ANSI S3.7-1995 (Reaffirmed 2008)

Standard Organization:

ANSI S3.7-1995 (Reaffirmed 2008)
American National Standard Method for Coupler Calibration of Earphones

• Recognition Date: 2012-03-16
• Recognition List: 028
• Recognition Number: 4-164
• Extent: Complete standard
• Standards Orgs: ANSI American National Standards Institute https://www.ansi.org/
• STG: Dental/ENT
• FDA Tech: Vasant Dasika FDA/OMPT/CDRH/ODE/DOED/ENTB/ 301-796-5365 vasant.dasika@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard specifies and describes earphone couplers that are in current use, together with their capabilities and limitations, and presents methods for the coupler calibration of earphones.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§874.1080	Set, Audiometer Calibration	Class 1	EWA
§874.1050	Audiometer	Class 2	EWO

FDA Guidance:

There is no relevant guidance developed at this time.