Recognized standard
S3.21-2004 (Reaffirmed 2019)
FDA recognition 4-167 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-167 |
|---|---|
| Designation | S3.21-2004 (Reaffirmed 2019) |
| Title | American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2, Class 1, Class 3 |
| Scope (excerpt) | Pure-tone threshold audiometry is the procedure used in the assessment of an individual's threshold of hearing for pure tones. Pure-tone threshold audiometry includes manual air-conduction measurements at octave intervals from 250 through 8000 Hz and at intermediate frequencies as needed. When… |
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: