• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 4-277
ANSI IEEE  C63.19-2019
American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
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 and WDs, including cellular phones, personal communications service (PCS), and voice-over-Internet-protocol (VoIP) devices, operating in the range of 614 MHz to 6 GHz. TIA-1083, Telecommunications Communications Products Handset Magnetic Measurement Procedures and Performance Requirements [B87], has become the recognized standard for measurement procedures and performance requirements for handset-generated audio band magnetic noise of wireline communications devices, including cordless telephones (cordless handsets with wireline-connected base units). Ongoing communications between the TIA TR-41.3.14 accessibility working group and ANSI C63.19 working group 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), completely-in-the-canal (CIC) types, and receiver-in-the-canal (RIC). 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(TM) [B65].
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§874.3300 Hearing Aid, Air-Conduction, Prescription Class 1 ESD
§874.3305 Hearing Aid, Air-Conduction With Wireless Technology, Prescription Class 2 OSM
§874.3325 Self-Fitting Air-Conduction Hearing Aid, Prescription Class 2 QDD
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.
FDA Technical Contacts
 Brian Beard
 Joshua Guag
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)
*These are provided as examples and others may be applicable.