Hearx SA (Pty) , Ltd. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
hearOAE510(k)Oct 27, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Oct 27, 2023
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application510(k)Mar 14, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Mar 14, 2023