| ANSI S3.6-2010 (Revision of ANSI S3.6-2004) American National Standard Specification for Audiometers |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 4-203 |
| Extent | Complete standard |
| Standards Orgs | ANSI American National Standards Institute https://www.ansi.org/ |
| STG | Dental/ENT |
| FDA Tech | Shu-Chen Peng FDA/OMPT/CDRH/ODE/DOED/ENTB/ 301-796-6481 shu-chen.peng@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Audiometers are electronic instruments intended for the testing of human hearing. This standard includes specifications and tolerances for audiometers and standard reference threshold levels for audiometric transducers such as supra-aural, circumaural, and insert earphones; bone vibrators; and loudspeakers.
This standard classifies audiometers according to the type of signal generated (pure tones, speech, or both), mode of operation, and complexity or range of auditory functions tested. Audiometers are also classified by type. Audiometers used for diagnostic assessment are classified as Types 1, 2, or 3, while audiometers having air-conduction facilities only are classified as Type 4.
| Regulation Number | Device Name | Device Class | Product Code |
| §874.1050 | Audiometer | Class 2 | EWO |
| There is no relevant guidance developed at this time. |