Tianle
Tianle’s invisible-in-the-canal hearing aid is a wearable air-conduction device for amplifying sound for a person with impaired hearing. Its in-canal form places the instrument within the…
Tianle’s invisible-in-the-canal hearing aid is a wearable air-conduction device for amplifying sound for a person with impaired hearing. Its in-canal form places the instrument within the ear canal, where the output speaker directs amplified sound into the ear.
A hearing aid’s microphone converts sound waves into electrical signals, and amplifier circuitry increases the signal before a speaker sends sound toward the ear. NIDCD describes the amplified vibrations as input for surviving inner-ear hair cells, which translate vibration into neural signals.
In-Canal Form
The filed device is identified as an invisible-in-the-canal aid in Tianle’s range. In-canal placement describes where the small aid sits; the acoustic path remains through air and the ear canal. Exact fit, controls and tuning depend on the specific model labeling.
Who Else Makes It
Concentrated in Guangdong (33), Fujian (9), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| 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 |
| Xiamen Melosound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 4 |
| Zhongshan Great-Ears Electronic Technology Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Eran Technology (Shenzhen)Co., Limited | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Rayson Technology (Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Winner Medical Co., Ltd. | Shenzhen | Guangdong | Specification developer | 25 |
| Cofoe Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 22 |
Showing 12 of 57. All 57 manufacturers in China registered for Hearing Aid, Air-Conduction, Over The Counter
Record
| Listed by | Zhongshan Tianle Hearing Technology Co., Ltd., China |
|---|---|
| FDA product code | QUF |
| Device type | Hearing Aid, Air-Conduction, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-27 |
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 |
|---|---|---|
| TE-200F | In distribution | |
| TL-218F | In distribution | |
| TL-213F | In distribution | |
| TL-650F | In distribution | |
| TF-959F | In distribution | |
| TL-211F | In distribution | |
| HA-9818F | In distribution | |
| TL-617F | In distribution | |
| TL-639F | In distribution | |
| TF-953F | In distribution | |
| TL-518F | In distribution | |
| TS-6213F | In distribution | |
| TL-008AF | In distribution | |
| TL-629F | In distribution | |
| TL-631F | In distribution | |
| TY-8012F | In distribution | |
| TY-8018F | In distribution | |
| TE-115F | In distribution | |
| HA-9826F | In distribution | |
| TL-113F | In distribution | |
| TS-6226F | In distribution | |
| TE-212F | In distribution | |
| TL-618F | In distribution | |
| TE-002F | In distribution | |
| TL-317F | In distribution | |
| TW-819F | In distribution | |
| HA-93CF | In distribution | |
| TL-621F | In distribution | |
| TE-005F | In distribution | |
| TS-6112F | In distribution | |
| TL-636F | In distribution | |
| TW-812F | In distribution | |
| TL-623F | In distribution | |
| TY-8015F | In distribution | |
| TF-955F | In distribution | |
| TS-6115F | In distribution | |
| TL-112F | In distribution | |
| TS-6113F | In distribution | |
| TL-319F | In distribution | |
| TY-8003F | In distribution | |
| TF-963F | In distribution | |
| TW-912F | In distribution | |
| TE-008F | In distribution | |
| TW-913F | In distribution | |
| HA-9812F | In distribution | |
| TL-216F | In distribution | |
| TL-612F | In distribution | |
| TW-813F | In distribution | |
| TL-625F | In distribution | |
| TY-8016F | In distribution | |
| TL-212F | In distribution | |
| TY-8010F | In distribution | |
| TL-635F | In distribution | |
| HA-98F | In distribution | |
| TL-638F | In distribution | |
| TL-219F | In distribution | |
| TL-316F | In distribution | |
| TL-630F | In distribution | |
| TL-119F | In distribution | |
| HA-9816F | In distribution | |
| TW-815F | In distribution | |
| TE-004F | In distribution | |
| TL-611F | In distribution | |
| TL-516F | In distribution | |
| TL-515F | In distribution | |
| TS-6119F | In distribution | |
| TF-962F | In distribution | |
| TF-960F | In distribution | |
| TS-6218F | In distribution | |
| TF-951F | In distribution | |
| TE-213F | In distribution | |
| TS-6120F | In distribution | |
| TW-919F | In distribution | |
| TW-915F | In distribution | |
| TL-116F | In distribution | |
| TL-313F | In distribution | |
| TF-968F | In distribution | |
| TL-009AF | In distribution | |
| TL-311F | In distribution | |
| TF-957F | In distribution | |
| HA-96F | In distribution | |
| TY-8011F | In distribution | |
| TW-816F | In distribution | |
| TF-961F | In distribution | |
| TW-920F | In distribution | |
| TL-118F | In distribution | |
| TE-007F | In distribution | |
| TS-6215F | In distribution | |
| TL-652F | In distribution | |
| TF-964F | In distribution | |
| TE-006F | In distribution | |
| HA-9829F | In distribution | |
| TW-818F | In distribution | |
| TL-312F | In distribution | |
| TS-6116F | In distribution | |
| TF-966F | In distribution | |
| TY-8013F | In distribution | |
| TY-8008F | In distribution | |
| TL-615F | In distribution | |
| TS-6212F | In distribution | |
| HA-93F | In distribution | |
| TL-626F | In distribution | |
| TY-8009F | In distribution | |
| TY-8002F | In distribution | |
| TE-116F | In distribution | |
| TE-009F | In distribution | |
| TY-8001F | In distribution | |
| TE-113F | In distribution | |
| TL-651F | In distribution | |
| TS-6220F | In distribution | |
| TE-211F | In distribution | |
| HA-9822F | In distribution | |
| TL-519F | In distribution | |
| HA-9825F | In distribution | |
| TY-8006F | In distribution | |
| TL-616F | In distribution | |
| TL-115F | In distribution | |
| HA-9858F | In distribution | |
| TL-315F | In distribution | |
| HA-95F | In distribution | |
| TL-632F | In distribution | |
| TW-911F | In distribution | |
| TE-003F | In distribution | |
| TF-956F | In distribution | |
| TE-112F | In distribution | |
| TS-6118F | In distribution | |
| TL-007AF | In distribution | |
| TL-613F | In distribution | |
| TW-811F | In distribution | |
| TL-628F | In distribution | |
| TY-8005F | In distribution | |
| TE-119F | In distribution | |
| TF-965F | In distribution | |
| TF-958F | In distribution | |
| TL-117F | In distribution | |
| TS-6216F | In distribution | |
| TF-950F | In distribution | |
| TL-318F | In distribution | |
| TL-622F | In distribution | |
| TW-916F | In distribution | |
| TL-633F | In distribution | |
| TS-6219F | In distribution | |
| TF-952F | In distribution | |
| HA-9813F | In distribution | |
| HA-9828F | In distribution | |
| TW-918F | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tomore | Tomore Medical (Shenzhen) Co., Ltd. | 70 |
| Tomore | Tomore Healthcare (Dongguan) Co., Ltd. | 65 |
| Austar | Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. | 41 |
| Retone | Xiamen Retone Hearing Technology Co., Ltd. | 39 |
| Melosound | Xiamen Melosound Technology Co., Ltd. | 27 |
| Mirasing | Xiamen Mirasing Technology Co., Ltd. | 18 |
| Ceretone | Audicon Corporation | 16 |
| Cofoe | Cofoe Medical Technology Co., Ltd. | 16 |
| RCA | Voxx Accessories Corp. | 15 |
| AcoSound | Hangzhou Acosound Technology Co., Ltd. | 15 |
| RCA | Huizhou Gold Rose Technology Co., Ltd. | 12 |
| Jinghao | Huizhou Jinghao Medical Technology Co., Ltd. | 10 |
Showing 12 of 96. All products under Hearing Aid, Air-Conduction, 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.