Cochlear Implant With Combined Electrical Stimulation and Acoustic Amplification
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Shanghai. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
- Mehow Innovative (Huizhou) Ltd. Guangdong, contract manufacturer
What Is This Device?
Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
How Is PGQ Classified?
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification is FDA product code PGQ, Class 3.
What Does It Take to Sell It in the United States?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Do the Recalls Say?
The FDA has recorded 3 recalls under this product code since 2018. None was by a company in China. The root cause the FDA records most often is Employee error (3).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.