Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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4-274
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Standard | |
ANSI ASA S3.2-2020 American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
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Scope/AbstractThis standard specifies a method for subjectively evaluating the speech intelligibility of communication systems. The standard specifies validated English word lists for performing the tests. The standard also specifies methods for selecting and training the talkers and listeners, for designing, controlling, and reporting the test conditions, and for calculating the intelligibility score, and for analyzing and reporting the test results. |
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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, Prescription
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Class 1
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ESD
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§874.3302 |
Hearing Aid, Bone Conduction
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Class 2
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LXB
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§874.3302 |
Hearing Aid, Bone Conduction, Implanted
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Class 2
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MAH
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§874.3320 |
Hearing Aid, Group And Auditory Trainer
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Class 2
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EPF
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§874.3320 |
Device, Assistive Listening
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Class 2
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LZI
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§874.3950 |
Hearing Aid, Air Conduction, Transcutaneous System
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Class 2
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NIX
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry: Noise Claims in Hearing Aid Labeling, Issued October 1998.
2. Guidance for Industry and Food and Drug Administration Staff: Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids, Issued December 2016.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |