Recognized standard
S3.35-2021
FDA recognition 4-312 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-312 |
|---|---|
| Designation | S3.35-2021 |
| Title | American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard describes techniques used to measure hearing aids under simulated conditions of real ear use. For the purpose of these measurements, a standard manikin and ear simulator are used to represent a typical hearing aid wearer. Acoustical requirements of the test space as well as how the… |
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: