The article was published after a November 13 memo penned by Senators Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass), calling on the agency to prioritize releasing the guidance.
The law gave the FDA three years to propose regulations that would govern OTC hearing for adults with mild-to-moderate hearing impairment. The rules were not released and the FDA cited interruptions caused by the COVID-19 pandemic.
A Message To the FDA
“As medical providers, we fully appreciate the impact the COVID-19 pandemic has had on all sectors of health care. However, this inaction for OTC hearing aids is leaving millions of Americans without the necessary devices they were promised and will benefit from through implementation of this law,” KevinFranck, PhD, a professor at the Harvard Medical School Department of Otolaryngology-Head and Neck Surgery, said in the NEJM commentary.
Frank continued, writing: “We call on the FDA to make OTC hearing aids a priority for the American people and address the deafening silence that has occurred since the federal government heard the call from advocates and issued a legislative mandate over three years ago."
Hearing aids are intended to be used for treating hearing loss, which is a medical condition. PSAPs are not intended to be used for medical conditions, according to the American Academy of Audiology (AAA).
You can get a PSAP without going to an audiologist. However, the devices cannot be marketed as being able to help with hearing loss. Audiologists can sell PSAPs, according to the AAA.
According to the National Institute on Deafness and Other Communication Disorders (NIDCD), OTC hearing aids would be regulated as medical devices under the FDA.
Benefits of OTC Hearing Aids
Franck notes that making OTC hearing aids available could drive price reductions as well as innovation and that the industry has “remained relatively insulated from competition because of consolidation among manufacturers, state licensure laws restricting commercial distribution, and vertical integration among manufacturers and distributors.”
On its website, the NIDCD states that “making hearing health care more accessible and affordable is a public health priority, especially as the number of older adults in the U.S. continues to grow."
Timeline of OTC Hearing Aids
The FDA’s proposed rule was due on August 18, 2020. The final rule was expected within six months of the comment period closing.
Franck tells Verywell that he thinks the FDA will release guidance by the end of the year. “I believe that the work was delayed due to COVID and some legal complexities around preempting state rules," he says.
After the proposed regulations are introduced and the comment period expires, the FDA will then review the comments and release guidance to manufacturers. Then manufacturers will need time to get approval on their products. “We’re probably around a year away from device availability," Franck says.
Getting OTC Hearing Aids
Franck explains that OTC hearing aids have hardware that is similar to prescription hearing aids, “but the hardware will be more limited to lower output than prescription hearing devices.”
While the study noted positive outcomes from existing research, it also identified many challenges surrounding device options, delivery method variables, trial data, long-term device outcomes, and clinician support.
OTC hearing aids will also have user interfaces that are designed to let the wearer adjust the physical fit of the device inside the ear, as well as the acoustic fit of the device (how it processes sound according to the individual’s hearing loss).
The device packaging will be designed for self-use, but will guide the wearer to seek clinical help when needed. Companies that sell OTC devices will have customer service to handle device problems.
Franck notes that insurance may not cover OTC hearing aids, but people might be able to use health savings accounts to make the purchase. “The consumer market may make it more likely for insurance companies to only cover professional fit hearing aids for patients with more severe hearing losses," he says.
