Recognized standard
S3.46-2013 (Reaffirmed 2023)
FDA recognition 4-211 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-211 |
|---|---|
| Designation | S3.46-2013 (Reaffirmed 2023) |
| Title | American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This standard covers the terminology, procedures and essential equipment characteristics for the measurement of the acoustic output and acoustic gain of hearing aids, coupled to human ears, in a variety of acoustic environments and for the measurement of certain acoustic properties of the ear… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: