ANSI S3.13-1987 (Reaffirmed 2012) American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
Recognition Date | 2014-07-09 |
Recognition List | 036 |
Recognition Number | 4-165 |
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 |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard specifies requirements for mechanical couplers used for calibrating bone-conduction audi-meters and for making measurements on bone vibrators and bone-conduction hearing aids, in the frequency range from 125 to 8000 hertz (Hz) inclusive.
Regulation Number | Device Name | Device Class | Product Code |
§874.3300 | Hearing Aid, Bone Conduction | Class 2 | LXB |
There is no relevant guidance developed at this time. |