Ear Nose & Throat › Prosthetic

Which Manufacturers in China Work in This Section?

168 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Zhejiang and Jiangsu, and 13 other provinces. 37 of them are contract manufacturers. Chinese manufacturers are registered for 22 of 64 device types here.

16 of those 22 device types need no premarket submission before sale in the United States. The FDA has recorded 59 recalls across the section’s product codes; the root causes it names most often are Device Design (9), Nonconforming Material/Component (5) and Packaging process control (5).

Which Device Types Are Made in China?

The device types with the most Chinese manufacturers are Hearing Aid, Air-Conduction, Over The Counter (57), Dilator, Nasal (55), Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter (52), Hearing Aid, Air-Conduction, Prescription (45) and Hearing Aid, Air-Conduction With Wireless Technology, Prescription (29). All 22 device types in this section with a Chinese manufacturer, most manufacturers first:

Hearing Aid, Air-Conduction, Over The Counter 57 manufacturers
Dilator, Nasal 55 manufacturers
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 52 manufacturers
Hearing Aid, Air-Conduction, Prescription 45 manufacturers
Hearing Aid, Air-Conduction With Wireless Technology, Prescription 29 manufacturers
Face Plate Hearing Aid 11 manufacturers
Hearing Aid, Bone Conduction 4 manufacturers
Masker, Tinnitus 4 manufacturers
Self-Fitting Air-Conduction Hearing Aid, Over The Counter 4 manufacturers
Active Implantable Bone Conduction Hearing System 3 manufacturers
Crimper, Wire, Ent, Non-Sterile 2 manufacturers
Punch, Gelfoam, Non-Sterile 2 manufacturers
Scissors, Wire Cutting, Ent, Non-Sterile 2 manufacturers
Self-Fitting Air-Conduction Hearing Aid, Prescription 2 manufacturers
Air-Conduction Hearing Aid Software 1 manufacturer
Device, Assistive Listening 1 manufacturer
Forceps, Wire Closure, Ent, Non-Sterile 1 manufacturer
Hearing Aid, Group And Auditory Trainer 1 manufacturer
Jig, Piston Cutting, Ent, Non-Sterile 1 manufacturer
Larynx, Artificial (Battery-Powered) 1 manufacturer
Myringotomy Procedure Kit 1 manufacturer
Scissors, Wire Cutting, Ent, Sterile 1 manufacturer

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Mecharge RIC AI 5p FP

2 catalogue numbers from incl. US EPS, listed by Sonova AG, Switzerland, under Hearing Aid, Air-Conduction With Wireless Technology, Prescription. 29 manufacturers in China are registered for this product code.

Hearing Aid, Air-Conduction, Over The Counter

Aoligi

2 catalogue numbers from JH-A17BT, listed by Huizhou Jinghao Medical Technology Co., Ltd., China, under Hearing Aid, Air-Conduction, Over The Counter. 57 manufacturers in China are registered for this product code.

Masker, Tinnitus

Audilab

Aligo 7 FW 1.3.0

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Insera S9-R

Insera S9-R: 1 catalogue number listed by Sonova AG, Switzerland, under Hearing Aid, Air-Conduction With Wireless Technology, Prescription. 29 manufacturers in China are registered for this product code.

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Memini E 2 5p R-R PH

4 catalogue numbers from (sand beige), listed by Sonova AG, Switzerland, under Hearing Aid, Air-Conduction With Wireless Technology, Prescription. 29 manufacturers in China are registered for this product code.

Ear Nose & Throat › Prosthetic

Which Manufacturers in China Work in This Section?

Which Device Types Are Made in China?

Where China Actually Supplies