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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 4-163
Standard
ANSI S3.5-1997 (Reaffirmed 2017)
American National Standard Methods for Calculation of the Speech Intelligibility Index
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
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
Relevant FDA Guidance and/or Supportive Publications
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.
FDA Technical Contact
 Shu-Chen Peng
  FDA/OMPT/CDRH/ODE/DOED/ENTB/
  301-796-6481
  shu-chen.peng@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
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