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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 4-163
Standard
ANSI ASA  S3.5-1997 (Reaffirmed 2020)
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
§874.3300 Hearing Aid, Air-Conduction, Prescription Class 1 ESD
§874.3302 Hearing Aid, Bone Conduction Class 2 LXB
§874.3302 Hearing Aid, Bone Conduction, Implanted Class 2 MAH
§874.3950 Hearing Aid, Air Conduction, Transcutaneous System Class 2 NIX
N/A Implant, Cochlear Class 3 MCM
N/A Implant, Hearing, Active, Middle Ear, Partially Implanted Class 3 MPV
Relevant FDA Guidance and/or Supportive Publications*
1. Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS) - Guidance for Industry and FDA, issued November 2002.

2. Guidance for Industry and FDA Staff: Implantable Middle Ear Hearing Device, issued August 2003.

3. Guidance for Industry: Noise Claims in Hearing Aid Labeling, issued October 1998.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Vasant Dasika
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB
  301-796-5365
  Vasant.Dasika@fda.hhs.gov
 Lindsay DeVries
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB
  240-402-1462
  Lindsay.DeVries@fda.hhs.gov
 Julie Cohen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB
  301-796-0772
  Julie.Cohen@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ASA Acoustical Society of America http://acousticalsociety.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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