Recognized standard
S3.35-2010 (Reaffirmed 2020)
FDA recognition 4-190 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-190 |
|---|---|
| Designation | S3.35-2010 (Reaffirmed 2020) |
| 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 | Apr 4, 2016 |
| Device classes | Class 1 |
| Scope (excerpt) | The purpose of this standard is to describe test methods which include the acoustical effects of a simulated median adult wearer on the performance of a hearing aid. Measurements made under simulated real-ear aided working conditions may be divided into two classes: - Direct simulated real-ear aided… |
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: