| ANSI S3.5-1997 (Reaffirmed 2017) American National Standard Methods for Calculation of the Speech Intelligibility Index |
| Recognition Number | Dental/ENT |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 4-163 |
| 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.
Defines a method for computing a physical measure that is highly correlated with the intelligibility of speech as evaluated by speech perception tests given a group of talkers and listeners. This measure is called the speech Intelligibility Index, SII. The SII is calculated from acoustical measurements of speech and noise.
| Regulation Number | Device Name | Device Class | Product Code |
| §874.3950 | Hearing Aid, Air Conduction, Transcutaneous System | Class 2 | NIX |
| §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 |
| 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 |
| Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS) - Guidance for Industry and FDA, Issued November 7, 2002. Guidance for Industry and FDA Staff: Implantable Middle Ear Hearing Device, Issued August 1, 2003. Guidance for Industry: Noise Claims in Hearing Aid Labeling, Issued October 21, 1998. |