Tianle
Tianle’s invisible-in-the-canal wireless hearing aid is a wearable air-conduction device for a person with impaired hearing. Its microphone converts incoming sound into an electrical…
Tianle’s invisible-in-the-canal wireless hearing aid is a wearable air-conduction device for a person with impaired hearing. Its microphone converts incoming sound into an electrical signal, amplifier circuitry increases that signal, and a speaker sends the amplified sound through the ear canal.
The filed product is identified as an invisible-in-the-canal aid. FDA’s wireless air-conduction category refers to wireless technology used in programming or operation; it does not identify a particular phone connection or wireless protocol for this Tianle model.
Air-Conduction and Wireless Functions
The hearing-aid sound path and the wireless category describe separate parts of the device: the microphone, amplifier and speaker process and deliver sound, while wireless technology relates to programming or operation. NIDCD describes the general hearing-aid signal path; the exact wireless implementation depends on the model.
Who Else Makes It
Concentrated in Guangdong (33), Fujian (11), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Xiamen Retone Hearing Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Hangzhou Acosound Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Minami Medical Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 4 |
| Living Science Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Hong YU Kang Technology (Guangdong) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
Showing 12 of 52. All 52 manufacturers in China registered for Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Record
| Listed by | Zhongshan Tianle Hearing Technology Co., Ltd., China |
|---|---|
| FDA product code | QUG |
| Device type | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3305 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TL-118G | In distribution | |
| TL-112G | In distribution | |
| TY-8015G | In distribution | |
| TS-6120G | In distribution | |
| TF-952G | In distribution | |
| TW-912G | In distribution | |
| TL-211G | In distribution | |
| TW-815G | In distribution | |
| TW-918G | In distribution | |
| TW-813G | In distribution | |
| TL-311G | In distribution | |
| HA-9825G | In distribution | |
| TL-636G | In distribution | |
| HA-93G | In distribution | |
| TF-963G | In distribution | |
| TS-6116G | In distribution | |
| TL-635G | In distribution | |
| TL-007AG | In distribution | |
| TL-008AG | In distribution | |
| TE-200G | In distribution | |
| TL-629G | In distribution | |
| TY-8006G | In distribution | |
| TL-219G | In distribution | |
| TY-8018G | In distribution | |
| TS-6213G | In distribution | |
| TF-953G | In distribution | |
| TW-816G | In distribution | |
| TL-630G | In distribution | |
| TS-6119G | In distribution | |
| HA-98G | In distribution | |
| TL-633G | In distribution | |
| TE-113G | In distribution | |
| TY-8010G | In distribution | |
| TF-966G | In distribution | |
| TF-961G | In distribution | |
| TW-911G | In distribution | |
| HA-9829G | In distribution | |
| TL-317G | In distribution | |
| TL-632G | In distribution | |
| TY-8005G | In distribution | |
| TL-618G | In distribution | |
| TL-617G | In distribution | |
| TS-6216G | In distribution | |
| TL-318G | In distribution | |
| TL-519G | In distribution | |
| TW-919G | In distribution | |
| TL-516G | In distribution | |
| TL-218G | In distribution | |
| TF-950G | In distribution | |
| TE-116G | In distribution | |
| TL-639G | In distribution | |
| TF-951G | In distribution | |
| HA-9826G | In distribution | |
| TF-960G | In distribution | |
| TL-315G | In distribution | |
| TF-955G | In distribution | |
| TF-956G | In distribution | |
| TW-916G | In distribution | |
| TL-117G | In distribution | |
| TL-116G | In distribution | |
| TY-8016G | In distribution | |
| TL-312G | In distribution | |
| TL-650G | In distribution | |
| TL-638G | In distribution | |
| TW-915G | In distribution | |
| TF-968G | In distribution | |
| TE-213G | In distribution | |
| TE-009G | In distribution | |
| TY-8002G | In distribution | |
| TE-006G | In distribution | |
| HA-95G | In distribution | |
| TL-628G | In distribution | |
| HA-9828G | In distribution | |
| TY-8011G | In distribution | |
| TL-316G | In distribution | |
| TL-518G | In distribution | |
| TL-615G | In distribution | |
| TY-8003G | In distribution | |
| TF-964G | In distribution | |
| TL-515G | In distribution | |
| HA-9812G | In distribution | |
| HA-9822G | In distribution | |
| HA-9813G | In distribution | |
| TE-112G | In distribution | |
| TL-319G | In distribution | |
| TS-6218G | In distribution | |
| TL-313G | In distribution | |
| TS-6220G | In distribution | |
| TL-113G | In distribution | |
| TE-119G | In distribution | |
| TF-957G | In distribution | |
| TL-212G | In distribution | |
| TS-6112G | In distribution | |
| HA-9816G | In distribution | |
| HA-93CG | In distribution | |
| TY-8012G | In distribution | |
| TE-007G | In distribution | |
| TW-920G | In distribution | |
| TL-611G | In distribution | |
| TF-959G | In distribution | |
| TL-612G | In distribution | |
| TY-8013G | In distribution | |
| TW-818G | In distribution | |
| TW-811G | In distribution | |
| TS-6118G | In distribution | |
| TE-211G | In distribution | |
| HA-9858G | In distribution | |
| TY-8009G | In distribution | |
| TL-631G | In distribution | |
| TL-115G | In distribution | |
| TL-616G | In distribution | |
| TL-621G | In distribution | |
| TL-623G | In distribution | |
| TL-216G | In distribution | |
| TL-622G | In distribution | |
| TS-6219G | In distribution | |
| TL-009AG | In distribution | |
| TE-004G | In distribution | |
| TS-6226G | In distribution | |
| TE-003G | In distribution | |
| TL-119G | In distribution | |
| TY-8008G | In distribution | |
| HA-96G | In distribution | |
| TL-626G | In distribution | |
| TY-8001G | In distribution | |
| TS-6113G | In distribution | |
| TW-913G | In distribution | |
| TW-812G | In distribution | |
| TE-002G | In distribution | |
| TS-6215G | In distribution | |
| TE-212G | In distribution | |
| TS-6115G | In distribution | |
| TL-652G | In distribution | |
| TE-115G | In distribution | |
| TF-965G | In distribution | |
| TL-651G | In distribution | |
| TW-819G | In distribution | |
| TE-008G | In distribution | |
| TS-6212G | In distribution | |
| TE-005G | In distribution | |
| TF-958G | In distribution | |
| TL-625G | In distribution | |
| TL-213G | In distribution | |
| HA-9818G | In distribution | |
| TL-613G | In distribution | |
| TF-962G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Hearing | GN Hearing A/S | 82 |
| Tomore | Tomore Medical (Shenzhen) Co., Ltd. | 62 |
| Tomore | Tomore Healthcare (Dongguan) Co., Ltd. | 44 |
| Austar | Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. | 42 |
| Lucid® | Hearing LAB Technology, LLC | 36 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Blue Deer Medical Equipment (Guangdong) Co., Ltd. | 28 |
| Lucid Hearing® | Hearing LAB Technology, LLC | 25 |
| AcoSound | Hangzhou Acosound Technology Co., Ltd. | 18 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Yeasound (Xiamen) Hearing Technology Co., Ltd. | 15 |
| Jiuyee, Smart Bluetooth Hearing Aid (RIC) | Hunan Jiuyee Medical Technology Co., Ltd. | 12 |
| Cearvol | Shenzhen Cannice Technology Co., Ltd. | 12 |
| NoviMed Hearing | Novidan, Inc. | 8 |
Showing 12 of 79. All products under Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.