Enhancing Hearing Through Smart Regulation

Consumer Affairs reports:

“The world’s most powerful retailer—prompted by Consumer Affairs’ reporting—says it is stepping up to make sure that consumers who purchase over-the-counter (OTC) hearing aids can be confident they’re buying a product that actually overcomes their hearing loss.”

The Center for Regulatory Effectiveness (CRE) has a long history in the OTC hearing aid rule. Central to CRE concerns was the need for a stringent enforcement program. Discussions with relevant regulatory agencies demonstrated that the federal agencies simply did not have sufficient resources to address the issue. The Consumer Affairs/Amazon Initiative should be reinforced by federal regulators.

CRE Initial Filing

OMB Submission

OTC Reg PSAP Guidance

WHO Technical

CRE OTC White Paper.Dec-15 (f)

WHO estimates reveal that :

• More than 430 million people (5% of the global population) live with disabling hearing loss resulting from a range of causes. This number is projected to increase substantially in the next decades unless action is taken to mitigate the risk factors for hearing loss.
  • 1.1 billion young people worldwide could be at risk of hearing loss as a result of unsafe listening practices.
  • Among teenagers and young adults aged 12–35 years in middle and high-income countries:
  – nearly 40% are exposed to potentially damaging sound levels in  recreational venues such as nightclubs, discotheques, and bars.
  – nearly 50% face the risk of hearing loss due to listening at high volumes or for prolonged time periods over their personal
  audio systems.

The Federal Trade Commission has been most vigilant in assuming a prominent role in promoting the health of our citizenry by taking the needed steps to ensure PSAPs are used as intended, as so described by the U.S. Food and Drug Administration. The FDA states that hearing aids and PSAPs differ “in that only hearing aids are intended to make up for impaired hearing…”. Choosing a PSAP as a substitute for a hearing aid can lead to more damage to your hearing.” To this end, in recent litigation, the FTC settled a suit against a party who overstated the merits of a sound amplifier and stated that it was suspending a judgment of $47 million given the defendants agreement to “an order that will require them to have human clinical testing to support future representations.”

The Center for Regulatory Effectiveness (CRE) applauds the work of the FCC to provide
access by users of hearing aids to wireless handsets. The action taken by the FCC in conjunction
with the oncoming creation of a new class of hearing aids, Over the Counter Hearing Aids (OTC
HAs), will result in a substantial rejuvenation of the market for hearing aids.

The resultant market will not only present an increased range of choice for consumers but
could also lead to their confusion if they are not provided succinct information from which to
base their decisions. The most significant source of confusion is the difference between a hearing
aid and a PSAP, a personal sound amplification product.

   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 Regulations.gov Never Close A Docket?

Completed Peer Review Submissions

Regulations.gov 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 Regulations.gov through January 18.2022.  Feel free to review CRE comments to the FDA on its NPRM.

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.

A review of the FDA Notice of Proposed Rulemaking (NPRM) on OTC Hearing Aids  reveals a wide disparity in the fundamental data in the record. To assist our readers in developing their comments on the NPRM we are providing for easy reference three critical documents.

Notwithstanding the fact that  two of  above  documents were prepared by governmental bodies and specifically address the subject matter in the OTC Notice of Proposed Rulemaking, it is puzzling why the FDA would summarily dismiss these documents  by not even mentioning them for public comment in the NPRM and instead devote their complete attention to a standard recommended by a trade association.

See statutory authority 1. [ See paragraph 47]

The key to the “smart” regulation of Over-the-Counter (OTC) Hearing Aids is to promulgate a series of requirements that provide consumers with adequate assurances of safety and effectiveness by ensuring that OTC devices (1) are used as intended (2) provide clinically significant positive results and (3) do not cause increased consumer confusion about hearing assistance devices. To achieve these goals, the FDA will need to (1) require potential users of OTC hearing aids to take a self-administered test to determine if they would benefit from the device and (2) require that the dispensing of traditional, non-OTC hearing aids be limited to ear
specialists, audiologists and dispensers as defined by FDA and licensed under state law. It is also critically important for the FDA to establish an effective enforcement program that addresses the potential pitfalls inherent in user-fitted, user-adjusted hearing aids. The introduction of OTC hearing aids could result in the emergence of novice manufactures located throughout the world who will attempt to enter the US market. The key to designing and implementing a smart regulatory program is to recognize immediately that FDA, acting alone, will not have sufficient resources to ensure that all new products meet relevant safety standards. Manufacturers, working with affected consumers, must be involved in the enforcement on a continuing basis.

New wirelessly-charged personal sound amplification products from Energous customer, Delight, are certified to sell in the United States

SAN JOSE, Calif., Dec. 27, 2018 (GLOBE NEWSWIRE) — Energous Corporation (NASDAQ: WATT), the developer of WattUp, a revolutionary wireless charging 2.0 technology, today announced the first customer product to receive FCC approval. With this certification, the WattUp-enabled personal sound amplification products (PSAP) from Delight, in partnership with SK Telesys, are now certified to be marketed and sold in the United States.