| ANSI S3.21-2004 (Reaffirmed 2009) American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 4-167 |
| Extent | Complete standard |
| Standards Orgs | ANSI American National Standards Institute https://www.ansi.org/ |
| STG | Dental/ENT |
| FDA Tech | James K. Kane FDA/OMPT/CDRH/ODE 301-796-6477 james.kane@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 abrupt differences of 20 dB or more occur between adjacent octave frequencies, additional frequencies may be included at the discretion of the tester. Bone-conduction measurements may be carried out if indicated by the test requirements at octave intervals from 250 through 4000 Hz. Also, when required, masking is to be used. The purpose of this standard is to present procedures for conducting manual pure-tone threshold audiometry whose use will minimize intertest differences based on test method.
| Regulation Number | Device Name | Device Class | Product Code |
| §874.3950 | Hearing Aid, Air Conduction, Transcutaneous System | Class 2 | NIX |
| §874.3400 | Masker, Tinnitus | Class 2 | KLW |
| §874.3300 | Hearing Aid, Air Conduction | Class 1 | ESD |
| §874.3300 | Hearing Aid, Bone Conduction | Class 2 | LXB |
| §874.3300 | Hearing Aid, Bone Conduction, Implanted | Class 2 | MAH |
| §874.1080 | Set, Audiometer Calibration | Class 1 | EWA |
| §874.1050 | Audiometer | Class 2 | EWO |
| Unclassified | Implant, Auditory Brainstem | Class 3 | MHE |
| Unclassified | Implant, Cochlear | Class 3 | MCM |
| Unclassified | Implant, Hearing, Active, Middle Ear, Partially Implanted | Class 3 | MPV |
| §874.3950 | Hearing Aid, Air Conduction, Transcutaneous System | Class 2 | NIX |
| There is no relevant guidance developed at this time. |