.

Question 2

Where is Zhongshan Tianle Hearing Technology Co., Ltd. based?

Accepted Answer

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.

Question 3

Which regulatory registries list devices from Zhongshan Tianle Hearing Technology Co., Ltd.?

Accepted Answer

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.

Question 4

How are the hearing aids manufactured by Zhongshan Tianle Hearing Technology Co., Ltd. classified under FDA regulations?

Accepted Answer

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.

Question 5

What distinguishes the wireless accessories produced by Zhongshan Tianle Hearing Technology Co., Ltd.?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Tianle	TW-813G	FDA UDI	Class II	Active
Tianle	HA-9828M	FDA UDI	Class II	Active
Tianle	TE-005F	FDA UDI	Class I	Active
Tianle	HA-9818M	FDA UDI	Class II	Active
Tianle	TL-626	FDA UDI	Class I	Active
Tianle	TL-628G	FDA UDI	Class II	Active
Tianle	TE-003F	FDA UDI	Class I	Active
Tianle	TW-819	FDA UDI	Class I	Active
Tianle	TF-965	FDA UDI	Class I	Active
Tianle	TE-004M	FDA UDI	Class II	Active
Tianle	TL-626G	FDA UDI	Class II	Active
Tianle	TL-518F	FDA UDI	Class I	Active
Tianle	TW-915F	FDA UDI	Class I	Active
Tianle	TE-211	FDA UDI	Class I	Active
Tianle	TL-516F	FDA UDI	Class I	Active
Tianle	HA-9813G	FDA UDI	Class II	Active
Tianle	TL-629M	FDA UDI	Class II	Active
Tianle	TL-112F	FDA UDI	Class I	Active
Tianle	TL-635	FDA UDI	Class I	Active
Tianle	TE-112F	FDA UDI	Class I	Active
Tianle	TE-008F	FDA UDI	Class I	Active
Tianle	TL-211	FDA UDI	Class I	Active
Tianle	TW-813	FDA UDI	Class I	Active
Tianle	TL-315M	FDA UDI	Class II	Active
Tianle	TE-115G	FDA UDI	Class II	Active
Tianle	TL-119F	FDA UDI	Class I	Active
Tianle	TY-8016	FDA UDI	Class I	Active
Tianle	TL-316F	FDA UDI	Class I	Active
Tianle	TL-211G	FDA UDI	Class II	Active
Tianle	TY-8009	FDA UDI	Class I	Active
Tianle	TS-6115G	FDA UDI	Class II	Active
Tianle	TE-200	FDA UDI	Class I	Active
Tianle	TL-616F	FDA UDI	Class I	Active
Tianle	HA-93G	FDA UDI	Class II	Active

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