Note to Federal Regulators: Expository Submissions on OTC Hearing Aids

   1.  An Interactive Public Docket for the FDA OTC Hearing Rule
   2.  CRE  Editorial
   3.  Completed Peer Review Submissions
   4.  Recommend Peer Review
   5.  Peer Reviews Conducted by the Public
   6.  Submit a Proposal to the IPD
   7.  Wikipedia Interactive Public Docket
   8.  Should Never Close A Docket?


Completed Peer Review Submissions has upwards to one thousand comments on the OTC NPRM.  CRE and its readers have identified a select number of submissions which make a cogent statement of policy and/or contain well documented arguments. The following list “Completed Peer Review Submissions” is not intended to be all inclusive and will be augmented as stakeholders review the forthcoming  submissions to through January 18.2022.  Feel free to review CRE comments to the FDA on its NPRM.

The National Grange Very Much On Point

The National Grange submitted this comment to the FDA on the OTC Hearing Aid Rule.

The following statement is  of particular relevance:

It would be a double tragedy if adults with impaired hearing were to suffer more damage because safety regulations were not in place. We have real concern that reliance solely upon the hearing aid user to determine whether the volume (output and gain) is at a safe level will not adequately protect them. For many reasons from mobility issues to distractions or situational difficulties that could arise, hearing aid users might be unable to remove devices quickly enough to prevent damage were the volume to be excessive.