| ANSI S3.2-2009 (Reaffirmed 2014) American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
| Recognition Date | 2015-01-27 |
| Recognition List | 038 |
| Recognition Number | 4-183 |
| 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 scope of this standard includes the measurement of the intelligibility of speech over entire communication systems and the evaluation of the contributions of elements of speech communication systems. The scope also includes evaluation of the factors that affect the intelligibility of speech.
In this standard the intelligibility of speech over a speech communication system is measured by comparing the monosyllabic words trained listeners receive and identify with the words trained talkers or speech coders speak into a communication system that connects the talkers (or speech coders) with the listeners. The standard requires the intelligibility measurements to be made with talkers and listeners who are native speakers of English and who have no speech or hearing defects.
| Regulation Number | Device Name | Device Class | Product Code |
| §874.3950 | Hearing Aid, Air Conduction, Transcutaneous System | Class 2 | NIX |
| §874.3320 | Hearing Aid, Group And Auditory Trainer | Class 2 | EPF |
| §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 |
| §874.3320 | Device, Assistive Listening | Class 2 | LZI |
| §874.3950 | Hearing Aid, Air Conduction, Transcutaneous System | Class 2 | NIX |
| Guidance for Industry - Noise Claims in Hearing Aid Labeling Document issued on: October 21, 1998 |