Sonic
ET100, KIT 312 2.4G NFM 90 PB R BE Enchant 100
4manufacturers in China registered for this device type
192catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (1). 2 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 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Sonic Innovations, Inc., United States |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Premarket notification | Exempt |
| Record published | 2018-08-20 |
| Record revised | 2025-03-05 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2028-03-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 192118 | In distribution | |
| 192080 | In distribution | |
| 186300 | In distribution | |
| 186222 | In distribution | |
| 192126 | In distribution | |
| 192152 | In distribution | |
| 186160 | In distribution | |
| 192081 | In distribution | |
| 186249 | In distribution | |
| 191363 | In distribution | |
| 192144 | In distribution | |
| 192076 | In distribution | |
| 186298 | In distribution | |
| 186188 | In distribution | |
| 186307 | In distribution | |
| 182861 | In distribution | |
| 192083 | In distribution | |
| 186276 | In distribution | |
| 186285 | In distribution | |
| 186165 | In distribution | |
| 214986 | In distribution | |
| 191353 | In distribution | |
| 182865 | In distribution | |
| 186241 | In distribution | |
| 186267 | In distribution | |
| 186232 | In distribution | |
| 186277 | In distribution | |
| 186255 | In distribution | |
| 192145 | In distribution | |
| 191387 | In distribution | |
| 192131 | In distribution | |
| 186301 | In distribution | |
| 192108 | In distribution | |
| 186292 | In distribution | |
| 192088 | In distribution | |
| 192165 | In distribution | |
| 186273 | In distribution | |
| 186279 | In distribution | |
| 186237 | In distribution | |
| 186225 | In distribution | |
| 186154 | In distribution | |
| 222298 | In distribution | |
| 186181 | In distribution | |
| 193197 | In distribution | |
| 192156 | In distribution | |
| 186266 | In distribution | |
| 191365 | In distribution | |
| 192150 | In distribution | |
| 201918 | In distribution | |
| 186185 | In distribution | |
| 222307 | In distribution | |
| 196004 | In distribution | |
| 186258 | In distribution | |
| 222310 | In distribution | |
| 186227 | In distribution | |
| 192146 | In distribution | |
| 222306 | In distribution | |
| 192103 | In distribution | |
| 186229 | In distribution | |
| 190108 | In distribution | |
| 192159 | In distribution | |
| 186319 | In distribution | |
| 186284 | In distribution | |
| 204549 | In distribution | |
| 192141 | In distribution | |
| 190122 | In distribution | |
| 186233 | In distribution | |
| 186199 | In distribution | |
| 182857 | In distribution | |
| 186314 | In distribution | |
| 192138 | In distribution | |
| 191376 | In distribution | |
| 192142 | In distribution | |
| 192112 | In distribution | |
| 192163 | In distribution | |
| 186197 | In distribution | |
| 187300 | In distribution | |
| 192087 | In distribution | |
| 192078 | In distribution | |
| 190061 | In distribution | |
| 191385 | In distribution | |
| 186151 | In distribution | |
| 186163 | In distribution | |
| 204547 | In distribution | |
| 186177 | In distribution | |
| 186311 | In distribution | |
| 186164 | In distribution | |
| 190109 | In distribution | |
| 193196 | In distribution | |
| 192160 | In distribution | |
| 186162 | In distribution | |
| 190110 | In distribution | |
| 192124 | In distribution | |
| 192158 | In distribution | |
| 186283 | In distribution | |
| 222293 | In distribution | |
| 222291 | In distribution | |
| 191368 | In distribution | |
| 186173 | In distribution | |
| 190120 | In distribution | |
| 191374 | In distribution | |
| 186293 | In distribution | |
| 192164 | In distribution | |
| 192101 | In distribution | |
| 182859 | In distribution | |
| 186295 | In distribution | |
| 192127 | In distribution | |
| 222295 | In distribution | |
| 187302 | In distribution | |
| 186240 | In distribution | |
| 192149 | In distribution | |
| 182856 | In distribution | |
| 214711 | In distribution | |
| 190133 | In distribution | |
| 192115 | In distribution | |
| 186312 | In distribution | |
| 186281 | In distribution | |
| 186280 | In distribution | |
| 191351 | In distribution | |
| 182187 | In distribution | |
| 186156 | In distribution | |
| 186157 | In distribution | |
| 190105 | In distribution | |
| 222297 | In distribution | |
| 192137 | In distribution | |
| 192095 | In distribution | |
| 222294 | In distribution | |
| 186247 | In distribution | |
| 222304 | In distribution | |
| 192111 | In distribution | |
| 193195 | In distribution | |
| 222305 | In distribution | |
| 186238 | In distribution | |
| 192134 | In distribution | |
| 191350 | In distribution | |
| 186254 | In distribution | |
| 192074 | In distribution | |
| 186182 | In distribution | |
| 186306 | In distribution | |
| 186174 | In distribution | |
| 186193 | In distribution | |
| 186159 | In distribution | |
| 192151 | In distribution | |
| 199525 | In distribution | |
| 186274 | In distribution | |
| 192129 | In distribution | |
| 192097 | In distribution | |
| 195938 | In distribution | |
| 192091 | In distribution | |
| 186236 | In distribution | |
| 186189 | In distribution | |
| 222292 | In distribution | |
| 191357 | In distribution | |
| 186299 | In distribution | |
| 192094 | In distribution | |
| 186282 | In distribution | |
| 186288 | In distribution | |
| 186313 | In distribution | |
| 182851 | In distribution | |
| 191373 | In distribution | |
| 186242 | In distribution | |
| 186168 | In distribution | |
| 190107 | In distribution | |
| 186303 | In distribution | |
| 222299 | In distribution | |
| 192147 | In distribution | |
| 186192 | In distribution | |
| 191383 | In distribution | |
| 186224 | In distribution | |
| 191379 | In distribution | |
| 186231 | In distribution | |
| 191348 | In distribution | |
| 186250 | In distribution | |
| 187303 | In distribution | |
| 185295 | In distribution | |
| 214710 | In distribution | |
| 192090 | In distribution | |
| 193702 | In distribution | |
| 186175 | In distribution | |
| 186317 | In distribution | |
| 186166 | In distribution | |
| 186246 | In distribution | |
| 222311 | In distribution | |
| 186198 | In distribution | |
| 192116 | In distribution | |
| 186196 | In distribution | |
| 205978 | In distribution | |
| 192133 | In distribution | |
| 222300 | In distribution | |
| 186219 | In distribution | |
| 186253 | In distribution | |
| 186260 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Phonak | Sonova AG | 448 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Audibel | Starkey Laboratories, Inc. | 318 |
| Unitron | Unitron Hearing Division | 292 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
Showing 12 of 86. All products under Masker, Tinnitus
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.