In July 2018, the U.S. Department of Justice (DOJ) announced that 3M Company, exclusive provider of the dual-ended Combat Arms Earplugs (CAEv2) to certain branches of the military, agreed to pay $9.1 million to resolve allegations that it knowingly sold defective earplugs that did not work as expected, thus putting soldiers at a higher risk of hearing damage.
The U.S. Department of Veterans Affairs (VA) states that hearing problems, including tinnitus, are “by far the most prevalent service-connected disability among American Veterans.” In 2017, there were over a million veterans receiving disability compensation for hearing loss and over 1.6 million receiving disability for tinnitus. The actual number may be even higher, as many do not report the problems or receive disability for them.
Hearing protection is now standard issue and mandatory for all active-duty service members, but according to a recent whistleblower lawsuit, the hearing protection provided to some service members by the military for over a decade may not have done much good.
What are 3M Combat Arms Earplugs?
3M Combat Arms Earplugs are made specifically for soldiers in combat and feature a unique two-sided design. Wear the earplugs with the dark side in, called the “closed position,” to block out all sound, including that created by aircraft, machinery, armored vehicles, explosions, and gunfire. Wear them with the yellow side in, called the “open position,” to block out loud sounds, but still allow softer sounds, like spoken commands and enemy movements, to be heard. It was this unique design that attracted the military, per the lawsuit that was eventually brought against 3M. It is common knowledge within the military that soldiers often want hearing protection from loud noises, but allows them to tune into important quieter ones.
3M Misleads Military and Hides Defects in Earplugs
In May 2016, competing earplug manufacturer Moldex-Metric, Inc., filed a whistleblower lawsuit against 3M claiming that the company made false statements to the government regarding its dual-ended Combat Arms earplugs, which were standard issue in certain branches of the military during foreign conflicts between 2003 and 2015. The U.S. Department of Justice later joined the suit.
According to the complaint, the earplugs “have likely caused thousands of soldiers to suffer significant hearing loss and tinnitus in addition to exposing millions to the risk caused by 3Ms defective earplugs.” The problem is the earplugs are too short to form the correct seal in some user’s ear canals. They can loosen imperceptibly, allowing more sound to enter the ear than expected, and increasing the risk of hearing damage.
The earplugs were first developed by Aearo Technologies, Inc., which was later acquired by 3M in 2008. (3M retained the employees at Aearo that developed and tested the earplugs). Even before Aearo won the military contract in 2003, they had performed tests on the dual-ended Combat Arms earplugs in 2000 and identified that the earplugs suffered from specific defects that rendered them less effective in providing hearing protection than expected and less effective than what their test results showed. Yet they never revealed these defects to the military.
3M Falsely Certifies that Their Earplugs Comply with Military Standards
When Aearo replied to the Government RFP in 2003, Aearo was required to certify that its earplugs complied with military standards. Specifically, the products were to provide protection from impulse noises produced by military firearms, while allowing the user to hear normal speech and other quieter sounds, such as spoken commands, on the battlefield. They were to have a certain noise reduction rating (NRR), as proven during testing. They were also supposed to be free from all defects and were to include instructions on proper use and handling.
To meet these standards, Aearo was required to test the earplugs to determine the NRR, which must be included on the product label. Rather than hire an independent firm to conduct the testing, the company chose to use its own employees. In January 2000, testing personnel recruited 10 test subjects, some of whom were Aearo employees, to test the earplugs under three conditions:
- Hearing ability without earplugs inserted.
- Hearing ability with the earplug inserted in open position (the yellow open side inserted).
- Hearing ability with the earplug inserted in the closed position (the dark closed side inserted).
After testing only eight of the ten subjects, Aearo personnel stopped the testing (violating testing protocol) on the closed position. Results showed an average NRR of 10.9, which was far below the 22 NRR that was expected. Some of the tested users experienced better results depending on the fit of the earplugs.
Testing continued with the open position on all ten subjects. Results showed an NRR of -2, reflecting the fact that the earplugs didn’t block sound, but rather, amplified it. According to the complaint filed against 3M, the company changed the NRR to a “0” and touted those results as beneficial to the military, stating that while wearing the earplugs, soldiers would be able to hear spoken commands and approaching enemy combatants.
Meanwhile, testing personnel investigated the issue of why the earplugs were not working well in the closed position and found that the stem of the earplug was too short and thus difficult to insert deeply enough into the ear canal to achieve a proper fit. They also found that when the closed end was inserted, the basal edge of the third flange of the yellow open end, pressed against the subject’s ear canal and folded backward. When pressure on the earplug was released, the yellow flanges returned to their original shape, which loosened the earplug just enough to decrease its effectiveness. Since both sides of the earplugs are shaped the same way, the problem was experienced in both open and closed positions.
To get the desired NRR results, users needed to fold back the flanges on the opposite side prior to insertion. After learning this, in February 2000, Aearo personnel allegedly retested the earphones in the closed position using modified fitting instructions. During this test, subjects folded back the yellow flanges to insert the plug more deeply into the ear and the earplugs worked better, which resulted in a significantly improved 22 NRR rating compared to the initial test results of 10.9 NRR.
There was no retest on the open end of the earplugs. The plaintiffs in the lawsuit claim this was because 3M wanted the low NRR they had already achieved on that side, to show that soldiers could hear important sounds while wearing the earplugs this way. If they fitted the open end by folding back the flanges as they had on the closed end, their NRR would have been higher, and thus they would have no evidence backing up their claims of “better hearing” in the open position.
Further, though the earplugs tested at 22 NRR when they were manually manipulated prior to insertion, 3M never included these fitting instructions in their packaging. They simply told the user to insert the earplugs normally into the ear canal. Without those extra instructions, soldiers were using the earplugs in a way that increased the risk of the earplugs loosening during use, eventually causing hearing loss. Yet, 3M/Aearo still stated the earplugs, when used in the closed position, would achieve a 22 NRR, falsely overstating the amount of hearing protection provided. “3M’s/Aearo’s packaging and marketing of such earplugs with a labeled NRR of ‘22’ thereby misleads the military,” the plaintiffs asserted, “and has likely caused thousands of soldiers to suffer significant hearing loss and tinnitus….”
Additionally, soldiers who wore the plugs in the open position thinking the products were blocking out dangerous impulse noises were at risk for hearing damage too, as 3M’s -2 NRR rating shows that when the plugs weren’t properly sealed, they gave diminished hearing protection in that position.
3M Agrees to Pay $9.1 Million for False Statements
Because of the government’s lawsuit, 3M agreed to pay $9.1 million to resolve allegations they knowingly sold defective earplugs to the military. Specifically, the United States alleged that 3M/Aearo knew their earplugs were too short for proper insertion into the ear and could loosen imperceptibly, therefore not performing well for certain individuals. Further, the company did not disclose this problem to the military. The company did not admit liability.
“Properly made safety equipment, for use by our soldiers,” said Frank Robey, director of the U.S. Army Criminal Investigation Command’s Major Procurement Fraud Unit, “is vital to our military’s readiness. Our agents will respond robustly to protect the safety of our military.”
Special Agent in Charge Robert E. Craig, Jr., DCIS Mid-Atlantic Field Office, added that the settlement “demonstrates the commitment” of the Defense Criminal Investigative Service to “hold companies accountable for supplying substandard products, in particular products that could directly impact our service members’ health and welfare.”
Types of injuries associated with 3M’s defective earplugs include:
- Hearing loss
- Tinnitus (ringing in the ears)
- Auditory processing disorder (APD)
Veterans are at a Higher Risk for Hearing Loss
The Centers for Disease Control and Prevention (CDC) has discovered that veterans are 30 percent more likely than nonveterans to suffer from severe hearing impairment. Those serving after the year 2001 are four times more likely.
The majority of hearing problems develop because of exposure to loud noises, including those from gunfire, heavy equipment, jet engines, machinery, blasts, and roadside bombs. Exposure may occur on the battlefield, during training, or during general job duties, and can contribute to eventual hearing impairments if adequate hearing protection is not available.
Though hearing loss is, in itself, a serious disability, recent research shows it can lead to other problems, as well. Researchers reported in a 2015 study that 79.1 percent of tinnitus sufferers had a diagnosis of anxiety, and 59.3 percent had depression, while 58.2 percent suffered both. A 2017 study, that scientists discovered post-deployment hearing loss or tinnitus typically occurred together with post-traumatic stress disorder (PTSD), depression, and traumatic brain injury.
Other studies have found similar results—that hearing loss can significantly affect the quality of life. In a 2018 review of the scientific literature, researchers reported that hearing loss is associated with a generally reduced quality of life, and that it was also a risk factor for distress. Additional research shows that older people with hearing problems typically have more limited lives, and are twice as likely as others to limit their living space to only nearby areas.
Noise-induced hearing loss is a permanent disability. There is no cure, though there are hearing aids and surgery that may help. The problem is preventable, however, which is why the U.S. government made hearing protection mandatory for military personnel.
When the government put out the Request for Proposal (RFP) looking for an earplug provider back in 2003, 3M bid for and won the contract, making it the exclusive provider of selective attenuation earplugs to certain branches of the military for years. The unique dual-ended design of their earplugs likely gave them the edge, but 3M neglected to tell the military that as early as the year 2000, they were aware of defects in those same earplugs that would leave soldiers at risk of developing hearing damage.
Have you suffered as a result of defective 3M Combat Arms Earplugs? Contact our attorneys to discuss your claim.