WASHINGTON, D.C. — On July 9, U.S. President Biden signed a sweeping executive order that is said to be aimed at helping “promote greater competition in the American economy”. One particular section of the order addresses the long-anticipated rules on the classification of over-the-counter (OTC) hearing aids.
The President’s order directs the U.S. Department of Health and Human Services “to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.”
Overdue OTC Hearing Aid Rules
First introduced in 2016 by Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), Congress ultimately passed a bill in 2017 directing the U.S. Food and Drug Administration (FDA) to develop regulations for a new category of OTC hearing aids.
The OTC provision of the legislation, better known as the Over-The-Counter Hearing Aid Act, would allow hearing aids to be used “by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. Additionally, the bill directed the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids within the next three years.
However, the FDA failed to meet the 2020 deadline and has yet to issue the proposed rules – this has prompted criticism from Senators Warren and Grassley, as well as consumer advocacy groups.
Inclusion of the OTC hearing aid rule within President Biden’s executive order is welcome news to many who championed the legislation.
“This is good news. The sooner we have FDA guidelines, the sooner these new products will be available for the millions of Americans with hearing loss who need them.”—Shari Eberts, Hearing Health Advocate and Founder of Living with Hearing Loss
“The hearing care community awaits the delayed release of the FDA’s OTC draft guidelines,” said Amyn Amlani, Ph.D., President of Otolithic Consulting and Editor of Hearing Economics at HHTM.
“Assuming that the FDA adheres to President Biden’s Executive Order and makes guidelines available within 120 days, manufacturers, providers, and patients will have an opportunity to gauge the general direction of the forthcoming frontier in hearing care intervention and patient management. This information will be helpful to the profession and industry as it relates to early considerations, for example, in service delivery, state licensure, academic training, distribution channels, and consumer education.”
When Will OTC Hearing Aids Become Available for Sale?
Even with latest order issued by President Biden, the new OTC category of hearing aids will likely not be available to consumers for some time.
“The practicability to act on these considerations will take effect upon the FDA releasing its final draft,” commented Dr. Amlani. “The final draft is expected within the next 18 months, after the completion of a public comment period and re-review of the guidelines.”
“There have been many calls on the FDA to release the much delayed OTC draft regulation. We hope that President Biden’s Executive Order will result in definitive action by the FDA within 120 days. Once the draft regulation is released, we anticipate a public comment period, followed by further FDA review. It could take up to nine months or more for the final regulation to be released. Effectively, OTC hearings aids are not likely to be available to consumers until mid to late 2023.”
–Kate Carr, President, Hearing Industries Association
If the purpose of penetrating the market with cheap hearing aids is the plan, then the bureaucrats need to know some deep down facts pertaining to people with hearing losses.
1. The identification of nerve damage among hearing loss patients is alarmingly high, about 62.5 % on the averages. Out of this high number, at least 25% of hearing loss patients will progress to cognitive impairments and suffer from brain related malfunctions. Allowing patients to walk out with OTC aids is like assigning the death warrant to their hearing faculties. Uncontrolled use of hearing aids without knowledge of brain will lead to more brain damage, and cognitive disorders, which if not detected and treated progressively will lead to a boom in dementia cases .The government is politicizing this issue to score points from a purely political standpoint!
2. Cognitive impairments will invite more psychological and social issues and the medical departments in psychology will be overrun with cases of borderline psychosis, but if proper care is provided by ENT offices, then the recovery standards will be better , even though the costs will run much higher!
There are but a few hearing aid companies that are focusing on brain performance, and the demand for such treatment entails sophistication in sound processing previously unknown. Sophistication in processing technology requires treatment by experienced technologists and audiologists. These professionals are hard to find! Medical offices need to pay them much more for better quality of services.
My suggestion is to allow the technology to improve with brain performance in mind before jumping in with hearing aids across the counter that can only harm hearing abilities even more, and more! Currently, only about 2-3% of the population is interested in hearing aids. The level of education is very poor with regard to consequences of hearing loss. This hasty jump to satisfy the population is politically motivated, and not in the health interests of the poor, and the ignorant. WE need action from insurance companies to alleviate purchase of hearing aids and cost of treatment. We need to educate the public in avoiding the use of blue tooth devices and in- the- ear amplification that causes almost instant degradation of nerves in the auditory system! White House is quite ignorant about the harmful effects of uncontrolled amplification.
Can’t hear you
Please tell President Biden not to sign this document. They are using his reduced cognitive skills to coerce him into actions that will create devastation among the hearing impaired populations. Do you read me?