Otodynamics, Ltd. - FDA 510(k) Cleared Devices

Otodynamics, Ltd. specializes in Ear, Nose, Throat diagnostic and screening instruments. Founded in 1988 by the discoverer of Otoacoustic Emissions, the company pioneered OAE screening technology. Otodynamics designs and manufactures Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) instruments for newborn screening, pediatric assessment, clinical audiology, and research applications.

The company has received 7 FDA 510(k) clearances from 7 total submissions since 1997. All submissions focus on Ear, Nose, Throat devices. Otodynamics remains active, with the latest clearance in 2024, demonstrating continued innovation and regulatory engagement in audiology diagnostics.

The company's product portfolio includes advanced clinical instruments and handheld screeners designed for diverse clinical settings. Products serve universal newborn hearing screening programs, pediatric assessment with animated distraction features, and comprehensive clinical testing across all age groups. Otodynamics operates globally through a partner network and maintains in-house engineering and scientific expertise spanning over 35 years in OAE technology.

Explore the complete list of cleared device names, product codes, and clearance dates in the FDA 510(k) database.

510(k) submissions have been managed by Rook Quality Systems as regulatory consultant.