The discovery of hearing abnormalities is critical. With the proper identification and diagnosis patients can receive corrective action to deal with hearing problems. This is crucial for language development where the critical period is from birth to the age of three years. Early detection allows for critical compensatory actions to adjust for this perceptional difference. Some devices actually evoke or stimulate the cochlea functions using known signals and measuring the very low level response signal from the cochlea. Compliance Consultants has submitted 510(k) applications for hearing devices and hearing measurement instruments.


Regulation Number: 21 CFR 874.1050, Product Code: EWO


Guidance Document: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. http://www.fda.gov/MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/ucm127086.htm