Tomore
62 catalogue numbers from 5216B(TE), listed by Tomore Medical (Shenzhen) Co., Ltd., China, under Hearing Aid, Air-Conduction With Wireless Technology, Prescription. 29 manufacturers in China are registered for this product code.
29manufacturers in China registered for this device type
62catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (17), Fujian (6), Jiangsu (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| 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 |
| VTech Communications Ltd | Dongguan | Guangdong | 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 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Yuezhongxing Technology Co., Ltd. | Huizhou | Guangdong | Repacker / relabeller | 10 |
| Hong YU Kang Technology (Guangdong) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Kangfu Medical Equipment Factory | Wenzhou | Zhejiang | Manufacturer | 6 |
Showing 12 of 29. All 29 manufacturers in China registered for Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Record
| Listed by | Tomore Medical (Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | OSM |
| Device type | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3305 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5216B(TE) | In distribution | |
| 5116H(TE) | In distribution | |
| 5216AE(TE) | In distribution | |
| 816TE | In distribution | |
| 216(TE) | In distribution | |
| IHP1216-IE | In distribution | |
| ADR-816TE | In distribution | |
| 5118L(TE) | In distribution | |
| 5122(TE) | In distribution | |
| APT818TE | In distribution | |
| Lucid516 RIC | In distribution | |
| 5116DH(TE) | In distribution | |
| Lucid508 | In distribution | |
| 5118DL(TE) | In distribution | |
| 5116L(TE) | In distribution | |
| 1108A(TE) | In distribution | |
| 3308B(TE) | In distribution | |
| 3308A(TE) | In distribution | |
| 1108B(TE) | In distribution | |
| 1208A(TE) | In distribution | |
| 5216A(TE) | In distribution | |
| 5116DL(TE) | In distribution | |
| 508OE(TE) | In distribution | |
| 5128H(TE) | In distribution | |
| 5120L(TE) | In distribution | |
| ADR-816TE | In distribution | |
| 5116A(TE) | In distribution | |
| 1216AE(TE) | In distribution | |
| 5120H(TE) | In distribution | |
| Lucid508-S | In distribution | |
| 308(TE) | In distribution | |
| 108(TE) | In distribution | |
| 5220(TE) | In distribution | |
| APT516TE-RIC | In distribution | |
| 7116(TE) | In distribution | |
| 1120(TE) | In distribution | |
| 5116AE(TE) | In distribution | |
| 1122(TE) | In distribution | |
| 5118H(TE) | In distribution | |
| 5003(TE) | In distribution | |
| APT818TE | In distribution | |
| 5006(TE) | In distribution | |
| 5128L(TE) | In distribution | |
| Eclarity mini | In distribution | |
| 1118(TE) | In distribution | |
| 1208B(TE) | In distribution | |
| 5116B(TE) | In distribution | |
| 1216BE(TE) | In distribution | |
| 5216C(TE) | In distribution | |
| 1124(TE) | In distribution | |
| 316(TE) | In distribution | |
| Eclarity LTE | In distribution | |
| 5222(TE) | In distribution | |
| 5126H(TE) | In distribution | |
| AT216 | In distribution | |
| 5118DH(TE) | In distribution | |
| 5126L(TE) | In distribution | |
| 7116T(TE) | In distribution | |
| 1216TE(TE) | In distribution | |
| Eclarity TE | In distribution | |
| 5005(TE) | In distribution | |
| APT616TE-RIC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Widex | Widex A/S | 6,599 |
| GN ReSound | GN Hearing A/S | 5,200 |
| Oticon | Oticon A/S | 3,931 |
| GN Hearing | GN Hearing A/S | 3,076 |
| Signia | WS Audiology USA, Inc. | 2,980 |
| Rexton | WS Audiology USA, Inc. | 2,876 |
| Phonak | Phonak, Inc. | 2,406 |
| Beltone | GN Hearing A/S | 2,196 |
| Unitron | Unitron Hearing Division | 1,901 |
| Unitron | Unitron Hearing | 1,745 |
| HHM | Oticon A/S | 1,329 |
| Miracle-Ear | WS Audiology USA, Inc. | 1,211 |
Showing 12 of 619. All products under Hearing Aid, Air-Conduction With Wireless Technology, Prescription
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.