Enhancing Hearing Through Smart Regulation Discussion Forum

Public Comments  (forthcoming)

• Policy
• Technical
• Background

CRE  Editorial

This page is dedicated solely to the implementation of  an IPD for the FDA OTC Hearing Aid Rulemaking and consequently it is reserved for submissions from our readers. You may submit your views using this contact mechanism; any and all submissions may be published on this website at the complete discretion of the Editor.

Subsequent to  receiving a submission a decision will be made as to whether it will be published and if so  to which of the aforementioned  categories it will be assigned.

January 22, 2022

The comment period for the OTC hearing  aid NPRM has closed. FDA will now embark upon the task of reviewing and distilling in excess of 1,000 submissions,

CRE believes prior to addressing program issues specific to the regulation, such as the standard for the output of hearing aids, that the FDA first address macro concerns such as the complete non-compliance with two governing statutes: (1) the National Technology Transfer and Advancement Act and (2)  the Information Quality Act, both of which are discussed in this public comment and so identified as a Tier I issue.

American Academy of Otolaryngology