Otodynamics

Otodynamics specializes in audiometric and otoacoustic emission devices. Their portfolio includes evoked-potential audiometers, such as those used for auditory brainstem response (ABR) testing, as well as battery-powered and line-powered otoacoustic emission systems. These systems measure hearing function and are used in clinical and screening applications. Accessories like probe assemblies, service kits, and wireless charging pads are also part of their offerings.

Otodynamics operates from the United States. The company’s headquarters and manufacturing operations are located within the country, though specific regional offices or facilities may vary. This U.S. presence aligns with their regulatory compliance requirements for medical devices in the region.

Otodynamics’ devices are listed in the FDA’s regulatory databases, specifically through 510(k) submissions and FDA Unique Device Identifier (UDI) records. These registries ensure compliance with U.S. medical device regulations and provide transparency on device authorizations. The Class II classification of their products requires such documentation to demonstrate safety and effectiveness.

All of Otodynamics’ devices fall under Class II classification in regulatory frameworks. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and performance. Class II devices like those from Otodynamics—such as audiometers and otoacoustic emission systems—must undergo 510(k) premarket notifications or other regulatory pathways to demonstrate compliance before commercial distribution.