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

I just had a patient buy hearing aids online and turns out they had an acoustic neuroma and almost died. What is the government doing allowing a bill like this exist?

Editor’s Note: The above is reproduced from a submission to Regulations.gov.  This post could have been expanded by adding more detail such as  how common are such events, what effects lead the patient to seek medical attention and was the online product accompanied by any medical consultation?  On another matter, we would appreciate receiving the link to any post on Regulations.gov which contains a technical  analysis in support of the 120 dB output standard recommended by the FDA; we may be contacted by using the “Contact” mechanism on this webpage.

Inside Health Policy, an insider’s  look at precedent-setting actions taken by federal regulators, has published  an in-depth review review of the 510 (k) program.

The report states:

Jim Tozzi, head of the Center for Regulatory Effectiveness and a former White House Office of Management and Budget official, and Kate Carr, president of the Hearing Industries Association, met with OMB’s Office of Information and Regulatory Affairs and FDA on Sept. 13 and Sept. 28, respectively.

Center for Regulatory Effectiveness

https://www.regulations.gov/comment/FDA-2021-N-0555-0605

A Select Quotation

“A review of the record for the FDA NPRM on OTC Hearing Aids reveals a wide disparity in the data submitted by interested parties. To assist readers in developing their comments on the NPRM we are providing for easy reference four critical documents dealing with the topic being addressed in the NPRM.

We suggest that commenters read the aforementioned documents, which are included in this submission, as they prepare their comments on the NPRM. The commenters should then attempt to ascertain why the FDA adopted a standard recommended by a trade association without the slightest recognition of the recommendations of two governmental organizations, so referenced herein,

National Consumers League

https://www.regulations.gov/comment/FDA-2021-N-0555-0737

Select Quotation

“The proposed output limit of 120 dB SPL is consistent with the standards used for consumer electronics products, but there is a significant difference between earbuds used to listen to music for short periods of time, and hearing aids that a person with mild-to-moderate hearing loss will wear for most of a day. Prolonged exposure to 120 dB amplification can, according to hearing and medical experts, place the user at risk for suffering increased hearing loss. The World Health Organization has declared, in fact, that sound levels as high as 100 dB can only be safely endured for 15 minutes each day.

Traditionally with the close of the public comment period, regulators close the curtain, perform their analyses and announce their decision in a final rule with no input from the public. The aforementioned approach is understandable in that a rulemaking must have a definite beginning and end.

However the public need not be shut out of the process completely. It is for this reason that CRE has  developed the Interactive Public Docket. Wikipedia states: