Recognized standard
S3.22-2014 (Reaffirmed 2020)
FDA recognition 4-220 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-220 |
|---|---|
| Designation | S3.22-2014 (Reaffirmed 2020) |
| Title | American National Standard Specification of Hearing Aid Characteristics |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This standard describes certain hearing aid measurements and parameters that are deemed useful in determining the electroacoustic performance of an air-conduction hearing aid. Some of these lend themselves to setting of tolerances for the purpose of maintaining product uniformity and for compliance… |
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: