Recognized standard
S3.35-2025
FDA recognition 4-352 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-352 |
|---|---|
| Designation | S3.35-2025 |
| 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 22, 2025 |
| Device classes | Class 1, Class 2 |
| 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
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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: