| ANSI S3.39:1987 (Reaffirmed 2012) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 4-90 |
| Extent | Complete standard |
| Standards Orgs | ANSI American National Standards Institute https://www.ansi.org/ |
| STG | Dental/ENT |
| FDA Tech | Shu-Chen Peng FDA/OMPT/CDRH/ODE/DOED/ENTB/ 301-796-6481 shu-chen.peng@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.
The instruments covered by this standard are designed primarily for the measurement of acoustic impedance, acoustic admittance, or both quantities, within the human external auditory meatus. The standard is concerned with the parameters and tolerances of instruments used for measurement of aural acoustic impedance and aural acoustic admittance when the probe-tone frequency is 226 Hz. It is not within the scope of this standard to establish normative values for human ears....
The purpose of this standard is to ensure that acoustic-impedance or acoustic-admittance measurements will be substantially the same for a given ear when these measurements are obtained with any instruments that meet the specifications and tolerances outlined in this standard, and when comparable test conditions prevail. This standard is not intended to inhibit development, to restrict incorporation of new features (such ads probe frequencies other than 226 Hz), or to discourage other improvements that may become useful in the measurement of aural acoustic impedance or acoustic admittance.
| Regulation Number | Device Name | Device Class | Product Code |
| §874.1090 | Tester, Auditory Impedance | Class 2 | ETY |
| There is no relevant guidance developed at this time. |