ANSI S3.37-1987 (Reaffirmed 2017) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids |
Recognition Number | Dental/ENT |
Recognition Date | 2019-01-14 |
Recognition List | 051 |
Recognition Number | 4-171 |
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.
This standard applies only to those postauricular hearing aids which utilize screw-on threads.
Regulation Number | Device Name | Device Class | Product Code |
§874.3300 | Hearing Aid, Air Conduction | Class 1 | ESD |
There is no relevant guidance developed at this time. |