Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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036
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Date of Entry 07/09/2014
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FR Recognition Number
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4-211
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Standard | |
ANSI ASA S3.46-2013 (Reaffirmed 2023) American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
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Scope/AbstractThis standard covers the terminology, procedures and essential equipment characteristics for the measurement of the acoustic output and acoustic gain of hearing aids, coupled to human ears, in a variety of acoustic environments and for the measurement of certain acoustic properties of the ear related to the application of hearing aids. These measurements can be divided into two classes: a) direct measures of sound pressure level (SPL), and b) insertion measurements. Direct measures (previously called in situ measurements) report SPL developed in an ear canal, with or without a hearing aid in place and are expressed as dB gain relative to the SPL at a field reference point. Insertion measurements report ear canal SPL with a hearing aid in place relative to the ear canal SPL without the hearing aid. Behavioral measures of real-ear hearing aid performance, such as functional gain, are excluded from this standard. |
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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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§874.3950 |
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*
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 Contacts
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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. |