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According to a recently settled whistleblower lawsuit, 3M Company and its predecessor Aearo Technologies, Inc. —which supplied the U.S. military with Combat Arms Earplugs version 2 (CAEv2) between 2003 and 2015—made false statements about the effectiveness of those earplugs, unnecessarily putting millions of veterans in danger of developing hearing loss and tinnitus.

Moldex-Metric, a competitor company that also manufacturers earplugs, filed the lawsuit under the False Claims Act. The U.S. Department of Justice later joined in the suit, and the plaintiffs secured a $9.1 million settlement agreement.

In the lawsuit, the plaintiffs’ alleged that 3M and Aearo (3M acquired Aearo in 2008) were aware of problems with the CAEv2 for years, yet continued to supply them to the military without disclosing the CAEv2’s defects.

Manufacturer Manually Manipulated Tests to Make Earplugs Look Effective

The CAEv2 have a dual-ended design, so they could be used as traditional earplugs or flipped over to provide normal hearing while protecting eardrums from gunfire and explosions.  If the earplugs were worn on the “closed” or “blocked” position (olive end in), the earplugs are supposed to block sound like traditional earplugs.

Defective 3M Yellow and Green Earplugs
Illustration of a 3M CAEv2 Earplug

If worn in the “open” or “unblocked” position (yellow end in), the earplugs are supposed to block or significantly reduce loud, impulse sounds of battlefield explosions, while still allowing the wearer to hear quieter noises such as commands spoken by fellow soldiers or approaching combatants.

Specifically, the earplugs were too short to be properly inserted into some user’s ears and could loosen imperceptibly, disrupting the seal and allowing loud noises to travel inside the ear canal and cause damage. After discovering as far back as the year 2000, that the products weren’t performing as expected during Aearo’s internal testing of the earplugs, company personnel manipulated the earplugs during retesting of the closed end of the earphones in order to achieve improved results.

Aearo never retested the open end despite its knowledge that the test data obtained was based on subjects being improper fitted with the earplugs which prevented the earplug from properly sealing to the ear and allowed noise to bypass the earplug filter, which artificially drove down the noise reduction rating (NRR).

3M Makes False Statements About The Effectiveness of Their Earplugs

In 2003, the company submitted a bid in response to the military’s request for proposal (RFP) to supply large quantities of the earplugs. In that proposal, Aearo had to certify that their earplugs complied with military standards. The sound attenuation of both ends of the “dual-end” earplugs was supposed to be tested, and the products free from all defects that would impair serviceability. Another applicable standard required, in essence, that the earplugs provide protection from impulse noises created by military firearms, while allowing the wearer to hear other quieter sounds, like spoken commands. As shown in the company’s own tests, the earplugs did not meet these requirements, but the company certified that they did anyway, in essence making a false statement in the proposal.

Aearo won the contract and received payments from the government based on false statements, yet the deception didn’t end there. Aearo/3M subsequently filled out additional RFPs and landed additional contracts to continue supplying these earplugs to the military, each time falsely asserting that the products complied with military standards.

Moreover, despite Aearo’s and later 3M’s knowledge of the proper fitting technique for the CAEv2s, 3M/Aearo did not include in their product instructions that the user had to fold back the flanges for the products to work correctly. Instead, they simply told wearers to insert the earplugs as-is into the ear canal. As a result, soldiers wearing the earplugs were at risk of serious hearing impairment.

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