ANSI S3.37-1987 (Reaffirmed 2017)

American National Standard Preferred Earhook Nozzle Thread For Postauricular Hearing Aids

S3.37-1987 (Reaffirmed 2017)

Standard Organization: ANSI

ANSI S3.37-1987 (Reaffirmed 2017)
American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids

Recognition NumberDental/ENT
Recognition Date2019-01-14
Recognition List051
Recognition Number4-171
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

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 applies only to those postauricular hearing aids which utilize screw-on threads.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§874.3300 Hearing Aid, Air Conduction Class 1 ESD

FDA Guidance:

There is no relevant guidance developed at this time.


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