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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 4-216
Standard
ANSI IEEE C63.19-2011
American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
Scope/Abstract
This 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.
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.
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FDA recognition of IEEE/ANSI C63.19-2011 [Rec# 4-216] will be superseded by recognition of IEEE/ANSI C63.19-2019 [Rec# 4-277].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.
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
FDA Technical Contacts
 Brian Beard
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2469
  Brian.Beard@fda.hhs.gov
 Joshua Guag
  FDA/OC/CDRH/OSEL/DBP/
  301-796-3638
  joshua.guag@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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