Sonic

ET100, KIT 312 2.4G NFM 85 PB R BE Enchant 100

Registry build 21.09.26
29manufacturers in China registered for this device type
676catalogue 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.

Chinese manufacturers registered for FDA product code OSM
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

Regulatory record for Sonic
Listed by Sonic Innovations, Inc., United States
FDA product code OSM
Device type Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Device class Class 2
Regulation 21 CFR 874.3305
Premarket notification Exempt
Record published 2017-05-31
Record revised 2025-03-05 (version 6)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, serial number
Distribution end date 2028-03-03
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Sonic
Catalogue number Size Status
179871 In distribution
215334 In distribution
192120 In distribution
192104 In distribution
159243 In distribution
177147 In distribution
196451 In distribution
192132 In distribution
215342 In distribution
161185 In distribution
139224 In distribution
159270 In distribution
205980 In distribution
215326 In distribution
162313 In distribution
177112 In distribution
215147 In distribution
126238 In distribution
196438 In distribution
179874 In distribution
131232 In distribution
126243 In distribution
192099 In distribution
197018 In distribution
136328 In distribution
179320 In distribution
196441 In distribution
142633 In distribution
149405 In distribution
186167 In distribution
159213 In distribution
178502 In distribution
197341 In distribution
222296 In distribution
165803 In distribution
142639 In distribution
205394 In distribution
222301 In distribution
159316 In distribution
192098 In distribution
215330 In distribution
186171 In distribution
195939 In distribution
186304 In distribution
176967 In distribution
162554 In distribution
186184 In distribution
177148 In distribution
159258 In distribution
196454 In distribution
186228 In distribution
192130 In distribution
187304 In distribution
156445 In distribution
137877 In distribution
196453 In distribution
159220 In distribution
165807 In distribution
191382 In distribution
118784 In distribution
186262 In distribution
215337 In distribution
196467 In distribution
196443 In distribution
159131 In distribution
118783 In distribution
159340 In distribution
136304 In distribution
127318 In distribution
196450 In distribution
136308 In distribution
205389 In distribution
186221 In distribution
197300 In distribution
196472 In distribution
126241 In distribution
215331 In distribution
136324 In distribution
187307 In distribution
205617 In distribution
186195 In distribution
127325 In distribution
159089 In distribution
177144 In distribution
196460 In distribution
136309 In distribution
177051 In distribution
222302 In distribution
156429 In distribution
102304 In distribution
192157 In distribution
149020 In distribution
196465 In distribution
182869 In distribution
159090 In distribution
163964 In distribution
215352 In distribution
127301 In distribution
125193 In distribution
159112 In distribution
186239 In distribution
192075 In distribution
205392 In distribution
165805 In distribution
215359 In distribution
142656 In distribution
191384 In distribution
205391 In distribution
215328 In distribution
156065 In distribution
142643 In distribution
165808 In distribution
118788 In distribution
159134 In distribution
159212 In distribution
177118 In distribution
127303 In distribution
176976 In distribution
162542 In distribution
191362 In distribution
127299 In distribution
177142 In distribution
156067 In distribution
196449 In distribution
197027 In distribution
192077 In distribution
142634 In distribution
158709 In distribution
165809 In distribution
201919 In distribution
215148 In distribution
119289 In distribution
118789 In distribution
191359 In distribution
191388 In distribution
197298 In distribution
191371 In distribution
186200 In distribution
142657 In distribution
142641 In distribution
136319 In distribution
156062 In distribution
205399 In distribution
161179 In distribution
186218 In distribution
222309 In distribution
119293 In distribution
205620 In distribution
196437 In distribution
191369 In distribution
126242 In distribution
215348 In distribution
176978 In distribution
197025 In distribution
136327 In distribution
136320 In distribution
186202 In distribution
125194 In distribution
215150 In distribution
181783 In distribution
162316 In distribution
208812 In distribution
192109 In distribution
156069 In distribution
177116 In distribution
156444 In distribution
196470 In distribution
156443 In distribution
192139 In distribution
205618 In distribution
176981 In distribution
159338 In distribution
197031 In distribution
136301 In distribution
196461 In distribution
196432 In distribution
186191 In distribution
159092 In distribution
197020 In distribution
187796 In distribution
196430 In distribution
119288 In distribution
191347 In distribution
118791 In distribution
192119 In distribution
197016 In distribution
127691 In distribution
189263 In distribution
159132 In distribution
162549 In distribution
162314 In distribution
214966 In distribution
177113 In distribution
196479 In distribution
159129 In distribution
177111 In distribution
127819 In distribution
215350 In distribution
186291 In distribution
118787 In distribution
136325 In distribution
186308 In distribution
196476 In distribution
159176 In distribution
118782 In distribution
205613 In distribution
208813 In distribution
159147 In distribution
127300 In distribution
186248 In distribution
116-26-210-10 In distribution
186261 In distribution
159261 In distribution
192105 In distribution
192106 In distribution
119924 In distribution
127302 In distribution
136316 In distribution
149403 In distribution
127323 In distribution
196481 In distribution
162691 In distribution
196471 In distribution
136317 In distribution
139223 In distribution
214708 In distribution
119291 In distribution
127298 In distribution
191354 In distribution
159111 In distribution
142637 In distribution
182867 In distribution
127873 In distribution
136322 In distribution
196431 In distribution
215355 In distribution
215353 In distribution
192143 In distribution
215345 In distribution
186252 In distribution
185787 In distribution
191367 In distribution
177048 In distribution
119287 In distribution
205623 In distribution
136335 In distribution
190106 In distribution
159175 In distribution
162320 In distribution
159205 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer