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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4-216
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Standard | |
ANSI IEEE C63.19-2011 American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids |
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Scope/AbstractThis standard applies to both wireless communications devices (WDs) and hearing aids. It sets forth uniform methods of measurement and parametric requirements for the electromagnetic and operational compatibility of hearing aids used with WDs, including cellular phones, personal communications service (PCS), and Voice-over-Internet-Protocol devices, operating in the range of 698 MHz to 6 GHZ. TIA-I083:2007 [B71] has become the recognized standard for wireline communications devices, including cordless telephones (cordless handsets with wireline-connected base units). Ongoing communications between the TIA-I083 and ANSI C63.19 working groups have been maintained with the objective of harmonizing the two standards to the maximum extent possible.
This standard is intended to apply to all types of hearing aids with acoustic output, including, as examples, behind-the-ear (BTE), in-the-ear (ITE), in-the-canal (ITC), and completely-in-the-canal (CIC) types. Test methods are provided for acoustic (microphone input) mode and tele-coil (T-Coil) hearing aid modes of operation.
Users of this standard are cautioned to maintain the field strength called for in various places in the document within the limits for radio-frequency (RF) safety specified in IEEE Std C95.1.
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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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Transition Period
FDA recognition of IEEE/ANSI C63.19-2011 [Rec# 4-216] will be superseded by recognition of IEEE/ANSI C63.19-2019 [Rec# 4-277]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-216] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 4-216] will not be accepted. |
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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 |
§874.3305 |
Hearing Aid, Air Conduction With Wireless Technology |
Class 2 |
OSM |
§874.3325 |
Self-Fitting Air-Conduction Hearing Aid |
Class 2 |
QDD |
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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. |