Recognized standard
S3.25-2009 (Reaffirmed 2019)
FDA recognition 4-184 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-184 |
|---|---|
| Designation | S3.25-2009 (Reaffirmed 2019) |
| Title | American National Standard For an Occluded Ear Simulator |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 1 |
| Scope (excerpt) | Ear simulators are intended for earphone response determination, measurement of hearing aid gain and performance, and measurements requiring simulation of the sound transmission characteristics of an external ear. Measurements performed with ear simulators are intended to provide data equivalent to… |
At a glance
- 1–9 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: