Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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038
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Date of Entry 01/27/2015
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FR Recognition Number
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4-183
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Standard | |
ANSI S3.2-2009 (Reaffirmed 2014) American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
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Scope/AbstractThe 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.
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§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 |
§874.3950 |
Hearing Aid, Air Conduction, Transcutaneous System |
Class 2 |
NIX |
§874.3320 |
Hearing Aid, Group And Auditory Trainer |
Class 2 |
EPF |
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§874.3320 |
Device, Assistive Listening |
Class 2 |
LZI |
§874.3950 |
Hearing Aid, Air Conduction, Transcutaneous System |
Class 2 |
NIX |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry - Noise Claims in Hearing Aid Labeling Document issued on: October 21, 1998 |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |