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UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF FLORIDA

PENSACOLA DIVISION

IN RE: 3M COMBAT ARMS ) Case No. 3:19md2885

EARPLUG PRODUCTS LIABILITY )

LITIGATION )

) Judge M. Casey Rodgers

This Document Relates to All Actions ) Magistrate Judge Gary R. Jones

ADOPTION OF PLAINTIFF’S PRIOR GENERAL EXPERT REPORT

MARK D. PACKER, M.D., COL. (ret), USAF, MC, FS

ORIGINALLY SERVED OCTOBER 9, 2020

UPDATED NOVEMBER 20, 2020 

UPDATED JULY 6, 2021

July 6, 2021

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UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF FLORIDA

PENSACOLA DIVISION

IN RE: 3M COMBAT ARMS EARPLUG

PRODUCTS LIABILITY LITIGATION Case No. 3:19-md-2885

This Document Relates to All Cases

Hon Judge M. Casey Rodgers

Magistrate Judge Gary R. Jones

RULE 26 EXPERT REPORT OF

MARK D. PACKER, M.D., COL. (ret), USAF, MC, FS

The following report is provided pursuant to the Federal Rules of Civil Procedure 26. All 

the opinions I offer herein I hold to a reasonable degree of medical or scientific certainty. My 

curriculum vitae is attached as Exhibit A, my testimony history is attached as Exhibit B, and my 

reliance materials are attached as Exhibit C. The materials I have relied on in forming my opinions 

in this report are included in this report and my reliance list. 

This report summarizes my knowledge, expertise, experience, leadership, and functional 

understanding of hearing conservation in the military, noise-induced hearing loss (“NIHL”), 

tinnitus, the diagnosis, treatment, and impact of NIHL and tinnitus on servicemembers, and 

attempts and efforts to prevent those injuries. This report also presents background information 

and my opinions on the Combat Arms Version 2 (“CAEv2”). My opinions include but are not 

limited to: (1) the CAEv2 is unreasonably dangerous and can cause NIHL and tinnitus; (2) 3M 

was negligent in testing, marketing and selling the CAEv2; (3) 3M failed to adequately warn about 

the CAEv2’s dangers; (4) 3M failed to train and instruct purchasers and users of the CAEv2; and 

(5) that there were safer alternative designs of the CAEv2. This is my report and does not represent 

the opinions of the Air Force, the United States Military, or the United States Government. Much 

of this report is based on my education, training, experience, and practice as a Board-Certified

physician in the fields of otology/neurotology.

I. QUALIFICATIONS

I am currently the Medical Director of Neurotology at Mercy Hospital in St. Louis, 

Missouri. After obtaining my Bachelor of Science degree from the University of Utah in 1990, I 

obtained my Medical Degree from the Uniformed Services University of the Health Sciences 

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(USUHS) in Bethesda, MD in 1995 through a direct commission in the United States Air Force. 

While at USUHS, I was elected into the Alpha Omega Alpha Medical Honor Society, Gamma 

Chapter. I completed an internship in General Surgery at Wright State University, Wright Patterson 

Air Force Base in 1996. I attended the School of Aerospace Medicine Primary Course at Brooks 

Air Force Base in Texas. While there, I trained in concepts and administration of the Air Force 

Hearing Conservation Program, which included a specific focus on environmental and 

occupational noise, noise mitigation and abatement, and the importance of engineering 

modifications and human protection via hearing protection devices (HPDs). 

I then served as a Flight Surgeon with the 16th Operations Support Squadron at Hurlburt 

Field, Florida. My duties included supervision of bioenvironmental engineering personnel in 

administration of the hearing conservation program. My duties also included noise hazard 

identification and analysis, hazardous noise area surveys, noise source surveys, noise control, 

education in the use and capabilities of HPDs, occupational audiometric analysis, and medical 

evaluation board processing. I was attached to the 15th Special Operations Squadron where part 

of my duties included medical didactic and field training of pararescue journeymen, combat 

controllers, and tactical training with all branches of special forces units. This included an 

understanding of HPDs and their specific uses for tactical training. I was familiar with the use and 

fitting techniques for foam earplugs (“foamies”), flange hearing protectors, custom molded ear 

plugs, and David Clarke headsets. My duties also included understanding and training as to 

physiologic environmental stressors such as altitude, heat, cold, noise, vibration, barotrauma, and 

regional public health and infectious disease requirements for rapid response deployment to any 

area of the world. I also was engaged in collecting and providing morphometric data for the 

development and modification of Bose Active Noise Cancelling Headsets.

From 1998 through 2002, I completed a four-year residency in Otolaryngology, Head and 

Neck Surgery at Wilford Hall Medical Center. From 2002 through 2006, I served as Chief 

Otolaryngology Element of the 3rd Medical Group at Elmendorf Air Force Base, Alaska. My 

clinical duties included the full scope of otolaryngology medical and surgical practice as well as 

participating in the Air Force Hearing Conservation Program by lecturing to technicians on hearing 

conservation, evaluating active duty and recently separated service members hearing profiles, and 

performing medical board profiles regarding occupational hearing loss and vestibular injury. 

During this time period, I deployed to Guam as a flight surgeon attached to a Barksdale, Louisiana

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B52 squadron from the 2nd Bomb Wing, during which time I was directly responsible for flight, 

flight line, and hearing conservation duties. During my deployment, I was exposed to noise 

hazardous settings that necessitated the use of HPDs, and I assessed the safety and efficacy of 

those devices on behalf of myself and my squadron.

In 2006, I entered training as a Fellow in Otology/Neurotology/Cranial Base Surgery at 

The Ohio State University. I successfully completed my fellowship in 2008 and received board 

certification in Otology/Neurotology in 2010. During my fellowship, I was responsible for medical 

school and resident education, full scope otology/neurotology clinical practice, as well as clinical 

and bench research related to diseases of the ear. I also assisted in implanting the first three 

auditory brainstem implants at The Ohio State Medical Center. 

From 2008 through 2013, I served as the Chief of Neurotology and Cranial Base Surgery 

and as an Otolaryngologist at Lackland Air Force Base. From 2008 to 2009, my practice included 

the full range of Otology and Neurotology issues from diagnosis to treatment, including surgery 

for hearing loss, tinnitus, full scope hearing rehabilitation, infectious diseases of the ear, as well as 

cranial base pathology and the lateral skull base approaches for access to the middle and posterior 

cranial fossae. I also worked at Brooke Army Medical Center, which was also a tertiary care center 

for wounds from the global War on Terror. My practice at Brooke Army Medical Center included 

the diagnosis and treatment of NIHL sustained by soldiers at war. I was also responsible for 

residency training. I delivered and supervised grand rounds and was responsible for directing 

surgical temporal bone dissection courses for resident surgical training. I conducted humanitarian 

otologic surgery missions in South and Central America to establish contingency medical and 

surgical skills and support local hearing restoration efforts. 

In 2009, I was selected by the Air Force Surgeon General to serve as the Interim Director 

of the Department of Defense (DoD) Hearing Center of Excellence (HCE). In 2011, I was 

appointed as the permanent Executive Director of the HCE. I served as the Executive Director 

until 2016. The HCE was legislated by Congress in the National Defense Authorization Act and 

directed to partner with the Department of Veterans Affairs (VA), institutions of higher education, 

and other mission-minded public and private organizations. HCE’s primary responsibilities 

include developing a data registry to track hearing loss and auditory injuries across the Armed 

Forces and to share the registry data with the VA; encourage and facilitate hearing health research; 

develop best practices and clinical education; standardize acquisition of supplies, including HPDs, 

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across service branches; and enhance the coordination and delivery of VA rehabilitation benefits 

and services to former Service members. 

As Director of the HCE, I advised the Assistant Secretary of Defense for Health Affairs 

and the Surgeons General of the Uniformed Services on hearing health-related matters and 

developed and executed the HCE’s Congressional mandate to oversee the prevention, diagnosis, 

mitigation, treatment, and rehabilitation of hearing loss and auditory system injury. I established 

the concept of operations for the HCE and executed the concept by staffing and directing the five 

HCE directorates to accomplish our mandate. I directly assisted each directorate in their missions 

and developed the partnerships with the VA and other private and academic entities to ensure 

hearing readiness and improve the hearing health and quality of life for service members and 

veterans. We developed the HCE’s Comprehensive Hearing Health Program with core tenets 

consisting of Education, Protection, and Monitoring. The Protection component involved 

developing DoD policy guiding acquisition and distribution of qualified products, including HPDs 

and tactical communication and protection devices (TCAP). These efforts were coordinated with 

subject matter experts from DoD research labs, the DoD Hearing Conservation Working Group, 

and senior military and civilian leadership. 

Program elements included annual fitting and counseling for service members with HPDs, 

emphasizing the importance of proper wear and use of HPDs whenever exposed to hazardous

noise. We also proposed the hearing protection Qualified Products List, which included 

identification of quality HPDs for service member’s use with coordination of Defense Logistics 

and VA Acquisition and Logistics processes to contract and supply HPDs, and coordinated 

proposals to centrally fund HPDs. This Qualified Products List included active and passive 

devices, linear and non-linear products including hand formed, multi flanged earplugs, muffs, and 

headsets. We pulled in experts from various service branches to determine requirements for 

particular services and specialties and worked with the HCE chartered collaborative auditory 

vestibular research network (CAVRN), which included US Army Aeromedical research lab, the 

Army Research Lab at Aberdeen Proving Grounds, the Walter Reed Military Medical Center

Auditory Research Center, the Navy Submarine Medical Research Lab, the Air Force Research 

Lab, the Naval Marine Medical Center San Diego auditory research lab, the San Antonio Military 

Medical Center’s Institute of Surgical Research and Joint Center for Battlefield Health and 

Trauma, and the VA National Center for Rehabilitative Auditory Research. This effort attempted 

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to define the appropriate measures for HPDs and match that to products that were available with 

the goal of creating an approved list of HPDs for centralized contracting, distribution, and 

education. This analysis included the review of the strengths and weaknesses of specific 

manufacturers’ HPDs, the noise reduction rating (NRR) represented by the manufacturers, and 

their qualities in an attempt to assist various services determine the best products for the needs of 

their troops. 

During this time period, we examined and considered innovative ways to customize and 

improve hearing protection as well as HPD priority, access, development, and technology. I served 

on the Defense Medical Research and Development Joint Programmatic committees for Military 

Operational Medicine, Clinical Rehabilitative Medicine, and the Human Performance 

Optimization Health Science Advisory Committee to prioritize and program Department of 

Defense funding in neurosensory research lines, which included hearing protection. We also 

worked with and facilitated CAVRN associated labs, institutions of higher education, and other 

mission-minded public and private organizations to focus on prioritized research requirements. As 

an example of this coordination, we worked with entities developing finite element and laser 

mapping of ear canal morphology, information technology solutions capable of data basing such 

information, companies with capabilities for 3-D printing customized ear protection for service 

members, and military/veterans logistics specialists to make such devices available on a large 

scale.

In development of the congressionally mandated Joint Hearing Loss and Auditory System 

Injury Registry (JHASIR), I worked with owners of disparate military health information databases 

and systems, including the DoD Trauma Registry, the Defense Medical Data Center, the Theater 

Medical Data System, the Defense Occupational and Environmental Health Registry System, the 

Enterprise Clinical Audiology Application, the VA Clinical Data Warehouse, and the Denver 

Acquisition and Logistics Center. We developed an Auditory Injury Module within the Joint 

Theater Trauma Registry, as well as with services to modify and streamline data entry for military 

data systems. We advised working groups to develop specificity to questions entered into the preand post-deployment questionnaires, the annual hearing conservation points of care, the accession 

and exit medical standards working groups, and the VA clinical data managers to add questions 

related to exposure, hearing protection devices, education, and tinnitus. We also worked to 

develop public service announcements, educational materials, and advocacy to ensure military 

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audiologists and VA audiologists understood and had tools to promote hearing loss prevention and 

hearing conservation and to ensure that data to be collected into the JHASIR would be clean, 

concise, and reliable. 

I helped to develop and participate in State of the Science (SoS) conferences that focused 

on highly prevalent or problematic hearing related topics. In November 2011, the DoD Blast 

Injury Research Program Coordinating Office (PCO), in collaboration with the Hearing Center of 

Excellence (HCE) and the VA, hosted an International State-of-the-Science (SoS) Meeting on 

Blast-Induced Tinnitus to review current knowledge regarding the cause, diagnosis, and treatment 

of tinnitus and to identify research gaps for further investigation. On behalf of the HCE, I helped 

organize, host and speak at the meeting. This was a landmark event in collaboration with academia 

and research centers to address tinnitus in the military including etiology diagnostics and 

treatment. 

In August 2011, I was asked to serve as the US Team Chief to the NATO Human Factors 

in Medicine (HFM) Exploratory Team (ET) 117. We proposed NATO collaborative efforts to 

focus on the Treatment, Rehabilitation and Reintegration of Soldiers with Severe Injuries to the 

Hearing System. With acceptance of our proposal, I co-chaired the NATO HFM Science and 

Technology Organization (STO) 229 effort, Optimizing Hearing Loss Prevention and Treatment, 

Rehabilitation and Reintegration of Soldiers with Hearing Impairment, March 2012 - 2016. This 

work included the development of standardized data collection for hearing loss prevention, hearing 

related injuries and hearing related outcomes observation. The achieved goal included, among 

other things, eliminating poorly gathered and incorrect data, and bringing consistencies towards 

gathering and reporting data on hearing loss prevention, hearing related injuries, and hearing 

outcomes of hearing loss management. I was the US Representative for the NATO Combat 

Clothing and Individual Equipment and Protection NOISE working group, 2015. I also 

coordinated efforts and initiate collaborations with the Medical Director of the UK’s Defense 

Medical Services in relation to hearing loss prevention, tinnitus, hearing injury, and hearing 

rehabilitation. In addition, I worked with military medical specialists from the Israeli Defense 

Force on HPD development. 

While serving as Executive Director of the HCE, we worked with 3M as they developed 

the Exercise in Communications and Hearing Operations (ECHO) one-day training program for 

hearing health professionals, policy makers, and senior military leaders. The program’s goal was 

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to increase basic understanding of military noise exposure and personal hearing protective gear 

and to highlight the tenet of communication through the direct context of field experience with 

hearing protection. 

I helped launch and was a member of the DoD Epidemiology and Economic Burden of 

Hearing Loss Study (“DEEBoHLS”) project team. The mission of the DEEBoHL was to examine 

the rates of hearing impairment and noise-induced hearing injury, examine relevant noise 

exposures, and determine the cost burden of hearing impairment and noise-induced hearing injury 

to the DoD and servicemembers. We also specifically studied the impacts of hearing loss and 

noise-induced hearing injury on the quality of life of servicemembers and the barriers to worker 

performance related to hearing loss among veterans in common post-military occupations. As a 

result of this effort, we developed a Markov model that estimates the costs of hearing loss over the 

service life cycle of servicemembers. This included the cost associated with hearing conservation 

programs, personnel, HPDs, hearing rehabilitation devices, and other treatments.

I realize that extending the understanding of the microanatomy and physiology of hearing 

is critical to hearing preservation and treatment. To this end, I presented policy recommendations 

to senior military leadership and health affairs towards linking temporal bone specimen collection 

in the military with the temporal bone registry. This effort would enable researchers to identify the 

microscopic effect of noise trauma which could be coordinated with the well documented 

occupational and clinical audiometry across a service member’s history. I also worked with the 

City College of New York to develop a supercomputer micro electromechanical system to model 

intracochlear fluid dynamics. This could further be applied to computer-based assessment of 

HPDs if critical injury thresholds are better understood. 

To further the understanding of critical injury thresholds, the HCE convened a two day 

conference at Lincoln Laboratories for a group of over 50 experts from Harvard, M.I.T., Mass. 

General Hospital, Walter Reed Army Hearing Program, Naval Research NIHL program, Military 

Operational Medicine research awardees, and the University of Pittsburgh Medical Center among 

other institutions. I directed the discussion related to the science of synaptopathy, continuous noise 

dosimetry, microcomputer modeling of cochlear forces and the current state of hearing diagnostics. 

This was an effort to establish longitudinal collaboration with the goal of identifying and linking 

noise hazard in real time (dosimetry) with more timely (boothless audiometry) and/or more 

sensitive testing (electophysiological or behavioral testing capable of identifying subclinical 

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cochlear damage) of individuals with known noise history (occupational hearing registry) and 

prospective methodology to directly correlate findings with human pathology (temporal bone 

registry). 

The meeting was met with exceptional enthusiasm. Dr. Sharon Kujawa, and Dr. Charlie 

Liberman, who first identified and led the science of synaptopathy, have continued interacting with 

the military through the HCE. Military personnel with NIHL generally have detailed hearing 

histories, serial audiometry and would be well suited for dosimetry, early injury diagnostics and 

synaptopathy screening diagnostic development. These efforts translate the science of 

synaptopathy and will help improve hearing conservation programs and HPD development. It also 

explains the common experience of military otologists and audiologists treating noise exposed 

service members that have no objective, or mild injury but yet have more significant trouble 

hearing than would be expected for the mild loss; or who have tinnitus and hyperacusis without 

hearing loss; or who have more rapidly progressive hearing loss then one would expect for their 

ages. 

Throughout my time in the HCE, I continued treating service members as a neurotologist 

in diagnostic, treatment and surgical rehabilitation. This included responsibilities for resident 

training, education and research development. I directed surgical temporal bone dissection labs, 

didactic and clinic-based education and grand rounds participation. Clinical responsibilities 

included caring and treating for service members injured at war that were relocated for stateside 

rehabilitation. I was involved in cutting edge medicine involving service members with blast 

injuries, conductive hearing loss and traumatic ear injuries. This included the use of novel hearing 

rehabilitation devices such as the Soundbite and the Vibrant Sound Bridge for conductive hearing 

losses caused by trauma at war. I was also certified to implant two middle ear implants and 

coordinated lab training and certification for all DoD neurotologists to implant the Ototronix 

Maxum and the Envoy Esteem. These products fit a niche gap in hearing restoration between when 

hearing aids fail to adequately meet patients’ needs but cochlear implant indications are not yet 

met. At the time, I was the only neurotologist to qualify for the Esteem. I have also worked with 

the Earlens which is a similar, but non-surgical direct drive system with recent FDA approval.

In 2016, I was awarded the Air Force Legion of Merit by the Air Force Surgeon General. 

This award is given for exceptionally meritorious conduct in the performance of outstanding 

services and achievements. 

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I retired from the Air Force with the rank of Colonel in 2016. Since that time, I have worked 

in private practice and served as the Medical Director of Neurotology at St. John’s Mercy Hospital 

in St. Louis, MO. Throughout my military and civilian experience, I have studied, diagnosed and 

treated NIHL and tinnitus in service members and veterans. I have routinely treated patients with 

hearing loss due to a variety of causes, including noise trauma, ototoxicity, age, congenital loss, 

genetics, head trauma, ear infections, auto-immune disorders, neoplastic disorders and metabolic 

conditions, among others. I routinely produce a differential diagnosis of a patient’s hearing loss 

which includes ruling in and ruling out causes of hearing loss in order to direct treatment. 

I have examined and treated soldiers exposed to impulse, blast noise, and long-term noise 

exposure. I have also seen patients with dizziness, PTSD and TBI from blast exposure. I treat 

patients with hearing loss and tinnitus who also have depression, which is a frequent comorbidity. 

I have referred such patients for further treatment to psychiatry or psychology. 

I regularly discuss HPDs with my patients who are exposed to noise in work or recreational 

activities. I advise them to evaluate the HPD’s noise reduction rating, which is disclosed on the 

device’s label in accordance with the Noise Control Act and EPA regulations. I advise patients 

that a higher NRR means stronger noise protection and that this is a measure that should be relied 

on when selecting HPDs.

I have also routinely treated patients with tinnitus. In treating such patients, it is routine 

for me to review the general causes of tinnitus, explain the current understanding of the 

mechanisms that generate tinnitus and explore possible causes with each patient. I review possible 

treatment options with those patients and make treatment recommendations. 

I have authored over 30 publications in peer-reviewed journals, including 5 publications in 

which I served as a Special Editions editor. I have also authored 12 chapters in textbooks.

Since 2011, I have been awarded multiple grants for research into issues related to NIHL 

and tinnitus. This includes grants for novel techniques for the management of tinnitus, research 

into pharmaceutical development for prophylactic measures to reduce NIHL, tinnitus 

reorganization training for management for combat related tinnitus, alternative tinnitus 

management techniques to find an objective measurement of tinnitus, the development of a multi 

scale electromechanical simulation of cochlear fluid dynamics the goal for which was to develop 

a better model for evaluating effectiveness of HPDs and other subjects in my field. I have also 

given more than 100 local, national and international presentations on issues related to this field. 

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II. ASSIGNMENT AND METHODOLOGY

In formulating my opinions and preparing this report, I reviewed scientific literature, 

corporate documents from Aearo and 3M, which acquired Aearo in 2007 (collectively referred to 

herein as “3M”), sample products, government and military documents, depositions of government 

agencies, and depositions of 3M employees. A list of the corporate documents, sample products, 

government and military documents and depositions that were supplied to me by counsel are 

included in Exhibit C. I understand discovery is still ongoing and I reserve the right to amend my 

opinions if further information is provided in any form including, but not limited to depositions, 

corporate documents, government and military documents, and the expert reports of both Plaintiff 

and Defense experts.

III. HOW WE HEAR

Sound is both a physical and a perceptual phenomenon. In the perceptual sense, sound is 

an auditory experience called hearing. In the physical sense, sound is produced when air molecules 

are set into vibration and generate pressure waves through a medium (e.g., air, water). The 

fluctuations in pressure create sound waves, which are physical input that is the basis of human 

hearing. The simplest sound wave is a pure tone. A pure tone can be characterized by its frequency, 

wavelength, phase, amplitude, and intensity. 

A. Frequency

The frequency of a sound refers to the number of cycles of a pure tone that take place at a 

given location and length of time. Pitch is the perceptual correlate of frequency. High frequencies 

are associated with treble or high pitches and low frequencies with bass or low pitches. The 

frequency is measured in cycles per second, or hertz. A person with good hearing can hear a range 

of sounds between 20 Hz and 20,000 Hz. The period of a pure tone is the inverse of frequency and 

is the time it takes to complete one cycle of the puretone. (Plack, 2018)

B. Wavelength

The wavelength of a sound wave is the physical distance covered by a complete cycle of 

the wave. The wavelength of a sound is a simple function of the frequency of the sound, because 

the speed of sound in a medium, in this case air, is constant. It is the speed of sound divided by the 

frequency of the sound wave. Higher frequencies are caused by shorter wavelengths and lower 

frequencies result from longer wavelengths. (Plack, 2018)

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C. Phase

Phase is the point reached on the pressure cycle at a particular time. Phase covers a range 

of 360 degrees and its measurements are relative. When two sounds are added together the effect 

they have on hearing depends on their relative phase. Adding two pure tones with the same 

frequency that have no phase delay between them, meaning the peaks of the waveforms coincide, 

will result in a combined waveform that has a high amplitude. (Plack, 2018)

D. Amplitude & Intensity

A sound wave’s amplitude is the magnitude of its pressure variations or displacement, 

measured with respect to the deviation from atmospheric pressure. (Plack, 2018) A sound wave 

with a higher amplitude sounds louder. Amplitude can be used to describe the pressure at the peak 

of the waveform or the average over time of the pressure variations squared-the root mean square 

pressure. Intensity is the sound energy passing through a given area every second. The intensity of 

a sound wave is proportional to the square of the root mean square pressure, such that I=kP2where 

I is the intensity, P is the root mean square pressure, and k is a constant. In other words, for a given 

medium, pressure and volume velocity are always proportional: Volume velocity (V) equals 

pressure (P) divided by the acoustic impedance (Z) of the medium (impedance is the opposition 

offered by the molecules to imposed pressure). Intensity (I) can thus be easily calculated, as it is 

proportional to pressure squared. Just as frequency (physical) is correlated with pitch (perceptual), 

acoustic intensity correlates with loudness: The more intense a sound, within limits of audibility, 

the louder it will be.

Since the surface area of a sphere is proportional to the square of its radius, sound intensity 

(power per unit area) is inversely proportional to the square of the distance from the sound source. 

This is known as the inverse square law. Recall that intensity is proportional to pressure squared; 

sound pressure is thus inversely proportional to distance (not its square). If the distance is doubled, 

the intensity will be one fourth as great, and the pressure will be halved. The general rule that 

sound pressure is inversely proportional to distance must be modified by two additional factors. 

First, even in an unbounded medium, there is some conversion (dissipation) of sound energy to 

heat through friction as it radiates out. This effect is greater for higher frequencies. Second, in 

enclosed spaces such as factories, there is considerable reflection of sound from interior walls; in 

such reverberant environments, sound pressure may drop off much less rapidly as distance 

increases than would be predicted by the inverse square law. 

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It is essential to remember the distinction between acoustic and perceptual variables, as the 

perceptual variable is not perceived linearly. In hearing-impaired persons, for example, the 

relationship between intensity and loudness may be abnormal. Soft sounds audible to normal 

listeners may be inaudible to impaired listeners, while more intense sounds may be equally loud 

to both normal and impaired listeners. This abnormally rapid growth of loudness for a given 

increase in intensity is called recruitment.

IV. THE DECIBEL SCALE

Using pressure and intensity to measure sounds humans hear can be problematic, because 

we perceive such an enormous range of pressures and intensities. A sound near the greatest sound 

that can be heard (pain threshold) is approximately one million times as intense as the softest sound 

we can hear (absolute threshold of hearing). We specify intensity on logarithmic units called 

decibels (dB). To get to the dB, an intensity scale, in which increments of intensity roughly 

correspond to increments in sensation, is used so that the large range of intensities can be 

represented by a narrower range of numbers. The scale is created by taking the logarithm (to the 

base of 10) of the ratio of sound intensity to a certain reference intensity. Because the units in the 

resulting scale, called bels, are very large, decibels (1/10th of a bel) are used. Decibels (dB) can 

be expressed in Intensity Level (dB IL) or Sound Pressure Level (dB SPL) and their equations are:

 dB IL= 10 log 10 (sound intensity/reference intensity)

 dB SPL= 20 log 10(sound pressure/reference pressure)

However, the decibel scale used when discussing hearing thresholds on the audiogram is 

a third scale called Hearing Level (dB HL). dB HL was determined by finding the dB SPL required 

to barely stimulate the hearing of an average normal-hearing individual at various frequencies. The 

pressure needed to barely hear at a particular frequency varies, such that less pressure is needed 

for middle frequencies and more pressure is needed to just barely hear lower and higher 

frequencies. The lowest sound intensity of each frequency is referred to as 0 dB HL on the 

audiogram in which audiologists use to graphically depict hearing sensitivity.

The dB HL scale is used when measuring hearing thresholds in humans. The threshold, or 

the softest dB HL level that is heard 50 percent of the time, is evaluated from 250-8000 Hz in 

octave steps. Interoctaves of 750, 1500, 3000, and 6000 Hz are also evaluated, particularly when 

there is greater than a 20 dB HL difference between adjacent octaves. This is often the case with 

steeply sloping hearing losses. Remember that the softest dB SPL level normal hearing listeners 

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could detect was averaged for each frequency and called 0 dB HL, and since it is an average 

amongst the group a range from -10 to 25 dB HL is accepted as the range of “normal hearing”. 

V. ANATOMY AND PHYSIOLOGY OF THE AUDITORY SYSTEM

In all mammals, including humans, the auditory system involves the outer ear, middle ear, 

inner ear, and the central auditory pathways to the brain. As sound waves move throughout the air, 

they can enter into the human auditory system first by entering the outer ear, traveling by acoustical 

energy as molecules vibrate or funnel into the ear canal. This acoustic energy hits the eardrum, 

which actively starts moving and in turn transforms acoustic energy into mechanical energy. The 

mechanical energy from the middle ear causes movement within the fluid of the inner ear creating 

hydromechanical energy. As the fluid moves across hair cells within the inner ear, an electric 

energy is generated. That energy will give rise to bioelectrical energy which is transmitted to the 

brain and is interpreted as sound.

(U.S. Army Public Health Command, 2014. Readiness through Hearing Loss Prevention: 

(Technical Guide 250). Available at https://phc.amedd.army.mil/PHC%20Resource%20Library/

TG250.pdf)

A. Outer Ear

The outer ear consists of a cartilaginous flange called the auricle (or pinna) and the external 

auditory meatus (or ear canal). The pinna is formed of external folds, ridges, and depressions of 

molded cartilage projecting out from opposite sides of the head. This includes the deep center 

portion of the pinna, called the concha, or the large bowel near the ear canal entrance. The structure 

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and various folds of the pinna act as somewhat of a funnel to get sound waves into the narrower 

ear canal. These structures facilitate the localization of sounds coming from in front, behind, below 

or above the head. The pinna is specifically designed to transmit more high-frequency components 

from an elevated source than from the same source at ear level, which allows humans to obtain 

important cues about the elevation of a sound source.

(3M_MDL000464853)

The pinna and ear canal form a complex acoustic cavity or tube, beginning at the concha 

and extending inward at a slight upward angle for approximately 1 inch (2.5 cm) in adults. 

Although it appears to be round, the canal is actually elliptical and averages about 9 mm in height 

and 6.5 mm in width. (Martin et al., 2012) The outermost portion of the ear canal consists of 

cartilage containing glands and lined with hair and the innermost portion is bony, with a very thin 

layer of skin. The ear canal is lined with a few layers of skin and is highly vascularized, especially 

the area nearest to the eardrum. This means there is an abundant flow of blood and the area can be 

quite sensitive.

The ear canal is often thought of as an open cavity enclosed on one end, by the eardrum. 

Because of its structure, the ear canal has a particular resonant frequency or natural frequency at 

which it vibrates most easily. In humans, the ear resonates somewhere between 2000 Hz and 5000 

Hz, giving an increase in pressure of about 10-20 dB. (Pickles, 2013) The resonant frequency of 

each ear changes slightly depending on size and shape of the ear canal. 

B. Middle Ear

The middle ear is an air-filled cavity where sound waves are converted into mechanical 

energy. This occurs at the eardrum, which is a thin, concave, nearly transparent membrane. It is 

the common boundary between the outer ear and middle ear. The eardrum is about 90 mm2 and 

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consists of three layers: the outer layer is made of skin, the inner layer is tough, fibrous, connective 

tissue. The third layer, which is within the middle ear space, is lined with mucous membrane. The 

third layer of the eardrum is connected to a chain of three small bones called ossicles--the malleus, 

incus and stapes--that are suspended from the bony wall of the middle ear cavity.

(Purves D, Augustine GJ, Fitzpatrick D, et al., editors. Neuroscience. 2nd edition. Sunderland 

(MA): Sinauer Associates; 2001. The External Ear. Available from: https://www.ncbi.

nlm.nih.gov/books/NBK10908/)

As sound moves through the ear canal, it strikes the eardrum and causes it to vibrate and 

buckle which results in movement of the ossicular chain. The innermost ossicle, the stapes, has a 

footplate that is in direct contact with the fluid-filled inner ear through a small opening called the 

“oval window.” The ossicular chain is about 2 to 6 mm in length and acts like a single unit when 

transmitting most sounds. 

The movement of the eardrum and the ossicles provides energy transformation that is 

needed to convert sound energy from acoustic waves to mechanical energy. Because the sound is 

going from an air-filled middle ear to a fluid-filled inner ear, the middle ear must provide a boost 

of pressure to overcome this. This is done in three different ways: first, the area of the eardrum is 

17 times larger than the area of the stapes footplate on the oval window. Because of this difference 

between the mass and area between these two structures, this increases the pressure. Second, the 

ossicles within the middle ear act as a lever (similar to that of a dolly), with the malleus being 1.3 

times larger/longer than the incus, which creates a mechanical advantage. Lastly, as the tympanic 

membrane moves from acoustic energy striking it, it does not move as one whole system, but rather 

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segmentally, which creates a boost in sound pressure level getting to the cochlea at the site of the 

oval window. In engineering terms, the middle ear acts as an impedance-matching transformer, 

similar in principle to the transformers used to connect electronic devices of different impedances 

(e.g., antenna or cable to a television set). The difference in area between the tympanic membrane 

and the oval window of the inner ear and the lever ratio generated by the ossicles together give a 

31.9 dB increase in sounds by the time they reach the inner ear. (Pickles, 2013) It is this transformer 

and the ear canal resonance combined with the inability of the inner ear to respond to very high 

and very low frequencies that determine the normal human sensitivity curve (or minimum 

audibility curve), with best hearing between 1 and 5 kHz and none outside the 20 Hz to 20 kHz 

range.

The stapedius and tensor tympani are small muscles connected to the malleus and stapes, 

respectively. These muscles contract in response to loud or startling noise. This response, called 

the acoustic reflex, stiffens the ossicular chain, which increases impedance and decreases the 

conduction of low-frequency sound to the inner ear. 

C. Inner Ear

The footplate of the stapes fits into the oval window of the cochlea, or the fluid-filled inner 

ear. As the stapes footplate moves, it creates pressure waves in the fluids of the cochlea, which 

also displace the membranes within the structure. The cochlea is a small shell-shaped portion of 

the body labyrinth that contains the organ of Corti, which is the sensory organ for hearing. The 

basilar membrane, which is tonotopically organized, runs the entire length of the cochlear duct on 

which the organ of Corti resides. This membrane changes in width and stiffness as it goes from 

base to apex, with it being narrow and tight at the base and wide and loose at the apex. (Yost, 

2008) The area in which the wave displacement occurs along the basilar membrane provides the 

brain with information regarding the frequency and level of the sound. Higher pitched sounds, or 

tones with shorter wavelengths show maximum displacement near the basal end, whereas tones of 

low frequencies, or long wavelengths show maximum displacement near the apical end. If a 

complex sound is heard, displacement will occur at multiple places along the basilar membrane. 

This tonotopic organization permits the inner ear to segregate sounds of different frequency 

content, which enable the listener to recognize those complex sounds (e.g., speech) based on the 

frequency patterns.

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As the basilar membrane moves up and down in response to the movement of the inner ear 

fluid, the inner and outer hair cells that are within the organ of Corti become “sheared.” The inner 

hair cells are the primary sensory receptors for hearing and the outer hair cells are responsible for 

actively sharpening the pressure wave in the cochlea. The outer hair cells, when stimulated, expand 

and contract in length, which change in the biomechanical vibratory pattern and create a highly 

sensitive cochlear response. (Yost, 2008). The hair cells and their stereocilia or the thin hair-like 

structures sit on top of the basilar membrane and underneath the tectorial membrane. When the 

basilar membrane moves, the tectorial membrane also moves, which then causes the shearing or 

deflection of the stereocilia of the outer hair cells due to the attachment they form to the tectorial 

membrane. The shearing of the inner hair cells most likely occurs due to the fluid movement 

between the stereocilia and the tectorial membrane. (Yost, 2008). As the stereocilia bend, ion 

channels open in the body of the hair cells. When the ion channels open, it allows for ionic 

transportation that is necessary for neural transduction. 

D. Auditory Nerve & Central Auditory System

Auditory nerve fibers act as a direct synaptic pathway between the hair cells in the cochlea 

and the cochlear nucleus in the brainstem. The human ear has about 30,000 auditory nerve fibers, 

with about 90% of them synapsing on inner hair cells. The signal is transmitted along the auditory 

nerve to the brainstem auditory centers, and projections are further sent to the cerebral cortex. The 

auditory cortex consists of core areas and surrounding regions which are tonotopically organized 

and housed within the temporal lobe. (Pickles, 2013) Sounds heard in only one ear are represented

and elicit cortical activity in both hemispheres of the brain. This binaural representation aids in 

localization of sounds through the comparison of interaural timing and intensity differences and 

allows humans to perceive location in azimuth, distance, and elevation of incoming sounds. 

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Injuries or lesions on one side of the brain may drastically impair localization. Additionally, if the 

brain does not receive adequate stimulation from all frequencies, as is the case with hearing loss, 

the organization of the auditory cortex can change and have lasting effects on one’s ability to 

process speech sounds. (Sharma et al., 2018)

VI. HEARING LOSS

Hearing losses can be divided into two primary categories based on the site of lesion: (1) 

conductive, and (2) sensorineural. A third category, mixed hearing losses, result from concomitant 

conductive and sensorineural dysfunction. Conductive hearing loss occurs when sound conduction 

to the inner ear is impeded by the external ear, the middle ear, or both (Isaacson et al., 2003). 

Conductive losses are commonly caused by complete blockage of the ear canal by cerumen (ear 

wax) or foreign bodies, outer ear infection (otitis externa) and/or middle ear infection (otitis 

media), eardrum perforation and erosion or fixation of the ossicles. Because these conditions are 

generally amenable to medical or surgical intervention, they tend to be temporary and reversible. 

As discussed in more detail below, conductive hearing losses are characterized by normal hearing 

thresholds on bone conduction testing, with elevated hearing thresholds on air conduction tests.

By contrast, elevated hearing thresholds on both air conduction and bone conduction tests 

demonstrate a sensorineural hearing loss (SNHL). SNHL includes two subcategories: (1) cochlear

(sensori) pathologies, and (2) retrocochlear (neural) pathologies, which involve damage in the 

neural pathway to the auditory cortex. Retrocochlear pathologies, which occur when sound enters 

the ear normally but is not organized in a way that the brain can understand due to inner ear or 

nerve damage, are uncommon relative to cochlear pathologies. (Shearer 2017)

Cochlear dysfunction, which accounts for most cases of SNHL, is primarily caused by the 

loss of hair cells within the organ of Corti. A variety of conditions and exposures may result in 

cochlear SNHL, including:

● Age-related sensory hearing loss, which is caused by the progressive loss of cochlear hair 

cells beginning at the base of the cochlea and developing toward the apex, resulting in 

bilateral deterioration of hearing that begins in the high frequencies and progresses to lower 

frequencies. Age-related hearing loss, or presbycusis, is the most common cause of SNHL.

● Ototoxic medications, including:

○ non-steroidal anti-inflammatory drugs (NSAIDs), which cause transient SNHL;

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○ aminoglycoside antibiotics, which cause bilateral SNHL and vestibular 

dysfunction;

○ chemotherapeutics, which cause permanent high-frequency (≥ 2000 Hz) SNHL;

○ loop diuretics;

○ antimalarials (e.g., chloroquine); 

○ certain anticonvulsants;

○ certain antivirals;

○ certain antifungals;

○ tricyclic antidepressants;

○ anti-anxiety medications; and

○ industrial solvents.

● Auto-immune disorders that cause progressive, bilateral SNHL and possible vertigo or 

disequilibrium, which generally resolve with administration of oral steroids.

● Inner ear infection (labyrinthitis) secondary to bacterial or viral infection, which result in 

sudden hearing loss.

● Meniere’s disease, which causes low-frequency SNHL that progresses into higher 

frequencies as the disease evolves, along with sudden, asymmetric fluctuating hearing loss, 

aural fullness, tinnitus, and episodic vertigo.

● Cochlear otosclerosis.

● Hazardous noise exposure, which is particularly relevant to members of the armed forces 

and will be discussed in greater detail in the following section of this report.

Cochlear hair cells do not regrow after permanent injury and degeneration, and there are 

no medical or surgical treatments that can repair them. SNHL is thus permanent. In the quest to 

develop better diagnostic, rehabilitative and treatment options for SNHL, it is necessary to 

understand the underlying sequence of events that lead to cochlear damage. The intracochlear 

microcellular anatomy, acoustic signal transduction, cellular respiration, cell signaling, 

physiological maintenance and physiological shifting of cellular gradients to initiate afferent 

auditory processing is becoming better understood. Methods for determining such function have 

largely been based on animal modeling with some human translation through correlation with postmortem human temporal bone specimens. Animal modeling is 1) necessary, as cochlear sampling 

causes immediate deafness, and there are no imaging techniques with adequate resolution for such 

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cochlear analysis; and 2) reasonable, as some transcription factors are highly conserved across 

species (Mulvaney et al., 2012), and inflammatory cascades and apoptotic pathways are 

comparable offering translational impact of modeling therapeutic solutions in animals. Progressive 

animal modeling with mouse, rat, guinea pig, chinchilla, rabbit, cat, and non-human primate 

species have correlated ototoxic, noise, and presbycusic events with histochemical temporal bone 

analyses.

VII. NOISE-INDUCED HEARING LOSS

Noise exposure is the most common form of acquired SNHL. Exposures to both impulsive 

and/or steady state noise can manifest as temporary threshold shifts (TTS) that seemingly improve 

with time, or permanent threshold shifts (PTS) that remain. In fact, significant intracochlear 

damage can exist with normal or near normal behavioral, or electrophysiological testing (Valero 

et al., 2017, McGill 1976, Schuknecht 1955). Patients that complain of tinnitus, hyperacusis and 

difficulty hearing can have normal or near normal audiometry. Behavioral and 

electrophysiological analyses are thus lag indicators of intracochlear damage. Animal studies 

assessing noise impact on hearing in TTS and PTS noise-induced models have determined that the 

most vulnerable structures affected by noise are the Inner Hair Cells (IHC) (Fu 2010, Jin 2011, 

Kobel 2017), synaptic junctions between IHC and spiral ganglion neurons (SGN) (Kobel 2017), 

synaptic connection between Auditory Nerve Fibers (ANF) and Inner Hair Cells. (Kujawa 2019) 

These findings have been coined synaptopathy and are suspected to be responsible for “hidden 

hearing loss” or poorer than expected hearing function hidden behind normal audiometry. 

Synaptopathy can explain why younger listeners with significant noise exposure histories but 

normal audiometry experience poor cochlear function. (Kumar 2012, Hope 2013)

Cochlear synaptopathy, or “hidden hearing loss,” has been identified as the earliest 

manifestation of noise related trauma. In the past, TTS was thought to be milder reversible damage 

to hearing thresholds and a less worrisome form of the same cochlear injuries that lead to PTS. 

However, incidence of transient hearing loss experienced at early ages have been shown to 

accelerate age-related hearing loss notwithstanding an ostensibly full recovery. (Le et al., 2017, 

Kujawa et al., 2006) The recovery of hearing in these circumstances are “probably a result of 

reversible uncoupling of the outer hair cell stereocilia from the tectorial membrane and/or 

reversible central gain increase and associated hyperacusis and tinnitus.” (Le et al. 2017) However, 

even when previous hearing thresholds are recovered, “there can be considerable damage to the 

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ribbon synapses, the degeneration manifest in cochlear synaptopathy. Cochlear synaptopathy 

results in loss of connections between the inner hair cells and their afferent neurons in the acute 

phase of noise-induced cochlear trauma and is most likely a result of glutamate excitotoxicity 

causing damage to the post-synaptic terminals. These synaptopathic mechanisms, similar to 

synaptopathic disease in certain types of auditory neuropathy, are involved in and likely contribute 

to NIHL. (Le et al., 2017)

Because there is no marker of synaptopathy, correlating histories of noise exposure, clinical 

experience of poorer than expected hearing performance associated with tinnitus and/or 

hyperacusis and faster than expected progression of hearing loss are symptoms suggesting an 

underlying synaptopathy. There is a need for non-invasive tests for synaptopathy. (Hickox 2016) 

Such testing would be useful to explain symptoms and quantify underlying damage, as well as 

improve risk analysis when coupled with noise dosimetry and longitudinal audiometry. (Tepe 

2017) Attempts to correlate underlying synaptic damage with behavioral and electrophysiological 

testing are being evaluated. Use of audiometry, high frequency sweep audiometry, distortion 

product otoacoustic emissions, speech in noise testing, word recognition in noise, with time 

compression or reverberation, medial olivocochlear reflex testing, electrocochleagraphy, and wave 

I amplitude of the auditory brainstem responses have all been conducted to this end. Further 

research is needed to translate animal modeling, to quantify exposure risk, to understand 

longitudinal expectations, and to validate non-invasive testing.

Science is clear that exposure to damaging noise can disrupt the most fragile component 

of the inner ear, the synaptic junction between the inner hair cells and the afferent auditory nerve. 

That these exposure related injuries manifest clinically is evident in temporally related subjective 

symptoms of damage, tinnitus and muffled hearing, as well as occasional TTS and PTS. These 

findings correlate to the clinical military medical experience observed by DoD and VA 

audiologists and otolaryngologists that military members exposed to damaging noise, regardless 

of objective evidence of hearing loss, can have significant difficulty due to bothersome tinnitus, 

as well as trouble hearing in noise and more difficulty than would be expected understanding 

normal conversations. It is also a common experience that hearing declines in these members at a 

faster than expected rate following their exposures. In my opinion this is a direct real world human 

translation of synaptopathic science.

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The characteristic pathological feature of permanent threshold shift (PTS) is structural 

damage in the cochlea, including diffuse degeneration of outer hair cells and nerves in the area 

sensitive to 3000-6000 Hz (the second quadrant of the basal turn). With sufficient intensity and 

duration of noise, sensory hair cells and the entire organ of Corti may be disrupted. There are two 

mechanisms that destroy the organ of Corti: metabolic decompensation after noise exposure over 

an extended period of time or, less commonly, mechanical destruction by shorter exposure to 

extreme noise intensities. (Le et al., 2017)

Metabolically induced changes include swollen nuclei of the outer hair cells, swollen 

mitochondria, stereocilia disruption, cytoplasmic vesiculation, and vacuolization. Metabolic 

overstimulation of the cellular elements within the organ of Corti results in the generation of 

reactive oxygen species (ROS) within hair cells during and after insult. (Le et al., 2017; Yong et 

al., 2015; Ryan et al., 2016) This leads to the activation of stress signaling pathways (e.g., JNK 

MAP kinase cascade), resulting in cell damage, apoptosis and/or necrosis. (Ryan et al., 2016) ROS 

persist for several days after overstimulation, spreading apically from the basal end of the organ 

of Corti and expanding the area of cell death. (Le et al., 2017) Overexposure can also result in 

glutamate excitotoxicity, where high levels of glutamate overstimulate postsynaptic cells resulting 

in swelling of dendrites and cell bodies. (Le et al., 2017) Acoustic overstimulation can also cause 

increased free calcium (Ca2+) in outer hair cells, which can also trigger apoptotic and necrotic cell 

death. (Le et al., 2017)

The organ of Corti can also result from exposure to high level, short duration noise (> 140 

dB SPL) can stretch delicate inner ear tissues beyond their elastic limits, resulting in mechanical 

disruption of the stereocilia, disassociation of the organ of Corti from the basilar membrane, 

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disruption of cell junctions, and mixing of endolymph and perilymph. (Kurabi et al. 2017; Le et 

al. 2017; Yong et al., 2015) This process, called “acoustic trauma,” can result from limited 

exposures to impulse noise - in some cases, just one exposure is enough. Following acoustic 

trauma, hearing may recover over the course of several weeks or months; however, some degree 

of hearing loss is generally permanent. 

A. Individual Susceptibility to NIHL

Individual susceptibility to NIHL varies widely and depends on a number of individual 

characteristics, some of which are inherent (endogenous) and others are external (exogenous). 

External factors that impact an individual’s susceptibility to NIHL include the combination of 

noise exposure and coincident use of certain ototoxic medications, which results in more hearing 

loss than would be expected for either agent individually. Other exogenous agents that may 

potentiate NIHL include chemical asphyxiants (e.g., carbon monoxide, hydrogen cyanide);

elevated body temperature; vibration with concurrent elevated body temperature; smoking; and 

electromagnetic fields.

Endogenous factors that predispose individuals to or protect them from NIHL are the 

subject of great interest in civilian and military research. In general, the human research on inherent 

susceptibility to NIHL has been inconclusive. Studies show that women tend to have better hearing 

than their male counterparts, but it is unclear whether that difference is caused by gender alone. 

Research has not conclusively established a link between race/ethnicity and susceptibility to NIHL, 

nor between age and susceptibility to NIHL. However, several animal studies suggest that genetic 

factors predisposing an individual to age-related hearing loss may also render him/her more 

susceptible to NIHL. (Ohlemiller et al., 2000) Additionally, some animal studies have identified 

the specific gene that increases predisposition to NIHL, and other studies suggest there may be a

genetic basis for resistance to NIHL. (Holme et al., 2003; Yoshida et al., 2000)

B. Deficits Resulting from NIHL

One of the most noticeable deficits that results from NIHL is speech misperception. Vowels 

are relatively powerful, low frequency (< 1500 Hz) sounds that alert the listener to speech. 

Consonant sounds, which are predominantly high frequency (> 1500 Hz), surround vowel sounds 

and have subtle differences that give meaning to speech. High frequency losses common to NIHL

create difficulty hearing and discriminating between consonant sounds. Consequently, individuals 

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with NIHL commonly experience a loss of speech clarity without a perceived loss of intensity. 

This problem is exacerbated by background noise and reverberant environments. 

Sound localization may suffer as a result of NIHL. As sounds enter each ear, they stimulate 

cortical activity on both sides of the brain. Comparing interaural differences in the timing, 

intensity, and phase of the sound in each ear allows the hearer to determine the vertical elevation 

of the sound source and to identify which ear is closer to it. Hearing loss in one or both ears 

impairs this localization function.

Additionally, as a result of NIHL and the loss of outer hair cells, quiet sounds may be 

difficult to hear, but more intense sounds may still be heard, sometimes as clearly as before the 

hearing loss. This causes the hearer to experience a phenomenon called recruitment, wherein an 

abnormally rapid growth of loudness is perceived. Hazardous noise exposure is also a major cause 

of hyperacusis, a rare auditory disorder in which a person’s hearing becomes extraordinarily 

sensitive.

NIHL is the most prevalent risk factor for triggering the development of tinnitus. (Ryan et 

al., 2016; International State of the Science Meeting on Blast-Induced Tinnitus) For some, tinnitus 

is a benign condition; however, a significant portion of people who suffer from tinnitus experience 

distress that can be extreme. (Ryan et al. 2016) Due to the prevalence of tinnitus among the 

demographic cohorts involved in this litigation, an in-depth discussion of the subject follows.

VIII. TINNITUS

Tinnitus is the perception of sound that has no external sound source. The sound is 

commonly described as “ringing in the ears,” buzzing, hissing, whistling, and/or humming. 

Tinnitus may localize to one ear (unilateral), both ears (bilateral), or may instead be perceived in 

the head (Hu et al., 2015). It may be transient or persistent (lasting ≥ 6 months), and persistent 

tinnitus may be constant or intermittent. (Hu et al., 2015) Tinnitus is usually associated with some 

degree of hearing loss and some tinnitus patients may have unsuspected or unnoticed hearing loss. 

(Tunkel) In addition, tinnitus can and often does exist in the absence of clinically significant 

hearing loss. 

Tinnitus is distinct from “somatosounds,” which result from acoustic events generated 

within the body--specifically, vibratory activity in the head or neck that is transmitted via bone 

conduction to the cochlea and causes the perception of sound. Because these events can be detected 

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and, in some cases objectified, by an examiner, this phenomenon is referred to as “objective,” 

“physical,” and “somatic” tinnitus. (Hofmann 2013) 

A. Physiology of Tinnitus

Though the mechanisms that give rise to tinnitus are not completely understood, research 

indicates that insult to the peripheral auditory system is where the condition originates. After 

peripheral injury, decreased sensory input causes a discontinuity in the spontaneous activity across 

auditory nerve fibers, resulting in reduced lateral inhibition and changes in the auditory cortex 

tonotopic map. Tinnitus is commonly discussed as a “release from inhibition,” caused by an 

alteration in the normal balance between excitatory and inhibitory nerve transmission brought 

about by loss of inhibition (disinhibition), leading to an increased firing rate. (Henry et al., 2016)

B. Causes of Tinnitus

There are multiple causes and numerous aggravating co-factors associated with tinnitus. 

Most cases of tinnitus are “primary” – that is, idiopathic or caused by SNHL. Secondary tinnitus, 

which is rare by comparison, arises from an identifiable organic condition or a specific underlying 

cause other than SNHL, including cerumen impaction, middle ear diseases (e.g., otosclerosis or 

Eustachian tube dysfunction), cochlear abnormalities (e.g., Meniere’s disease), and auditory nerve 

pathology (e.g., vestibular schwannoma). Secondary tinnitus is managed with treatment of the 

underlying condition. 

Although primary tinnitus may be idiopathic or may result from any form of sensorineural 

hearing loss (e.g., presbycusis, ototoxic medication), the most prevalent and direct cause of tinnitus 

is loud noise exposure. (Hu et al., 2015) The risk for developing tinnitus is significantly greater 

for individuals with a history of military service as compared to the civilian population. (Moore, 

et al., 2015) Military occupational specialties commonly involve long-term exposure to continuous 

noise, or exposure to a combination of impulses and continuous noise, which are also known to 

cause tinnitus. Tinnitus induced by noise exposure is often described as high-pitched. 

Transient tinnitus commonly occurs after hazardous noise exposure and may be the first 

indication of auditory injury. After an acute acoustic trauma, tinnitus is reported in the initial stages 

in 90% of cases and often persists even when the hearing loss is temporary. (Shargorodsky et al., 

2010) Many military occupational specialties may involve proximity to extremely loud noise that 

can cause acoustic trauma and lead to the onset of tinnitus. (Moore et al., 2019) 

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IX. NOISE IN MILITARY SERVICE

Hearing is the sentinel sense, which enables the detection, localization and identification 

of potential hazards, and facilitates communication. In many settings, occupational and otherwise, 

the inability to hear can be a liability. Many workplaces include tasks that are considered hearing 

critical--i.e., tasks that require the ability to detect, recognize and localize sounds and/or 

understand speech, which can only be performed to a specified level of accuracy by a normalhearing person using the sense of hearing alone. (Tufts et al., 2009) Occupations with hearingcritical components include, e.g., law enforcement, firefighting, air traffic control, manufacturing, 

mining, and radio operation. Additionally, for many military occupational tasks, the ability to hear 

is absolutely critical.

Auditory fitness for duty (AFFD) refers to the possession of hearing abilities sufficient for 

safe and effective job performance. In military settings, combat readiness depends in part on the 

auditory fitness of service members. For example, the ability to detect sounds (e.g., footsteps, loose 

cartridges) and localize their source is fundamental to safety in combat. Responding safely and 

effectively depends on the ability to identify the source of the sound by differentiating enemy 

vehicles and weapons from friendlies. (FALLON00008; USAPHC TG 250, 2014; Nakashima et 

al, 2013; Tufts et al., 2009) These functions are particularly important in maintaining the safety 

and mission effectiveness of the U.S. Armed Forces.

(USAPHC TG 250, 2014)

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Accordingly, applicants to military service are subject to an intensive battery of tests, 

including audiological testing, at Military Entrance Processing Stations (MEPS). Those who 

cannot meet medical standards due to medical conditions, including hearing loss, are disqualified 

from service. Throughout most of the 21st century and until 2018, the medical standards for 

appointment, enlistment, or induction in the military services disqualified individuals with an 

average hearing loss of ≥ 30 dB across several frequencies or ≥ 35 dB hearing loss at any single 

frequency. (Tufts et al., 2009; DODI 6130.03, 2010) Applicants who rely on hearing aids and those 

with a history of certain ear conditions are also generally disqualified (DODI 6130.03, 2010; DODI 

6130.03, 2018)

Hearing loss is one of the top five conditions for which military applicants are medically 

disqualified, and for which accession waivers are sought. (Gubata et al., 2013; AMSARA, 2013) 

Accession waivers are only granted when a condition is unlikely to impact an individual’s 

suitability for military duty, so recipients of medical waivers for hearing loss are assigned to 

Military Occupational Specialties (MOS) that do not involve hearing critical tasks. 

Noisy equipment and processes are common in military operations, making hazardous 

noise exposure one of the most common occupational health hazards faced by service members.

(GAO at 3; Jokel et al., 2015) The risk of auditory damage that results from hazardous noise 

exposure depends on its sound pressure level, frequency, type and duration. Using these factors, 

noise is broadly divided into one of two categories: (1) steady state (or “continuous”) noise, which 

lasts one second or longer and varies little over time (e.g., jet engines), and (2) impulse noise, 

which involves a sharp rise and rapid decay lasting 1 second or less (e.g., weapons fire). Due to 

the qualitative differences in these noises, they discussed and regulated separately. 

A. Steady-State Noise

Prolonged exposure to intense, steady state noise is believed to cause NIHL as a result of 

repeated temporary threshold shifts that incrementally fail to recover back to baseline. (Royster, 

2017) Department of Defense Instruction 6055.12 states that continuous or intermittent noise with 

an 8-hour time-weighted average at or above 85 dBA is hazardous; it mandates the use of HPDs 

in those situations. (DODI 6055.12) 

Nearly all ground and air transportation platforms expose passengers and crew to 

continuous noise in excess of 85 dBA. The noise level of trucks and other wheeled transports 

increases with increased speed and payload (Army in Europe Regulation 40-501, 2018). The noise 

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level in wheeled vehicles is generally below 85 dBA at low to medium speeds, increasing to the 

mid-to high-90 dBA range with increased load and speed. Tracked vehicles create more noise than 

wheeled vehicles, often reaching levels in excess of 110 dBA while in motion. Integrated weapons 

systems, including mortars, missiles, and machine guns, may compound vehicular noise. (AE 40-

501; Jokel et al., 2019)

Sound levels in rotary wing aircraft range from the high-90 to low-100 dBA, and reach 105 

dBA to 122 dBA in the cabin noise of fixed wing aircraft. (Jokel et al., 2019) On the flight deck

of aircraft carriers, crew are exposed to noise levels that reach up to 148 dBA for tactical aircraft. 

At fixed-base installations, fewer personnel are adjacent to the aircraft and, as such, they are less 

likely to face hazardous noise exposure. Below deck, personnel on board aircraft carriers are 

exposed to around the clock noise that measures between 87 and 102 dBA in berthing spaces and 

ready rooms. (Jokel et al., 2019) Noise levels measure 92-94 dBA in the mess deck and reach up 

to 105 dBA in the lower aft of the ship where laundry facilities are located. (Jokel et al., 2019) On 

other classes of ships, engine rooms routinely measure in excess of 85 dBA, with diesel-powered 

engine rooms reaching up to 118 dBA. (Jokel et al., 2019)

B. Impulse/Impact Noise

Impulse noise is the product of a release of pressure (e.g., gunfire) and impact noise is 

generated by the forceful collision of two solid objects (e.g., a hammer to a nail). (Davis et al., 

2017; Smalt et al., 2017) Notwithstanding the nominal distinction, high-level, short duration noises 

are commonly referred to as “impulse” noise. Impulse noise creates several special hazards to the 

auditory system and is generally considered more damaging than steady state noise for a number 

of reasons: (1) the middle ear muscles cannot contract and reduce the input to the cochlea due to 

the short duration of impulsive noise, (2) the non-linear shape of the cochlea may “interact with 

the noise to increase the hazard, (3) the high peak levels associated with impulse noise may cause 

rapid mechanical failure, and (4) high-level acoustic impulse noise can be transmitted to the 

cochlea through bone conduction pathways. (Davis et al., 2017) 

Because impulsive sounds cause mechanical damage to the ear, the noise duration is not as 

important as its maximum sound pressure level (SPL). (Yong et al., 2015) Unlike steady state 

noise, a single unprotected exposure to impulse noise may result in irreversible damage. (Jokel et 

al., 2019) As such, the DoD’s definition of potentially hazardous noise includes “exposure to 

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impulse or impact noise levels of 140 dBP peak or greater, regardless of duration. (DODI 6055.12, 

2004; DODI 6055.12, 2010; DODI 6055.12, 2019)

Virtually all military weapon systems produce impulse noise that exceeds 140 dBP, 

necessitating the use of HPDs. Service members routinely use large caliber weapon systems, 

including mortars, missiles, howitzers, and crew-served weapons, which can emit noise over 180 

dBP. Military personnel may also be exposed to loud impulse noise caused by exploding ordnance, 

including improvised explosive devices (IEDs), which have peak sound levels similar to those 

associated with large caliber weapons. (Jokel et al., 2019) Blasts may be accompanied by 

supersonic shockwaves caused by the outward movement of explosion fragments, which may 

break the seal between the HPD and the skin, leading to increased hearing damage. (Jokel et al., 

2019; Amrein et al., 2012)

Small arms, such as pistols, shotguns, rifles, machine guns and 40-mm grenade launchers 

have relatively modest peak sound levels that are generally within the mitigation capability of 

standard-issue HPDs. But, due to the large number of rounds that may be fired by an individual,

the noise hazard associated with small arms fire remains a serious concern.

The risks associated with impulse noise were thought to be correlated with the number of 

rounds, peak sound pressure level (“dBP”), and B-duration (i.e., the amount of time it takes for the 

SPL to decrease 20 dB from the peak) (Jokel et al., 2019). For over 20 years, these metrics were 

used to calculate the number of rounds to which an individual could be exposed depending on the 

weapon and hearing protection. (MIL-STD 1474D; Jokel et al., 2019). In 2015, the DoD adopted 

MIL-STD 1474E, which has two impulse noise criteria: one depends on the overall energy or the 

noise produced by the weapon (using a dBA value associated with the impulse, that integrates the 

exposures to estimate the risk for a given mission). The other criterion uses an electro-acoustical 

model of the acoustic energy transmitted into the cochlea to calculate a number of Auditory Risk 

Units (ARUs) associated with the sound. The allowable number of rounds (“ANOR”) value is a 

function of the ARUs. (Jokel et al., 2019).

In the military, the great majority of NIHL occurs during training and other garrison 

activities. (3M_MDL000028418; ctrl3m000001127; Gates 05/29/20 Depo at 177:9-178:3; 

Merkley 02/26/20 Depo at 258:12-260:9) Approximately 13% of military personnel have 

permanent hearing loss following basic training with ballistic weapons shooting. (Jokel et al., 

2019) Indoor firing ranges are commonly used for training and weapons qualification at military 

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installations. The reverberant properties of the indoor range result in a substantially louder 

environment than exist in outdoor ranges. Even in partially covered ranges, sound waves reflect 

off the ground, walls, and/or overhead surfaces. Although the reflected sounds have lower peak 

levels, the reflection affects the B-duration, increasing it 10 to 20 times over the pressure envelope 

duration experienced at outdoor ranges. Several shooters at a large indoor range firing nearly 

simultaneously create persistent noise that continues longer than the one second typically used to 

distinguish impulse noise from steady-state noise. (Jokel et al., 2019)

X. DIAGNOSIS OF AUDITORY DYSFUNCTION

As a practicing otologist/neurotologist, I use the filtering method of differential diagnosis 

to determine the etiology of an injury or symptom. This methodology is essentially a process of 

determining a condition’s potential causes, then using clinically available information to evaluate 

and eliminate possible causes. This process is an essential aspect of my daily clinical practice and 

has been routinely used in the care and treatment of thousands of patients--including civilians, 

service members and veterans--throughout my career. I also used this method to form the opinions 

in each of my Plaintiff-specific expert reports.

For patients with hearing loss and/or tinnitus, I consider all etiologies and conditions that 

might be causing my patient’s symptoms or injuries (rule in) and then eliminate potential causes 

(rule out) based on the patient’s medical history, occupational and recreational history, family 

history, sound exposures, HPD use, and trauma, in addition to my physical examination, testing, 

and review of the available data. This information allows me to determine the etiology of the injury 

by ruling out potential causes of hearing loss and/or tinnitus. 

A. Medical History

A complete medical history begins with identification of the patient’s chief complaint (e.g., 

hearing loss, tinnitus, both hearing loss and tinnitus, vertigo, etc.), including detailed information 

about the timing, severity and progression of symptoms.

● Description of symptoms, including the symmetry and severity

● Onset of symptoms, including identification of precipitating event

● Progression of symptoms

● Frequency of symptoms, including aggravating and mitigating factors

Other detailed information, including the patient’s ability to hear in quiet settings and 

situations with disruptive background noise, should also be obtained. 

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A current and past medical-surgical history, including age and current medications, with 

particular focus on history of

● Ear surgery, ear injury, or chronic ear infections 

● Traumatic brain injury (TBI), concussion, or other head trauma

● Cancer treated with chemotherapeutics

● Infection requiring intravenous (IV) antibiotic treatment

● Congestive heart failure and/or chronic kidney disease treated with loop diuretic 

medication

● Surgery under general anesthesia

● Use of prescribed narcotic medications

● Use of non-steroidal anti-inflammatory drugs (NSAIDs)

● Metabolic disorders, including diabetes mellitus and hypothyroidism

● Stroke, diabetes or heart disease

● Hypertension and high cholesterol

To determine the cause, or etiology, of auditory dysfunction, occupational background is a 

uniquely important aspect of the patient history. Individuals with a history of employment in 

industrial settings, construction, and/or the military are screened for exposure to ototoxic 

chemicals and hazardous noise, and additional information regarding the use of personal protective 

equipment (PPE), including HPDs, is obtained.

For patients with a history of military service, relevant information includes military 

occupational history, participation in Hearing Conservation Programs, pre-deployment 

prophylactic antimalarial medication use, and exposure to solvents or agents known to cause 

medical conditions resulting in auditory dysfunction. 

The patient’s social history is discussed specifically, hobbies that involve hazardous levels 

of noise (e.g., hunting, target shooting, riding motorcycles, and performing or listening to loud 

music), tobacco use, caffeine intake, and narcotic substance abuse. Family history is obtained to 

assess hereditary hearing problems and susceptibility to hearing loss.

B. Otoscopy

External ear pathologies are characterized by conductive hearing losses caused by 

occlusion blocking sound from moving normally through the external ear canal. The physical exam 

begins by using an otoscope to visually inspect the pinna and the external auditory canal to identify 

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any anatomical anomalies, lesions or infections processes, and cerumen or obstructing material. 

Many outer ear conditions are diagnosed using otoscopy, including cerumen (ear wax) or foreign 

body blockages of the ear canal, outer ear infections (otitis externa), and benign, bony growths 

(exostoses and osteomas) that interfere with the migration of cerumen and cause blockage. Cysts 

or tumors are generally visible during the otoscopic exam.

The mobility, color and surface anatomy of the tympanic membrane are also assessed 

during otoscopy and/or binocular microscopy, which uses a binocular operating microscope for a 

more detailed view of the eardrum. Normal tympanic membrane is translucent, convex and intact. 

Perforation of the tympanic membrane, caused by chronic middle ear infections (otitis media) or 

trauma, will cause a hole to form in the surface anatomy. A perforated eardrum reduces the 

available surface for sound transmission to the ossicles, thereby resulting in a conductive hearing 

loss.

A pneumatic otoscopy is used to evaluate the mobility of a patient’s eardrum and the 

aeration of the middle ear in response to pressure changes. For this exam, an otoscope with a 

pneumatic attachment is inserted into the patient’s ear canal and the tympanic membrane is 

visualized as a puff of air is released. A normally functioning eardrum moves in response to 

pressure. An immobile eardrum manifests in a conductive loss, generally caused by a perforation, 

a middle ear infection (otitis media), or tympanosclerosis. 

C. Pure Tone Air Conduction Tests

Pure tone air conduction audiometry tests the hearing sensitivity of the entire auditory 

system by presenting pure tone signals to the ear through earphones and varying the intensity of 

the signals until the level is identified at which the patient is just able to hear the sound. 

Otolaryngologists routinely rely on audiologists (and trained personnel working under their 

supervision) to administer audiometric testing, including pure tone air conduction tests. These tests 

are administered in quiet rooms, so as to avoid sound masking by ambient noise. The patient is 

provided earphones (“earbuds”) or supra-aural earphones (“over-the-ear” headphones), through 

which pure tones at frequencies across the range of human hearing (typically 250 to 8000 hertz) 

are presented to each ear. Each tone is played for 1 to 2 seconds. Patients are instructed to raise 

their hand or finger or press a button while they hear a tone, and to lower their hand/finger or 

release the button when it stops. (3M_MDL000322497; Saunders et al., 1990)

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The purpose of a pure tone air conduction test is to determine the patient’s hearing 

threshold level (“HTL”): an intensity level at which a sound is audible, and below which it is not. 

In order to identify the threshold at each frequency, the tones are presented in a sequence designed 

to estimate the lowest level to which the participant responds correctly on at least 50% of 

presentations (e.g., level changes of 5 dB up after each failure to respond and 10 dB down after 

each response). 

Pure tone air conduction tests are an integral part of military and occupational hearing 

surveillance programs and are critical to the clinical evaluation of auditory dysfunction. Serial 

audiometric testing, which is common among occupationally noise-exposed persons, provides 

critical information on the etiology of auditory dysfunction and substantial insight on the extent of 

injury. The vast majority of patients with a military background were subject to intermittent 

hearing exams that included pure tone air conduction testing (along with an otoscopy and history 

of noise exposure). Identifying the etiology of hearing loss is relatively straightforward when an 

individual is exposed to a single hearing hazard (e.g., ear infection, noise) that is “bracketed” by 

pre- and post-event audiometric testing. Determining etiology of hearing loss is somewhat more 

complicated in cases of simultaneous exposure to more than one hearing hazard. Nevertheless, 

serial audiograms provide a snapshot of the individual’s hearing at a moment in time, as well as 

insight into the trajectory of hearing loss. This data, in combination with the detailed patient 

history, provides a reliable basis for determining the relative contribution of one or more 

simultaneous exposures. 

Hearing loss that results from hazardous noise exposure is typically characterized by 

substantial hearing threshold increases at 3000, 4000, and 6000 Hz, followed by improved 

thresholds at higher frequencies. On audiograms, this results in a signature “noise notch,” 

illustrated below. 

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(Sataloff et al., 2006) Noise-induced hearing loss and the signature “noise notch” audiogram may 

result from shorter exposures to high-intensity impulse noise (≥ 140 dBP) and/or prolonged 

exposure to less intense (≤ 85 dBA) continuous noise. (Sataloff et al., 2006) This clinical hallmark 

can be used to distinguish NIHL from other forms of SNHL (e.g., presbycusis). Generally, a 

detailed case history along with the noise-notch pattern of hearing loss leads to an NIHL diagnosis. 

“Asymmetry of hearing loss after weapon noise exposure is well recognized.” (Cox et al., 

1995.) This occurs because the source of the noise--the weapon --is in closer proximity to one ear 

than the other. For the right-handed shooter, the weapon’s impulse noise reaches the left ear at a 

higher intensity than the right ear, which is slightly shielded by the head. (Le et al., 2017.) This 

commonly results in asymmetrical hearing loss. (Le et al., 2017) Asymmetrical SNHL may also 

be the result of a retrocochlear lesion (acoustic neuroma/vestibular schwannoma)--a potentially 

serious finding that may indicate investigation with MRI. (Le et al., 2017; Sheppard et al., 1996; 

Cox et al., 1995) However, in the absence of other clinical indications, patients with substantial 

asymmetry who report a history of military service and considerable weapons noise exposure will 

not require imaging. (Le et al., 2017; Sheppard et al., 1996; Cox et al., 1995) Rather, a clinically 

reliable and cost-effective diagnosis of noise-induced asymmetrical hearing loss can be reached 

where a thorough occupational history and serial audiology clearly demonstrate that the hearing 

loss is, in fact, noise-induced. (Le et al., 2017; Sheppard et al., 1996; Cox et al., 1995) 

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D. Bone Conduction

In the private clinical setting, AC tests are followed by bone conduction (BC) tests, which 

provide additional information about the etiology of hearing loss and/or confirm the NIHL 

diagnosis. Bone conduction testing is done by striking a tuning fork and placing at various points 

on the patient’s skull, causing the sound signal to be transmitted to the cochlea as bone vibrations. 

BC testing bypasses the function of the outer and middle ear, thereby isolating and testing the 

functionality of the inner ear and the central nervous system. Such testing is used diagnostically to 

identify conductive hearing loss, which affects the middle and/or outer ear. (Saunders 1990; 

3M_MDL000322497) In the clinical setting, otologists commonly use tuning forks to perform 

basic bone conduction testing. 

The Rinne test enables real-time comparison of bone conduction and air conduction 

hearing thresholds. To perform this test, a 512-Hz tuning fork is struck and the butt is placed firmly 

on the patient’s mastoid bone, thereby conducting sound to the patient’s ear through the skull 

bones. The patient indicates when the sound of the tuning fork can no longer be heard, at which 

time the tuning fork is moved adjacent to the ear canal. A patient with normal hearing or a 

sensorineural loss will hear sound when the tuning fork is adjacent to the ear canal, but a patient 

with a conductive loss will not. (Isaacson et al., 2003)

Weber’s test is performed by softly striking a 512-Hz tuning fork and placing it midline on 

the head (e.g., scalp, forehead, teeth, or nasal bones), resulting in stimulation of the auditory system 

via bone conduction. If the tone is heard primarily in one ear, asymmetry of hearing loss is 

indicated. For purely conductive asymmetric losses, the sound will be heard in the worse ear. 

Conversely, asymmetric losses caused by SNHL cause the sound to be heard in the better ear. If 

the hearing loss is conductive, the sound will be heard best in the affected ear. If the loss is 

sensorineural, the sound will be heard best in the normal ear. For patients without asymmetric 

hearing loss, the sound remains midline. (Isaacson 2003)

Audiologists commonly opt to perform bone conduction tests using a calibrated bone 

oscillator that is located on the mastoid bone and held there by a strap. The oscillator delivers pure 

tones directly to the skull at the same frequencies tested in pure tone air conduction testing. 

Otolaryngologists and audiologists compare the results of pure tone bone conduction tests with air 

conduction hearing thresholds to determine the site of lesion--i.e., conductive or sensorineural. 

Conductive pathologies are indicated by air conduction thresholds that are significantly elevated 

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(>15 dB) compared to bone conduction thresholds (known as the “air-bone gap”). A mixed hearing

loss is indicated where the air-bone gap is observed concurrently with elevated bone conduction 

thresholds. (Baiduc et al., 2013)

E. Tinnitus

Clinical evaluation of tinnitus involves a targeted patient history and physical exam that 

are substantially similar to the elements described above. In order to identify secondary tinnitus--

i.e., tinnitus with an organic and potentially treatable underlying cause--the following additional 

details are obtained during the patient history: 

● Laterality: Unilateral tinnitus may indicate focal auditory lesions (e.g., vestibular 

schwannoma or vascular tumor) that warrant additional evaluation (Tunkel). 

However, a plurality of individuals with NIHL (up to 47%) present with unilateral 

tinnitus that, like asymmetrical hearing loss, tends to be more prevalent on the left 

side (Le et al., 2017).

● Pitch: Tinnitus associated with Ménière’s disease has been described as a lowpitched sound, patulous Eustachian tube causes a loud rushing sound during inhale

(IOM (2006) at 117; Sataloff at 185). By contrast, noise-induced tinnitus is 

commonly described as high-pitched (id.).

● Pulsatile nature: Pulsatile tinnitus is a somatosound associated with cardiovascular 

disease and vascular lesions that warrant additional follow-up (Tunkel; Hofmann 

2013). Primary tinnitus is non-pulsatile.

Patient reports of tinnitus presence, onset, change over time, loudness and annoyance are 

the primary means of diagnosis. Among those patients who experience clinically significant 

tinnitus, clinical needs vary. The level of intervention is determined by evaluation of patient needs. 

This can be achieved efficiently using patient questionnaires, e.g., Tinnitus Impact Screening 

Interview (TISI), an 8-question interview completed in the clinical setting, and the Tinnitus 

Handicap Inventory (THI), a self-administered questionnaire that results in a 0 to 100 index score 

placing a patient in one of four handicap ranges (no handicap, mild handicap, moderate handicap, 

severe handicap). In some cases, it may be helpful to measure tinnitus loudness, pitch and 

maskability, which can be done using a clinical audiometer.

Additional otologic testing that may be undertaken, as indicated, includes but is not limited 

to:

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2. Tympanometry

Tympanometry provides an objective measurement of middle ear function. The test is 

performed by inserting into the ear canal an airtight probe equipped with a speaker, an air pump, 

and a microphone. The probe seals the ear canal and the air pump modulates the pressure while 

the speaker emits a low-frequency pure tone (typically, 226 Hz). The microphone records the 

sound that is reflected by the eardrum.

Tympanometry permits a distinction between sensorineural and conductive hearing loss, 

when evaluation is not apparent via Weber and Rinne testing. 

3. Speech Audiometry

In addition to testing pure tones, clinical hearing evaluations include testing with speech 

sounds. These tests are intended to estimate the degree of difficulty a hearing-impaired individual 

may have with speech communication, and to confirm the validity of pure-tone test results and 

thereby distinguish cochlear disorders (i.e., hearing loss caused by dysfunction of the cochlea) 

from retrocochlear disorders (i.e., hearing loss caused by dysfunction of the auditory nerve or 

brainstem). (Schoepflin 2012)

4. Otoacoustic Emissions

Functioning outer hair cells in the cochlea of a healthy ear emit low-intensity sounds at the 

frequencies to which they are tuned. These sounds, called Otoacoustic Emissions (OAEs), occur 

spontaneously and can be evoked by delivering acoustic stimuli (brief clicks or longer puretones) 

to the ear and recording the resulting “echo.” To do this, a probe is inserted into the ear canal, 

where a speaker plays the auditory stimulus and a microphone records the resulting OAEs.

OAEs may be evoked using two puretones that create distortion product OAEs (DPOAEs) 

which are mathematically related to the stimulus frequencies and sensitive to minor changes in 

cochlear physiology (Baiduc et al., 2013). DPOAEs are rarely present when hearing loss exceeds 

60 dB HL, and are reduced in cases of mild to moderate hearing losses. Transient Evoked 

Otoacoustic Emissions (TEOAE), which use a very brief click or tone pip, are used to screen 

infants for hearing loss, assess cochlear function and validate other testing. 

5. Auditory Brainstem Response Testing

Retrocochlear pathologies can be identified using the Auditory Brainstem Response (ABR) 

test, which uses small electrodes to measure electrical activity in the brainstem and auditory nerve 

following the delivery of auditory stimuli (Baiduc et al., 2013). Within 15 milliseconds of the 

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stimulus delivery, the ABR is recorded as a “waveform” with seven peaks that represent neural 

activity. Computers measure and analyze the waves to identify any increase in latency--i.e., the 

length of time between stimulus delivery and neurological response--indicating a retrocochlear 

lesion.

XI. TREATMENT OF AUDITORY DYSFUNCTION

NIHL and tinnitus are permanent and progressive conditions. There are no cures for these 

conditions, which are not amenable to medical or surgical treatment. Treatment for NIHL is 

essentially limited to hearing aids, which are designed to increase the volume of sound at 

frequencies impacted by hearing loss, but they do not repair the damage sustained by the auditory 

system. (Baiduc et al., 2013) Amplification can also be used to manage NIHL-related tinnitus by 

treating the hearing loss and mitigating the annoyance of tinnitus. Hearing aids can improve 

hearing in some situations, but they cannot completely and seamlessly compensate for NIHL. For 

example, many hearing aid users struggle to understand speech in noisy environments as a result 

of loudness recruitment and other distortions, which are exacerbated by hearing aids. In addition 

to these inadequacies, personal reservations and social stigma deter potential hearing aid users 

(Baiduc et al., 2013).

Sound therapy uses broadband noise sound generators, hearing aids, or combination 

devices to promote habituation (i.e., an adaptation process of the auditory system that reduces the 

perceived signal intensity of the tinnitus as well as an individual’s reaction to it) by reducing the 

contrast between the tinnitus and environmental sound, providing sounds that are soothing to 

induce a sense of relief from stress or tension caused by tinnitus, or providing sounds that are 

interesting with the goal of distracting the patient’s attention away from the tinnitus. 

Cognitive behavioral therapy is also used in the treatment of tinnitus. This approach 

integrates behavioral interventions including relaxation techniques and instruction on sleep 

hygiene with cognitive skills to identify negative thoughts that result in distress and restructure 

them in a manner considered more accurate or helpful. This approach, originally developed for 

treatment of depression and anxiety, and has been shown to be effective in the treatment of tinnitusrelated distress. 

Tinnitus Retraining Therapy seeks to habituate the patient to the tinnitus sound by using 

directive therapy to neutralize negative emotional reactions to the tinnitus and using sound therapy 

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to decrease the perceived contrast between the background noise and the patient’s tinnitus-related 

neuronal activity. 

There is no FDA-approved medication for the treatment of tinnitus nor are there any 

medications that can diminish the perceived loudness of tinnitus. Medications for the treatment of 

comorbid conditions, including anxiety, depression and insomnia, are prescribed to reduce overall 

suffering. (International State of the Science Meeting on Blast-Induced Tinnitus)

XII. IMPACT OF AUDITORY DYSFUNCTION

Hearing impairment has numerous negative consequences, including depression, anxiety, 

irritability, isolation, fatigue and cognitive decline.

Communication interference caused by hearing loss substantially affects social integration, 

functional ability and self-image, leading to increased social stress, embarrassment, and poor selfesteem (Le et al., 2017; Baiduc et al., 2013). Some individuals who suffer from hearing loss try 

to minimize or overcome their impairment by listening strenuously and/or guessing to fill in 

missing information, which results in misunderstanding and embarrassment (Sataloff). Marital 

and other close relationships are particularly impacted by the communication detriment caused by 

hearing loss (Sataloff; Le). Efforts to overcome these difficulties and to hide the resulting 

frustration result in fatigue and irritability (Sataloff).

Hearing loss significantly impacts workplace safety and productivity (Baiduc et al., 2013). 

Difficulty hearing alarms, warning signals, and the cries of co-workers can increase workplace 

accidents, injuries and fatalities (Tufts et al., 2009; Baiduc et al., 2013). In fact, each dB of hearing 

loss increases the likelihood of workplace injuries requiring hospitalization (Baiduc et al., 2013). 

Employees with hearing loss are much more likely than their normal hearing counterparts to 

experience mental distress requiring sick leave (Tufts et al., 2009). Hearing loss is also associated 

with declines in cognition, memory and attention (Le et al., 2017).

Noise induced hearing loss and tinnitus have long been associated with co-morbid 

psychiatric conditions such as anxiety, social isolation and depression, and have a known 

correlation to elevation of stress related to cardiovascular disease (Hahad 2019). The World Health 

Organization attributes 1.5 million health life years lost in Western Europe to the elevated metal 

stress, inflammation and oxidative stress from the annoyance, cognitive impairment, and sleep 

disturbances associated with long-term low-level noise exposure. (Hahad, Oxid Med Cell Longev 

Nov 2019). Noise induced mental stress linked to increased stress hormone levels, blood pressure 

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elevation, and tachycardia which lead to cerebrovascular disease, stroke, arterial hypertension, 

ischemic heart disease, and myocardial infarction. More recently hearing loss has been associated 

with cognitive decline and dementia. Correction of hearing loss has also been shown to benefit 

cognitive decline, and early intervention is recommended (Jafari, Ageing Res Rev Dec 2019).

Several systematic reviews of the literature have linked tinnitus to psychiatric disorders, 

with a high prevalence of anxiety and depression seen. Pinto et al reviewed 16 articles from a 

search identifying 153 published between 2000-2012 showing a high prevalence of psychiatric 

disorders in tinnitus-affected patients, especially anxiety and depression (Pinto, J Laryngol Otol 

Aug 2014). Similarly, Ziai et al found 15 of 53 articles relevant for review also showing a strong 

association between tinnitus, depression, and anxiety, and recommended all tinnitus patients be 

screened for psychiatric disorders (Ziai Int Tinnitus J Jun 2017). Another systematic review of 117 

published scientific papers revealed a 45% lifetime prevalence of anxiety disorders in the tinnitus 

population. In this Pattyn et al also recommend screening for psychiatric disorders in moderate 

severe tinnitus (Pattyn Hear Res Mar 2016). In the VA Martz et al found that 116,358 of 769,934 

OEF/OIF/OND Veterans, in a retrospective analysis, were shown to have been diagnosed with 

tinnitus by the VA. Of these, depression co-occurred in 21%, anxiety in 8%, and both anxiety and 

depression in 17%. (Martz Ear Har Nov/Dec 2018). 

The strong association between dementia, cognitive impairment and hearing loss is 

becoming better understood. A prospective cohort of 37,898 older men followed for a mean 11.1 

years showed that 18.3% of men with hearing loss were more likely to develop dementia than men 

free of significant hearing loss (Ford, Maturitas. Jun 2018). This systemic meta-analysis showed 

an aggregated hazard of dementia of 1.49 (95% CI), and noted that earlier hearing loss in mid-life 

may account for up to 9.1% of dementia cases world-wide. Osler et al, in an attempt to assess the 

effect of hearing loss occurring early in life with the later development of dementia, examined a 

cohort of 942,567 Danish men that were followed from conscription at age 19 in which they 

identified 59,834 men with a diagnosis of hearing loss (Osler, Eur J Epidemiol Feb 2019). 

Dementia was more highly associated with hearing loss diagnosed prior to age 60 (HR 1.9), than 

hearing loss diagnosed after age 60 (HR 1.15). They recommended early diagnosis stating that 

correction of hearing loss may improve mental decline. Another assessment looked at three 

prospective cohort studies analyzing the association of hearing loss with Alzheimer’s disease, and 

one assessing the association of hearing loss with mild cognitive impairment (Zheng Neurol Sci. 

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Feb 2017). A relative risk for Alzheimer’s disease developing in subjects with hearing loss was 

shown to be 4.87 in three studies, and relative risk of 2.82 for the development of cognitive 

impairment overall in subjects with hearing loss was shown. Like tinnitus, psychiatric diagnoses 

prevalent in hearing loss. Specifically, symptoms of depression were associated with occupational 

noise-induced hearing loss in 53% (Deng, Noise Health Jan-Feb 2019). The duration of noiseinduced hearing loss was also associated with significant elevation of cortisol levels, and poor 

indices on standardized testing for tinnitus and sleep

The association of hearing loss in general and noise-induced hearing loss and tinnitus 

specifically and their association with depression, anxiety, cognitive decline and other chronic 

cardiovascular stress related disease is well recognized. Prevention, early identification, and 

adequate rehabilitation are helpful in mitigating or avoiding these complications of hearing loss 

and tinnitus. Jafari recommends hearing amplification to alleviate hearing handicap, depression 

and tinnitus, as well as to improve cognition, social communication and quality of life. Hearing 

aids may ameliorate cognitive decline by improving audibility independent of the association of 

hearing loss on social isolation or depression (Dawes, PLoS One 2015). Hearing conservation and 

prevention efforts with adequate noise abatement and hearing protection, as well as advocacy for 

and early treatment of hearing loss and tinnitus appear to be the best courses of action to diminish 

the deleterious psychological and cognitive effect of long-term hearing loss and tinnitus.

XIII. NOISE-INDUCED HEARING LOSS & TINNITUS ARE PREVENTABLE

Even in the presence of the significant noise hazards present in military settings, NIHL is 

preventable. In fact, the National Institute of Deafness and other Communications Disorders 

(NIDCD), which is a part of the National Institute of Health clearly proclaims “NIHL is the only 

type of hearing loss that is completely preventable.”

3M not only agrees, but also claims NIHL is entirely preventable in order to increase sales 

of its HPDs. For example, 3M’s marketing materials declare that “Noise Induced Hearing Loss is 

100% Preventable!” (3M_MDL000716257) 3M’s website further states that “NIHL is entirely 

preventable, and reliable hearing protection is the key.” The CAEv2 inventor, Elliott Berger 

likewise acknowledges that NIHL is preventable, stating: “When properly and consistently worn, 

hearing protectors can effectively attenuate noise and prevent hearing loss. That much is clear.” 

(3M_MDL000233892)

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The Department of Defense agrees. To that end, in 1978, the DoD issued an Instruction 

establishing a uniform hearing conservation program. The Instruction has evolved since it was first 

adopted in 1978 but every iteration has included the following elements: (1) hearing surveillance 

programs for occupationally noise-exposed personnel, (2) noise hazard identification, and (3) noise 

abatement strategies. (Nelson et al., 2017)

Since 1987, the Instruction has required each branch of the military to create its own 

Hearing Conservation Program for personnel exposed to hazardous noise, which is defined as:

1. Continuous and intermittent noise that has an 8-hour time-weighted average (TWA) 

noise level of 85 decibels A-weighted (dBA), or above. Implementation may also 

be started regardless of the duration of noise exposure. Those criteria apply only to 

energy in the frequency range from 20 to 16,000 Hertz (Hz).

2. Impulse noise sound pressure levels (SPLs) of 140 decibels (dB) peak, or greater.

3. Upper sonic and ultrasound acoustic radiation exposures occur under special 

circumstances that require specific measurement and hazard assessment 

calculations.

Additionally, since 1996, the Department of Defense has required all military personnel--

not just those exposed to hazardous noise--to have a reference audiogram at basic training prior to 

noise exposure. (DODI 6055.12 (2004) at § 6.8.3.)

By 2004, 42% of the active duty Air Force and more than 14,000 civilian employees were 

enrolled in the Air Force’s Hearing Conservation Program. (Humes et al., 2006) As of 2005, the 

Navy had 285,000 sailors and 67,000 Marines enrolled in the Navy’s Hearing Conservation 

Program, and in 2012, the Marine Corps began requiring annual audiograms for all Marines. 

(Nelson et al., 2017). In 2003, the Army’s Hearing Conservation Program covered 77% of active 

duty soldiers (approximately 375,000 individuals), and 53,986 civilians. Then, in September 2006, 

the Army implemented a “hearing readiness monitoring” regime that rapidly increased enrollment 

in its Hearing Conservation Program to include 100% of its active duty force as of 2017. (Nelson 

et al., 2017)

Under DODI 6055.12, all personnel assigned to occupations that involve routine hazardous 

noise exposure must have an audiogram before placement, periodically (at least annually) 

thereafter, and upon leaving an occupation in a hazardous noise area. 6.8 Subsequent audiograms 

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are compared to the reference audiogram to monitor for a Significant Threshold Shift—that is, a 

change in hearing thresholds of either ear averaging 10 dB at 2000, 3000 and 4000 Hz.

When an STS is identified, the service member must be sent for medical evaluation with 

an audiologist, otolaryngologist or other physician to perform follow-up testing and to determine 

if additional medical evaluation is necessary. For personnel with a positive STS (decrease in 

hearing threshold from the reference audiogram), at least two follow-up audiograms must be 

administered to establish the permanency and the severity of the hearing loss. If the positive STS 

is present on both follow-up audiograms, it is considered a permanent threshold shift (PTS) and a 

new baseline hearing threshold is established. If the follow-up audiograms show that hearing 

improved and the STS is absent, the hearing loss is considered a temporary threshold shift (TTS).

Reference audiograms and subsequent hearing tests are uniformly recorded on Department 

of Defense forms (DD Form 2215 and 2216, respectively), which are centrally maintained in the 

Defense Occupational and Environmental Health Readiness System – Hearing Conservation 

(“DOEHRS-HC”) database. This data can be obtained by audiologists and physicians responsible 

for evaluating service-connected disability claims on behalf of the U.S. Department of Veterans 

Affairs, and by civilian healthcare providers who use it for clinical treatment purposes.

Despite the DoD’s concerted effort at hearing surveillance and auditory injury 

identification, there are limitations to this testing regime. Subclinical injury can occur below the 

threshold of hearing sensitivity and may, therefore, go undetected. Additionally, military 

exposures and/or hearing losses may not be evaluated because (1) service members don’t want to 

let team down and they know substantial hearing loss may result in medical separation or change 

in job specialty code; (2) service members may not have access (or convenient access) to testing 

facilities in a timely manner; and/or (3) changing HCP regulations over time/between branches. 

Consequently, loss of auditory function is often compensated for and put off.

The DoD Instruction requires the services to strategically mitigate noise hazards according 

to the following hierarchy: (1) engineering controls, (2) administrative controls, and (3) personal 

protective equipment. (DODI 6055.12; Nelson et al., 2017) DoD policy dictates that engineering 

controls—i.e., procuring quieter equipment, improving noise reduction technology, and/or 

building barriers to deflect noise—are the primary means of eliminating hazardous noise exposure. 

“Where engineering controls are undertaken, the design objective shall be to reduce steady-state 

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levels to below 85 dBA, regardless of personnel exposure time, and to reduce impulse noise levels 

to below 140 dB peak SPL.” (DODI 6055.12)

It is well-understood that “engineering out” the noise is not always feasible, particularly in 

the military setting. In such cases, administrative controls (i.e., policies, procedures and shift 

design) are implemented to minimize exposure. For example, the Army may implement a 

limitation on tracked vehicle travel distance to protect personnel against long exposures to 

hazardous noise. (Jokel et al., 2019) Administrative controls are not always feasible in military

settings, including training and combat scenarios, which generally do not adhere to the typical 

civilian workday. Where engineering and administrative controls are inadequate or unworkable, 

personal protective equipment such as HPDs are used to mitigate the impact of hazardous noise 

exposure. Although noise hazards are prevalent in military settings, most hazardous noise can be 

mitigated to a non-hazardous level through the use of hearing protection.

XIV. HEARING PROTECTION DEVICES (HPD)

Hearing protection devices are used to significantly reduce the amount of sound coming 

into the ear. HPDs can provide protection against continuous noise and impulse noise and thereby 

provide protection against NIHL and tinnitus. (Ramakers et al., 2016.; Theodorff, et al., 2015) 

The best type of hearing protection removes noise from entering the ear. Typically, they provide 

the most protection from high frequency noise and protection against low frequency noise. There 

are numerous types of HPDs. These include passive (linear and nonlinear) devices as well as 

electronic systems (tactical and non-tactical). It is crucial to protect against both continuous and 

impulse noises while allowing situational awareness so that soldiers can detect low-level sound, 

communicate and recognize and identify sounds. It is well documented that “Soldiers will develop 

noise-induced hearing loss if no protector is worn or when their hearing protectors are fitted poorly, 

used inconsistently or improperly, or provide inadequate noise reduction.” (Vause et al., 2001) 

Hearing protection is crucial in the military environment to protect against continuous and 

impulse noises that soldiers encounter daily. The continuous noise producers include helicopters, 

generators, tanks, armored vehicles, etc. Impulse noises include machine guns, pistol fire and 

mortar rounds. It is important to protect against the above while allowing situational awareness. 

Soldiers also must be able to communicate effectively and accurately. 

Hearing Protection Devices can significantly reduce the decibel level that passes into the 

circuitry of the ear. HPDs reduce noise exposure levels and the risk of hearing loss. Essentially, 

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they significantly reduce or eliminate the amount of sound reaching the ears. Hearing protection 

devices try to reduce a persons’ noise exposure by reducing the amount of Decibels (dBs) they are 

being subjected to by noise reduction. The amount of reduction a certain HPD can produce is 

called a Noise Reduction Rating.

A. Types of Hearing Protection Devices

HPDs can be both passive and electronic. Passive devices can be both linear and nonlinear. 

Linear earplugs provide the same amount of noise attenuation at all times. The noise attenuation 

of non-linear earplugs varies depending on the level of ambient noise: attenuation increases with 

increased ambient noise. (CTRL_3M_Touhy00000021) 

“Non-Linear earplugs are protectors that permit low level speech to be heard with very 

little reduction at the ear (about 2-3 dB) while providing almost the attenuation of standard 

earplugs at the high noise levels produced by rifles, howitzers, and mortars. The non-linear effect 

is obtained by placing a small aperture inside the earplug which allows the particle velocity of low 

level sound (speech) to enter the ear, while creating turbulence at the entrance to the aperture 

thereby attenuating high-level impulse noise as well as a normal earplug.” (DOD00000059)

The main categories of HPDs are:

1. Foam Plugs (“Foamies”)

Foam plugs are typically a quarter to half inch piece of foam/fiber that are rolled and 

inserted into the ear canal where they expand filling the ear canal and conforming to the unique 

shape of the ear canal. The foam helps seal the ear canal and blocks noise from entering the ear. 

They are available in a variety of sizes (small, medium and large) so they do not require fitting by 

trained personnel. They are comfortable and inexpensive.

2. Pre-Formed (Molded/Pre-Molded) Ear Plugs

Pre-formed earplugs are typically flanged earplugs which are made with single, triple or 

quad flanges that provide flexibility and seal off the ear canal wall from noise. They can be made 

from a variety of materials (rubber, plastic, silicone, foam) and there are numerous styles and sizes. 

They need to work in a way that creates an individual fit for different size ears. If fit and insertion 

is proper, they provide effective protection. Examples of pre-formed plugs are included in the chart 

below:

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3. Ear Muffs

Earmuffs are cushions that block noise from entering the ear by creating an airtight seal 

against the head and outer ear. This decreases the amount of sound that is transmitted to the ear. 

They are easy to fit and designed to universally fit most individuals. They are often worn with 

foam ear plugs for double protection. Earmuffs provide noise protection and easily be taken on 

and off. Individuals also typically get noise protection even if they have not received instruction 

on how to properly use them.

4. Active (Electronic) Ear Muffs

Earmuffs can also have communication circuitry or be active models. Active models can 

have microphones and external audio devices. There can be volume controls to amplify sounds 

from outside the earmuffs. Some active systems have both hearing protection and communications 

built into the earmuff. These systems provide ear protection as well as allowing situational 

awareness through radio connections and ear-level stereo microphones. They are called Tactical 

Communication and Protective Systems (TCAPS).

B. Importance of Fit and Selecting the Right HPD

One of the most important features of an HPD is comfort as well as proper fit and ease-ofuse. (3M_MDL000409110) Testing can be performed to determine the actual noise reduction for 

each user. This is called a Personal Attenuation Rating (PAR). According to 3M, “predicting 

individual performance from group average is not possible” because derating does not account for 

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an individual’s differences. (3M_MDL000409110) There is a lot of real-world variability for 

HPDs. This is especially true for military service members.

Selecting and fitting the appropriate hearing device is complicated in the military setting, 

as one must look at the environment, the use of HPDs with other protective equipment and the 

soldier’s need for communication and situational awareness. They must also look at how Soldiers 

will use the HPDs. “All hearing protectors require an air-tight seal in the ear canal to block sound 

from reaching the inner ear. Like a cork in a bottle, an earplug must fit the ear canal perfectly to 

keep sound from leaking around the plug and into the ear canal.” (3M_MDL000369525) If a 

Hearing Protection Device does not fit properly because of lack of proper instruction in using it or 

it is improperly designed, it can cause more damage than no hearing protection device at all as the 

soldier believes they have protection when they do not actually have adequate protection. In order 

to get good hearing protection, you must have a good fit and seal between the skin of the ear and 

the HPD. If the air leaks through the seal, the HPD will not be as effective. It is also well known 

that HPDs show a great deal of variability in their “real world” performance as compared to 

laboratory measurements. (Berger, 2003. Hearing Protection Devices, in The Noise Manual (5th 

ed.) 421-23)

3M is aware that NRR values obtained in the laboratory setting do not translate to the real 

world. (3M_MDL000464853 at 26; “[Noise Reduction Ratings] are based upon an optimized 

fitting scenario in a controlled laboratory environment that bears little resemblance to the 

conditions under which workers wear HPDs on a daily basis, in what is often referred to as the real 

world.” (3M_MDL000464853) Berger also states that, in “[n]o less than 22 studies conducted in 

7 countries in over 90 industries with over 2,900 subjects have found a significant disparity 

between the amount of protection afforded between laboratory results and those achieved in the 

workplace.” (3M_MDL000345123) This is especially true for a soldier due to their day to day 

duties when they are on the move, riding on tanks, working in raining, cold, hot, humid, sweating 

conditions. “The degree of noise reduction depends on the quality of fit.” (3M_MDL000369525) 

The Combat Arms Earplug at issue in this case was promoted as a “one-size-fits most” and did not 

require ear canal sizing across all military. (3M_MDL000426573) 

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XV. BACKGROUND: THE COMBAT ARMS EARPLUG

The Combat Arms Earplug version 2 (“CAEv2”)—the earplug at issue here—was 

manufactured and sold by 3M. The CAEv2 is dual-ended and ultimately consists of two earplugs: 

one “closed” end (green) and one “open” end (yellow).

(3M_MDL000345123 at 31, A-9; 3M_MDL000393840) There had never been a dual-ended 

earplug like the CAEv2 before 3M sold it, and there has never been another similar dual-ended 

earplug since 3M stopped selling it. It was the only one ever. 

The CAEv2’s yellow or “open” end was intended to provide “non-linear” protection. It had 

a hole in the tip, and housed a filter that was intended to allow low-level noise to pass through 

without attenuation, while increasing the attenuation as the level of noise increased. 

(3M_MDL000188689; 3M_MDL000345123 at A-9) In other words, this end was supposed to 

allow low-level noises (e.g., voices) to be heard while simultaneously protecting the wearer from 

impulse noise (e.g., gunfire such as that encountered on the firing range in training) in order to 

allow for communication and “situational awareness.” The green or “closed” end on the other 

hand, was designed to provide “linear” protection. It was a conventional earplug intended to 

provide a constant level of protection and protect the wearer from steady-state or continuous noise 

(e.g., tanks, generators, etc.). 

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The CAEv2 was the second of five earplugs in 3M’s Combat Arms series.

(3M_MDL000259868; the fifth earplug, version 4.1, not shown) The other versions of the Combat 

Arms earplugs included non-linear filters, but none of them were dual ended like the CAEv2. A 

discussion of 3M’s development of each plug—with emphasis on the development, testing, and 

claims 3M made related to the CAEv2—is below. (3M_MDL000259866)

A. The Original Combat Arms Earplug Version 1 (CAEv1)

For several decades, researchers have studied non-linear hearing technology in an effort to 

protect users from loud, impulse noise while also allowing low-level, continuous noise to be heard. 

The documents produced in this litigation show that as far back as the 1990s, 3M worked with The 

French-German Institute in Saint-Louis (“ISL”) to research and design nonlinear HPDs. 

(3M_MDL000712631)

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In the late 1990s, ISL designed an acoustic valve known as a “non-linear filter” and inserted 

it in 3M’s UltraFit earplug. (3M_MDL000188671; 3M_MDL000779978 at 25) This single-ended, 

triple-flange plug became “version 1” of the Combat Arms Earplug (CAEv1):

(3M_MDL000005686) The CAEv1 was introduced in 2000 and is also known as the “European 

Nonlinear Plug” (“ENLP”) or “French plug.” (3M_MDL000006623; 

CTRL_3M_Touhy00000298)

3M conducted a ten subject Real-Ear Attenuation at Threshold (“REAT”) test on the 

CAEv1 and calculated an NRR of 8. (3M_MDL000006630; 3M_MDL000039506) The Army 

conducted Blast overpressure testing on this “French No. 1” plug in 1996. The Army found it 

performed “better” than other non-linear plugs. (3M_MDL000014064; 3M_MDL000014089; 

3M_MDL000014158)

In early 2007, 3M discontinued the CAEv1 due to low sales and because 3M’s new version, 

CAEv3, was on the market. (3M_MDL000692589)

B. The Design And Development Of Version 2 (CAEv2)

Development of the CAEv2 began in the 1990s. In 1997, 3M and ISL designed a single 

earplug combining non-linear and linear functions. (3M_MDL000013024) The single-ended 

prototype allowed users to twist the filter in order to change between the open and closed modes 

of protection. 3M and ISL also designed a dual-ended prototype that had a non-linear plug on one 

end and a linear plug on the other. (3M_MDL000006631) After modifying the filter, this dual-end 

design became the earplug that was ultimately marketed and sold by 3M as the CAEv2. 

(3M_MDL000006631) During development in 1997, however, Armand Dancer, a scientist at ISL 

who worked with 3M to design and develop the CAEv2, had concerns about the design of the stem 

and filter. (3M_MDL000013024) Specifically, he was concerned that the diameter of the stem was 

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too large and, as a result, would lead to fitting problems. (3M_MDL000013024) Dancer 

recommended that the diameter of the stem be reduced from its current diameter, but 3M actually 

increased the diameter of the stem in the final design rather than following Dancer’s 

recommendation. (Berger 30(b)(6) 9/25/2020 Depo. at 204:17-206:14; 3M_MDL000017774; 

3M_MDL000013027) 

Doug Ohlin of the U.S. Army’s Hearing Conservation Program was “interested” in ISL’s 

“bidirectional” design, and the French Army believed 3M’s UltraFit (the same triple-flange plug 

used in the CAEv1) was the “best vehicle” for ISL’s filter. (3M_MDL000425673) The DoD 

Hearing Conservation Working Group, which Ohlin chaired, gave the DoD approval to purchase 

the CAEv2. (3M_MDL000188689) 

Neither Ohlin nor the DoD, however, provided formal specifications for the CAEv2. 

(3M_MDL000527305; Ohlin 4/24/2013 Depo. at 130:6–131:10, 241:5–6). Although the DoD was 

“interested” in a single earplug combining linear and non-linear functionalities, 3M developed, 

designed, and tested the plug. (3M_MDL000425673; 3M_MDL000434810). 3M then “came up 

with the [CAEv2’s] design,” which it intended to sell to the military as well as non-military users. 

(3M_MDL000259188) ISL’s patents, which 3M licensed, covered the design, but 3M considered 

itself to be the CAEv2’s “creator.” (3M_MDL 000277773; 3M_MDL000343622).

In April 1999, before 3M sold the CAEv2 to the DoD, Ohlin asked 3M if it could “shorten 

the plug” to fit into the Army’s carrying case. (30(b)(6) 12/12/19 Depo at 504:5–505:19). 3M 

decided to shorten the stem by 0.184 inches without additional military involvement. 

(3M_MDL000393831). 3M then began selling the CAEv2 and “feature identical” products to both 

civilians and the military. (30(b)(6) 10/17/19 Depo at 38:13–40:14, 51:5-24).

3M sold millions of CAEv2s to the military and consumers for fifteen years until it was 

abruptly discontinued in October 2015. (3M_MDL000332111).

C. The Tip Technology in the CAEv2: UltraFit and UltraFlex

The “tips” are the part of the CAE earplugs that are inserted in users’ ears. 3M has over 

the years had multiple products that have similar “UltraFit- type” tips. Tips from single ended 

earplugs are the tips that ended up on the CAEv2. Specifically, the yellow end of the CAEv2 was 

an Ultrafit tip (modified to house a filter), and the green end was the UltraFlex tip (which was also 

modified from the UltraFit). (30(b)(6) 09/25/20 Depo at 25:4–26:6; 3M_MDL000017784)

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Robert Falco of 3M invented and patented the UltraFit, the single ended plug, in 1989. 

(3M_MDL000779978) During the early 1990s, 3M used this design to design additional tips 

(30(b)(6) 09/25/19 Depo at 32:3–7) For example, 3M modified the UltraFit to include a sound 

channel, creating a tip called the UltraTech. (30(b)(6) 09/25/20 Depo at 50:22–51:4) This open 

channel inside the tip allowed for the placement of a non-linear filter. In short, the UltraTech was 

similar to the modified UltraFit used for the CAEv2’s yellow end, but the notable difference was 

3M used a hard-plastic adapter stem in the CAEv2. (Id. at 65:2–24.)

The diameter of the hard adapter stem used in the CAEv2 was problematic. Dancer and 

Hamery of ISL told Aearo that “the increase in diameter of the prototype plug because of the 

surrounding stem” could cause “fitting problems” referring to a prototype plug with a diameter of 

4.2mm (3M_MDL000013027) In fact, 3M actually increased the diameter of the stem for the 

CAEv2 from 4.2mm to 4.45mm. (Id..; 3M_MDL000017784)

Another variation on the UltraFit tip was the UltraFlex tip. 3M’s NRR testing of the 

UltraFlex yielded NRRs of 24.1, 24.2, and 27.4. (3M_MDL000320306-08) Despite using a 

modified UltraFlex in the CAEv2, the green end of the CAEv2 never achieved those protective 

levels. (30(b)(6) 09/25/20 Depo at 194:15–196:3) Berger testified about the differences between 

these two tips, including that the original “UltraFlex earband didn’t have the rubber stem cut off” 

and “also had an adapter that was of a different shape and a lower diameter than the adapter used 

in the [CAEv2].” (Id. at 197:21–198:7) Specifically, the original UltraFlex tip design has an 

adapter stem that barely breached the third and largest flange, whereas the UltraFlex used in the 

CAEv2 has an adapter stem that pushed further into the largest flange and noticeably deeper into 

the plug. Another problem was Aearo’s choice of stem adapter for the CAEv2. Aearo could have 

used the “more flexible” material from the UltraFlex band in the CAEv2, but it did not do so. 

(30(b)(6) 09/25/20 Depo at 189:16–23, 201:21–202:1). The problems resulting from these 

modifications are set forth in the Flange Report. (3M_MDL000728812)

Another tip Aearo designed was the UltraFit Plus. Berger testified the UltraFit Plus was 

based on the UltraFlex tip. (30(b)(6) 09/25/20 Depo at 227:24–228:23) The UltraFit Plus used a 

flexible vinyl material called Unichem Vinyl. (3M_MDL000605262) Compared to the CAEv2, 

the UltraFit Plus had a longer and more flexible stem. (30(b)(6) 09/25/20 Depo at 254:15–255:1) 

Thus, though both the green end of the CAEv2 and the UltraFit Plus used the same UltraFlex tip, 

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ended design. (Id. at 254:15–255:1, 256:1–256:9) The UltraFit Plus also yielded better NRR results 

than the green end of the CAEv2. Test 213014 of the UltraFit Plus Plug produced a greater NRR 

than what was achieved in the 213015 test even though they had the same tip. 

(3M_MDL000534450) The UltraFit Plus was designed circa March 1999, so it was available when 

Aearo designed the CAEv2. (30(b)(6) 09/25/20 Depo at 227:24–228:23)

Several years after the CAEv2 went to market with these problematic tips, Berger finally 

admitted that the inflexible adapter stem posed a problem and required redesign. Berger stated “the 

principal reason for discomfort is the plastic insert in the earplug stem,” and he recognized that “if 

the filter were smaller in diameter” then the “diameter of the plastic insert [could be] smaller as 

well.” (3M_MDL000192859)

D. Version 3 (CAEv3)

Aearo recognized “there [were] a number of problems that need[ed] to be addressed” with 

the CAEv2, which prompted them to go back to the drawing board and design a “New & Improved 

(N&I) CAE.” (3M_MDL000362403) In December 2005, Aearo entered into a Prototype 

Agreement with the U.S. Army to design and develop the “Improved Combat Arms Earplug.” 

(3M_000689903) This eventually became known as “version 3” (“CAEv3”).

When redesigning the CAEv2, Aearo returned to the CAEv2’s single-ended but dual mode 

design, with just one Ultrafit type tip like the CAEv1. The CAEv3 contains a similar filter and 

linear/non-linear technology as the CAEv2, but switches mode with a “rotating plastic dial that 

opens and closes the sound pathway, providing lower or higher amounts of protection, depending 

on the position of the dial.” (3M_MDL000259868)

(3M_MDL000259883) According to 3M marketing documents, this model was an improvement 

because it allowed for “easier selection” of attenuation modes and “less protrusion from ear” 

compared to the dual-ended design. (3M_MDL000002067; 3M_MDL000020024) 

Some relevant changes that were made to develop the CAEv3 included producing a new 

filter with a smaller diameter “in an attempt to correct” problems with inserting the plug and user 

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discomfort. (3M_MDL000259885; 3M_MDL000259889) Other modifications included changing 

the stem length, enlarging holes in the filter, and using slotted stainless steel disks as filters. 

(3M_MDL000259885–3M_MDL000259899) 

The CAEv3 also came in multiple different sized tips—small, medium, and large. 

(3M_MDL000259886–3M_MDL000259887)

(3M_MDL000259906) This was an improvement from the CAEv2’s “one-size-fits-all approach.” 

The CAEv3 plugs ranged in size from 0.456 inches to 0.624 inches wide. All three sizes had a 

similar total length (approximately 0.84 inches from end to end), but employed varying flange 

measurements and arrangements to achieve that length, as depicted below:

SMALL MEDIUM LARGE

(3M_MDL000259908)

According to 3M testing, the CAEv3, when properly fitted, “provided slightly-higher levels 

of protection in the open position than the earlier versions”—an NRR of 7. (3M_MDL000259883–

3M_MDL000259885; 3M_MDL000259907) The closed position, akin to the green end of the 

CAEv2, provided an NRR of 21. (3M_MDL000259907; 3M_MDL000259883–

3M_MDL000259885) 

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This plug was on the market from approximately 2007 to approximately 2010, when it was 

replaced with the version 4. (3M_MDL000020024) 

E. Version 4 (CAEv4)

Version 4 (“CAEv4”) was developed from approximately 2007 to 2009. Like the CAEv3, 

it was single-ended and came in three different sizes. (3M_MDL000019712; 

3M_MDL000259900) Instead of a twisting dial, there is a “rocker arm assembly that opens and 

closes the sound channel.” (Id.)

(3M_MDL000259900) According to 3M marketing documents, the CAEv4 was an improvement 

because there is “less protrusion from the ear,” the plug is “easier to insert correctly for a good 

seal,” and the user “can select protection while plug is in the ear.” (3M_MDL000013575; 

3M_MDL000020025; 3M_MDL000612663–3M_MDL000612664)

The final version of the CAEv4 produced an NRR of 7 for the open position and an NRR 

of 23 for the closed position. (3M_MDL000259900–3M_MDL000259904; 3M_MDL000259907) 

This was achieved by modifying the fitting instructions to instruct users to choose the “smallest 

tip to provide a good seal/fit.” (3M_MDL000259904; 3M_MDL000259913–3M_MDL00025914)

The CAEv4 has been on the market from approximately 2009 to the present. 

(3M_MDL000020024) In December 2010, 3M recalled the large CAEv4 after discovering that 

“the attenuation . . . may increase in the open position after multiple disassemblies and 

reassemblies.” (3M_MDL000499202) When 3M abruptly discontinued the CAEv2 in 2015, they 

directed consumers that “[t]he replacement is the Single Ended Combat Arms Earplugs, 

Generation 4.” (3M_MDL000013574) In 2017, 3M again ordered a limited recall of specific lots 

of small and large size CAEv4 earplugs due to a raw material issue that could result in more 

attenuation than indicated when used in the open mode. (3M_MDL000616416)

F. Version 4.1 (CAEv4.1)

Next came the generation 4.1 (“CAEv4.1”), which was developed around 2011. 

(3M_MDL000358291) Like the CAEv4, it was single-ended and came in small, medium, and large 

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tip sizes. (3M_MDL000783336) Berger described how each additional version of the Combat 

Arms Earplug included “improvements each time,” and that the CAEv4.1’s primary advantages 

and innovations were a “switch button” and “retainer clip.” (3M_MDL000277926; 

3M_MDL000523220; 3M_MDL000804574)

(3M_MDL000783336)

The CAEv4.1 “comprise[d] an easier-to-use rocker-switch mechanism, with better and 

more definitive tactile feedback that can be operated even while wearing protective gloves.” 

(3M_MDL000523220) It also offered “a new retaining device that fits in the concha of the external 

ear to help ensure the product remains seated,” and “a smaller stem that inserts in the earplug tip 

for enhanced comfort.” (Id.) Finally, the plug contained “a non-reflective and replaceable tether 

cord.” (Id.)

The CAEv4.1 produced an NRR of 8 in the open position and 20 in the closed position. 

(3M_MDL000278456) Also notable is that the “sell sheet” for the CAEv4.1 contained step-bystep instructions about “ensuring proper fit and use,” including information about a “quick and 

easy fit check” called “the pump test.” (Id.) “The seal can be tested by gently pumping the plug in 

and out of the ear canal while the rocker switch is in the Closed Mode position. When a proper 

acoustic/pneumatic seal is present, the pumping motion will cause the pressure changes in the ear, 

which the wearer should be able to detect. When the rocker switch is in the Open Mode position 

the wearer may notice little or no pressure change when the pump test is performed. If no difference 

can be detected between the Open and Closed Modes, the plug is probably not sealing the ear. 

Also, the user’s voice should sound louder and deeper when they speak or hum.” (Id.)

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The plugs were sold primarily to the French military from 2014 to 2018. 

(3M_MDL000523220) Thereafter, they were introduced at trade shows for other applications. 

(3M_MDL000490754) 3M sells the CAEv4.1 commercially to this day. (See

https://mremountain.com/products/3m-peltor-combat-arms-4-1-earplugs?variant=1280829652

9954.)

G. 3M Sold the CAEv2 to the Military and Consumers Without Conducting REAT 

Testing and Without Properly Labeling The Product, in Violation of EPA Labeling 

Regulations

Since the late 1970s, EPA regulations have required HPD manufacturers to provide 

consumers with information about the noise protection characteristics of new products. (42 U.S.C. 

§ 4907(b); 44 Fed. Reg. 56120 (Sept. 28, 1979) (codified at 40 C.F.R. §§ 211, et seq.) The 

regulations require manufacturers to affix a label to an HPD that includes an NRR, among other 

content, form, and placement requirements. (40 C.F.R. §§ 211.104(a), 211.105, 211.106, 211.107, 

211.204, 211.204-1(b), 211.204-2, 211.204-3, 211.204-4) As stated above, the NRR is derived 

from REAT testing and measures the product’s effectiveness in reducing noise. The higher the 

number, the greater the noise protection. NRR labels allow consumers to compare NRRs among 

competing products. A sample NRR label is below, prominently displaying the NRR for the 

consumer’s benefit: 

(40 C.F.R. § 211.108)

The Noise Control Act defines “product” to include “any manufactured article or goods or 

component thereof.” (42 U.S.C. § 4902) There is an exception for “military weapons or equipment 

which are designed for combat use,” but the CAEv2 was not designed exclusively for combat. 

Because the CAEv2 was designed for both military and commercial users, it is subject to the Noise 

Control Act and accompanying EPA regulations. (40 C.F.R. § 211,210-1(a) (stating that HPDs 

“[m]st be labeled at the point of ultimate purchase or distribution to the prospective user” and 

“meet or exceed the [NRR] values determined by the procedure” set forth in other regulations; 40 

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C.F.R. § 210-2) REAT testing is thus required for HPDs before they are sold. (Id.; 40 C.F.R. §§ 

211.206-1, 211.206-2, 211.207) 3M executives agree, stating “an EPA label should be placed on 

all hearing protection packaging,” including for the CAEv2, and “there is no exception for the US 

military.” (3M_MDL000446689)

In the case of the CAEv2, however, 3M ignored these regulations and sold the plugs to the 

military without testing or providing an EPA compliant label and without any instructions. 

Because 3M sold the CAEv2 to the military before testing it, the plugs were shipped without the 

required NRR. On May 18, 1999, Ohlin requested a price quote from 3M for 1,000 pairs of the 

CAEv2 to be purchased by the Army’s Southern European Command. 

(CTRL_3M_Touhy00000135) The first official purchase order for the CAEv2 was dated July 22, 

1999 and was shipped to CHPPM at Aberdeen Proving Ground. (3M_MDL000393647) Orders 

were received from all branches of the military thereafter. (3M_MDL000393647)

In November 1999, after supplying the CAEv2 to the Army for four months, it “occurred” 

to 3M that it had “no [testing] data on the actual version” of the earplug being sold in the United 

States. (3M_MDL000257805) 3M did not begin any REAT tests on the CAEv2 until December 

of 1999. (3M_MDL000313390) Therefore, soldiers wore the CAEv2 to protect their hearing from 

hazardous noise before 3M had even tested the plugs. 

H. Testing Showed the CAEv2 had “Problems”

Shortly after it “occurred” to 3M that it had not conducted any safety testing on the CAEv2 

that service members were already using, Elliot Berger, 3M’s Manager in the Acoustical 

Engineering Department, directed 3M’s acoustical lab technician (Ronald Kieper) to REAT test 

the closed and open ends of the plug. (3M_MDL000257805; Kieper 12/19/19 Depo at 111:25–

113:1) From December 1999 to January 2000, 3M tested both ends using “Experimenter Fit” 

REAT testing under ANSI S3.19. Testing of the open end (Test 213016) resulted in a -2 NRR. 

(3M_MDL000188143) When it advertised and labeled the plug, however, 3M claimed the NRR 

was 0 (rather than -2). (3M_MDL000425527) Testing of the closed end (Test 213015) was halted 

after 8 of 10 subjects were tested, which 3M determined resulted in an NRR of 11. 

(3M_MDL000313390; 3M_MDL000728812) These tests demonstrated that the CAEv2 had 

significant design problems making it difficult to insert, seal, and keep the plugs in place.

Berger prematurely terminated Test 213015 after eight of ten subjects were tested because 

the interim NRR at that point was only 10.9, which was unacceptably low. (3M_MDL000313390; 

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Kieper 12/19/19 Depo at 166:10-16) In fact, Berger admitted the NRR obtained in Test 213015 

was far below the “anticipated values of protection” for the CAEv2. (30(b)(6) 11/13/19 Depo at 

276:3–277:4) According to Richard Knauer, 3M’s Senior Technical Director for Passive Hearing 

Protection, the military expected an NRR for the CAEv2 “up closer to where the UltraFit was,” in 

the range of 20. (Knauer 12/17/19 Depo 117:10–17; Berger 12/10/19 Depo at 559:5–13) Several 

other witnesses conceded that an 11 NRR was unacceptable. (Myers 12/12/19 Depo at 275:5–

276:1; Fallon 09/03/20 Depo at 197:24–199:13) Jeffrey Hamer, 3M’s Global Laboratory Manager 

for Hearing Protection, testified as follows: 

Q: Wouldn’t it be a big problem for 3M if it had to list the NRR on the closed end 

of its Combat Arms Version 2 as being 11 rather than 22?

A: I would think that would be insufficient.

(Hamer 10/17/15 Depo at 174:11–15) 

Because the original REAT testing revealed an unacceptable NRR of 11 for the closed end 

of the CAEv2 and would have created a problem as far as selling the plugs, 3M decided to “retest” 

the closed end. (3M_MDL000005365; Kieper 12/19/19 Depo at 162:17–166:16) The details of the 

original test that was abandoned, Test 213015, and the later retest of the CAEv2, Test 213017, 

were documented by Kieper and Berger in an internal report titled “How Folding the Flanges Back 

Affects REAT Results of the UltraFit EarPlug End of the Combat Arms Plug” (“Flange Report”). 

(3M_MDL000728811–3M_MDL000728816)

The Flange Report memorialized three different design defects that prevented the earplug 

from providing consistent hearing protection during the study. First, Berger and Kieper 

documented that the length of the Ultrafit end was “too short for proper insertion,” making it 

“difficult . . . to insert the plug deeply,” especially for individuals with “medium and larger” ear 

canals. (3M_MDL000728812) Second, “the geometry of the ear canal opening sometimes 

prevented the deep plug insertion,” inhibiting proper fit. Third, the earplug “imperceptibly” 

loosened due to the basal edge of the third flange of the outward facing plug pressing against the 

ear, folding up, and then returning to its original shape once the inward pressure on the plug is 

released. (3M_MDL000728812) These defects identified in the testing demonstrated the CAEv2 

provided “variable” and “low” amounts of protection, regardless of which end was used. 

(3M_MDL000728812)

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These findings related to the CAEv2 were so concerning to Berger that he sent a draft of 

the Flange Report in May 2000 to his boss, Brian Myers, 3M’s Vice President of Marketing for 

Hearing Conservation Products, and asked, “Should I share this with Ohlin? It looks like the 

existing product has problems unless instructions are revised.” (3M_MDL000258590) As stated 

previously, Ohlin worked for the military and was 3M’s main contact with the military about the 

CAEv2. Based on my review of the documents and testimony, 3M evidently decided not to “share” 

the problems with CAEv2 with Ohlin or the military. Rather, 3M decided to maintain the 

instructions used for the CAEv2 and to proceed full speed ahead with selling the product. 

Even though Berger ordered retesting on the closed end of CAEv2, he did not retest the 

open end of the plug. This is true even though he and Kieper both conceded that the defects seen 

with the closed end of the plug could apply to the open end of the plug as well. (Berger 12/11/2019 

Depo at 415:14–25; Kieper 12/19/19 Depo at 213:16–21) In addition, the individual results of Test 

213016 showed large variances in the attenuation the plug was providing subjects consistent with 

a plug that has a problem being fit and sealed, just like in Test 213015. Yet, Berger chose to accept 

the results of Test 213016, presumably because the company got the low NRR it and the military 

desired on the open end. (Knauer 12/17/19 Depo at 40:4–20) 

The details of the “retest” of the closed end (Test 213017) are also detailed in the Flange 

Report. This time, Kieper altered the CAEv2’s configuration when he inserted the plug into 

subjects’ ears by rolling back the flanges of the outward facing end. (3M_MDL000005366; 

3M_MDL000728812) Kieper’s retest with the altered plug configuration doubled the NRR to 22. 

(3M_MDL000005365) Nonetheless, 3M has confirmed this modification was “improper” because 

the flanges were not designed to be folded. (Hamer 10/17/15 Depo at 165:20–166:1)

The Flange Report provides additional details about this retest. By changing the 

configuration of the plug, it was easier to create “a long, stiff quasi-stem for the experimenter to 

grasp” and, thus, get “a deeper and more consistent fit.” (3M_MDL000728812) Berger and Kieper 

also noted that when the product was altered in this way, the outer flange would not contact the 

“subjects’ conchae” and thus would not “compromise[] the fit.” This is important because 

Kieper—an expert at fitting earplugs—specifically noted that when the plug was inserted as 

intended, without its flanges folded back, the flanges would compromise fit. 

(3M_MDL000728812)

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These problems with the CAEv2 should have been especially concerning to 3M given its 

prior communication with the co-developer of the CAEv2 that the size of stem used in the CAEv2 

could lead to problems for users. In fact, during the development of the CAEv2, Armand Dancer, 

a French scientist at ISL informed Elliott Berger about his concerns about the size of the filter and 

the stem in the prototypes. He informed Berger that the diameter of the stem was “too big” and 

asked if the diameter could be decreased. (3M_MDL000013024) Dancer recommended a diameter 

in the range of 3mm to 3.6mm. The CAEv2 has a stem diameter of 4.45mm. 

(3M_MDL000340512; CAEv4 Rocker Stem_3M_MDL000825699) 3M’s Ted Madison also 

internally acknowledged that the “structure of the stem” containing the filter could cause the 

CAEv2 to “behave differently in the earcanal” and lead to lower attenuation. 

(3M_MDL000008430)

In summary, 3M had the results of testing that showed the CAEv2 had “problems” (in 

Berger’s words) by the beginning of 2000. Four months later, 3M retested the closed end of the 

plug attempting to get a more marketable NRR, but did nothing to fix the problems and did nothing 

to inform or warn the military or consumers about the problems. This is true, even though 3M had 

been warned about the potential for problems by the one who helped develop the product. 

I. It Was Improper for 3M to Retest the Closed End of the CAEv2 with the Flanges 

Folded Back

As discussed above, when Berger was faced with the test results for the first eight subjects 

on the closed end of the CAEv2, he terminated Test 213015 and four months later he retested the 

closed end by folding back the yellow flanges. (Berger 10/08/15 Depo at 106:2–108:25; 

3M_MDL000728812) On the open end, however, he completed Test 213016 and never did a retest 

on that end. (3M_MDL000188143; Berger 10/08/15 Depo at 129:7–21; Kieper 12/19/19 Depo at 

101:20–102:15, 105:9–14)

According to 3M documents, “products should be tested as they are designed to be worn.” 

(3M_MDL000427651) The CAEv2 was designed as a dual-ended earplug with all flanges folded 

down, as designed. (3M_MDL000449441) Richard Falco, 3M’s Project Engineer, agreed that the 

CAEv2 was not designed to be worn with the flanges folded back. (Falco 2/12/20 Depo at 648;18–

653:8) According to Jeffrey Hamer, 3M’s Global Laboratory Director, 3M’s retesting of the 

CAEv2 with its flanges folded back was improper: 

Q: Okay. Would it be fair to say that if they did not test the open mode with the 

flange rolled back, but they did test the closed end with the flange rolled back, 

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that that would be improper because the two tests were using the product in two 

different ways?

A: My opinion is that testing the product with the flange rolled back is improper. 

(Hamer 10/07/15 Depo at 165:20–166:1)

Q: And so the labeling test that 3M is using for the closed end of the Combat Arms 

Version 2 actually involves using the plug in a different configuration than is 

advertised or shown in the plug; right? It involves folding back that flange

A: It appears so.

Q: So really, the labeling test that 3M’s using for Combat Arms Version 2 for the 

green end is not the appropriate test; isn’t that true?

A: It appears so.

(Hamer 10/07/15 Depo at 163:24–164:8) Indeed, unlike its procedure for testing the CAEv2’s 

green end, 3M did not fold back the opposing flanges when testing the plug’s yellow end. (Berger 

10/08/15 Depo at 146:22–147:12; Ohlin 04/24/13 Depo at 192:19–23) 3M thus “utilized two 

different methods.” (CID File0028 (“Moldex stated that the testing in this case is key because 3M 

utilized two different methods which does not meet the ANSI requirements.”))

Second, as further acknowledged by Hamer, it was improper for 3M to terminate Test 

213015 after testing only eight subjects simply because Kieper found the CAEv2 did not fit well 

and Berger was disappointed by the results:

Q: And 3M never stops a labeling test for any – if it thinks the numbers aren’t – are 

looking too variable or too low?

A: Correct.

. . .

Q: If the product doesn’t fit right, can you stop a labeling test? 

A: No.

(Hamer 10/07/15 Depo at 104:25–105:3, 136:10–12) Other evidence confirms 3M should not have 

stopped a labeling test like Test 213015 without testing all subjects; nor should it have retested the 

same product with new fitting instructions. (3M_MDL000237670; Berger 10/08/15 Depo at 

39:18–40:25, 86:9–87:25; Hamer 10/07/15 Depo at 87:5–89:9, 104:25–105:23)

ANSI S3.19-1974 section 3.2.3 says “3.2.3 Listeners who satisfy other requirements of this 

standard and who do obtain an adequate fit with the test item (3.3.3.1) may not be dismissed for 

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reporting small amounts of protection. In reporting the results, listeners for whom an adequate fit 

cannot be obtained should be noted, but should not be included in the evaluation.” (ANSI S3.19-

1974 Section 3.2.3) 

Documents and testimony in this case reflect that 3M has a longstanding practice of halting 

REAT tests used for HPD labeling when the company is not satisfied with the results, followed by 

retesting the plug until desired NRR results are obtained. (3M_MDL000004550–

3M_MDL000004552; 3M_MDL000208205; 3M_MDL000321562–3M_MDL000321563; 

3M_MDL000434769; Berger 12/10/19 Depo at 166:21–168:1; Kieper 12/19/19 Depo at 351:14–

353:6, 403:5–404:2) This practice contradicts 3M’s own policy, which states that it “goes without 

saying” that “multiple testing attempts with the same product are not allowed because this is 

prohibited by the EPA.” (3M_MDL000014573–3M_MDL000014639; 3M_MDL000332847; 

Kieper 12/19/19 Depo at 253:14–255:8) In fact, 3M’s predecessor company paid a $900,000 civil 

penalty to resolve alleged violations of EPA testing and labeling protocols due to similar testing 

practices. (3M_MDL000024833–3M_MDL000024843; Berger 10/08/15 Depo at 92:7–93:10) 

This evidence shows 3M’s improper testing of the CAEv2 was a pattern and practice. (Kieper 

12/19/19 Depo at 314:14–21)

J. Subsequent Testing Confirmed the Problems with the CAEv2

Test 215009 in June 2004 was another 10-subject test on the open end of the plug that once 

again led to a negative NRR (-1) rounded up to 0. (3M_MDL000481953; 3M_MDL00089665) 

This test was a “dual protection study” in which three subjects (CLC, BAK, TLS) had large 

variability in their attenuation values just like 3M had seen in the prior labeling test on the open 

end (Test 213016). 3M never reported these findings to the military. 

Starting in 2005, 3M did several tests of the open and closed ends comparing the CAEv2 

to new design prototypes used for Version 3. (3M_MDL000259866; 3M_MDL000481953) These 

development tests involved either three or five subjects and were not conducted pursuant to the 

same protocol as 3M’s labeling tests. (3M_MDL000481953) The NRRs for three of these tests 

(Tests 215508, 215512, 215516) were 15, 16 and 17, respectively - all much lower than the 

advertised NRR for the closed end. (3M_MDL000481953) In these tests, Kieper continued to 

observe that “some of the individual’s data [were] significantly different, either from trial 1 to 

trial 2 or from the other persons in the test” and that 3M considered this data “aberrant.” 

(3M_MDL000481953) The data from 3M’s additional testing of the CAEv2 continued to show 

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wide variability in attenuation experience both intra- and inter-subject. Rather than report that 

information, Kieper and Berger “removed” the aberrant data to make the results reflect “what 

[they] expect[ed] to obtain in a full, 10-subject test.” (3M_MDL000481953) 

In 2006, 3M tested the closed end of the Arc plug (an identical plug branded for consumer 

use) pursuant to ANSI S12.6-1997, Method B, Subject Fit testing. (3M_MDL000313220; 

3M_MDL000473611) Test 213030 was a “subject fit” test, meaning that the subjects inserted the 

plugs in their own ears (without folding back the flanges) and no expert fitter inserted the plug in 

the ears of the 20 subjects. This type of test more accurately reflects “real world” attenuation. 

(Berger, E., 2003. Hearing Protection Devices, in: Berger E., Royster, L., Royster, J., Driscoll, D., 

Layne, M. (Ed.) The Noise Manual (5th edition). American Industrial Hygiene Assn., Fairfax, VA, 

414-416; Myers 12/13/19 Depo at 516:24–517:23) This test generated an extremely low NRR of 

4.4. (Myers 12/13/19 Depo at 494:19–498:10) Several test subjects did not have a good fit and the 

NRR rose to 10.5 if four of the test subjects were excluded. (3M_MDL000313220) Again, this 

testing more closely resembled the fitting done by soldiers in the field than prior testing with a 

professionally trained fitter. 3M never disclosed the results of Test 213030 to the military. (Myers 

12/13/19 Depo at 516:24–517:23) 

There were non-3M tests of the CAEv2. The Air Force Research Laboratory tested both 

the open and closed ends in January 2009 pursuant to ANSI S12.6-1997 (Method A ExperimenterSupervised Fit). (Hobbs, Hudson, McKinley and Brungart, Air Force Research Laboratory, 

“Wideband Hearing, Intelligibility, and Sound Protection (WHISPr): Tactical Headset Evaluation” 

(January 2009)) This fitting technique is different than experimenter fit testing in that the subject 

inserts the plugs with some input from the expert fitter. It is difficult to determine from the report 

what assistance the expert fitter provided during this test but, regardless, this test would not be 

considered “real world” fitting like a subject-fit test. There are no individual test results available 

from this test so it is difficult to determine the variability of the data or whether some subjects 

were not able to be properly fit. But, the published NRR on the closed end is 15, far less than the 

labeled NRR, and the NRR was 3 on the open end. As part of the CID investigation, Mr. Hobbs 

“stated that 3M should have told the US Government about the slippage issues with the CAE. Mr. 

Hobbs stated that the US Government would not have found out any of the issues regarding 

slippage through their own tests nor were they looking for that issue during the test.” (CID File 

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0241) Hobbs testified that he stands behind the statements he gave in that investigation. (Hobbs 

7/16/20 Depo at 242:4–18)

The U.S. Army Aeromedical Research Laboratory conducted REAT testing on both ends 

of the CAEv2 in 2014 pursuant to ANSI S12.6-2008, (Method A Trained Subject Fit). 

(3M_MDL000005607) This was a 20-subject test where the NRRs were not calculated. Dr. 

Franks’ analysis also found that multiple subjects (at least six) obtained a poor fit with the CAEv2 

when wearing both ends of the plug. (Rule 26 Expert Report of John R. Franks, Ph.D., para 132-

135) This study further supports the problems with fit and seal and loosening revealed in the Flange 

Report. 

The subsequent testing of both the open and closed ends of the CAEv2 supports that the 

plug is difficult to fit, seal, and to keep seated in users’ ears. 3M’s subject-fit test, Test 213030, 

most closely represents the protection service members and consumers received in the real world, 

and those results were clearly unacceptable. Rather than inform the military or consumers about 

the concerning tests results, however, 3M buried the studies and marched forward with promoting 

and selling the plugs. 

K. The Flange Report was Never Disclosed to the Military, Consumers, or Distributors 

of the CAEv2

The documents and testimony support that the CAEv2 had problems with fit, seal, and 

loosening. However, 3M never shared the Flange Report or the test results described therein with 

the military or consumers. (Berger 12/10/19 Depo at 206:7–14) 

Berger testified that he told a military employee (Doug Ohlin) about folding back the 

flanges during testing and how “rolling back the flanges would be important for some people.” 

(30(b)(6) 11/13/19 Depo at 337:8–18; Berger 10/08/15 Depo at 109:6–110:15) But 3M never 

disclosed that the plug was too short for proper insertion, that the plug was difficult to insert in 

most ear canals, or that the plug could imperceptibly loosen in all ear canals. (30(b)(6) 11/13/19 

Depo at 295:14–25; Berger 12/10/19 Depo at 82:9–-22, 212:2–213:9; Berger 12/12/19 Depo at 

151:8–21) 3M also never told the military that users must fold back the flanges to obtain the 

claimed 22 NRR, or that the NRR without doing so would be 11—only a small fraction of the 

claimed protection. (Berger 12/10/19 Depo at 83:3–18; McNamara 03/11/20 Depo at 152:20–

153:9) Nor did 3M communicate any of this information to non-military consumers. (Myers 

12/12/19 Depo at 352:16–353:24)

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Likewise, there is no evidence that the Flange Report was shared with any of the 

distributors who distributed the CAEv2 to the U.S. Military or base stores. Brock Sales distributed 

hundreds of thousands of CAEv2 plugs. (BROCK00000085) Yet, no one at 3M ever told Brock 

about the risks identified in the Flange Report, including that the plug loosened imperceptibly to 

the subject. (Brock 9/10/20 Depo at 99:16–102:16)

Only in the context of a separate litigation in 2015 was the Flange Report shared outside 

the company. (Hamer 10/07/15 Depo at 149:8–157:8) After the Flange Report was shown to a 

witness in a patent lawsuit filed by 3M in 2015, 3M discontinued sales of the CAEv2 the very next 

day. (3M_MDL000332061; 3M_MDL000332111; Hamer 10/07/15 Depo at 149:18–157:8)

L. 3M Did Not Provide Instructions for Use with the CAEv2 for Years, and When It Did, 

the Instructions Were Not Adequate to Cure the CAEv2’s Defects

As previously stated, Berger emailed his boss (Brian Myers) four months after learning 

about Test 213015. (3M_MDL000258590) Berger advised that the CAEv2’s “problems” could be 

cured only by “changing the instructions.” Shockingly, though, 3M sold the CAEv2 to the military 

without any instructions whatsoever from 1999 to 2005. (30(b)(6) 10/18/19 Depo at 178:20–

179:12, 198:7–199:13; 3M_MDL000056553; Berger 12/10/19 Depo at 224:6–226:12) When a 

package insert with instructions were included with some plugs starting in or around December 

2005 (30(b)(6) 10/18/19 Depo at 200:17–202:12, 212:6–15), the instructions were inadequate to 

cure the defects in the plugs that 3M knew about , including that some users must fold back the 

opposing flanges to achieve proper fit, that the stem was too short for proper insertion, that the 

plug did not fit certain ear canal geometries, and that the plug could imperceptibly loosen. (30(b)(6) 

10/18/19 Depo at 251:25–254:7, 255:20–257:16; Hamer 12/18/19 Depo at 299:4–300:22, 323:11–

22, 300; Myers 12/13/19 Depo at 685:4-686:5)

3M has represented that it did not provide instructions for use when selling “bulk” packages 

of the CAEv2 to the military. (Berger 12/10/19 Depo at 224:6-226:12; Moses 12/5/19 Depo at 

162:21–164:7) This is significant because most military sales were bulk sales, meaning the CAEv2 

plugs were shipped in boxes containing 50 pairs—totaling 100 plugs—inside a plastic bag. (Moses 

12/5/19 Depo at 181:5–17; Myers 10/18/19 Depo at 81:2–8, 85:14–19) Corporate witnesses 

confirmed they could not identify any instructions for use inside the bulk-shipment box or on the 

box. (30(b)(6) 10/18/19 Depo at 198:7–199:13; Berger 12/10/19 Depo at 226:2–12) As a result, 

thousands of service members did not receive written instructions from 3M in the ordinary course 

of receiving and using the plugs. (Cimino 12/11/19 Depo at 209:15–209:5; Moses 12/5/19 Depo 

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at 162:21–164:17, 171:13–174:20; Myers 10/18/19 Depo at 205:6–13) As stated previously, 3M’s 

failure to include instructions for use of the CAEv2 was a violation of EPA regulations which 

provide that “[i]n the case of bulk packaging and dispensing,” supporting information including 

“[i]nstructions as to the proper insertion” of the earplug “must be affixed to the bulk container or 

dispenser in the same manner as the [NRR] label.” 40 C.F.R. § 211.204-4, 

One of 3M’s largest distributors, Brock Sales Company, did include instructions written 

by 3M with some of its bulk package shipments. (BROCK_00000083; Brock Tr. 111:15–114:13) 

But, these instructions failed to state anything about the findings identified in the Flange Report, 

including that some users must fold back the opposing flanges to achieve proper fit, that the stem 

was too short for proper insertion, that the plug did not fit certain ear canal geometries, and that 

the plug could imperceptibly loosen. 

Several years after selling the CAEv2 to the military, 3M started providing written 

instructions for use on a package insert in “blister packs” containing one pair of the plugs. (30(b)(6) 

10/18/19 Depo at 178:20–179:12, 212:6–15; 3M_MDL000080183) Retail stores on military bases 

began selling blister packs in late 2005 (30(b)(6) 10/18/19 Depo at 200:17–202:12; 

3M_MDL000148609), but few soldiers purchased them. (Moses 12/5/19 Depo at 181:5–17) 

Therefore, it is likely that very few service members actually saw the package insert inside the 

blister packs. Putting that issue aside, though, the insert in the blister packs merely recommended 

that users fold back the outward-facing flanges to “improve” fit, but did not include any 

information about the difficulty fitting the plugs, that the labeled attenuation values were the result 

of improper testing, or that the plugs could loosen imperceptibly. (3M_MDL000042065; Hamer 

12/18/19 Depo at 299:4–300:22, 318:24–321:11; Santoro 12/3/19 Depo at 306:1–22) There was 

nothing on the insert sheet that warned users that the CAEv2 was too short for proper insertion, 

especially in users with medium and larger ear canals or that ear-canal geometry prevents deep 

insertion in some users. (30(b)(6) 10/18/19 Depo at 251:25–254:7; Myers 12/13/19 Depo at 676:5–

20) There was also nothing on the insert informing users that initial testing generated an 11 NRR 

that would not protect against loud noises. (Myers 12/13/19 Depo at 685:4–686:4) To the extent 

the blister-pack insert told users to “grasp the plug by the stem and insert it into the ear canal” and 

then “adjust the plug for best sealing performance,” this generic instruction did not advise users 

that the CAEv2 is “unusual,” difficult to fit and seal, and that it loosens imperceptibly. 

(3M_MDL000434769; Hamer 12/18/19 Depo at 323:15–22)

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I am aware that certain versions of the CAEv2 were accompanied by either a “wallet card” 

or a “fitting tip.” (30(b)(6) 11/13/19 Depo at 295:1–10; Berger 12/10/19 Depo at 82:24–83:7) The 

wallet card and fitting tip did not provide users with information about the CAEv2’s defects, and 

confirm that the military was not aware of all the critical information about the problems with the 

plugs.

The wallet card was created by 3M and Ohlin in late 2004. (3M_MDL000017330; 

CTRL_3M_Touhy00000712; McNamara 3/11/20 Depo at 435:24-436:5) The final version of the 

wallet card states, “[f]or very large ear canals, fold opposing plug back,” and it shows the green 

flanges folded back. (3M_MDL000229331) The card also depicts the plug inserted in an ear 

without the flanges folded back and recommends using the standard “tug test” to assess fit:

(3M_MDL000229331) A draft of the wallet card was reviewed by several 3M employees, and 

they testified that they did not revise the instructions. (CTRL_3M_Touhy00000712; Berger 

12/10/19 Depo at 205:1–9, 212:2–213:9; McNamara 03/11/20 Depo at 435:24–440:15; Myers 

12/12/19 Depo at 745:15–748:13) In contrast to the Flange Report, the wallet card recommends 

folding back the flanges only “for very large ear canals.” (3M_MDL000229332; 30(b)(6) 11/13/19 

Depo at 346:9–23, 373:12–374:6; McNamara 03/11/20 Depo at 439:13–441:24) The wallet card 

is also silent as to other issues discussed in the Flange Report, including that fitting the plugs--

especially in medium and larger ear canals-- is difficult, that the geometry of the ear canal opening 

prevented deep plug insertion, that the opposing flanges could cause imperceptible loosening, and 

that the 22 NRR was only obtainable if the flanges were folded. (3M_MDL000728812; Berger 

12/10/19 Depo at 218:4–15; Berger 12/11/19 Depo at 545:8–19; Hamer 12/18/19 Depo at 80:19–

24; Murphy 01/29/20 Depo at 309:7–310:18; Myers 12/12/19 Depo at 335:6–336:6, 338:18–-

339:13, 344:6–345:9) 

The “fitting tip” was 3M’s creation. (3M_MDL000042065) It is just what it sounds like: a 

tip for users on how to “improve” fit of the plug. (Hamer 12/18/19 Depo at 299:5–300:22, 318:24–

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321:11) As stated above, the fitting tip was displayed on a package insert that contained 

instructions for use, among other information. The language of both the military and consumer 

fitting tips is identical: “Fitting is easier if the ear is pulled upward and outward during insertion 

and is also improved if the sealing rings of the outward directed plug are rolled back upon 

themselves.” (3M_MDL000425527; 3M_MDL000425680) 

It appears that a fitting tip was provided on commercial packaging, such as the AO Safety 

Indoor/Outdoor plugs for civilian markets, as early as 2000:

(3M_MDL000425527) But, as mentioned above, the military was not provided these inserts with 

“bulk” CAEv2 sales and it was only when 3M began selling individual blister packs in 2005 that 

inserts were included. (3M_MDL000042065; 3M_MDL000456241; 3M_MDL000573846; Moses 

10/17/19 Depo at 128:4–129:2; Santoro 12/03/19 Depo at 182:17–184:18) 

(3M_MDL000042067; 3M_MDL000425680) The fitting tip was removed in March 2012, 

meaning there was no instruction to fold back the flanges at all from 2012 to discontinuation of 

the CAEv2 in 2015. (30(b)(6) 10/18/19 Depo at 314:3–317:5; 3M_MDL000193296–

3M_MDL000193301)

The fitting tip provides additional evidence that 3M did not inform the military about the 

CAEv2’s problems. Even if the military knew about the fitting tip before 2005, the tip merely 

recommended folding the flange back for comfort and “improved” fit, not as a requirement to 

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obtain the claimed protection or to avoid imperceptible loosening. (30(b)(6) 10/18/19 Depo at 

251:24–252:5, 405:8–406:11; Berger 12/10/19 Depo at 220:10-18; Hamer 12/18/19 Depo at 

323:11–22; Myers 12/12/19 Depo at 338:18–25) 

Neither the wallet card nor the fitting tip contained adequate instructions to protect soldiers 

and marines from the dangers associated with the CAEv2. 3M knew from its testing and the Flange 

Report that the CAEv2 had problems with being properly fit, properly sealed and with 

imperceptible loosening. 3M also knew that the only way to achieve the advertised 22 NRR was 

by folding back the flanges and having the plugs inserted by a professional fitter. The wallet card 

and the fitting tip simply do not convey the risks associated with the CAEv2 or that the protection 

on the label was only achieved when the flanges were folded back - information that the military 

and consumers needed to know. 

M. 3M Misrepresented NRRs for Both Ends of the CAEv2 

Although the testing of the CAEv2 revealed problems with fitting, sealing, and 

imperceptible loosening, 3M made multiple misrepresentations to both the military and consumers 

about how effective both ends of the CAEv2 were at providing hearing protection. 3M did so by

providing inaccurate NRRs. 3M represented to the military and consumers alike that the NRR of 

the open end was 0 and the closed end was 22. They made this claim on the EPA-required label, 

among other places:

(3M_MDL000425527; 3M_MDL000573846) This same NRR information was repeatedly 

communicated to the military and consumers in sales sheets, advertisements, written 

correspondence, and oral conversations. (30(b)(6) 10/17/19 Depo at 216:8–217:25; 

3M_MDL000002663; 3M_MDL000042067; 3M_MDL000425680; McNamara 03/11/20 Depo at 

413:10–415:9; Santoro 12/03/19 Depo at 235:7–236:18; Warren 01/23/20 Depo at 174:9–25, 

178:20–180:12)

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3M decided to label the green, closed end of the CAEv2 as providing an NRR of 22 without 

including any sort of instruction or warning that the labeled level of protection could only be 

achieved if the configuration of the plug was altered by folding back the flanges. (Berger 10/08/15 

Depo at 112:2–113:1, 146:22–147:12; Madison 12/10/19 Depo at 114:12–115:23) The label did 

not disclose that without folding the flanges, the plugs could be 90% less protective, delivering an 

NRR around 11. (3M_MDL000728812; McNamara 03/11/20 Depo at 152:20–153:9) As 

mentioned, Test 213030, conducted using Method B, yielded an even lower NRR of 4.4, which 

was also never shared with the military. (3M_MDL000313220; Myers 12/13/19 Depo at 489:6–

501:1, 516:24–517:23, 623:10–25)

Labeling the product in this manner most certainly made users believe that the CAEv2 

would protect their hearing without the need to modify or alter the product—a fact that 3M knew 

to be false. (3M_MDL000023410; Hamer 10/07/15 Depo at 162:9–164:12, 174:11–24) It most 

certainly influenced the military’s decision to purchase the CAEv2 and some consumers’ decisions 

to purchase commercial equivalents. (3M_MDL000259198–200 (“Users focus on NRR rating as 

an indicator of hearing protector performance...Many users want higher NRRs”); 

3M_MDL000440368 at 30 (“There is evidence that purchasing decisions are often based on NRR 

alone.”)) 

With respect to the other side of the CAEv2, the yellow end, 3M also misrepresented the 

NRR. At all times while the CAEv2 was on the market, the yellow, open end of the CAEv2 was 

labeled as having an NRR of 0. The internal documents from the company reveal that although the 

initial REAT test on the yellow end of the plug (Test 213016) resulted in an NRR of -2, 3M 

rounded it up to 0. (3M_MDL000188143; 3M_MDL000259907; Berger 10/08/15 Depo at 261:5–

7)

There were multiple other REAT tests subsequently done on the yellow end by 3M that 

yielded NRRs higher than 0. Specifically, below is a listing of all of 3M’s REAT testing on the 

yellow open end of the CAEv2 from its internal document titled “The Development of the Combat 

Arms Earplug, Version 1 through Version 4.” (3M_MDL000259866) The NRRs for each study 

are highlighted below, demonstrating the variability and inconsistency of 3M’s testing results.

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Test ID and N Date Ver. Position NRR

213016* {10} Jan. 2000 2 Open 0 (-2)** 

215009 {10} June 2004 2 Open 0 (-1)**

215507 {5} June 2005 2 Open 4

215511 {5} June 2005 2 Open 6

215515 {5} Sept. 2005 2 Open 5

215012 {10} April 2006 2 Open 5

** - Note that when the real-ear test results compute to a negative number for the NRR, they choose 

to label the device with a 0. (3M_MDL000259907)

The first two REAT studies resulted in negative NRRs (-2 and -1), rounded up to 0 by the 

3M, and the four additional studies all resulted in NRRs much higher than 0 (4, 6, 5, 5). (Berger 

10/08/15 Depo at 162:11–163:24) The negative-value NRRs suggest the CAEv2 was actually 

amplifying sounds. (3M_MDL000034896 (“Values less than 0 make no sense and are typically 

not reported”); CTRL3M000000942 (indicating a -2 NRR “is equivalent to hearing amplification 

not protection”)) 3M suspected the negative NRRs were the result of “the low mean attenuation 

values and the large [standard deviations] of the test data,” (3M_MDL000259881), but 3M thought 

a 0 NRR was a more “suitable” NRR because “lower attenuation is more desirable.” 

(3M_MDL000259910) 

The positive NRRs, on the other hand, suggest that the yellow end of the plug—which was 

advertised and marketed as providing an NRR of 0 was actually attenuating low-level sounds much 

more than advertised. 3M advertised “hear-through protection,” stating that the yellow end allowed 

“lower-level sounds to pass without interruption.” (3M_MDL000042067; 3M_MDL000425680)

Ultimately, in July 2010, Berger and Kieper stated internally (ten years after the product 

had been on the market): “We are unsure of the ‘correct’ REAT for the open end of the CAE Ver. 

2 and, in fact, Figure 15 graph suggests that later REAT tests are the more appropriate.” 

(3M_MDL000259878) I have not seen any evidence to suggest 3M ever told the military or 

customers about these subsequent tests or that it was “unsure” of the actual NRR with the CAEv2 

or that subsequent testing suggested that the higher value NRRs were “more appropriate,” even 

though the CAEv2’s was advertised as providing an NRR of 0. 

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This information should have been shared with the military and consumers so that such 

purchasers could have considered whether the risks of these plugs outweighed their potential 

benefit. 

In 2015, when the CAEv2 was abruptly pulled from the market, Brian Myers of 3M 

admitted that “we cannot distribute this [product] with the current NRR on the package.” 

(3M_MDL000332061; 3M_MDL000332090; Myers 12/12/19 Depo. at 352:16-353:16). Based on 

my review of documents and testimony in this case, at no time during the life of the CAEv2 or at 

the time of its discontinuation was an accurate NRR for either the open or closed end provided to 

service members or consumers. (3M_MDL000574437; Myers 12/12/19 Depo at 354:9–356:14) 

N. 3M Misrepresented to the Military And Consumers That the CAEv2 was Safe for Use 

on the Firing Range and Battle 

The military expected that the CAEv2 would protect soldiers’ hearing from weapons fire. 

The 2006 Medical Procurement Item Description (MPID) includes as a “salient characteristic” that 

the “[e]ar plugs shall be designed to provide protection from the impulse noises created by military 

firearms.” (3M_MDL000000055). In certifying the product conformed to the MPID, 3M 

represented to the government that the plug was safe for use on the range. (3M_MDL000000057). 

In addition, the CAEv2 was marketed and sold to the military as well as consumers as safe for use 

on both indoor and outdoor shooting ranges. (3M_MDL000010065 (“[CAEv2] is ideal for outdoor 

shooting” and “[f]or hundreds or thousands of rounds fired at indoor reverberant ranges it will 

provide good protection”); 3M_MDL000163130 (“range, hunting, military”); 

3M_MDL000619485 (“The ARC and Combat Arms Earplug . . . could both be used on a gun 

range.”); 3M_MDL000716271 (“the ultimate shooter’s earplug” that is “ideal for an outdoor 

range”); 3M_MDL000716271 (advertising that yellow end “limit[s] harmful noise from gunfire –

ideal for an outdoor range”)) Indeed, one commercial variant was even called the “Indoor/Outdoor 

Range” plug. (3M_MDL000425526; Murphy 01/29/20 Depo at 98:6–99:13) 

Disturbingly, 3M’s internal documents and deposition testimony reveal that 3M’s scientists 

knew that, in fact, the CAEv2 did not protect users on the range. (3M_MDL000005528; 

3M_MDL000010140 (“[T]he CAE is not the optimal choice for a gun range, and . . . is probably 

inadequate for indoor gun ranges.”); Madison 12/10/19 Depo at 219:19–221:20; Murphy 01/29/20 

Depo at 341:5–348:11)

I reviewed multiple marketing and promotional pieces for the CAEv2. One 2005 brochure 

(“sell sheet”) directed to the military states that the yellow end “provide[s] instant protection from 

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high-level noises like weapons fire and explosions. It’s that easy. It’s that quick.” 

(3M_MDL000005685; 3M_MDL000286137) Another brochure circa 2007 promises “High 

Impulse Noise Blocked Instantly” and touts the experience of “a soldier in Iraq” that the “Combat 

Arms earplugs work great in this environment.” (3M_MDL000002065–3M_MDL000002066) 

Other marketing pieces also promised protection against weapons noise and stated: “When needed, 

the plug’s filter reacts to afford instant protection from impact noises such as weapons fire or 

improvised explosive devices. Combat Arms earplugs provide protection from blasts that can 

critically damage hearing.” (3M_MDL000193307 (“Noise-Activated Attenuation for Instant 

Protection Against Weapon Noise”); 3M_MDL000570625 (“sell sheet” stating “Insert YELLOW 

plugs for weapons fire”); 3M_MDL000716271 (advertising that yellow end “limit[s] harmful 

noise from gunfire – ideal for an outdoor range”))

This is consistent with the testimony of 3M officials about the company’s 

misrepresentations to consumers and the military, whether in advertisements or during base visits. 

(McNamara 03/11/20 Depo at 292:13–293:17) One employee went so far as to call it “marketing 

hype” when 3M claimed the CAEv2 was “ideal for an outdoor range” and “the ultimate shooter’s 

earplug.” (Murphy 01/29/20 Depo at 331:21–333:15) Another employee testified that he 

personally “never went to the range . . . with a Combat Arms,” opting for an electronic headset 

instead. (Gavin 01/29/20 Depo at 151:2–5)

3M’s Internal documents reveal that top marketing managers and scientists inside 3M were 

convinced that the open mode of the CAE plugs was not safe and effective on gun ranges. Jason 

Jones, a Marketing Manager at 3M, was asked how much protection a later version of the CAEv2 

using the same filter and technology would provide against impulse noise in response to a question 

by a customer; he replied, “If you are at the range shooting and the guns are going off a lot (every 

30 seconds, etc.), the open position of the combat arms plug is NOT going to provide protection. 

Your ear cannot take a 110 db blast every 30 seconds.” (3M_MDL000008474–

3M_MDL000008476; Jones 6/19/20 Depo at 251:7-20). Elliott Berger then responded and said: 

“At indoor ranges with many weapons firing more protection than can be provided by the CAE is 

required. We have no experimental data one way or the other on this issue.” 

(3M_MDL000008473–3M_MDL000008474). Berger responded, “I also agree that the CAE is not 

the optimal choice for a gun range, and as I said in my original comments is probably inadequate 

for indoor gun ranges.” (3M_MDL000008470) Ted Madison added, “I’m not sure CAEs make 

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sense in this application.... [F]or qualifying on a shooting range where the user is likely to have 

exposure to a large number of shots fired, I would recommend a level-dependent ‘tactical’ 

electronic headset. If the number of shots being fired is very high, I would recommend a tactical 

headset worn together with foam earplugs.” (3M_MDL000008471)

Ultimately, the 3M decided it needed to make a change to the labels for the Combat Arms 

plugs to add an “impulse noise warning.” (3M_MDL000587314) Unfortunately, the label change 

did not actually occur until some two years later in 2016—after the CAEv2 and other versions of 

the Combat Arms plugs had already been worn on ranges by hundreds of thousands of troops and 

after the CAEv2 had been discontinued. (3M_MDL000587314; Madison 12/10/19 Depo at 

266:16–267:4) Madison testified that a soldier’s complaint gave rise to action within the company 

to add an “impulse noise warning” to the label. (Madison 12/10/19 Depo at 246:7–267:4) He 

drafted the following text to be added to the label: 

When worn according to the User Instructions, these hearing protectors help reduce 

exposure to both continuous noises, such as industrial noises and noises from 

vehicles and aircraft, as well as very loud impulse noises, such as gunfire. It is 

difficult to predict the required and/or actual hearing protection obtained during 

exposure to impulse noises. For gunfire, the weapon type, number of rounds fired, 

proper selection, fit and use of hearing protection, proper care of hearing protection, 

and other variables will impact performance. If your hearing seems dulled or you 

hear a ringing or buzzing after any noise exposure (including gunfire), or for any 

other reason you suspect a hearing problem, your hearing may be at risk.

(3M_MDL000587314) Fallon reviewed Madison’s suggested warning and agreed with the 

addition. (3M_MDL000280956) This was similar to the language in the 2014 letter from Fallon to 

the military, though there is no evidence the label was ever changed in the interim. 

(3M_MDL000082841) Madison testified that he does not know if the language he suggested ever 

made it into the labels for later versions of the Combat Arms plugs, but he agrees that it never 

made it into the CAEv2 label. (Fallon 09/03/20 Depo at 352:23–353:20; Fallon 09/04/20 Depo at 

496:22–497:3; Madison 12/10/19 Depo at 266:16–267:4) 

I was unable to locate language in any label for any version of the CAEv2 that 

recommended or advised against using the open end of the Combat Arms earplugs on the range or 

in battle. And, deposition testimony supports the opposite—that the military and consumers never 

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knew. (Babeu 03/10/20 Depo at 173:11–176:6, 391:15–18; Madison 12/10/19 Depo at 223:6–12; 

McNamara 03/11/20 Depo at 301:1–7, 303:1–305:21; Merkley 02/26/20 Depo at 426:6–11; 

Murphy 01/29/20 Depo at 98:6–99:13, 349:19–352:11)

The fact that the non-linear end of the plug could allow for communication and detection 

of combat sounds, but also protect from impulse noises from weapons, was obviously very 

important to the military in deciding to provide the CAEv2 as hearing protection for the troops. 

(3M_MDL000000055) And the military relied on 3M’s representations and certification regarding 

whether the plugs were safe and effective for hearing protection for soldiers who would obviously 

be exposed to frequent gunshot noise. (3M_MDL000000057; CID File0224; McNamara 02/26/20 

Depo at 311:3–312:14) 3M, therefore, should have informed the military that the open end was 

not safe for use on ranges or in gun battles. (McNamara 03/11/20 Depo at 293:23–294:15; Merkley 

02/26/20 Depo at 424:9–425:16, 426:6–14; Murphy 1/29/20 Depo at 354:2-12). Based on the 

record and evidence, if 3M had done so, it would have impacted the military’s decision about 

whether or not to provide the CAEv2 to the troops. (Babeu 03/10/20 Depo at 176:3–6; CID 

File0036; CID File0038; CID File0214; CID File0222; CID File0239; CID File0243)

O. The Department Of Justice Investigated 3M For Making False Claims To The U.S. 

Government And Found That The Military Did Not Know About The CAEv2’s 

Testing Defects 

In 2016 and 2017, the United States Department of Justice investigated 3M for False 

Claims Act violations. (CID File0001–CID File0004) The investigation was prompted by a qui 

tam complaint brought by a whistleblower, 3M’s competitor Moldex-Metric. (CID File0001) The 

allegations were essentially that 3M violated ANSI testing requirements when testing the CAEv2 

and that 3M knew the CAEv2 did not meet the military’s requirements and therefore defrauded 

the government by selling the plugs to the military. (CID File0001–CID File0002; Complaint in 

United States ex rel. Moldex-Metric, Inc. v. 3M Co., 3:16-1533 (May 12, 2016)) The complaint 

specifically alleged that 3M manipulated testing in order to get a higher NRR for the plugs, but 

did not instruct the military how to use the product in order to get the advertised protection. 

(Complaint in United States ex rel. Moldex-Metric, Inc. v. 3M Co., 3:16-1533 (May 12, 2016), at 

8–14) The complaint also alleged that the testing done on the CAEv2 violated ANSI standards that 

apply to REAT testing. (Complaint in United States ex rel. Moldex-Metric, Inc. v. 3M Co., 3:16-

1533 (May 12, 2016) at 7, 9, 11, 13) 

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The report of the investigation by the U.S. Army Criminal Investigation Command (CID 

Report) summarizes interviews with approximately 15 witnesses. (CID File0002–CID File0004) 

All government witnesses testified they did not know about the manipulation of the plugs during 

the testing or that the hearing protection was not as claimed. (CID File0240) Essentially all 

witnesses testified that if they had known, it would have been very important in the military’s 

decision about whether to use the plugs and how to advise and instruct soldiers. (CID File0038; 

CID File0040; CID File0214; CID File0225; CID File0236–CID File0237; CID File0239) Some 

witnesses testified the military would not have purchased the CAEv2 had it known the testing of 

the was not as claimed. (CID File0214; CID File0222) 

Consider the testimony of Chuck Jokel, an employee of the Army Hearing Program at 

Aberdeen Proving Ground, and LTC Marty Robinette, the Chief of the Army Hearing Program. 

(CID File0234) They were shown the Flange Report and the differences in the NRRs based on 

folding back the flanges on the CAEv2 versus not doing so. (CID File0236) They both agreed 3M 

needed “to be on the level with the US Government” so the military “can take appropriate 

remediation steps for the service members, including advising soldiers on the proper way to fit the 

earplugs.” Jokel and Robinette agreed that 3M “should have leveled with them about the data so 

that they could inform the wearer of any issues, so they could have made informed decisions.” 

(CID File0237)

They also noted that the testing showed that the flanges should “always be pulled back,” 

and that 3M “should have informed the military of this problem, so that the military could [have] 

advised the soldiers of the slippage problem.” (CID File0237) Finally, they testified that had the 

US Government known of the slippage issue, they would have insisted on instructions saying the 

“flanges must always be folded back” - adding that there “was no practical way that soldiers could 

determine the size of their ear canals.” 

Commander Joel Bealer, the Deputy Director of Safety and Occupational Health, was also 

interviewed. (CID File0238) Commander Bealer addressed the testing of the CAEv2 by the Air 

Force. He testified that the Air Force Laboratory did not test for imperceptible slippage, but he 

noted that had they known about the issues with the plugs, they would have changed the way the 

testing was handled. (Id.) He ultimately testified that “3M owed it to the military to tell them of 

any potential problems.” (CID File0239) 

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The interview of Brian Hobbs, an Audiologist in the Navy and Marine Corps Public Health 

Center, was also informative. Hobbs was involved with the Air Force testing of the CAEv2. (CID 

File0240) He confirmed that the testing did not look at the “efficacy” of the plugs. He stated that 

he was not made aware of any problems with the plugs and, thus, would not have told anyone to 

fold the flanges back for testing. (CID File0240) He would not have been comfortable instructing 

subjects that way because he would not have known what the outcome would have been for folded 

back flanges versus unfolded; when he was told that there was instruction to fold the flanges back 

for a large ear canal, “he questioned the definition of a large ear canal.” (CID File0240) He agreed 

with others that 3M should have told the US Government about the “slippage issues” and reiterated 

that the US Government would not have found out about that issue during its testing. (CID 

File0241) 

The CID Report ultimately concludes that had the US Government known about 3M’s 

initial test results showing that the CAEv2 was too short for proper insertion and did not perform 

well in certain individuals, the Government may not have purchased the plugs. (CID File0002) 

According to the Report, 3M entered into a settlement agreement with the US Department of 

Justice on July 23, 2018 and agreed to pay $9,100,000. (CID File0002)

P. 3M Finally Discontinued the CAEv2 After the Flange Report was Discovered 

3M never revealed the Flange Report or its findings to the military or anyone else during 

the entire 15 years that the CAEv2 was on the market. (Dkt. 1280 at 15) Fortunately for soldiers 

and consumers, however, the Flange Report was eventually discovered in litigation 3M was 

involved in with Moldex. Specifically, 3M employee Jeffrey Hamer was confronted with the 

Flange Report at his deposition. (Hamer 10/07/15 Depo at 149:18–157:8) Hamer confirmed that 

he knew nothing about the report or its findings. The very next day, 3M demanded in internal 

emails that all sales of the CAEv2 be discontinued. (3M_MDL000332111)

Brian Myers sent an internal email on October 8, 2015, instructing that the CAEv2 was 

“immediately” discontinued. (3M_MDL000332111) Internal emails from later that month 

admitted that the CAEv2 could not be distributed “with the current NRR on the package,” so “sadly 

it won’t be a phase out but an abrupt stop.” (3M_MDL000332061–63; Myers 12/12/19 Depo at 

352:16–353:16) He instructed 3M employees to “dispose of” remaining inventory and “cancel” 

pending orders. (3M_MDL000332061–3M_MDL000332070) At his deposition, Myers testified:

Q: And your instruction back to Luis [at 3M’s manufacturing plant] was what?

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A: My e-mail said: “Please dispose of them.”

Q: Okay. And you understood that to mean destroy them, right? 

A: To get rid of them, yes.

. . .

Q: And disposing of them, that would mean make sure they don’t get used, right? 

A: That was my intention.

Q: You didn’t want them to be used in your plant, right? 

A: No.

(Myers 12/12/19 Depo at 360:16–361:12)

Even though 3M told its own employees to “immediately” stop selling the CAEv2 and to 

dispose of them so they could no longer be used, 3M never told the military to stop using the plugs 

and dispose of their inventory. (Madison 12/10/19 Depo at 305:8–307:20) All 3M did was publish 

a “product notification” in November 2015 stating that “3M has made the decision to discontinue” 

the CAEv2 “effective immediately.” (3M_MDL000013574–3M_MDL000013577; 

3M_MDL000549104) In fact, Myers was asked about this and testified as follows:

Q: When did you tell the military, sir, that Hey, you shouldn’t use these anymore, 

the NRR of 22 can’t be used with this product? When did you tell them that?

. . . 

A: Again, I don’t know that there was any announcement or communication on 

that.

. . . 

Q: When did you tell the people about the problems with these or that the NRR of 

22 should not be assumed for the product? . . . 

A: Again, I don’t recall any – any announcement.

(Myers 12/12/19 Depo at 362:25–363:21)

Q: Okay. And so at what point in time, sir, in 2015 or 2016 or 2017 or 2018 or 2019 

did the company communicate to the millions of people or hundreds of

thousands of people in possession of these [earplugs] that you shouldn’t use this 

with an expectation that it’s going to provide you with an NRR of 22?

. . . 

A: I don’t know that we did. 

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(Myers 12/12/19 Depo at 366:10–19)

In July of 2018, following the Department of Justice investigation and findings, the military 

took steps to “verify . . . that any 3M Dual-Ended Combat Arms Earplugs [were] not being used 

for hearing protection purposes” because “these earplugs were found to be defective” and 

“inventory may remain.” (CTRL_3M_Touhy00002040) According to the Chief of Occupational 

Health Operations at the Office of the Surgeon General, the CAEv2 was “found to be defective 

and did not protect the wearer to the advertised level of protection,” and “there is a risk of hearing 

loss should individuals continue to use these earplugs.” (CTRL_3M_Touhy00002253–55)

XVI. OPINIONS

The CAEv2 was a novel hearing protector when 3M designed and developed it in the late 

1990s. I am not aware of a dual ended earplug before the CAEv2 or that there has been one since. 

3M, nevertheless, promoted and then sold the CAEv2 to the military without first testing it to see 

if it actually worked. When the CAEv2 was finally tested, its “problems” as Berger described it, 

were revealed but never fixed. 

Given the many problems with the CAEv2 and 3M’s failures to remedy those problems, as 

discussed above and below, it is my opinion to a reasonable degree of medical and scientific 

certainty that the CAEv2 is unreasonably dangerous due to 3M’s failure to properly design and 

test the product, properly evaluate and act after uncovering problems with fit and seal and 

performance of the CAEv2, and properly warn and inform the military and consumers about the 

CAEv2’s risks. For all of these reasons, it is my opinion that the CAEv2 did not perform as would 

have been expected by a reasonable user of the earplug and the risks outweigh the benefits. 

It is also my opinion that the CAEv2’s design defects and 3M’s negligence, 

misrepresentations, and failure to warn of the CAEv2’s inadequate hearing protection, caused or 

was a substantial factor in causing NIHL and tinnitus suffered by Service Members and consumers. 

It is well known that continuous noise exposure of 85dB or more, and impulse noise exposure of

140 dB or more can cause damage to the ear that may result in hearing loss. When the CAEv2 was 

worn as intended and promoted by 3M, in the sound environments where service members needed 

protection, the CAEv2 did not protect users as required and represented. Because the CAEv2 failed 

to protect users when alternative, available plugs would have, the CAEv2 must be considered when 

performing a differential etiology of user’s NIHL and tinnitus. 

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A. The CAEv2 is Unreasonably Dangerous and Can Cause NIHL and Tinnitus

1. The CAEv2 Has Design Defects That Make It Difficult to Properly Fit and It 

Imperceptibly Loosens Even If Proper Fit Is Achieved

As stated above, HPDs will not protect users if they do not fit. 3M’s own internal 

documents and marketing materials recognize as much. (3M MDL000416820 at slide 12; 

3M_MDL000409110) Indeed, the inventor of the CAEv2 and 3M’s own employee concedes “the 

degree of noise reduction depends on the quality of the fit.” (Berger, E.H., Custom Hearing

Protection: Have it Your Way ...Maybe, Industrial Hygiene News, May/June 2011) If an HPD 

does not fit well, it will not seal to the ear and thus not protect the user. (P490 (Earlog 5) (“For 

maximum protection the device must make a virtual airtight seal with the canal or the side of the

head. Inserts must accurately fit the contours of the ear canal.”)

The Flange Report documents multiple design defects that prevented the CAEv2 from 

adequately fitting users, which made it difficult, if not impossible, for the CAEv2 to maintain the 

air-tight seal necessary to protect service members and consumers. (3M_MDL000728811–

3M_MDL000728816) The Flange Report expressly states the CAEv2 is “too short for proper 

insertion,” which made it difficult for the experimenter to insert the plug deeply into some subjects’ 

ear canals, “especially those subjects with medium and larger canals.” (3M_MDL000728812) In 

addition, the CAEv2 does not fit in the “geometry” of some ear canals. Finally, even if the CAEv2 

is properly inserted, “the basal edge of the third flange” of the outward facing plug can “press[] 

against the subject’s ear canal,” folding up, and then return to its original shape once the inward 

pressure on the plug is released, causing the plug to loosen “imperceptibly” to the user. 

(3M_MDL000728812) These design flaws—documented by Berger and Kieper (3M’s expert 

fitter) when identified by Kieper when the CAEv2 was first tested—demonstrate the CAEv2 is 

difficult to fit and/or maintain a proper seal. It is therefore defectively designed and unreasonably

dangerous. 

The foregoing fit problems are especially concerning when recognizing that an earplug is 

tested in a laboratory but will be worn in the real world. First, Kieper was an expert fitter and not 

even he could properly fit the CAEv2 or ensure that the plug maintained a proper seal in many test 

subjects. (Kieper 12/19/19 Depo at 92:15–93:14 (Kieper has conducted over 2200 full tests)) 

Kieper’s performance reviews identify “his skills in fitting subjects” as “undoubtedly, in large part, 

responsible for the high NRRs [3M] continue[s] to achieve on many of [its] earplugs.” 

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(3M_MDL000259134) in a controlled test setting. Based on my education, training, and 

experience and the published literature, it is more likely than not that any user will not be able to 

consistently replicate the fit and seal achieved by an expert fitter such as Kieper in a controlled test 

setting. If an expert experimenter cannot obtain proper fit in a laboratory, neither an ordinary 

consumer nor a servicemember on the range or on the battlefield stands a chance of consistently 

obtaining proper fit and seal when inserting the plug, or maintaining proper fit and seal due to the 

CAEv2 propensity for “imperceptible loosening.” It is well established that hearing protection 

measured in a laboratory is greater than real-world protection. (Berger, The Naked Truth About 

NRRs, Earlog 20, 2000) Therefore, the fit problems observed by Berger and Kieper in the 

laboratory should have been a red flag that the CAEv2 was defective and would ultimately not 

protect consumers and military users. 

Second, it is important to note that although Kieper did notice that the CAEv2 was difficult 

to fit in people, he used his decades of experience to achieve what he thought was a “best fit” (a 

seal) before he started the tests. It was Kieper’s job for all REAT testing to provide an expert fit 

and satisfy himself that the plugs were perfectly inserted before conducting any testing. (Kieper 

12/19/19 Depo at 439:17–440:8) Kieper testified that for Test 213015 he “believe[s] that the fit 

obtained on each subject, each fit was the best that could be gotten at that time.” (Kieper 12/20/19 

Depo at 911:24–912:9) But Kieper did more than just assume that he was able to achieve a “best 

fit” with each subject, he visually inspected the fit, played a fitting noise, and then confirmed with 

the test subject to ensure that he had achieved a “best fit” and good seal each time he ran a test. 

(Kieper 12/19/19 Depo at 105:18–106:9, 207:25–208:4) But, even after fitting the plug to his 

satisfaction, the plugs failed to attenuate as expected. This is important evidence that supports the 

danger of these plugs because if the expert fitter cannot get a good fit even after professional 

insertion, and inspection, soldiers and civilian users certainly will not be able to do so consistently 

either. 

Third, even if proper fit and seal could be obtained in the real world, the CAEv2 loosens 

“imperceptibly.” Experts in NIHL and hearing protection know that preformed earplugs can loosen 

over time and may occasionally need to be reseated. Users must therefore rely on their “feel” of 

fit and “sense” of hearing to perceive such loosening. But Kieper observed that users do not 

perceive when the CAEv2 loosens. (3M_MDL000728812) This was so even though subjects sat 

perfectly still and were not allowed to move their heads during testing. This is partially because 

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the opposing flanges apply slight pressure against the ear that affects the seal without alerting 

either a user or an experimenter, even upon visual inspection and the playing of a fitting noise. 

This risk of a hearing protective device loosening as a result of being put under pressure by coming 

into contact with a user’s ear was known to3M. (3M_MDL000846273 (“EPA Regulatory Analysis 

Supporting the Noise Labeling Requirements for Hearing Protectors, August 1979”)) But with the 

CAEv2, this risk is accentuated when wearing the yellow end because there is no vacuum effect 

and users were told to expect noises to sound louder (3M_MDL000716855; FALLON00318) 

Brian Myers of 3M specifically found the CAEv2’s open end lacks the distinctive “plugged up” 

feeling typically associated with earplugs, so users might not “feel like they are working.” 

(3M_MDL000398074) Thus, a consumer or service member might believe the CAEv2 is properly 

fit but in fact receive little to no protection from hazardous noise at the gun range or in battle. The 

fact that these plugs “imperceptibly loosen,” makes the risks associated with using them even 

greater than an ordinary plug that a user knows will not stay seated in the ear, because with the 

CAEv2, this design defect is latent or hidden. And this is definitely not something that an ordinary 

consumer would expect from its earplug.

An earplug that is difficult to consistently fit and seal is unreasonably dangerous, because 

when used as intended it will not provide the protection necessary to prevent NIHL or tinnitus. An 

earplug that is not just difficult to insert, but too short for proper insertion and incompatible with 

common ear geometries is unreasonably dangerous because it will not provide the necessary 

protection to prevent damage when used in a high noise environment. In my opinion and based 

on my experience, a personal protective device that loosens without notice and/or in a manner that 

is difficult to discern is also unreasonably dangerous, especially when used in an environment with 

substantial hazardous noise, like a military environment. 

Given the defects identified when 3M first tested the product and for the additional reasons 

set forth throughout this report, it is my opinion to a reasonable degree of medical and scientific 

certainty that the CAEv2 was unreasonably dangerous and was capable of causing or contributing 

to cause NIHL and tinnitus in service members and consumers who were exposed to hazardous 

noise when wearing the plug. Additionally, for these reasons, the CAEv2 failed to perform as 

safely as a reasonable consumer would expect when using it as intended or in a reasonably 

foreseeable manner. 

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2. Internal 3M Data Demonstrates that the CAEv2 was Defective and 

Unreasonably Dangerous

Data from Tests 213015 and 213016 also show the CAEv2 was defectively designed and 

unreasonably dangerous. In fact, Berger admitted at his deposition that “[w]hen we looked at the 

data, they were more variable than we had ever observed for a solid plug that requires a good 

acoustical seal in the ear.” (Berger 10/8/2015 Depo at 106:9–14) Data from the open end (Test 

213016) also indicate Kieper had serious difficulty getting the CAEv2 to fit and seal in the 

subjects’ ears. Individual data from these tests reveal the design defect that makes it difficult for 

CAEv2 users to obtain an adequate fit and seal, existed for both ends of the device. (30(b)(6) 

11/13/19 Depo at 290:9–22) 

I have reviewed the data from Tests 213015 and 213016 and also reviewed the analysis of 

the data of Dr. John Franks, a psychoacoustics expert with over 35 years of experience performing 

and evaluating REAT testing. I agree with Berger that the data from these tests are extremely 

variable. In fact, the majority of the ten subjects who participated in these tests, had variability in 

their results indicative of the inability to get a good fit and seal with the plug. 

As stated in Dr. Franks report, there are huge variations in attenuation levels for several 

subjects in Tests 213015 and 213016. (Rule 26 Expert Report of John R. Franks, Ph.D., para 132-

135, 138-150) One subject identified as TRS, had results revealing that when testing the CAEv2’s 

closed end at 500 Hz, his attenuation was -4 dB in trial one, 25 dB in trial two, and 24 dB in trial 

three. His levels at 1000 Hz were likewise asymmetric: 0 dB in trial one, 26 dB in trial two, and 

22 dB in trial three. (3M_MDL000019514; (Rule 26 Expert Report of John R. Franks, Ph.D., para 

133) These significant variations in attenuation levels show TRS could not obtain adequate fit in 

trial one of the REAT testing on the closed end. Similar examples exist for the open end of the 

plug. GWG’s results show she did not obtain adequate fit in trials two or three. 

(3M_MDL000019339; (Rule 26 Expert Report of John R. Franks, Ph.D., paras 138-141) In trial 

two, she had -1dB at 250 Hz, -2 dB at 50 Hz, and -1 Db at 1000 Hz, which all indicate 

amplification, not attenuation. (3M_MDL000019339) GWG’s attenuation levels in trial one, 

however, were 3 dB at 250 Hz, 8 dB at 500 Hz, and 18 dB at 1000 Hz - which is 19 dB lower than 

in trial one. (3M_MDL000019339; Rule 26 Expert Report of John R. Franks, Ph.D., ¶¶ 138-141) 

Variance between trials one and three were similarly large. Such variations indicate that GWG did 

not have an adequate fit during the second and third trials on the open end. (3M_MDL000019339; 

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Rule 26 Expert Report of John R. Franks, Ph.D., para 141) These are just a few examples that 

show the CAEv2 was very difficult to fit and to maintain a seal. In fact, Dr. Franks’s analysis of 

the data shows that six out of the ten subjects in Tests 213015 and 213016 (GWG, TLS, TRS, and 

RTM in open end test and BAK, TRS, and JMW in the closed end test) had inadequate fit of the 

CAEv2 during at least one trial. (3M_MDL000019514;3M_MDL000019339; Rule 26 Expert 

Report of John R. Franks, Ph.D., ¶ 154) 

The data reflects and Dr. Franks also pointed out that the subjects who were not able to be 

fit properly in one or more of their trials, had small, medium, and extra-large ear canals. This 

finding from the individual data seems to suggest that the design defects leading to difficulty with 

fitting and maintaining a good seal apply to all ear canal sizes.(Rule 26 Expert Report of John R. 

Franks, Ph.D., para 135)

Kieper’s testimony supports Franks’s analysis. According to Kieper, GWG had “big” 

variances in attenuation levels at 1000, 2000, and 3150 Hz. (Kieper 10/9/2015 Depo at 107:3–

108:21) Kieper also conceded that it was “apparent” GWG had a worse fit with the open end of 

the plug in his second trial compared to his first trial. (Kieper 10/9/2015 Depo at 109:20–110:7) 

Finally, Kieper testified that TRS was likely not fit as well with the earplug in the second trial as 

he was in the first trial. (Kieper 10/9/2015 Depo at 110:22–111:20) 

The significant variability in these data is additional evidence that the CAEv2 is defective 

because it is too difficult to properly fit and/or to maintain a seal in ear canals of all sizes. These 

results are particularly concerning because users in the real world will generally not fit the CAEv2 

as well as an expert fitter in a laboratory setting. It is therefore my opinion to a reasonable degree 

of medical and scientific certainty that the data from Tests 213015 and 213016 provide additional 

support that the CAEv2 was unreasonably dangerous as designed and capable of causing or 

contributing to can cause NIHL and/or tinnitus in service members and consumers who used either 

end of the CAEv2 when exposed to hazardous noise. Additionally, for these reasons, the CAEv2 

failed to perform as safely as a reasonable consumer would expect when using it as intended or in 

a reasonably foreseeable manner. 

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3. 3M’s Subsequent Testing of the CAEv2 Continued to show the Defects with 

the Plugs

As discussed previously above, in addition to Tests 213015 and 213016, 3M conducted 

additional testing that reinforced the defective design of the CAEv2. Most notably, in June 2006, 

3M completed Test 213030—a REAT test of the CAEv2’s closed end conducted according to the 

ANSI S12.6-1997 Method B standard. (3M_MDL000313220) That test generated an extremely 

low NRR of 4.4, and that test was the only “real world” test 3M performed. (3M_MDL000313220; 

Kieper 12/20/19 Depo at 571:22–572:7)

Method B is a type of REAT test that provides for a “subject-fit method” and “was 

developed to approximate the real-world attenuation achieved in actual hearing conservation 

programs.” (ANSI S12.6-1997 Section 0.5) ANSI recognizes that “human factors considerations 

must be included in the laboratory model if valid field estimates are to be obtained.” Method B 

thus calculates an NRR based on the attenuation a test subject achieves when fitting their hearing 

protector according to the manufacturer’s written instructions and without any assistance from the 

experimenter. (ANSI S12.6-1997 at Section 9)

Test 213030 reinforces the concerns revealed in the initial testing and the Flange Report. 

First, a 4.4 NRR shows the CAEv2 provides almost no protection when users fit the plug 

themselves according to the provided instructions. I agree with LTC Merkley that an NRR of 4.4 

would be concerning given noise exposure in the military. (Merkley 2/26/20 Depo at 411:8–17) 

As Elliott Berger testified, this result indicates that even in a lab setting, for some users, the CAEv2 

is not providing much protection at all. (Berger 12/11/19 Depo at 641:16–642:25) According to 

3M, even an 11 NRR is “quite low.” (3M_MDL000019514) Further, the data shows that seven of 

the test subjects had extremely variable attenuation demonstrating poor fit and seal in both trials 

and several others had a poor fit in one trial. (3M_MDL000313220) 

This subject-specific data is further confirmation of the inability to properly fit and seal the 

CAEv2 as a result of the design defects- only this study also confirms just how bad the protection 

is in more of a real-world fitting. The Flange Report mentioned that “it was difficult for the 

experimenter to insert the plug deeply into some subjects’ ear canals, especially those subjects 

with medium and larger earanals.” (3M_MDL000019514) For Test 213030, 3M tested 20 subjects, 

none of which had ear canal sizes that were larger than a medium. (3M_MDL000019514) Even

so, subjects like DJS and LLE reported almost no attenuation at all, suggesting they could not 

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achieve a proper seal. Others like JJS and KAC reported wide variations in attenuation between 

trials. These results reinforce prior findings that tests of the CAEv2 reported “individual results 

[that] were quite variable.” (3M_MDL000019514)

These troubling results should have immediately been disclosed to the military, as the 

results showed that even in a laboratory, users were not able to adequately fit the plug using 

standard fitting instructions (i.e., without the opposing flanges rolled back upon insertion). 

3M’s additional “experimenter fit” studies on both ends of the CAEv2 were limited, yet 

they also confirmed that the CAEv2 provided variable and inconsistent attenuation results and, 

further, that the protection of the closed end was far less than the 22 NRR advertised on the label. 

The data from the REAT testing supports that the CAEv2 was defectively designed and 

unreasonably dangerous for its intended uses and, further, that it could cause NIHL and/or tinnitus 

in users exposed to hazardous noises. 

4. A Comparison of Test 213014 and Test 213015 Supports that the Design of the 

CAEv2 is Defective

I have reviewed data from the CAEv2’s Test 213014 and Test 213015 as well as Dr. 

Franks’ analysis of that test data. A comparison of the data from these two studies is telling with 

respect to whether or not the CAEv2 is defective when compared to other similar products. 

Test 213014 was a July of 1999 REAT test pursuant to ANSI S3.19-1974 performed on 

3M’s single sided linear earplug called the UltraFit Plus (just six months before the original REAT 

tests on the CAEv2). The UltraFit Plus earplug tip (the insertion end of the plug) is virtually 

identical to the tips used on the open and the closed end of the CAEv2. The only difference between

the UltraFit Plus and the CAEv2 is that the stem connecting the ends of the CAEv2 is a wider, 

more rigid tube, whereas the UltraFit Plus stem is thinner and more flexible. A comparison and 

analysis of the REAT test data from these two studies is revealing because these two plugs use the 

same insertion tips, yet the results as far as the levels of attenuation are very different. 

Five of the test subjects 3M used in Test 213014 (UltraFit Plus) were also used in Test 

213015, the test on the closed end of the CAEv2 - the one that was abandoned by 3M after 8 

subjects were tested because the NRR was so low. (3M _MDL000534450) When Dr. Franks 

looked at the five subjects who were tested using both products, four of the subjects (KJC, GWG, 

BAK, JMW) received much less attenuation when tested wearing the CAEv2 without the flanges 

rolled back. Although imperceptible loosening cannot be ruled out, this data suggests that the 

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stiffer stem used in the CAEv2 is another design feature that made fitting and sealing the CAEv2 

difficult. (30(b)(6) 09/25/20 Depo at 194:15–196:3; 197:21–198:7;189:16–23; 201:21–202:1) 

The Flange Report addressed the difficulty of inserting the plug and found that the

geometry of some ears prevented the deep insertion needed to fit the plug. From a medical and 

scientific standpoint, it makes sense that a more rigid and stiff plug would be more difficult to 

conform to ear canals than a more flexible stem. This supports my opinion that the large, rigid 

stem in the CAEv2 contributes to the inability to consistently fit and maintain a seal with this plug. 

3M knows that larger inflexible stems can cause fitting problems. As stated previously, 

Armand Dancer, a scientist at ISL and someone who 3M consulted with on the design of the 

CAEv2, specifically told 3M in 1997 that an adapter stem that is too large - greater than 4.2 mm 

in diameter- would cause fitting problems and be unsuitable for most ears. (3M_MDL000013024) 

Although Dancer warned 3M about the stem issue, 3M ultimately ended up actually making the 

stem on the CAEv2 even larger. In 2015, Ted Madison, an audiologist at 3M opined that the 

CAEv2’s stem structure could cause the plug to “behave differently in the earcanal” leading to 

lower attenuation. (3M_MDL000008430) Berger, credited by some as the inventor of the CAEv2, 

admitted that the inflexible adapter stem posed a problem and required redesign:“the principal 

reason for discomfort is the plastic insert in the earplug stem,” and he recognized that “if the filter 

were smaller in diameter” then the “diameter of the plastic insert [could be] smaller as well.” 

(3M_MDL000192859)

It is my opinion based on the findings comparing Tests 213014 and 213015, as well as 

reviewing the information related to the size and stiffness of the CAEv2 in comparison to the stem 

of other better performing products, that the CAEv2’s wide, stiff stem makes it difficult for the 

CAEv2 to properly fit earcanals and is design defect among others that makes the CAEv2 

unreasonably dangerous. 

5. Statistical Analysis of 3M’s Testing Supports That the Design Of The CAEv2 

Was Defective

I have also reviewed the analysis conducted by Dr. David Madigan. This analysis examined 

the NRRs, subject-level NRRs, and variability in the attenuation determined in the labeling tests 

conducted by 3M of the CAEv2 (opposing flanges unfolded versus folded), subsequent versions 

of the Combat Arms, and several UltraFit earplugs.

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As Dr. Madigan’s analysis reflects, when compared to the REAT tests of the CAEv2’s 

closed end with the flanges folded and the tests of the CAEv3, the CAEv4, and the UltraFit, the 

REAT test of CAEv2’s closed end without folded flanges produced a lower NRR; individualNRRs that are statistically significantly lower; and within subject variability that are statistically 

significantly larger for all but one of the comparison products. In short, when the closed end of the 

CAEv2 was tested as it was worn, with the flanges unfolded, 3M’s own testing showed greater 

variability and lower attenuation than the other products intended for similar uses that 3M tested.

It is my opinion that the 213015 test should have been a major red-flag for 3M. The UltraFit 

was a triple-flange pre-formed earplug that 3M sold for nearly a decade before the CAEv2 was 

created. Both Richard Knauer, 3M’s Senior Technical Director for Passive Hearing Protection,

and Berger have testified that the military expected an NRR for the CAEv2’s green end to be in 

the same range as the NRR for the UltraFit. (Berger 12/10/19 Depo at 559:5–13; Knauer 12/17/19 

Depo at 117:10–17) But 3M’s labeling testing demonstrates that the CAEv2-when used without 

folding the flanges - provided less subject level NRR and greater within-subject variability than

the UltraFit. These results should have further demonstrated to 3M that the CAEv2 should not 

have been sold until the source of the problems had been identified and corrected.

B. The Risk of Danger From the Design Of The CAEv2 Outweighs the Benefits

Based on my education, training, experience, and my review of all the documents, data and 

depositions in this case, it is my opinion that the CAEv2 was unreasonably dangerous as described 

fully above, and that the risks associated with use of the CAEv2 outweigh any benefits received 

by users. 

The purported benefits included: (1) protection from continuous noise while using the 

green end; (2) situational awareness/hear-through on the yellow end while also providing 

protection from impulse noises; and (3) both functions in a single plug which might increase the 

likelihood of use. (3M_MDL000569956) Admittedly, situational awareness is important for 

dismounted soldiers and marines as well as consumers. But, a plug that inconsistently fits or seals, 

if at all, and is loose will not provide adequate protection from hazardous noise. Given the 

CAEv2’s design defects, this plug did not provide reliable situational awareness or protection, 

making the product useless. Its inconsistent fit and inability to achieve or maintain a seal meant 

that users who were exposed to dangerous sounds and were vulnerable to damage from impulse

noise from firearms and continuous hazardous noise when riding in vehicles or working near 

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generators, etc. In addition, the fact that the plug loosened imperceptibly, made the danger from 

the defect essentially unavoidable. 

Given these defects in the CAEv2, it was substantially likely that wearing them over the 

course of a military career would result in NIHL and/or tinnitus. Because there were other safer 

options for non-linear and linear hearing protection available, as discussed more fully below, it is 

my opinion that the risks of wearing the CAEv2 far outweighed any purported benefit users may 

have received. 

C. A Reasonable Manufacturer Of a Hearing Protective Device Would Have Tested 

The CAEv2 Before Selling It 

HPDs like the CAEv2 are safety devices. Therefore, it is very important for HPDs to be 

tested to make sure they work. As a hearing health professional and conservation practitioner in 

the military, and as an otologist in the civilian world, I have routinely recommended and advised 

soldiers and patients on hearing protection. I have to rely on manufacturers to adequately test the 

HPDs to make sure they are safe, and I have to rely on their reported product efficacy (e.g., NRR 

ratings), so that I can make well informed recommendations to the service members and patients 

that look to for guidance on how to protect their hearing. In addition, medical professionals, 

audiologists, military decision makers, occupational safety professionals, and leaders in noise 

industries rely on the label and the ratings provided by hearing protection device manufacturers in 

their decision making in selecting appropriate hearing protection for patients, users, military 

members, etc.

With respect to the CAEv2, though, 3M failed to test the CAEv2 before selling it to the 

military. It was not until four months after the first sale to the military that it “occurred to” 3M that 

it had not tested the CAEv2. Based on my experience in the military and in private practice, 3M’s 

failure to test and label the CAEv2 before selling it was a violation of the industry standards, to 

REAT test HPDs before selling them. Gary Warren, 3M’s President of Global Safety Products 

agrees: 

Q: And a safety device manufacturer should test its products to understand the risks 

before they actually sell it and make money, fair?

A: Yes.

Q: Because if you see a product without knowing what the risks are, then needless 

harm can happen in the end user, fair?

. . .

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A: Again, I would say that if we – if we sold a product without, you know, knowing 

how it performed, then, yes, absolutely.

Q: That would be wrong?

A: Yes.

(Warren 1/23/2020 Depo at 98:4–99:1) (3M_MDL000718635 (Berger stating “[o]ne other issue 

we need to be alert to that has bitten us in the past -- is selling products for which we do not have 

US REAT data.”)) Beyond 3M’s duty, its failure to test the CAEv2 before selling it violated EPA 

regulations. As stated previously, EPA regulations require HPD manufacturers to REAT test their 

products and label their products with an NRR. (40 C.F.R. §§ 211, et seq.) Testing is required 

before selling the product. (40 C.F.R. § 211.210-2) These regulations are clearly designed for 

safety and to protect users, and 3M ignored these regulations. 

Because the CAEv2’s dual-ended design was the first of its kind, it was especially 

important for 3M to test the plugs to make sure they would work. Had 3M done the required 

testing and learned of the CAEv2’s design defects before selling the plugs, 3M could have and 

should have redesigned the plugs or not sold them at all. By failing to do so, service members and 

consumers wore defective earplugs and suffered NIHL and tinnitus. 

It is also my professional opinion, based on my education, training, and experience, that if 

3M tested the CAEv2 earplug prior to distribution, achieved the variable and poor results that they 

subsequently did, and informed the military and/or consumers of the NRR achieved, then the 

military and the consumer would more likely than not have purchased or used the CAEv2 earplugs 

because it would not provide the hearing protection necessary to avoid hearing loss and tinnitus. 

D. A Reasonable Manufacturer Would Have Stopped Selling The CAEv2 After Its 

Testing Revealed The CAEv2’s Defects And Told The Military And Users About 

The Risks 

As discussed above, the CAEv2 was shown to be defectively designed when 3M conducted 

its first REAT testing of the product in January of 2000—after it had already been purchased by 

the military. The design defects that caused the CAEv2’s highly variable and low attenuation were 

memorialized in the Flange Report and can be seen upon examination of the subject-level data 

from Tests 213015 and 213016. 

In 2000, when 3M learned of the problems with the CAEv2, 3M had the duty to stop selling 

the plugs until it made sure that the plugs were safe. 3M’s Global Laboratory Director, Jeffrey 

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Hamer, agreed that it would have been wrong to sell the CAEv2 without solving the known issues 

with the plug: 

Q: You know that they were testing the plug and that because of its structure and 

design, in some cases the fit was being pulled out by the other end of the plug 

from the end being inserted; right?

A: In --In this design, yes.

Q: And don't you think that you should stop selling it until you figure out whether 

or not this is a problem?

A: I do not know that this Is the design that we have on the market.

Q: I'll rep- - - I'm unaware of any changes. I can tell you that much. Assuming there 

have -- don't you think in 2000 when 3M found this problem with this plug 

pulling out, they should have stopped and figured out what it was and stopped 

selling it until they solved it?

A: I don't know that they didn't.

Q: If they didn't, don't you think that would have been wrong?

A: If they did not, yes.

(Hamer 10/7/15 Depo at 175:9–176:7) But 3M never stopped selling the CAEv2 for 15 years, until 

the product was suddenly discontinued the day after 3M was confronted with the Flange Report 

was discovered in litigation. 3M, thus, breached its duty as an HPD manufacturer and needlessly 

subjected users to NIHL and tinnitus. 

3M should have halted sales in 2000 when it discovered the CAEv2’s defects, just like it 

did in 2015. This is especially true because the CAEv2 defects that were described and noted in 

the laboratory were problems with fit, seal and loosening, which the company knew or should have 

known would be even more of a problem in the real world. 3M also knew that a 10.8 NRR on the 

closed end of the plug would not provide adequate protection to the military or to civilians in a 

real world setting and that if the NRR was 10.8 in a lab, it would be much lower in a real-world 

environment. In fact, it was well known by 3M’s management running its laboratory (Berger) that 

pre-molded earplugs’ performance in the laboratory would be considerably worse in the real world. 

Two decades before the failed CAEv2 REAT test, Berger opined that laboratory tests, like 

a REAT test, “significantly overestimate the [real world] performance of HPDs, due to the 

unrealistic, optimized manner in which experimental subjects can wear these devices for short 

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duration tests.” (Berger, EARLOG5, 1980) In fact, as early as 1980, 3M recognized that laboratory 

testing related “poorly” to the real world. (The Performance of Hearing Protectors in Industrial 

Noise Environments by Elliott Berger in EARLOG4, 1980; Methods of Fit Testing Hearing 

Protectors, with Representative Field Test Data, Elliott H. Berger, Jeremie Voix, Lee D. Hager) 

Berger has more recently written that “although the database has grown substantially larger since 

appearance of the earliest studies and summary reports, the conclusions remain the same: realworld performance of HPDs, especially earplugs, demonstrates less attenuation and greater 

variability than currently standardized laboratory tests would predict.” (Scientific Basis of Noiseinduced Hearing Loss, Chapter 29, International Review of Field Studies of Hearing Protector 

Attenuation at p. 375 (Berger, Franks and Lindgren (1996)) Indeed, as discussed above, the results 

of the CAEv2’s Method B testing were much worse than the 10.8 NRR in the laboratory. 

Armed with this knowledge, a reasonable HPD manufacturer would have immediately 

conveyed the problems with the plugs to users upon discovering them. It would have been 

reasonable for 3M to have further investigated the problems with the plug or to have redesigned 

the plug at that point. But, it was not at all reasonable for the company to storm forward with sales. 

Instead of burying the January 2000 experimenter fit test that resulted in a rounded NRR of 11, 

retesting it with a post-manufacturing alteration, and reporting only the retest to the military, 3M 

should have immediately ceased sales of the product and recalled the product that had already been 

shipped. Doing so would have prevented countless men and women in the armed services and 

consumers from suffering NIHL and tinnitus. 

E. 3M Failed to Adequately Warn

The CAEv2 was required to be labeled according to EPA regulations. (40 C.F.R. §§ 

211.210-1(a), 211.10-2) Part B of the regulations applies specifically to HPDs and requires that 

earplugs like the CAEv2 are labeled with an accurate NRR and with “instructions as to the proper 

insertion or placement of the device.” HPD manufacturers should also warn users and 

intermediaries about dangers associated with using the hearing protector, especially if the hazards 

are latent or unknown to them. 3M’s senior executive and former President of North America 

Safety Products, Gary Warren, confirmed that 3M was aware of the duty to warn of known risks:

Q: Because it's important for folks using a device, any device, but particularly a 

device designed to enhance their safety, to know of risks so they can properly 

protect themselves, correct?

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A: Yes.

. . . 

THE WITNESS: Again, if there were risks that were known, then, yes, I think we 

have an obligation to do that.

(Warren 1/23/20 Depo at 97:16–98:2), 129:11–131:6 (“It was our responsibility to educate those 

gatekeepers, you know, in terms of how to properly use the plug and so forth.”); 30(b)(6) 10/17/19 

Depo at 280:7–15 (Q: You’d expect decision-makers to rely on a company’s representations in 

their marketing materials about the performance and safety capabilities of hearing protectors, 

right? . . . A: They should be able to count on those – on the claim that we make.”), 281:16–282:5 

(“I would think it’s likely that they would read those claims and, yes, rely on them”); Madison 

12/10/19 Depo at 346:20–347:4 (“I agree the manufacturer’s information needs to be accurate.”))

The obligation to properly label its HPDs should have been well known to 3M because its 

predecessor company was fined $900,000.00 by the Department of Justice for violating EPA 

labeling regulations. The Department of Justice’s findings stated: 

Correct labeling and adequate testing are absolutely necessary for the safety of the 

public...EPA’s regulations under the Noise Control Act are designed to assist 

workers and consumers by requiring product information about ear plug or ear muff 

noise protection capacity to help prevent hearing loss due to workplace or 

environmental noise.

(3M_MDL000024833) 

As a physician in the military and in private practice, I have personally utilized and

reviewed warning labels so that I can gain information about the safety, risks, and information 

about HPDs. At the HCE, I worked with all branches of the Military to develop a qualified or rated 

products list of hearing protection devices for the purpose of guiding military leadership, hearing 

conservation teams, and military units towards making informed decisions about which HPDs to 

offer to ensure appropriate protection and features for various military tasks. The single most 

important factor related to any HPD’s function is the protection rating, the NRR. The NRR serves 

as a benchmark for mathematical calculations of protection against known noise sources and is a 

measure that could not be compromised when other product related variables might be tolerated. 

Making informed decisions to protect the service men and women that serve to protect our country 

was the ultimate mission of the HCE. We relied on industry leaders to develop and provide 

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dependable HPDs trusting that their products would deliver the protection that they promoted and 

printed on the NRR label. 

In addition, I am not able to properly weigh the risks and benefits of using an HPD or 

recommend an HPD to my patients if the manufacturer does not provide all of the important 

warnings and risk information on the HPD’s label. When at the HCE, I worked on HPD 

acquisition, and the government needed this information to evaluate HPD safety. Audiologists and 

directors of hearing conservation programs in companies around the country likewise need this

information for the same reasons, as do consumers who buy HPDs on the market. Accordingly, 

HPD manufacturers should not only provide accurate information about protection and instructions 

for using the HPD in a safe manner, but the manufacturer must also identify all significant risks 

associated with the HPD on its label. 

As stated more fully below, it is my opinion based on my education, experience, training, 

and my review of the documents and testimony in this case, that 3M failed to warn that:

● Testing has shown that the CAEv2 may be difficult to fit or seal which may lead to little 

or no hearing protection; 

● It received test results that showed problems with the CAEv2 and that it manipulated 

testing data

● the CAEv2 is too short for proper insertion and, as a result, may be difficult to properly fit 

or seal;

● The geometry of the ear canal opening in some individuals prevents the deep insertion 

needed for proper fit and seal of the CAEv2;

● The large, inflexible stem can make the CAEv2 difficult to fit and seal depending on ear 

canal geometry and size;

● the dual ended design of the CAEv2 can lead to loosening if the non-inserted earplug is in 

contact with the user’s ear;

● the labeled NRR (22) on the CAEv2 was achieved only by folding back the flanges;

● When the CAEv2 was tested pursuant to the instructions for use (without the flanges folded 

back on the non-inserted earplug) the NRR was 11; and

● the CAEv2’s yellow end may not be sufficient to protect soldiers from repeated, high 

intensity impulse noises (gunshots) and, therefore, should not be used on the outdoor range.

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1. 3M Did Not Warn the Military and Consumers Before REAT Testing That the 

CAEv2 was Being Sold Without the Required Testing 

As discussed above, even though the CAEv2 was an untested dual-ended earplug, the first 

ever marketed and sold, and the last one ever marketed and sold, 3M decided to start selling the 

CAEv2 to the military without first REAT testing it to make sure the plugs would work and be 

safe for users. This was a clear violation of 3M’s duty as a manufacturer of hearing protection and 

of the law, and it was also inappropriate and unreasonable not to warn the military and users that 

it was selling the device without the necessary testing before doing so. Warren, 3M’s former Senior 

Executive agreed, and testified: 

Q: Well, are there any tests listed here prior to January of 2000, the 016 and 017 

tests?

A: Again, I’ve never seen this before, I don’t know how to read this chart, but if I 

look over on the date, it looks like there are -- well, no, it doesn’t look like 

there’s anything dated before January of 2000. 

Q: But if the company had been selling the product prior to testing the product, 

you would agree that would have not been appropriate, correct? The Combat 

Arms version 2, that is?

A: Yes. 

(Warren 1/23/20 Depo at 117:8-22)

It simply is undisputed that 3M had the duty to test the CAEv2 before selling to the military 

and consumers, and the military and users also had the right to know that the CAEv2 had never 

been tested before it was promoted and sold. Without that information, the military was unable to 

make an informed decision about whether to acquire the CAEv2 for its troops. Had the military 

been told that the safety testing required to determine the NRR had not yet been completed, the 

military and users may have decided against using the CAEv2 until the testing was done, or at all. 

Regardless, they had the right to know and 3M’s failure to tell the military led to women and men 

in the armed services being provided and wearing defective hearing protection that had not been 

tested. 

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2. For the First Several Years And Through Most Channels Thereafter the CAEv2 

was Sold to the Military Without the Required Label, Or Any Warnings of Its 

Risks, Or Any Instructions For Its Safe Use

As discussed above, 3M had a duty to label the CAEv2, provide instructions for use, and 

warn the military and consumers when selling the product. Nonetheless, as also explained above, 

3M did not do so when it first sold the CAEv2 to the military and for several years thereafter. 

(30(b)(6) 10/18/19 Depo at 178:20–179:12, 198:7–199:13; 3M_MDL000056553; Berger 12/10/19 

Depo at 224:6–226:12) In fact, 3M failed to provide any of this required information to the military 

for at least five or six years – from 1999 until late 2005. (30(b)(6) 10/18/19 Depo at 200:17–

202:12, 212:6–15) Based on my experience educating others and recommending HPDs at the HCE, 

this early time period was critical for the military to determine whether to acquire these plugs. This 

was also an opportunistic time for 3M as the U.S. entered a war with Afghanistan in October of 

2001 in response to the terrorist attack on the World Trade Center the month prior. This war was 

extended to Iraq in March of 2003. This escalation in military manpower and operations led to an 

increase in noise threat for military members in training and in battle. 3M’s claims that its novel 

HPD would not only provide linear protection but also situational awareness was no doubt 

appealing. At this time, more than ever, the military needed and should have been provided all the 

information about the safety and efficacy of the CAEv2. The military needed this information to 

vet the safety of the CAEv2, yet 3M denied it this information. Non-disclosure of this information 

to the Military contributed to the CAEv2 being unreasonably dangerous and caused service 

members to suffer NIHL and/or tinnitus. 

3. At All Times the CAEv2 Was on the Market, 3M Failed to Warn The Military 

and Consumers About The Findings In The Flange Report

When 3M got around to testing the CAEv2 (Tests 213015 and 213016), it learned that its 

design was defective and could not be properly fit or maintain a proper seal in most users. 

Nevertheless, 3M chose to sell the CAEv2 rather than redesign or simply discontinue it. The 

military and consumers had the right to know about the CAEv2’s design defects or “problems,” as 

Berger called them, that 3M uncovered. These findings were memorialized in the Flange Report 

and should have been shared before selling the CAEv2 to the military, so that the military could 

make an informed decision about whether to purchase the plugs. Once 3M decided to sell the 

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CAEv2 to the military and to consumers, the fitting problems and the problem maintaining a proper 

seal needed to be disclosed on the label or packaging of the product. 

First, 3M should have warned users that testing of the CAEv2, showed that the CAEv2 is 

difficult to fit and to maintain a seal which could lead to little or no hearing protection. The military 

and users should know this

Second, 3M had a duty to warn or inform the military and consumers of the CAEv2 that 

its closed end was “too short for proper insertion” and thus obtaining proper fit and seal may be 

difficult or not possible. 3M learned this design characteristic caused fitting problems in multiple 

subjects in Tests 213015 and 213016 and in further testing thereafter. This information was 

especially important for users, because this was a finding by an expert earplug fitter in a laboratory 

environment. 3M should have realized that users in the real world environment would not be able 

to obtain a fit like an expert fitter in a laboratory, at least on a consistent basis. The CAEv2 users 

needed to be warned about this fitting defect and the inherent risk uniquely associated with the 

CAEv2 that was known to 3M. Without this information, the military and users of the plugs would 

not be able to make an informed decision about whether they should purchase or accept the risk of 

using these plugs. (CID File0237)

Third, for the same reasons stated above, 3M had the duty and obligation to inform the 

military and consumers that the “geometry of the ear canal opening” “prevents” deep insertion of 

the CAEv2 and the ability to obtain a proper seal in some individuals. 3M needed to warn the 

military and users of this because the testing of the CAEv2 revealed that this plug would actually 

not fit, seal, or stay seated in some ear canals as a result of its design. This unique design 

characteristic (compared to other earplugs like foamies) could lead to little or no protection for 

service members and consumers. Therefore, the military and all users needed to be warned about 

this known risk of danger associated with the CAEv2. 

Fourth, 3M had the duty and obligation to warn and inform the military and consumers that 

this dual-ended plug had a unique design characteristic that could cause “imperceptible loosening” 

of the plug, thereby leading to little or no protection. It was also important for 3M to actually warn 

about the mechanism of this dangerous characteristic - that is, that the flange on the outward facing 

plug could press against the ear canal opening, fold up and subsequently return to its original shape, 

causing the plug to loosen imperceptibly to the user. This defect was a hidden or latent defect that 

would be unknown to users and intermediaries and, therefore, it was critical that users be told 

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about this.. The warning and information about this unique and dangerous characteristic was 

necessary so that the military and users could understand the risks of danger associated with 

wearing this earplug.

Fifth, 3M had the duty and obligation to inform the military and consumers that the NRR 

of 22 was only achieved by folding back the flanges and that failing to do so could lead to much 

less protection - specifically that testing of the device according to the instructions for use on the 

label resulted in an NRR of only 11. 3M chose to advertise an NRR of 22 for the CAEv2, yet 

failed to tell users that the claimed NRR was only achieved by manipulating the configuration of 

the plug and that doing so was mandatory to achieve the stated protection. Without this important 

information, users could not get the protection claimed and this added to the risk of unreasonable

danger from wearing these plugs. 

In sum, 3M failed to warn the military and consumers about any of the CAEv2’s dangerous 

defects. These warnings discussed above and throughout this report needed to be provided in 

writing with the product on a label or in a package insert or in another manner that would 

reasonably ensure that users had access to this critical safety information. 3M did, in fact, put 

“Caution[s]” and “Warning[s]” in CAEv2 package inserts and promotional materials, so the 

company was clearly capable of providing warnings about its earplug. (3M_MDL000005445) 

Instead, 3M buried Test 213015 and the Flange Report and stormed forward with selling this 

dangerous and defective product. Doing so was a violation of 3M’s duty as an HPD manufacturer.

The lack of proper warnings made the CAEv2 even more unreasonably dangerous. In my opinion, 

had the military been warned about these dangerous characteristics, the military likely would not 

have purchased the CAEv2, and soldiers and marines would have been able to obtain adequate 

protection for their hearing. This is true, in part, because there were other safer alternatives 

available (as discussed more fully below). Physicians and audiologists recommending HPDs also 

needed this important information so that they could weigh the risks and benefits of recommending 

these dangerous plugs.

4. The Fitting Tip and The Wallet Card Did Not Make the CAEv2 Safe for Use, 

Nor Did They Adequately Inform the Military and Consumers about the 

CAEv2’s Dangers 

Neither the “Fitting Tip” nor the Wallet Card adequately warned or informed the military 

and consumers about the CAEv2’s design defects or dangers. 

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First and foremost, it is important to again point out that I have not seen any evidence that 

the “Fitting Tip” was provided to military users for at least five years after 3M started selling the 

CAEv2 to the military. Further, it seems that only soldiers or marines who purchased the plugs (as 

opposed to having them provided by the military free of cost) would have had access to the package 

insert and exposure to the Fitting Tip. As to the wallet card, it was not created until 2004, and I 

have not seen evidence that suggests that the wallet card was widely dispersed to all service 

members. 

Even if the Fitting Tip and the wallet card were seen by many users, neither one provided 

adequate warnings or information about the CAEv2’s dangers. The Fitting Tip is simply that - a 

tip - that says fitting may be “improved” if the flanges are rolled back and does not say that doing 

so is required, or that the NRR of 22 could only be achieved if the flanges were rolled back. Nor 

does it say anything about the fitting difficulty due to the plug's short stem, that the plug would 

simply not fit in certain ear canal geometries, or that the plug could imperceptibly loosen. An 

adequate instruction would have mentioned all of these fitting problems. The same is true for the 

wallet card, but to make matters worse it misstates the Flange Report. The tip notes that the 

CAEv2’s opposing flanges should be folded back only for “very large” ear canals. It did not 

mention any fitting issues due to ear canal geometry or that imperceptible loosening could apply 

to all sized ear canals. 

Thus, even if users saw the fitting tip or the wallet card, the information contained therein 

did not adequately warn about the dangerous characteristics of the CAEv2. Moreover, because the 

folding back the flanges does not cure the CAEv2’s other design defects, the plug was 

unreasonably dangerous with or without the fitting tip and wallet card. 

5. 3M Failed to Warn About and Misrepresented the CAEv2’s NRR of 22 On Its 

Label and In Its Marketing Materials 

The NRR listed on 3M’s label and marketing pieces for the closed end of the CAEv2 was 

always 22. In my opinion, the NRR of 22 was false and misleading and 3M violated the standard 

of care for an HPD manufacturer and EPA regulations by labeling the CAEv2 with that misleading 

NRR. 3M should not have labeled the CAEv2’s closed end as providing a 22 because that NRR 

was achieved in a test where the CAEv2’s opposing flanges were folded. As mentioned, however, 

the CAEv2’s instructions for use never required users to fold the flanges. (Hamer 12/18/19 Depo 

at 318:1–14; Santoro 12/13/19 Depo at 306:1–22) More importantly, 3M knew the CAE2 was not 

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being worn in the real world with flanges folded back. In fact, multiple 3M witnesses testified that 

they had never seen or heard of the flanges being folded back on the CAEv2 before this litigation. 

(30(b)(6) 10/17/19 Depo at 298:23-299:18; Knauer 12/17/19 Depo at 93:24-94:10) Many 3M 

witnesses who were selling the CAEv2 to the military, some for years, were asked in depositions 

about folding the flanges back, and did not even understand what it meant or how to fold back the 

CAEv2’s opposing flanges. (Cimino 12/11/19 Depo at 227:16–228:20; Murphy 1/29/20 Depo at 

291; 293:1, 296:17–297:8; Moses 12/5/19 Depo at 197:14–199:12; Santoro 12/3/19 Depo at 

296:9–20) The fact that 3M continued doing REAT testing on the CAEv2 years after labeling the 

product with an NRR of 22 without folding the flanges back also makes it clear that 3M knew that 

folding the flanges back was not the way the CAEv2 was designed to be worn. Accordingly, it was 

unreasonable and inappropriate for 3M to label and advertise the CAEv2 as providing an NRR of 

22, when it knew it had only obtained an NRR of 10.8 in the laboratory. 

When 3M tested the CAEv2 the way that men and women in the service and consumers 

were wearing the plugs, the REAT test revealed an NRR of 10.8, only 10% of the NRR of 22 that 

it was promoting. (McNamara 3/11/20 Depo at 152:2–153:9) Clearly, 3M had a duty to either 

inform the military of the true NRR of 10.8 from the halted Test 213015, or to complete a REAT 

test on the closed end and report that before selling it to the military and to consumers. Based on 

my experience with HPDs, I think it is highly unlikely that the military, or consumers for that 

matter, would purchase plugs for constant noise that only provided an NRR of 10.8 or anything 

close to that NRR. An NRR of 10.8 would not compete in the military or consumer marketplace 

because many other HPDs have much higher NRRs. Although service members might be willing 

to use the CAE2 with a slightly lower NRR on the closed end due to the purported “situational 

awareness” benefit, in my opinion an NRR as low as 10.8 on the closed end would not be 

marketable. (Berger 12/11/19 Depo at 559:5–13; Knauer 12/17/19 Depo at 117:10–17) 

Nevertheless, because the military and consumers were not told the correct NRR for the product, 

they were left to rely on the false NRR when choosing the plugs, and, as a result countless users 

suffered severe hearing damage.

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6. 3M Misrepresented That the Open End of the CAEv2 Was Appropriate For 

Use On Gun Ranges Or In Battle And Failed To Warn The Military And 

Consumers That The Open End Of the CAEv2 Was Not Appropriate For Such 

Use 

3M misrepresented that the CAEv2 was protective from weapons fire on gun ranges and 

in battle. 3M also falsely claimed that the plug was “ideal for” outdoor ranges and would provide 

“instant protection” from weapons fire. Internally, however, 3M scientists knew that the open end 

of the CAEv2 was inadequate to protect against frequent gunfire. Yet, 3M never told users that it 

was dangerous to wear the open end on the range or in battle and, as a result, countless soldiers 

suffered NIHL and tinnitus. 

Service members and consumers wore the open end of the CAE2 to gun ranges for over 

fifteen years. But, 3M’s most senior scientists knew that the open end of the CAEv2 was not safe 

for use on gun ranges. Berger admitted that the CAEv2 “is not the optimal choice for a gun range” 

and “is probably inadequate” for indoor gun ranges. Another 3M executive admitted that he 

“wouldn’t recommend the CAEv2 at a gun range if there is “frequent” gun fire. Although the 

marketing department considered changing the language to use for “infrequent gunshot noise”, 3M 

worried that this change in language “could cause concern for potential users.” 

(3M_MDL000473502) This is exactly the type of safety information that 3M should have provided 

to users of the plugs. Yet, there is no evidence that 3M ever told anyone (the military or consumers) 

anything other than that the CAEv2 would protect against weapons fire.

Based on my experience while in the military, including my work with the HCE, the 

military relies on manufacturers’ representations about the protection their HPDs provide. I, along 

with doctors and audiologists throughout the country, rely on manufacturers’ representations when 

recommending hearing protection for patients. Users rely on those same representations when 

choosing hearing protection. Therefore, it is very important for manufacturers of HPDs to inform 

users truthfully about the protection provided by the device and to avoid exaggerating the 

protection an HPD provides to users.

3M knew that service members were wearing the open end of the CAEv2 when exposed to 

gunfire on ranges and in battle. 3M was obligated and had a duty to warn users that the CAEv2 

was unsafe for use in the vicinity of frequent weapons fire, instead of continuing to misrepresent 

that the plugs were safe for use on gun ranges and in battle where gunshots are frequent. By failing 

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to do so, men and women in the military and other users relied on 3M’s misrepresentations and 

suffered NIHL and tinnitus. 

F. 3M Knew the CAEv2’s Dual-Ended Design was Difficult to Fit and Use, Yet 3M 

Failed To Provide Adequate Training and Instructions to the Military and Users

As stated previously, the CAEv2 was the first dual-ended earplug ever sold to service 

members and consumers. Its dual-end design was unlike any pre-existing earplug. Indeed, 3M 

retested the CAEv2 after terminating its labeling test because, according to Berger, “there is a 

learning effect as the experimenter better understands how to insert this unusual earplug.” 

(3M_MDL000434769) Given 3M’s knowledge that the CAEv2 was difficult to fit and seal—as 

memorialized in the Flange Report—3M had a duty to train and instruct the military and users 

about this “unusual” earplug. 

This is especially true because 3M knew users did not understand how to use the CAEv2. 

More than five years after selling the CAEv2 to the military, 3M acknowledged “the troops [did] 

not understand[] the purpose of our plugs or how they work” and that “an instruction guide with 

ear pair” should be included. (3M_MDL000620089) Other emails show that 3M “continue[d] to 

hear that the soldiers don’t understand how the plugs should be used or how to properly wear 

them.” (Santoro 12/3/19 Depo at 301:4-302:14) Not even 3M’s marketing and sales team knew 

how to use this product. (Cimino 12/11/19 Depo at 227:16–228:20; Moses 12/5/19 Depo at 

197:14–199:12; Murphy 1/29/20 Depo at 291:22–293:1, 296:17–297:8; Santoro 12/3/19 Depo at 

296:9–20) Despite the “problems” fitting and sealing these unusual earplugs 

(3M_MDL000258590), 3M did not adequately train or instruct either the military itself or users 

about how to use the plug safely. As a result, thousands of service members and consumers were 

never advised about the CAEv2’s problems or how to use the plug safely, thus increasing their risk 

for suffering NIHL and tinnitus.

It is my opinion that 3M could have and should have provided the military—including 

service members and audiologists—as well as other users detailed instructions and training and 

warnings about the CAEv2’s problems with fit, seal, and imperceptible loosening. 3M could have 

instructed the military and users that folding back the flanges in testing helped achieve higher 

NRRs in a laboratory setting, but that other design problems, such as imperceptible loosening and 

the failure of the plugs to fit the ear canal geometry of some users, persist outside the laboratory. 

3M could have provided detailed training with this information as well. Given 3M’s knowledge of 

the significant fitting and sealing problems with the CAEv2, 3M had a duty to provide this 

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information and instruct the military and users. Unfortunately for all users, 3M failed to do so, 

causing thousands of users to remain in the dark about the CAEv2’s dangers.

G. There Were Safer Alternative Designs Available That Would Have Reduced or 

Eliminated the Harms Caused By The CAEv2

During the time the CAEv2 was on the market, there were numerous other, safer HPDs on 

the market that provided noise reduction to safe levels but did not have the design flaws described 

above. These alternative designs would have eliminated or substantially reduced the hearing loss, 

injuries and damages suffered by service members. These alternative designs were cost effective

and feasible, and they would have prevented the HPD from being unreasonably dangerous. These 

designs did not have the CAEv2 flaws described in the Flange Report—i.e., opposing flanges and 

a large, inflexible inner stem that made it difficult to get a “deep and consistent seal to get proper 

protection.” (Berger 10/08/15 Depo at 109:6-13)

When determining a safer alternative design for HPDs, numerous factors should be 

considered. Simply reviewing REAT measurements to determine whether a device is a safer 

alternative design would be inappropriate. This is particularly true where one is looking at 

experimenter fit data, which attempts to show optimal performance versus real world performance 

where actual users wear the HPDs for extended periods of time. Factors that are often overlooked 

in evaluating HPDs include, but are not necessarily limited to:

1. Comfort. Crucial in the real world, as it impacts compliance.

2. Utilization. Earplugs may be incorrectly inserted or adjusted.

3. Fit. This must be done for each ear or performance can be affected.

4. Compatibility. Must be matched to the user.

5. Readjustment. Since HPDs can work loose, users must be advised of the need for 

readjustment.

6. Deterioration. HPDs must be maintained and repaired as necessary. (Berger et al., 

2003)

One particularly concerning aspect of the CAEv2, which is relevant to the evaluation of 

safer alternative designs, is the imperceptible loosening that occurred in the lab setting. The fact 

that the CAEv2 could loosen in the minutes it takes to perform REAT testing is highly problematic 

as REAT testing subjects sit immobile in a laboratory. The fact that a plug could loosen in minutes 

with little to no motion indicates a problem that will worsen as users move around, talk, chew, or 

undertake any physical activity. This problem of loosening is compounded by the fact that such 

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loosening was “imperceptible” to the users. The perception of loosening will generally prompt 

HPD users to readjust their plugs, as is set forth above. However, when loosening is imperceptible, 

there is no trigger to cause the HPD user to readjust the plug. Unfortunately, the imperceptibly 

loosened plug provides no guidance to the user that there is a fit issue that must be addressed. This 

is particularly true on the yellow end of the CAEv2, which was designed to allow sound to pass 

unimpeded (this is the goal of the plug/ISL filter) up to certain levels. Consequently, when the 

yellow end is working as designed, a user will not be able to discern sound differences caused by 

a loose fit from those caused by a secure fit, because in both cases, lower level sounds are reaching 

the ear canal unimpeded. Thus, any HPD that does not have the defect of imperceptible loosening 

will have a significant advantage over one that suffers from this defect.

Another issue with the CAEv2 is the rigidity of the stem. Typically, for an earplug to work, 

it must conform to the ear canal of the user. For this reason, most earplugs are made exclusively 

with softer materials that will conform to the unique curvature and shape of the individual user’s 

ear canal. The white plastic insert of the CAEv2 was made of Delrin, a plastic known for its tensile 

strength and stiffness. Its manufacturer, Dupont, describes Delrin as “the ideal material in parts 

designed to replace metal.” Because of the stiffness of the Delrin, it is not able to conform to the 

curves and contours of various individual ear canals. Instead, it maintains its shape, which will 

prevent it from conforming to any ear canal, other than one that is straight. If hard material like 

Delrin is used in the stem of an earplug, placement is critical. For instance, is the hard material 

inserted deep within the ear canal versus exterior to ear canal. Flexibility is very important with 

respect to comfort, fit and seal.

I am familiar with several safer earplugs that were on the market at the same time as the 

CAEv2. For protection against steady-state noise, there were numerous foam and pre-molded 

flanged earplug alternatives which could provide adequate protection against steady state noise 

hazards, but which did not have the CAEv2’s design problems of achieving and maintaining a 

proper seal. These are listed in the 2006 CHPPM Technical Guide 41. (3M_MDL000345123)

There existed alternative designs for nonlinear devices that provided noise hazard 

protection against impulse noise, which are desired for dismounted combat service members and 

in various live fire training exercises, where communication and situational awareness are 

beneficial.

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The non-linear filter developed by ISL in 1996/1997 was similar to an earlier nonlinear 

earplug called the “Gunfender,” which was used by the British military. (3M_MDL000016506). 

The ISL non-linear filter was first utilized in the Aearo/3M CAEv1, which was sold to the 

European military market. CAEv1 came to market in 1999. CAEv1 utilized the same ISL nonlinear filter later used in the CAEv2, which was incorporated into the preexisting Aearo/3M 

UltraFit earplug design. (3M_MDL000259866) A similar “version one” single sided CAE earplug 

utilizing the ISL filter and the UltraFit earplug was available to the DoD in 2003 and this version 

is also in noted in the TG41 in 2006. (3M_MDL000345123) This was a safer alternative for use 

in impulse noise environments, because it allowed for situational awareness but it did not have the 

sealing problems of the CAEv2. Contrary to the CAEv2, the CAEv1 had a flexible stem and was 

single sided without an opposing flange which could “imperceptibly loosen” the plug.

3M’s Combat Arms versions 3 and 4 and 4.1 were also single ended earplugs utilizing the 

ISL filter, but these had a “switch” which allowed them to be used for both steady state and impulse 

noise environments. They came in multiple sizes and the version 4 was based on a 1998 Aearo/3M 

patent for a “selective nonlinear earplug” granted in 2000. (3M_MDL000338061; 

3M_MDL000351438)

These were safer alternatives which did not have the design problems of the CAEv2. The 

2018 Hearing Center of Excellence poster gives several examples of acceptable nonlinear devices, 

including multiple versions of the Surefire Sonic Defender and the Moldex Battle Plugs. (HCESelection of passive hearing protection) These were safer alternatives for both steady-state 

protection and impulsive noise protection, and they did not suffer from the same design flaws that 

plagued the CAEv2. Finally, custom molded earplugs are also safer alternatives and can even have 

nonlinear filters placed in them.

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EXHIBIT A

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 110 of 265
CURRICULUM

VITAE

Mark D. Packer, M.D.

Col (ret), USAF, MC, FS

Medical Director Neurotology, Mercy St Louis Hospital

314-931-5990 | mpacker@soundhealthservices.com

Business address: Home Address:

Town and Country Head and Neck Surgery Division 997 Tara Oaks Dr.

607 S. New Ballas Rd., Ste 2300 Chesterfield, MO

St. Louis, MO 63141 63005

EDUCATION

Undergraduate: Bachelor of Science

University of Utah

Salt Lake City, UT

Major: Psychology

June 1990

Medical: Doctor of Medicine

Uniformed Services University of the Health Sciences (USUHS)

Bethesda, MD

May 1995

POST-GRADUATE EDUCATION

Internship: General Surgery 7/95-6/96

Wright State University, Wright Patterson AFB, OH

Program Director: James B. Peoples, MD

Residency: Otolaryngology – Head and Neck Surgery 7/98-6/02

Wilford Hall Medical center, TX

Program Director: Joseph Wiseman, MD

Fellowship Otology/Neurotology/Cranial Base Surgery 7/06-6/08

The Ohio State University

Columbus, OH

Program Director: D. Bradley Welling, MD, PhD

PROFESSIONAL TRAINING AND WORK EXPERIENCE

9/2016-Present Medical Director Neurotology, St. John’s Mercy Hospital, St. Louis MO

Clinical Practice in partnership at Town and Country Head and Neck 

Surgery Division of Sound Health Services, St. Louis, MO

10/2009-9/2016 Founding Director of the Department of Defense and Veterans 

AdministrationHearing Center of Excellence

7/2008-Present Otolaryngologist, Chief Neurotology and cranial base surgery

59 MDW/SGKNE

Lackland AFB, TX, 78236

7/2006-6/2008 Fellow Neurotology

The Ohio State University

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Air Education and Training Command

Columbus, OH

2007 Gamma Knife Radiosurgery Course

University of Pittsburg

Pittsburg, PA

2002-2006 Chief Otolaryngology Element

3rd Medical Group

Elmendorf AFB, AK

1998-2002 Resident Otolaryngology – Head and Neck Surgery

Wilford Hall Medical center, 59th MDW

Lackland AFB, TX

1996-1998 Flight Surgeon

16th Operations Support Squadron

Hurlburt Field, FL

Emergency response team leader

Medical Director, Education and Training

Medical Director NBC Rapid Response Team

1995-1996 Intern General Surgery

74th Medical Operation Squadron – Wright State University

Wright Patterson AFB

1991-1995 Medical Student USUHS

Air Education and Training Command

Andrews AFB, MD

1990-1991 Associate Counselor adolescence

Charter Summit Hospital

Salt Lake City, UT

Mental Health Worker

Western Institute of Neuropsychiatry

Salt Lake City, UT

Volunteer: Physical Therapist Aide

Utah/Colorado High Mountain Search and Rescue Team

EMT High Country Snowmobile Tours, Park City UT

MILITARY TRAINING

School of Aerospace Medicine, primary course

Brooks AFB, TX

Graduate 9/96

Medical Management of Chemical and Biological Warfare

Ft. Detrick, MD / Aberdeen Proving Grounds

Baltimore, MD

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Graduate 9/97

CERTIFICATION/LICENSURE

Board Certification: Otolaryngology 4/2003

Neurotology/Otology 4/2010

Otolaryngology Inservice exam: 3/2002 – general 93, otology 99 percentile

United States Medical Licensing Examination:

Step I: 6/93

Step II: 9/94

Step III: 6/96

Medical License:

Ohio # 35-07-1378 – unrestricted, current

Missouri #2016009560 – unrestricted, current

Implant Certification

Envoy Esteem Totally Implantable Middle Ear System 2012

Ototronix Maxum Middle Ear Implant System 2012

Med El Soundbridge Bone conduction system 2017

Earlens indwelling hearing aid system 2018

MEMBERSHIPS

St Louis ENT Club

Alpha Omega Alpha Honor Society

American Academy of Otolaryngology – Head and Neck Surgery

HONORS AND AWARDS

Eagle Scout

Sterling Scholar, English

Honors at Entrance, University of Utah

Three Departmental Scholarships – accepted Mining Engineering, University of Utah

Deans List, University of Utah

Distinguished Graduate, HPOIC Lackland AFB (8/91)

Outstanding Academic Achievement Award, USUHS, June 1991, and June 1993

Alpha Omega Alpha medical honor society 9/95

Air Force Achievement Medal, United States Air Force, Hurlburt Field (7/98)

Golden Bone Award, First Place, WHMC Temporal Bone course, Lackland AFB (2/00)

Meritorious Service Medal, United States Air Force, Elmendorf AFB (2006 & 2013)

Surgeon General’s award for outstanding paper; SAFCS 54th annual symposium 2008

The OSU School of Medicine Ambulatory Care Clerkship Appreciation 2008

The Legion of Merit, United States Air Force, Lackland Air Force Base (2016)

LEADERSHIP ROLES

Medical Director Neutorology, St. John’s Mercy Hospital, St. Louis, MO 2016-Present

Executive Director Department of Defense Hearing Center of Excellence 2010-2016

Interim Director Department of Defense Hearing Center of Excellence 2009 - 2010

Chairman Defense Hearing Center of Excellence Work Group (WG) 2009-2010

Co-chair Joint Hearing Loss and Auditory System Injury Registry WG 2009-2010

Department of Defense ex officio representative of National Institute of Health (NIH) National 

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 Deafness and other Communication Disorders (NDCD) Advisory Council 2016-Pres

Department of Defense Otology Working Group Chair 2010-2016 

Defense Health Agency Center of Excellence transition working Group 2014 - 2016

Neurosensory Representative to the Defense Medical Research and Development Program 

 capabilities based analysis of the Clinical Rehabilitative Medicine Research Program, 2015

US team chief, NATO Human Factors in Medicine (HFM) Exploratory Team (ET) 117,

Treatment, Rehabilitation and Reintegration of Soldiers with Severe Injuries to the Hearing

System, Aug 2011

US team chief, NATO HFM Science and Technology Organization (STO) 229, Optimizing 

 Hearing Loss Prevention and Treatment, Rehabilitation and Reintegration of Soldiers with 

 Hearing Impairment. Mar 2012-2016

US representative, NATO Combat Clothing and Individual Equipment and Protection NOISE

 working group, 2015

Co-Chair, NATO HFM Research Technical Group (RTG) Technical Activity Proposal, ”Speech 

 understanding of English language in native and non-native speakers/listeners in NATO with 

 and without hearing deficits”

American Academy of Otolaryngology Head and Neck Surgery Representative to the Council 

 for Accreditation of Occupational Hearing Conservation, 2015-Present

Neurosensory Rep, Joint Programmatic Committee 8, Chr Rehabilitative Medicine, 2013-2016

Chairman Scientific Steering Committee, Chr Rehabilitative Medicine, 2013-2016

Neurosensory Rep, Joint Programmatic Committee 5, Military Operational Med, 2013-2016

Task Area Manager, Military Operational Medicine JPC5 USAMRMC, 2013

Executive Stakeholder, Military Health System 5-year strategic plan for collaborative research

 and shared resources roadmap task force

Chairman Source Selection Evaluation Board, USAMRAA 2014-2015

DoD Sponsor/Advisor to Institute of Medicine committee on accessible and affordable

 hearing health care for adults

Department of Defense Individual Medical Readiness Working Group, 2012 - 2014

Human Performance Optimization Health Science Advisory Committee member, 2012 – 2016

Director, Auditory Fitness For Duty (AFFD) Working Group 2010-2016

Director and Panel Chair AFFD Symposium, San Diego, CA; Mar 2011

Director and Panel Chair AFFD Symposium, Dallas, TX; Mar 2012

Director and Panel Chair AFFD Symposium, San Antonio, TX; Apr 2014

Director, Pharmaceutical Intervention in Hearing Loss Working Group 2011-2016

Team leader, Defense Center of Excellence Consensus Group Clinical Practice

Guideline, Nov 2011

Chief Otolaryngology Element, 3 MDG, Elmendorf AFB, AK, 2006

Recurrent reporting responsibilities

MILITARY SENIOR LEADERSHIP, DEPT of HEALTH AFFAIRS, CONGRESS

President’s Council of Advisors for Science and Technology

House Armed Services Committee 

Senate Armed Services Committee 

House Committee on Veterans Affairs 

Recovering Warrior Task Force

Senior Military Medical Advisory Committee 

Center of Excellence Oversight Board

Joint Executive Committee

Health Executive Committee – Research business line

HUMANITARIAN EAR SURGERY MISSIONS

Kingston Jamaica; June, 2002

David, Panama; April, 2009

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Georgetown, Guyana; Aug, 2009

Ica, Peru; June 2012

TEXT BOOK CHAPTERS

1. Packer MD and Welling DB. Trauma to the Middle Ear, Inner Ear and Temporal Bone. In

Ballenger’s Otorhinolaryngology Head and Neck Surgery, 17th edition. B.C. Decker Inc., Editors

James Snow and Ashley Wackym, Chapter 40, 2007.

2. Welling DB, Packer MD, Akhmametyeva EM, Chang LS. The Biology and Genetics of

Vestibular Schwannomas in Surgery of the Cerebellopontine Angle. In Surgery of the

Cerebellopontine Angle. B.C. Decker Inc., Editors Bambakidis, Megerian, Porter, and Spetzler.

Chapter 9, 2007.

3. Welling, DB, Packer MD, Chang LS. Molecular Studies of Vestibular Schwannomas. In

Current Opinion in Otolaryngology & Head & Neck Surgery. Wolters Kluwer/Lippincott

Williams & Wilkins Inc., Editor Karen Doyle, 15(5):341-346, 2007.

4. Packer MD and Welling DB. Surgery of the Endolymphatic Sac. In Otologic Surgery, 3rd

edition. Elsevier inc., Editors Derald Brackmann, Clough Shelton, Moises Arriaga, Chapter 34,

2008.

5. Packer MD and Welling DB. Vestibular Schwannoma. In Surgery of the Ear, 6th edition.

B.C. Decker Inc., Editors Michael E. Glasscock, Julianna Gulya, Lloyd B. Minor and Dennis S. Poe.

Chapter 38, 2008.

6. Welling DB and Packer MD, Chang LS. The Biology and Genetics of Vestibular

Schwannomas. In Surgery of the Ear, 6th edition. B.C. Decker Inc., Editors Michael E. Glasscock,

Julianna Gulya, Lloyd B. Minor and Dennis S. Poe. In editorial review. Chapter 8, 2009.

7. Packer MD and Welling DB. Radiation Therapy of Benign Tumors of the Skull Base. In

Cummings Otolaryngology: Head and Neck Surgery, 5th edition. Editor John K. Niparko.

Chapter 179, 2010.

8. Conner M, Packer MD. Patient Assessment. Resident Manual on Trauma to the Face,

Head, and Neck, First Edition. American Academy of Otolaryngology-head and Neck

Surgery; eBook. Chapter 1, 2012.

9. Spears, S, Packer MD and Welling DB. Trauma to the Middle Ear, Inner Ear and Temporal

Bone. In Ballenger’s Otorhinolaryngology Head and Neck Surgery, 18th edition. B.C. Decker

Inc., Editors James Snow and Ashley Wackym, Chapter 40, in editorial review.

10. Spears S, Packer MD, and Welling DB. Vestibular Schwannoma. In Surgery of the Ear, 7th

edition. B.C. Decker Inc., Editors Michael E. Glasscock, Julianna Gulya, Lloyd B. Minor and 

Dennis S. Poe. Chapter 37. In Editorial review.

11. Spears, S, Packer MD and Welling DB. Radiation Therapy of Benign Tumors of the Skull

Base. In Cummings Otolaryngology: Head and Neck Surgery, 6th edition. Editor John K.

Niparko. Chapter 179, 2015.

12. Packer MD, Welling DB. Surgery of the Endolymphatic Sac. In Otologic Surgery, 4th

edition. Elsevier inc, Editors D. Brackmann, C. Shelton, M. Arriaga. Chapter 34, 2015.

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 115 of 265
PUBLICATIONS

1. Davis, LR; Packer MD; Brennan JA. Airway-obstructing laryngeal candidiasis in an

immunocompetant host. Otolaryngology Head and Neck Surgery; Nov 133(5): 808-810, 2005.

2. Welling, DB, Packer MD, Chang LS. Molecular Studies of Vestibular Schwannomas- A

Review. In Current Opinion in Otolaryngology & Head & Neck Surgery. Wolters

Kluwer/Lippincott Williams & Wilkins Inc., Editor Karen Doyle, 15(5):341-346, 2007.

3. Wiet GJ, Rastatter JC, Bapna S, Packer MD, et al. Training Otologic Surgical Skills Through

Simulation—Moving Toward Validation: A Pilot Study and Lessons Learned. Journal of

Graduate Medical Education. Sept 1(1): 61–66, 2009.

4. Lee T, Packer MD, Huang J, Akhmametyeva,EM, Jacob, A, Kulp,S, Chen,CS, Giovannini,M,

Welling,DB, Chang, LS. Growth Inhibitory and Anti-Tumor Activities of OSU-03012, a Novel

PDK1 Inhibitor, on Vestibular Schwannoma and Malignant Schwannoma Cells. European

Journal of Cancer 45:1709-1720, 2009.

5. Bush ML, Pritchett C, Packer MD, Ray-Chaudhury A, Jacob A. Hemangioblastoma of the

Cerebellopontine Angle. Archives of Otolaryngology - Head & Neck Surgery. 136(7) 734-738,

2010.

6. Yates C, Weinberg M, Packer MD, Jacob A. Fatal case of tumor-associated hemorrhage in a

large vestibular schwannoma. Annals of Otology Rhinology and Laryngology; 119(6) 402-5,

2010.

7. Packer MD - Clinical Practice Guideline – Assessment and Management of Dizziness

Associated with Mild TBI. Defense Center of Excellence Consensus Group. Nov 2011.

8. Bandino ML, Packer MD, Tankersley M. Successful treatment of exercise-induced

anaphylaxis with omalizumab. Ann Allergy Asthma Immunol; 109:A89, 2012.

9. Weber, DW, Fallis, DW, Packer, MD. Three-Dimensional Reproducibility of Natural Head

Position. American Journal of Orthodontics and Dentofacial Orthopedics 143(5) 738-744, 2013.

10. . Formby C, Scherer R et al. Rationale for the Tinnitus Retraining Therapy Trial. Task

Force contribution Packer MD. Noise and Health 15, 63; 134-142, 2013.

11. Packer MD, Tepe V. Issues, Diagnosis, and Management of Polytraumatic TBI. Guest

Editorial. Psychiatric Annals 43(7), 305-306, 2013.

12. Packer MD, Hammill T, Nelson J, et al. Integrated Care of Multisensory Injury. Featured

Article. Psychiatric Annals 43(7), 334-337, 2013.

13. Packer MD. Department of Defense Hearing Center of Excellence. Federal Practitioner

30(6), e3-e4, 2013.

14. De Ru A, Heerens W, Packer M. Voluntary contraction of the tensor tympani muscle and its

audiometric effects. J Laryngol Otol. Mar 19:1, 2014.

15. Packer MD. A Fight for the Long Haul. Hearing Health. Summer, Vol 1, 2014.

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 116 of 265
16. Cooper SP, Alamgir H, Whitworth KW, Gorrell NS, Betancourt JA, Cornell JE, 

Delclos G, Douphrate DI, Gimeno D, Marko D, Kim SY, Sagiraju HR, Tucker DL, 

Whitehead LW, Wong NJ, Hammill TL, Senchak AJ, Packer MD. The Department of 

Defense Epidemiologic and Economic Burden of Hearing Loss study. Mil Med. 2014 

Dec;179(12):1458-64. doi: 10.7205/MILMED-D-14-00100.

17. Dion GR, Packer MD. Anaplastic large-cell lymphoma presenting as a nasopharyngeal 

mass and cervical lymphadenopathy. Ear Nose Throat J. 2015 Jun;94(6):E26-9.

18. Packer MD, Reid, P. Hearing Health Matters. Federal Practitioner. April 2015.

19. Packer MD. Protecting Sensory Health. Federal Practitioner. 2015 May;32(5):29.

20. Sharon P Cooper, Hasanat Alamgir, Kristina W Whitworth, Natasha S Gorrell, Jose A 

Betancourt, John E Cornell, George Delclos, David I Douphrate, David Gimeno, Dritana 

Marko, Sun-Young Kim, Hari R Sagiraju, David L Tucker, Lawrence W Whitehead, 

Nicole J Wong, Tanisha L Hammill, Andrew J Senchak, Mark D Packer. The Department 

of Defense Epidemiologic and Economic burden of Hearing Loss study. Mil Med 2014 

Dec; 179(12): 1458-1464. MILMED-D-14-00100.

21. Agnès Job, Roland Jacob, Yoann Pons, Marc Raynal, Michel Kossowski, Jérôme 

Gauthier, Bertrand Lombard, Chantal Delon-Martin. Specific activation of the operculum 

3 (OP3) brain region during provoked tinnitus–related phantom auditory perceptions in 

humans. Submitted to Brain Struct Funct. 2015. Mark Packer, advise and review.

22. Hasanat Alamgir, PhD; Caryn A. Turner, MPH; Nicole J. Wong, MPH; Sharon P. 

Cooper, PhD; Jose A. Betancourt, DrPH; James Henry, PhD; Andrew J. Senchak, MD; 

Tanisha L. Hammill, MPH; Mark D. Packer, MD. The impact of hearing impairment and 

noise-induced hearing injury on quality of life in the active-duty military population: 

challenges to the study of this issue. Mil Med Res. 2016 Apr 12;3:11

23. Hasanat Alamgir, David L Tucker, Sun-Young Kim, Jose A Betancourt, Caryn A 

Turner, Natasha S Gorrell, Nicole J Wong, Hari K R Sagiraju, Sharon P Cooper, David I 

Douphrate, Kristina W Whitworth, Dritana Marko, David Gimeno, John Cornell, Tanisha L 

Hammill, Andrew J Senchak, Mark D Packer. Economic Burden of Hearing Loss for the 

U.S. Military: A Proposed Framework for Estimation. Mil Med 2016 Apr;181(4):301-6

24. Hammill, Tanisha L.; Packer, Mark. Introduction to the Pharmaceutical Interventions 

for hearing loss clinical research guidance papers. Otol Neurotol. 2016 Sep; 37(8): e261–2.

25. K. Yankaskas, T. Hammill, M. Packer, J. Zuo. Editorial: Auditory injury – A military 

perspective. Hearing Research 349 (2017), 1-3.

26. J.T. Nelson, A.A. Swan, B. Swiger, M. Packer, M.J. Pugh. Hearing testing in the U.S. 

Department of Defense: Potential impact on Veterans Affairs hearing loss disability 

awards. Hearing Research 349 (2017), 13-20.

27. A.A. Swan, J.T. Nelson, B. Swiger, C.A. Jaramillo, B.C. Eapen, M. Packer, M.J. Pugh. 

Prevalence of hearing loss and tinnitus in Iraq and Afghanistan Veterans: A Chronic Effects 

of Neurotrauma Consortium study. Hearing Research 349 (2017), 4-12.

28. Annalisa De Paulis, Marom Biksom, Jeremy T. Nelson, J. Alexander de Ru, Mark 

Packer, Luis Cardoso. Analytical and numerical modeling of the hearing system: 

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 117 of 265
Advances towards the assessment of hearing damage. Hearing Research 349 (2017), 111-

128.

29. Aldag, M, Armstrong RC, Bandak F, Bellgowan P, Bentley T, Biggerstaff S, Caravelli

K, Cmarik J, Crowder A, DeGraba TJ, Dittmer TA, Ellenbogen RG, Greene C, Gupta RK, 

Hicks R, Hoffman S, Latta 3rd RC, Leggieri Jr MJ, Marion D, Mazzoli R, McCrea M, 

O'Donnell J, Packer M, Petro JB, Rasmussen T, Sammons-Jackson W, Shoge R, Tepe V, 

Tremaine L, Zheng J. The Biological Basis of Chronic Traumatic Encephalopathy 

Following Blast Injury: A Literature Review J Neurotrauma2017 Sep;34(S1): S26-S43. 

30. Packer MD. The Department of Defense Hearing Center of Excellence. Journal of 

Rehabilitation Research and Development. Submitted for publication.

31. Hasanat Alamgir, Lung-Chang Chien, Xiao Yu, David Tucker, Caryn Turner, Jose 

Betancourt, Sharon Cooper, LTC Andrew Senchak, Col Mark Packer, Tanisha Hamill. 

Outpatient Costs of Hearing Impairment and Noise-Induced Hearing Injury borne by the 

U.S. Department of Defense. Submitted for publication.

32. Hasanat Alamgir, Lung-Chang Chien, Xiao Yu, David Tucker, Caryn Turner, Jose 

Betancourt, Sharon Cooper, LTC Andrew Senchak, Colonel Mark Packer, Tanisha 

Hamill. Estimating costs through Markov Models: Economic Burden of Hearing Loss to 

the US Military. Submitted for publication.

 Special Edition Editor - Subject coordination

1. Psychiatric Annals. Diagnosis, and Management of Polytraumatic TBI. Seven articles 

coordinated for publication. 43(7), 2013.

2. Otology Neurotology. Pharmaceutical Intervention for Hearing Loss. Twelve articles 

coordinated and published. 37(8), 2016.

3. Hearing Research. Noise and Hearing – Performance, Monitoring and Degeneration. 

Twenty Three articles coordinated and published. Vol 349 June, 2017.

4. International Journal of Audiology. Ototoxicity and Targeted Therapeutics for 

Hearing Loss. Supplement and manuscripts in development.

5. Frontiers in Cellular Neuroscience. Ototoxicity: basic cellular mechanisms. 

Supplement and manuscripts in development.

CONTRIBUTING AUTHOR/COLLABORATOR/EDITOR/COORDINATION REVIEW

 VA/DoD Collaboration Guidebook for Healthcare Research, First Edition, 2010

 Defense Center of Excellence for Psychological Health and Traumatic Brain Injury

(TBI) Assessment and Management of Dizziness Associated with Mild TBI, 2012

 Agency for Health Quality Research – Clinical Evidence Review – Tinnitus, 2012

 Bouton K. Shouting Won’t Help. Why I – and 50 Million Other Americans – Can’t

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 118 of 265
Hear You. Sarah Chrichton Books – Farrar Straus and Giroux. Contributor, Packer

MD. 2013

 Military Health System 5-Year Strategic Plan for Collaborative Research and Shared

Resources, 2013.

 VA/DoD Collaboration Guidebook for Healthcare Research, Second Edition, 2013

 Institute of Medicine – Chronic Effects of Blast Trauma, 2013

 American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice

Guidelines – Tinnitus, 2014

 National Research Action Plan, Jan, 2014

 Gulf War: Long-Term Effects of Blast. Institute of Medicine, National Academies Press,

2014

 Anatomy, Physiology and Diseases of the Ear: Training video and Chapter for CAOHC 

certification courses 

PEER REVIEW FOR:

Journal of Rehabilitation Research and Development

The Laryngoscope

Annals of Otolaryngology

Agency for Health Quality Research

International Journal of Audiology

Joint Programmatic Committee 5 – Military Operational Medicine Research Program

Joint Programmatic Committee 8 – Clinical Rehabilitative Medicine Research Program

RESEARCH SUPPORT

1. Grant/Award Number: PI: D. Bradley Welling 9/01/2012 to 8/31/2016

Title: Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

Role: PD/PI

Total Amount: $1,494,334

Brief Description of Goals: Evaluate the efficacy of topically placed FGF assisted tympanic

membrane healing on chronic tympanic membrane perforation.

2. Grant/Award Number: PI: Mark D. Packer 9/2012 to 10/27/2015

Title: “Vagus Nerve Stimulation for the Relief of Combat Related Tinnitus”

Role: PI

Total amount: $2,450,389.35

Brief Description of Goals: Utilization of a fully implanted vagal nerve stimulator to enhance

neuroplasticity through neuromodulation of combat related tinnitus.

3. Grant/Award: PI: Kathleen Campbell 3/1/2011 to 3/31/2015

Title: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL): A Phase 3 Clinical Trial

Role: Medical Monitor

Total Amount: $2,646,812

Brief Description: To determine the role for D-Methionine (D-Met) to reduce or prevent NIHL.

This clinical trial will also provide assessment of protection from noise induced tinnitus.

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 119 of 265
4. Grant/Award: PI: Marom Bikson Sept 2013 – Sept 2014

Title: Multi-Scale Electro-Mechanical Stimulation (MEMS) of the Human Head

Role: Associate PI

Total Amount: $ 250,000

Brief Description: High Resolution anatomical and physics-based biomechanical models to

predict effects of neuromodulation, auditory implants and cochlear mechanics.

5. Grant/Award: PI: Mark Packer Sept 2012- Dec 2014

Title: Tinnitus Reorganization Training: Treating Combat-Related Tinnitus by Combining

Individually Modulated and Filtered Music with transcutaneous Vagal Nerve Stimulation.

Role: PI

Total Amount: $350,000

Brief Description: Use of novel percutaneous means of cranial nerve neuromodulation in

conjunction with sound therapy as a treatment for tinnitus.

6. Grant/Award: PI: Mark Packer Oct 2015- Sept 2018

Title: Alternate tinnitus management techniques developed using blood-oxygen-level-dependent

MRI with neurofeedback.

Role: PI

Total Amount: $1,811,000

Brief Description: Use of neuroimaging techniques to guide tinnitus management.

SMALL BUSINESS INNOVATION RESEARCH AWARD AUTHOR

Mobile Applications/Web-Based Management Solutions for Hearing Injuries - 2013

Objective Measurement tool for detection and monitoring of noise-induced hearing loss - 2014

OTHER RESEARCH/SCHOLARLY ACTIVITIES

Health Performance Physiology Laboratory–Research assistant - USUHS, 1993-94

The effect of micro-electric current therapy on postoperative narcotic use patterns, 1996.

The Effects of 2-Octyl-Cyanoacrylate (Dermabond) On the Middle and Inner Ear Using a

Chinchilla Model.

Otologics Fully-Implantable MET Ossicular Stimulator Re-Implant Clinical Trial – Phase III IDE

multisite trial. Site PI - 2009

Developing policy for accessing blast effected ears for the temporal bone registry – 2010.

North Atlantic Treaty Organization (NATO), Human Factors in Medicine Science and

Technology Organization 229, United States Representative:

Koblenz, Germany 2011

Brussels, Belgium 2012

San Antonio, Texas 2012

Munich, Germany 2014

National Tinnitus Retraining Therapy - Multisite Trial. San Antonio Site PI. Study PI Craig

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 120 of 265
Formby, 2012-present.

Chronic Effect of Neurotrauma Consortium; Neurosensory advisor and Associate Investigator,

2014.

Defense Epidemiological and Economic Burden of Hearing Loss Study Director, 2012-Pres.

Oticon Medical Scientific panel member, Copenhagen, Denmark, 2013.

American Academy of Otolaryngology – Head and Neck Surgery; Miniseminar – The role of the

military otolaryngology surgeon in treating blast injuries; Washington DC, 2012.

Air Force Trends in Hearing Loss – Can We Identify Ears at Risk? IRB approved, 2015.

NATIONAL/INTERNATIONAL PRESENTATIONS

1. Southern Medical Association. Basaloid Squamous Cell Carcinoma: A series of Cases and

Review of the literature. Orlando, FL; Nov, 2000.

2. Southern Medical Association. Neurofibromatosis Type II...NOT. A case of Neurosarcoidosis

Presenting as Bilateral IAC masses. Nashville, TN; Nov, 2001.

3. American Otologic Society at Clinical Otolaryngology Spring Meeting. Cochlear Hemorrhage

as the Presumptive Cause of Sudden Sensorineural Hearing Loss, A Series of Cases. Boca Raton,

FL; May 2002.

4. 26th Annual Politzer Society. Giving Mutant Merlin a Hand: Potential medical management of

Vestibular Schwannoma. Cleveland, OH; October 2007.

5. 54th annual Society of Air Force Clinical Surgeons Symposium. Inhibition of the PI3 Kinase /

AKT pathway as a treatment strategy for HMS/VS. Cincinnati, OH; Apr, 2008.

6. 54th annual Society of Air Force Clinical Surgeons Symposium. Biological progression of a

rapidly growing recurrent VS. Cincinnati, OH; Apr, 2008.

7. 17th annual alumni symposium Saunders lectureship. The Ohio State University; Biological

progression of vestibular schwannoma: Implications for a novel treatment strategy. Columbus,

OH; June, 2008.

8. Grand Rounds Georgetown Hospital. Anatomy and Physiology of Hearing and Balance.

Georgetown Guyana; Aug, 2009.

9. Grand Rounds Georgetown Hospital. Surgical Treatment of Vertigo. Georgetown Guyana;

Aug, 2009.

10. Telemedicine and Advanced Technology Research Center Integrating Research Team state of

the science seminar. Hearing Center of Excellence. San Diego, CA; Feb, 2010.

11. National Center for Rehabilitative Auditory Research. Updates and integrations of the 

Hearing Center of Excellence. Portland, OR; Aug, 2010

12. Chairman, Hearing Loss Panel, Annual Symposium of the National Trauma Institute. San

Antonio, Aug 2010.

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13. The Third Annual Trauma Spectrum Conference: Emerging Research on Polytrauma,

Recovery and Reintegration of Service Members, Veterans and their Families. The Hearing

Center of Excellence and its Role in Multisensory Trauma and Rehabilitation. Bethesda, MD;

Dec, 2010.

14. Advanced Technology Applications for Combat Casualty Care; Director and Panel Chair,

auditory sensory breakout, Tampa, FL, Feb 2011.

15. Joint Defense and Veterans Audiology Conference. Auditory Center for Excellence –

Stacking the deck Against Auditory Injury. San Diego, CA; Mar 2011.

16. North Atlantic Treaty Organization Human Factors in Medicine Exploratory Team 117,

Optimizing Hearing Loss Prevention, Treatment, and Rehabilitation of Soldiers with Hearing

Impairment. Koblenz, Germany; Aug 2011.

17. National Center for Rehabilitation and Auditory Research; Panel Member 5th international:

Expanding our Horizons Panel. Oct 2011

18. International State-of-the-Science Meeting on Blast-Related Tinnitus; Clinically Objective

Manifestations of Tinnitus; Nov, 2011.

19. Recovering Warrior Task Force. Hearing Center of Excellence update. San Antonio, TX;

Dec, 2011.

20. DOD Auditory Research Working Group. Establishing a Hearing Health Research Network.

National Center for Rehabilitation and Auditory Research. Portland, OR; January 23, 2012.

21. Congressional Hearing Health Caucus. Department of Defense Hearing Center of Excellence.

Washington DC; Feb 2012.

22. Joint Defense and Veterans Audiology Conference. Department of Defense Hearing Center

of Excellence Web based Network tools. Dallas, TX, Mar, 2012.

23. Joint Defense and Veterans Audiology Conference. Developing the DOD HCE Hearing

Health Improvement Network. Dallas, TX; Mar, 2012.

24. North Atlantic Treaty Organization Human Factors in Medicine Science and Technology

Organization 229. Joint Hearing Loss and Auditory Injury Registry development. Brussels,

Belgium; Mar, 2012.

25. 55th Annual Society of Air Force Clinical Surgeons. DOD Hearing Center of Excellence

- Establishing a Hearing Health Improvement Network. San Antonio, TX; Apr, 2012

26. Traumatic Brain Injury Consortium. Allied NeuroSensory Warrior Related

Research (ANSW2R) – Defining Common Sense. Albuquerque, NM; May, 2012.

27. Joint Program Committee 8 Programmatic Review. DOD Hearing Center of Excellence -

Research Directorate Update. Fredrick, MD; May 2012.

28. USAMRMC Research Area Directorate council. Allied Neurosensory Warrior Related

Research integration. Fredrick, MD; May 2012.

29. Military Health Service Research Symposium; Director/Panel Chair, Neurosensory injury

breakout. Ft Lauderdale, FL, Aug 2012.

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30. American Academy of Otolaryngology – Head and Neck Surgery; Miniseminar - the role of

the military otolaryngology surgeon in treating blast injuries; Washington DC, Sept 2012.

31. North Atlantic Treaty Organization; Science and Technology Organization 229. Institutional

support of Hearing Health programs, DoD Policy. San Antonio, TX, Oct 2012.

32. North Atlantic Treaty Organization; Science and Technology Organization 229.

Epidemiology of Hearing Loss and Auditory Injury. San Antonio, TX; Oct 2012.

33. US Army Medical Research and Materiel Command Task Force - 5yr research roadmap.

Translational Research through the Auditory Research Working Group. Ft Detrick, MD, Dec

2012.

34. Recovering Warrior Task Force. Hearing Center of Excellence Update. Crystal City Virginia,

Jan 2013.

35. Keynote Presentation - Joint DoD/VA Audiology Conference. Hearing Center of Excellence:

a Hearing Health Improvement Network. Nashville, Mar 2013.

36. DoD Individual Medical Readiness Working Group. Individual medical Readiness –

Implementing newborn hearing screening as a military surveillance strategy. Falls Church, VA,

2013.

37. Director, Panel Chair, Neurosensory injury breakout, Military Health Service Research

Symposium, Ft Lauderdale, FL, Aug 2013.

38. Military Health Services Research Symposium. A Comprehensive Hearing Health Program.

Fort Lauderdale, FL, Aug 2013.

39. Military Health Services Research Symposium. Hearing Readiness – Use of Otoacoustic

Emissions as an Individual Medical Readiness Metric. Fort Lauderdale, FL, Aug 2013.

40. Recovering Warrior Task Force update: DoD Hearing Center of Excellence. San Antonio,

TX Dec 2013.

41. Senate Armed Service Committee update: DoD Hearing Center of Excellence. Washington

DC, February 2014.

42. Keynote Presentation - Joint DoD/VA Audiology Conference. A tincture of transparency

for the invisible injury - A 2020 auditory vision. Las Vegas, NV, March 2014.

43. Joint DoD/VA Audiology Conference. A retrospective record review of cervicogenic vertigo

in a traumatic brain injury population. Las Vegas, NV, March 2014.

44. Joint DoD/VA Audiology Conference. New Developments in Implantable Devices –

Emerging Technologies in Bone Conduction and Middle Ear Implants. Las Vegas, NV, March,

2014.

45. Collaborative Auditory Vestibular Research Network (CAVRN) Symposium. Prioritized

mining of the CAVRN. Auditory Research Lab, Aberdeen Proving Grounds. April, 2014.

46. Collaborative Auditory Vestibular Research Network (CAVRN) Symposium. Defense

Epidemiologic and Economic Burden of Hearing Loss Study – development of the Markov

model. Auditory Research Lab. April, 2014.

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 123 of 265
47. Collaborative Auditory Vestibular Research Network (CAVRN) Symposium. Cochlear

modeling through Multiscale Electro Mechanical Simulation. National Intrepid Center of

Excellence. April, 2014.

48. Academy of Occupational Medicine Conference – Hearing Conservation. Defense Hearing

Excellence – A Comprehensive Hearing Health Program. April, 2014.

49. Navy Submarine Medical Research Laboratory. The Defense Hearing Center of Excellence;

submerged – Occupational Hearing requirements. Groton, CT, May, 014.

50. American Industrial Hygiene Conference & Exposition – AIHCE. The Department of

Defense Epidemiologic and Economic Burden of Hearing Loss Study: Progress on Economic

Burden Study. San Antonio, TX, June, 2014.

51. American Industrial Hygiene Conference & Exposition –AIHCE. The Department of Defense

Epidemiologic and Economic Burden of Hearing Loss Study: Project Overview. San Antonio,

TX, June, 2014 San Antonio

52. Anatomy and physiology of a blast. Audiology on Line. June, 2014.

53. Military Health System Research Symposium. Reintegration through newly FDA approved

Middle Ear Implant Devices. Ft Lauderdale, FL, August, 2014.

54. MHSRS Military Health System Research Symposium. Comparison of Electronic Research

Intelligence Networking Tools. Ft Lauderdale, FL, August, 2014.

55. Defense Hearing Excellence Pharmaceutical Intervention for Hearing Loss Symposium.

Guidelines to finding the right PIHL. Annapolis, MD, August, 2014.

56. VA Denver Acquisition and Logistics Center. Solutions to the Military Paradox - Tactical

Communication and Hearing Protection. Golden, CO, September, 2014.

57. Exercise in Communication and Hearing Operation – Tactical Communication and

Protection Systems. Quantico, Marine Corp Base; Sept, 2014.

58. Defense Hearing Requirements. Joint Programmatic Committee 8. Ft Detrick, MD; Dec,

2015.

59. Novel modeling of the human cochlea - high resolution imaging and super computer

technologies overcoming inherent anatomical barriers New York, NY; Jan, 2015.

60. Hearing Performance enhancement and protection. Joint Programmatic Committee 5. Ft

Detrick, MD, Jan, 2015.

61. Hearing Health, a Military responsibility. 25th annual SAUSHEC temporal bone surgical

dissection course. San Antonio, TX, Feb, 2015.

62. Fluid Solid Interface through Finite Difference, Time Domain modeling. MEEI breakout at

Association for Research in Otolaryngology. Baltimore, MD, Feb, 2015.

63. Hearing Center of Excellence annual update. Joint Defense and Veterans Audiology

Conference. Orlando, FL, Mar, 2015.

64. Defense Epidemiology and Economic Burden of Hearing Loss update. NATO RTO 229.

Chamonix, France, Mar, 2015.

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 124 of 265
65. Gaining Reintegration Potential in Hearing Rehabilitation through Middle Ear Implants.

NATO, RTO 229. Chamonix, France, Mar, 2015.

66. The Department of Defense Hearing Center of Excellence Research Coordination. UK

Health Services Research Directorate. University of Birmingham, Birmingham, UK, Mar, 2015.

67. Collaborative Auditory Vestibular Research; Enhancement, Prevention, Diagnostic,

Therapeutic and Restorative Hearing Health Care. San Diego, CA, Mar, 2015.

68. Epidemiological update on DoD hearing loss. San Diego, CA, Mar, 2015.

69. Otoacoustic Emission and other booth-less strategies for Defense hearing conservation. San

Diego, CA, Mar, 2015.

70. Tinnitus Reorganizational Therapy with transcutaneous vagal nerve neuromodulation. Mass

Eye and Ear Infirmary/Harvard. Boston, MA, Apr, 2015.

71. Auditory and Vestibular Effects of Repeated High-Level Blast. State of the Science

Symposium Blind and low vision and Hearing impairment care and rehabilitation for wounded,

injured, and ill Veterans. USUHS, Bethesda, MD, Apr, 2015.

72. Department of Defense Military Health System Perspective on Hearing Rehabilitation. 

Institute of Medicine Task Force assessing restrictions to hearing rehabilitation. Washington 

DC, Apr, 2015.

73. The Hearing Paradox, applying Physics through Microscale ElectroMechanical Simulation.

Massachusetts Institute of technology, Mass Eye and Ear Infirmary/Harvard. Boston, MA, Jul,

2015.

74. Moving Hearing Conservation Forward, Protecting Against Hidden Hearing Loss. San

Antonio Military Medical Center/ University of Texas Research Forum. San Antonio, TX, Jul,

2015.

75. The Defense Epidemiology and Economic Burden of Hearing Loss Study. San Antonio

Military Medical Center/ University of Texas Research Forum. San Antonio, TX, Jul, 2015.

76. Acoustic Injury: Lessons Learned From a Decade of War. Military Veterans Health

Conference. Washington, DC, Jul, 2015.

77. Combat Tinnitus: The Din of War. Tinnitus Miniseminar. American Academy of

Otolaryngology Annual Meeting, Dallas, TX, Sept 2015.

78. Cochlear Implantation across the age spectrum: a military perspective. American 

Cochlear Implant Association, CI2015, Washington, DC, Oct 2015.

79. United States personal protective standards update: hearing protective equipment. 

Land Capabilities Group, Combat Clothing Individual Equipment and protection 

(CCIEP), NOISE workshop, Budapest, Hungary, Oct 2015.

80. Lessons Learned from a Decade of War: Hearing Center of Excellence. AMSUS, 

San Antonio, TX, Nov, 2015.

81. The Epidemiology of Hearing Injuries, Noise Exposures and Hearing Loss in the 

Military. AMSUS, San Antonio, TX, Dec, 2015.

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 125 of 265
82. Introduction to Pharmaceutical Interventions for Hearing Loss (PIHL) plenary 

block - Standardizing research developing SNHL countermeasures. Association for 

Research in Otolaryngology, San Diego, CA, Feb, 2016.

83. Epidemiology of Hearing Impairment and Injuries among Active Duty U.S. 

Military Service Members. JDVAC, St Louis, MO, Feb, 2016.

84. Candidacy Considerations for Middle Ear and Cochlear Implants. JDVAC, St 

Louis, MO, Feb, 2016.

85. Research Update: Echoes of the Collab Auditory/Vestibular Research Network. 

JDVAC, St Louis, MO, Feb, 2016.

86. Strategic Planning for Hearing Health. Decibel Therapeutics Clinical 

Translational research Workshop. Boston, MA, Oct, 2017.

POSTER PRESENTATIONS

Ow, RA; Packer, MD; Carrier, DA; Arriaga, MA. Imaging and Surgical

Technique of Cochlear Implantation for Advanced Otosclerosis. Presented at the 100th

Annual meeting, American Academy of Otolaryngology-Head and Neck Surgery,

Washington, D.C., Sept. 1996.

Packer, MD; Simko, EJ; Fowler, C. Basaloid Squamous Cell Carcinoma: A series of Cases and

Review of the literature. Southern Medical Association, Orlando, FL, Nov. 2000.

Packer, MD; Horlbeck, D. Effects of 2-Octyl-Cyanoacrylate (Dermabond) On the

Middle and Inner Ear Using a Chinchilla Model.

Mark Packer, Elena M. Akhmametyeva, Long-Sheng Chang, and D. Bradley Welling. An

Unusually Large, Recurrent Vestibular Schwannoma. Neurofibromatosis and the Childrens

Tumor Foundation; Park City UT, June 2007.

Packer MD. Department of Defense Hearing Center of Excellence’ Role in Multisensory

Trauma and Rehabilitation. Third Annual Trauma Spectrum Conference; Dec, 201.

Hammill T, Packer MD. Department of Defense Hearing Center of Excellence: Providing

Facilitation of Translational Research in Auditory Injuries. Practice Based Research

Convocation; San Antonio, TX, Oct 2011.

Hammill T, Dion G, Packer MD. Association for Research in Otolaryngology. Providing

Facilitation of Translational Research in Auditory Injury. Baltimore MD, Jan 2013

Bandino ML, Packer M, Tankersley M. Successful treatment of exercise-induced anaphylaxis

with omalizumab. Poster/Presentation at the American Academy of Allergy, Asthma and

Immunology conference, San Francisco, CA, 2012.

Hammill T, Packer MD. The Defense Hearing Center of Excellence Pharmaceutical Intervention

in Hearing Loss Collaborative Research Working Group. Military Health Services Research

Symposium, Fort Lauderdale, FL, Aug 2015.

Packer MD, Nelson J, Crawford JV. Middle Ear Implants: Brining Reintegration Potential to the

Fight. Military Health Services Research Symposium. Fort Lauderdale, FL, Aug, 2015.

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 126 of 265
De Paolis, A; Fung, L; Nelson, J; Biksom; M Packer, M; Cardoso, L. The Traveling Wave

Paradox in the Human Ear. Military Health Services Research Symposium. Fort Lauderdale, FL,

Aug, 2015.

Hammill T, Fallon E, Gates K, Packer M. The Department of Defense Hearing Center of

Excellence (HCE) Exercise in Communication and Hearing Operations (ECHO) training.

Military Health Services Research Symposium. Fort Lauderdale, FL, Aug, 2015.

Buchanan K, Cook L, Slade M, Esquivel C, Camou E, Packer M. Investigating Hearing Loss as

Risk Factor for Mishap. Military Health Services Research Symposium. Fort Lauderdale, FL,

Aug, 2015.

Lewine JW, Packer MD. Tinnitus ReOrganization Therapy. Military Health Services Research

Symposium. Fort Lauderdale, FL, Aug, 2015.

Hammill T, Packer MD. Fostering “Joint” Research Collaboration: an Overview of the Hearing

Center of Excellence (HCE) Collaborative/Auditory/Vestibular Research Network (CAVRN).

Portland, OR, Sept, 2015

Gimeno D. Almagir H, Betancort J, Packer MD. The Epidemiology of Hearing Injuries, Noise 

Exposures and Hearing Loss in the Military. AMSUS, San Antonio, TX, Dec, 2015.

Hammill T, Marshall K, Murphy S, Camou E, Brooks K, Crawford J, Packer M. “Research 101”-

A Hearing Center of Excellence Initiative to Encourage and Facilitate Research Engagement 

Across DoD Medical Treatment Facilities. Submitted to JDVAC – San Diego, CA, Mar 2017.

MEDIA INTERVIEWS:

Philpott T. Addressing an epidemic of hearing-loss injuries. For Stars and Stripes. 8 Sept, 2011.

Philpott T. War Veterans Facing an Epidemic of Hearing Loss. F or The Hearing Journal. Oct,

2011.

Yishane Lee. Managing Hearing Loss – The Military Paradox. Hearing Health Foundation. Vol

27(3); 2011.

Stump, E. A Salute to the Veterans. Hearing Health. For Hearinghealthmag.com 20-23, 2012.

Bohannon J. Hearing loss and Military Service. For The Jim Bohannon Radio Show, May

2012.

CBS Armed Forces Day interview with Mark Packer MD. May 2012.

Fink J. Otolaryngologists Work to Heal Hearing Loss in U.S. Military Troops. For ENT Today Jan 

2013.

Strauss A. Florida Psychiatric Society Podcast. Sept 2013.

Kime P. DoD’s new battle against hearing loss. For Army Times. Jan 2014.

Jarvis, Lisa. Growing Need: The military is trying to coordinate research efforts around

hearing loss. For The Journal of Chemical and Engineering News. Apr 2014.

Philpott, Tom. Better surveillance key to reducing hearing loss. For Military update/Military.com

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 127 of 265
Fink, Jennifer. War Wounds: Hearing Loss Tracks Gulf War Vets. For MedPage Today. May 

2014.

Lee, Yashine. The Promise of PIHL. Hearing Health Magazine. Summer, 2014,Vol.30(3),p22.

Marcus, Amy. Army Tests Hearing Drug at the Rifle Range. The Wall Street Journal. Aug, 2015.

Roach, Mary. Grunt: The Curious Science of Humans at War, Fighting by Ear – The conundrum 

of military noise. 2016.

Cahn, Dianna. Doctors say long-neglected ear injuries from war now getting the critical attention 

needed. For stars and Stripes. Dec, 2015.

Mingle, Katie. 99percentinvisible podcast. July, 2016.

Bradley, Ryan. New Public Magazine. July, 2016.

LOCAL PRESENTATIONS:

(1-8) Presentations given at the Columbus Children’s Research Institute grand rounds 2006-2008

1. -A Two-Step Mechanism underlies the planar polarization of regenerating sensory hair cells.

2. -Ocular Pathologic Findings of Neurofibromatosis Type 2.

3. -Lipid Raft Localization of ErbB2 in Vestibular Schwannoma and Schwann Cells.

4. -Malignant Transformation and new primary tumours after therapeutic radiation for benign 

disease: substantial risks in certain tumor prone syndromes.

5. -Aggressive vestibular schwannoma showing postoperative rapid growth – association with 

decreased P27 expression.

6. -Giving Mutant Merlin a Hand: Potential medical treatments.

7. -PTC-124 as potential treatment of Vestibular schwannoma in nonsense mutations

8. The Ohio State University School of Medicine MSIII lecture series - presented quarterly 2007,

2008. General Otology

9. The Ohio State University School of Medicine MSI lecture series - 2007, 2008.

10. Neuroradiology Grand Rounds, The Ohio State University School of Medicine. Cranial

base lesions and their management. February, 2008.

11. The Ohio State University, Otology lecture. Hearing and Balance - Central

Audiovestibular pathways. August, 2006.

12. The OSU School of Medicine annual Temporal Bone Course. Temporal bone basics,

anatomy and microsurgery. April 2007, 2008.

13. The Ohio State University, Otology lecture. Surgical Treatment of Vertigo. March 2007.

14. Grand Rounds, The OSU Departments of Neurology and Neurosurgery. Surgical

Treatment of Vertigo. March 2007.

15. The Ohio State University, Otology lecture. Trauma to the inner ear and temporal bone.

March 2008.

16. The OSU School of Medicine annual Temporal Bone Course. Temporal bone basics,

anatomy and microsurgery. April 2008.

17. The Ohio State University, Otology lecture. Skull base surgery; Approaches and technique.

August 2007.

18. 19th Annual Temporal Bone Surgical Dissection Course, Wilford Hall Medical Center.

Temporal Bone Radiological Anatomy and Pathology. February 2009.

19. SAUSHEC Neurology Grand Rounds. Neuroanatomy of the Eighth Cranial nerve. 22

November 2009.

20. SAUSHEC Neurology Grand Rounds.Vestibulopathies and their treatment. 29 November

2009

21. SAUSHEC Allergy and Infectious disease. Review of sinonasal pathology and treatment, The

art of nasopharyngoscopy. January 2010

22. 20th Annual Temporal Bone Surgical Dissection Course, Wilford Hall Medical Center.

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 128 of 265
Pseudofractures of the Temporal bone. January 2010.

23. 20th Annual Temporal bone Surgical Dissection Course, Wilford Hall Medical Center.

January Approaches to the petrous apex. January 2010.

24. SAUSHEC Otology Grand Rounds, Wilford Hall Medical Center. Atypical Dizziness,

Superior canal dehiscence syndrome. February 2010

25. SAUSHEC Otology Grand Rounds, Wilford Hall Medical Center. Traumatic Temporal Bone

Complications. February 2010.

26. SAUSHEC Grand Rounds. Conditions that Make your Head Spin. January, 2011.

27. SAUSHEC 21st Surgical Dissection Course, Imaging of the auditory-vestibular system.

January 2012.

28. SAUSHEC Otology Grand Rounds Vestibular disease updates. January 2012.

29. SAUSHEC Annual Orbital Dissection Course; Temporal Bone trauma. August 2013.

30. SAUSHEC 23rd Surgical Dissection Course, Hearing Center of Excellence update. February, 

2014.

31. SAUSHEC 24th Surgical Dissection Course, a Microscale ElectroMechanical Simulation of 

hearing transduction – microanatomy and energy transfer. February, 2015. 

32. SAUSHEC 25th Surgical Dissection Course, Research 101. February, 2016.

33. SAUSHEC 25th Surgical Dissection Course, Middle Ear Implants, Indications and Outcomes. 

February, 2016.

34. Glomus Tumors of the Lateral Skull Base. Sound Health Services Case Conference. St Louis, 

MO, Feb, 2017

35. Atypia confounding Conductive Hearing Loss. Sound Health Services Case Conference. St 

Louis, MO. Feb, 2018.

TEMPORAL BONE COURSES

SAUSHEC Wilford Hall Medical Center 1998-2002

University of Texas Southwestern, Dallas, TX, Course Director Fred Owens 2001

The House Ear Institute, Los Angelas, CA, Course Director John House 2005

The University of Pittsburgh, Pittsburgh, PA, Course Director Moisses Arriaga 2006

The Ohio State University, Columbus OH, Course Director Ed Dodson 2007, 2008

Course Director, 19th Annual SAUSHEC Feb 2009

Course Director, 20th Annual SAUSHEC, Jan 2010

Course Director, 21st Annual SAUSHEC, Jan 2011

Course Director, 22nd Annual SAUSHEC, Feb 2012

Course Director, 23rd Annual SAUSHEC, Feb 2013

Instructor, 24th Annual SAUSHEC, Feb 2014

Instructor, 25th Annual SAUSHEC, Jan 2015

Instructor, 26th Annual SAUSHEC, Feb 2016

Defense Otology Course Director, Emerging technologies in Middle Ear Implants, Feb 2012

Defense Otology Course Director, Emerging technologies in Middle Ear Implants, Jun 2012

Defense Otology Course Director, Esteem implant training, June 2013

Defense Otology Course Director, Emerging technologies in Middle Ear Implants, June 2014

EXTRACURRICULAR ACTIVITIES:

Alyeska Ski Patrol Hill Doctor

Boy Scouts of America leader and volunteer 

Uniformed Services University basketball team

The Church of Jesus Christ of Latter Day Saints teaching, organizational, and leadership positions

University of Utah baseball team

Missionary for the Church of Jesus Christ of Latter Day Saints, Finland

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 129 of 265
EXHIBIT B

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 130 of 265
TESTIMONIAL HISTORY

Mark D. Packer, MD

Brandt v. Breckenridge Material Company, Circuit Court of St. Louis County, Missouri

In re: 3M Combat Arms Earplug Products Liability Litigation, USDC NDFL Case No. 3:19-md-2885 

– December 17 and 18, 2020 – Deposition Testimony – General and re:

• Lloyd Baker, 7:20-cv-00039 

• Luke Estes, 7:20-cv-00137 

• Vernon Rowe, 7:20-cv-00026

In re: 3M Combat Arms Earplug Products Liability Litigation, USDC NDFL Case No. 3:19-md2885-Trial Testimony:

• April 12 & 13, 2021 (Estes, 7:20cv137; Keefer, 7:20cv104; Hacker, 7:20cv131);

• June 14, 2021 (Baker, 7:20-cv-39)

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 131 of 265
EXHIBIT C

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 132 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

8/14/1974 ANSI S3.19-1974 - Method for the 

Measurement of Real-Ear Protection of 

Hearing Protectors and Physical 

Attenuation of Earmuffs

3M_MDL000187991 3M_MDL000188001

1/1/1979 ANSI S3.19-1974 (R 1979) - Method for 

the Measurement of Real-Ear Protection 

of Hearing Protectors and Physical 

Attenuation of Ear Muffs

3M_MDL000023299 3M_MDL000023318

8/1/1979 Regulatory Analysis Supporting the 

Noise Labeling Requirements for 

Hearing Protectors

3M_MDL000846273

8/1/1979 US EPA (1979) Product Noise Labeling 

Requirements

1/1/1980 Berger (1980) Hearing Protector 

Performance - How They Work and 

Why They Fail in the Real World

CTRL3M000000224

12/17/1984 ANSI-ASA S12.6-1984

1/23/1986 Letter re Notice of Revised NRR Testing 

and Labelling 

3M_MDL000019674 3M_MDL000019677

9/19/1989 Falco Description of Claims re U.S. 

Patent No. 4,867,149

9/19/1989 U.S. Patent No. 4,867,149

7/2/1991 Kieper (1991) Comparison of the 

UltraFit Earplug to a Stiff-Stemmed 

Version of the Plug (V2.2)

3M_MDL000195431 3M_MDL000195454

5/19/1992 Etymotic Audibility Earplug U.S. Patent 

5113967

3M_MDL000109345 3M_MDL000109356

11/17/1992 Importance of EARCAL Log 20 and 

Incremental Impact on its Liability is 

Small

3M_MDL000321233 3M_MDL000321234

4/7/1993 DoJ Fine to Cabot EARCAL Lab 3M_MDL000024833 3M_MDL000024843

6/23/1993 Berger Ltr to Dancer re Development of 

Non-Linear Plug

3M_MDL000712631 3M_MDL000712631

1

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 133 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

6/24/1994 Gardner, Falco (1994) Critique of the 

UltraFit Earplug

3M_MDL000495675 3M_MDL000495675

6/24/1994 Gardner, Falco (1994) Critique of the 

UltraFit Earplug

3M_MDL000779978 3M_MDL000779978

10/26/1994 European Patent No. 0 440 572 81 3M_MDL000019719 3M_MDL000019726

2/1/1996 Cabot Safety Corp January Monthly 

Report

3M_MDL000438024 3M_MDL000438024

2/1/1996 Doty Lab Notebook 3M_MDL000684796

4/1/1996 Cabot Safety March Monthly Report 3M_MDL000627013 3M_MDL000627013

9/1/1996 Daniel L. Johnson Army Research Lab 

Blast Overpressure Studies

10/3/1996 EAR Plug HPDA Database Entry (Test 

121634)

3M_MDL000319672 3M_MDL000319673

1/1/1997 Dancer, Evrard (1997) Study and 

Production of Nonlinear Perforated 

Earplugs (Translated ISL Article - 

Colored)

3M_MDL000325290 3M_MDL000325290

01/13/1997 Dancer Ltr to Ohlin re CAEv2 Product 

Dev and Confidentiality Agreement 

Correspondence

CTRL_3M_Touhy000

00130

CTRL_3M_Touhy0000

0134

2/21/1997 ANSI-ASA S12.6-1997

3/26/1997 Aearo Blueprint re ISL UltraFit 

Assembly

3M_MDL000425507 3M_MDL000425507

3/28/1997 EARCAL Attenuation Test Report 

143001 - UltraFlex 

3M_MDL000320306 

3/30/1997 EARCAL Attenuation Test - 143003 

UltraFlex 

3M_MDL000320308 

4/16/1997 Berger Ltr to ISL re Modifying UltraFit 

to Fit Non-Linear Filter

3M_MDL000425674 3M_MDL000425674

2

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 134 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

4/16/1997 Berger to ISL re Reducing Filter Size, 

Developing New Molds, and ISL 

Testing New Samples

3M_MDL000637265 3M_MDL000637266

4/24/1997 EARCAL Attenuation Test Report - 

143002 - UltraFlex 

3M_MDL000320307 

6/9/1997 ISL Email re Favorable Results for 

UltraFit Plus ISL Filter vs HL Classic 

Earplugs and Logistics

CTRL_3M_Touhy000

00234

CTRL_3M_Touhy0000

0235

7/1/1997 Johnson, Patterson (1997) Effectiveness 

of a Leaking Earmuff vs Leaking 

Earplug (USAARL Report 97-23) 

7/4/1997 Dancer Email to E. Berger re Stem and 

Diameter Reduction

3M_MDL000013024 3M_MDL000013026

7/11/1997 Berger Notes on A. Dancer Email re 

Stem and Diameter Reduction

3M_MDL000013027 3M_MDL000013028

7/25/1997 ISL Email to Berger re CAE Prototypes 

and Potential Problems with Prototype 

Designs

3M_MDL000427465 3M_MDL000427467

8/4/1997 Aearo Company Issues and Position 

Statements

3M_MDL000427651 3M_MDL000427651

8/11/1997 Doty's Technical Notebook from 1997 

08 11 to 2000 01 25 

3M_MDL000654953

12/16/1997 Aberdeen Proving Ground Minute Mtg 

Notes

3M_MDL000425673 3M_MDL000425673

12/24/1997 December Monthly Aearo Lab Memo 3M_MDL000434810 3M_MDL000434810

12/27/1997 December Monthly EARCal Lab Memo 3M_MDL000434810 3M_MDL000434810

01/22/1998 Schematic Nonlinear Ultrafit Plug 3M_MDL000572003 3M_MDL000572004

3/24/1998 Aearo CAEv2 Blueprint Drawing - 

Reversible Nonlinear UltraFit Plug 

Assembly

3M_MDL000571966 3M_MDL000571967

3

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 135 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

3/24/1998 Knauer Ltr to Ohlin re 25 Non-Linear 

Earplug Samples and Possible Color 

Change

DOD00000257

4/9/1998 DoD Hearing Conservation Mtg Agenda 

with Garinther-ISL Notes

CTRL_3M_Touhy000

00059

CTRL_3M_Touhy0000

0075

4/9/1998 DoD Hearing Conservation Mtg Agenda 

with Garinther-ISL Notes

DOD00000059

5/1/1998 Johnson (1998) Blast Overpressure 

Studies

3M_MDL000014015 3M_MDL000014292

09/23/1998 213017 UFit end CAE 3M_MDL000319276

9/23/1998 CAEv4.1 testing; compares attenuation 

of the CAEv4 and CAEv4.1

3M_MDL000326207

9/23/1998 Test ID 215009 3M_MDL000033784

11/25/1998 Summary of Attenuation Data 3M_MDL000057368

1/10/1999 CAEv 4 NRR 17 on closed end 3M_MDL000313398

2/4/1999 design blueprint/CAD drawing for 

"Ultrafit Stem"

3M_MDL000605261

2/4/1999 Policies and Procedures Manual for 

Aearo EARCAL Acoustical Lab (V5.2)

3M_MDL000014573 3M_MDL000014639

3/3/1999 Aearo-ISL License Agreement 3M_MDL000020535 3M_MDL000020568

3/23/1999 Design and specs for Traceable UltraFit 3M_MDL000654766

4/6/1999 DoD Memo re Request for Modification 

of Earplug Carrying Case

CTRL_3M_Touhy000

00318

CTRL_3M_Touhy0000

0321

4/9/1999 Aearo-Military Thread re CAE Purchase 

and Design Change - E1_A1 (DOJ 

Touhy Production)

CTRL_3M_Touhy000

00135

CTRL_3M_Touhy0000

0141

4/9/1999 Aearo-Military Thread re CAE Purchase 

and Design Change

DOD00000135

4/9/1999 Ohlin and Myers re Shortening the 

CAEv2 Stem by 1/4''

3M_MDL000569995 3M_MDL000569996

4

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 136 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

4/9/1999 Shaver Design Meeting Memorandum re 

Combat Arms Earplugs

3M_MDL000570344 3M_MDL000570345

4/12/1999 Myers Forward Email re Justification 

Memo Edits and Ohlin CAEv2 

Comments

3M_MDL000569956 3M_MDL000569958

4/12/1999 Ohlin to Hoffman (Army) re Three 

Reasons for Shorting Production 

Samples

3M_MDL000569956 3M_MDL000569958

4/27/1999 CAE Ultraflex Parts and Whole 

Assembly Blueprints

3M_MDL000393831 3M_MDL000393841

4/27/1999 specs with original double sided design 3M_MDL000017774 3M_MDL000017784

4/27/1999 specs with original double sided design 3M_MDL000017774 3M_MDL000017784

5/18/1999 Ohlin letter re CAEv2 CTRL_3M_Touhy000

00292

CTRL_3M_Touhy0000

0297

5/20/1999 Ohlin-Myers Thread re Selling CAEv2 

to John King for Italian Army: Myers 

10/18/2019 Deposition Exhibit 35

6/8/1999 Kieper to Knauer and Falco Memo re 

CAE ARMM Measurements of 

Production Filters

3M_MDL000011806 3M_MDL000011806

6/30/1999 Kalb, Garinther, Golden, Price (1999) 

ARL-HRED HPD Assessments in 

Reverberating Environments

CTRL_3M_Touhy000

00090

CTRL_3M_Touhy0000

0094

7/7/1999 UltraFit Plus NRR Test 213014 3M_MDL000534450 3M_MDL000534450

7/21/1999 Shaver Meeting Notes re CAE 

Manufacture and Delivery Progress

3M_MDL000590438 3M_MDL000590440

08/02/1999 Aearo Email re New CAEv2 NSN 3M_MDL000332281 3M_MDL000332281

8/3/1999 Myers and Knauer re Falco 

Recommends Proceeding with Assembly 

Tolerance between Stem and Filter

3M_MDL000591375 3M_MDL000591375

08/10/1999 United States Patent -5,936,208 3M_MDL000692972

5

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 137 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

08/16/1999 Shaver Design Meeting Memorandum re 

Combat Arms

3M_MDL000569932 3M_MDL000569934

8/23/1999 Michael & Associates Letter re Ultrafit 

Plus Attenuation Data (Q040A)

3M_MDL000227606

9/1/1999 Berger (1999) So, How Do You Want 

Your NRRs - Realistic Or Sunny Side 

Up? Article

3M_MDL000439465 3M_MDL000439465

9/7/1999 Ohlin Email re CAEv2 Fits for 95% 

Adult Male Population (Missing 

Attachments)

CTRL_3M_Touhy000

00129

CTRL_3M_Touhy0000

0129

10/12/1999 4046-1- stem assembly for CAEv2-3M 3M_MDL000017802

11/8/1999 Myers to Ohlin re Specs and Data 

Request from Bosanko

3M_MDL000258589 3M_MDL000258589

11/17/1999 Aearo Product Management Org Chart 3M_MDL000015373 3M_MDL000015373

11/18/1999 Project Summary Sheets re CAEv2, 

ANSI Adoption, etc.

3M_MDL000334224 3M_MDL000334225

11/19/1999 Email attaching Bubble Sheets and 

CAEv2 Project Summary Sheet

3M_MDL000259188 3M_MDL000259221

11/19/1999 Email re No Testing Data on CAEv2 

Before Selling to US Military in 1999

3M_MDL000257805 3M_MDL000257805

11/22/1999 Email re ISL to Test CAEv2 3M_MDL000257806 3M_MDL000257806

12/13/1999 Ultrafit Stem Technical Drawing 4055-

A

3M_MDL000605262 3M_MDL000605262

12/17/1999 Raw Audiogram Data for Test ID 

213016 Subject MKF

3M_MDL000311816 3M_MDL000311818

12/28/1999 Aearo Company Analytical Laboratory 

Report re CAEv2 Plug

3M_MDL000755094 3M_MDL000755100

1/1/2000 Berger (2000) The Naked Truth about 

NRRs

1/18/2000 Ultrafit Plus Technical Drawing 2067-A 3M_MDL000654767 3M_MDL000654767

6

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 138 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

01/24/2000 Bosanko to Myers re CAEv2 

Information Packet Request and Basic 

Unit Implementation

3M_MDL000332277 3M_MDL000332277

1/24/2000 Work Order Request for CAEv2 Slides 

to Brief Navy

CTRL_3M_Touhy000

00716

CTRL_3M_Touhy0000

0720

1/25/2000 EARCAL Attenuation Test Report 

(NRR -2.0) (Open - 213016) with 

Audiograms

3M_MDL000019339 3M_MDL000019373

1/25/2000 EARCAL Attenuation Test Report 

(NRR -2.0) (Open - 213016)

3M_MDL000188143 3M_MDL000188147

1/25/2000 EARCal CAEv2 Attenuation 

Measurements (Closed - 213015)

3M_MDL000107680 3M_MDL000107691

1/25/2000 EARCal CAEv2 Attenuation 

Measurements (Closed - 213015)

3M_MDL000313390 3M_MDL000313390

2/1/2000 January Monthly EARCal Lab Memo 3M_MDL000434769 3M_MDL000434769

4/17/2000 Berger to Kieper re Results of ShortStemmed UltraFit Plug Tests3M_MDL000627115 3M_MDL000627115

5/9/2000 EARCAL CAEv2 (NRR of 21.7) 

(Colored) Test Report (Closed - 213017) 

3M_MDL000195517 3M_MDL000195524

5/9/2000 EARCAL CAEv2 (NRR of 21.7) Test 

Report (Closed - 213017)

3M_MDL000006952 3M_MDL000006959

5/9/2000 EARCAL CAEv2 (NRR of 21.7) Test 

Report (Closed - 213017)

3M_MDL000005365 3M_MDL000005368

5/11/2000 EAR Memo re Results of ShortStemmed UltraFit Plug Tests 

[DEMONSTRATIVE]

3M_MDL000570612 3M_MDL000570613

5/12/2000 Email re Existing Product has Problems 

unless User Instructions are Revised

3M_MDL000258590 3M_MDL000258590

5/30/2000 U.S. Patent No. 6,068,079 3M_MDL000188671 3M_MDL000188674

6/6/2000 U.S. Patent No. 6,070,693 3M_MDL000188664 3M_MDL000188670

7

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 139 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

6/13/2000 Knauer to Myers re Considering Falco's 

Advice to Tackle Separating Top Flange 

Issue

3M_MDL000332433 3M_MDL000332433

7/10/2000 Flange Report (Kladden) 3M_MDL000728811 3M_MDL000728816

7/10/2000 How Folding Flanges Back Affects 

REAT Results of Ultrafit End of CAEv2 

(v1.2) (1st Rog Response)

3M_MDL000005285 3M_MDL000005290

7/10/2000 How Folding Flanges Back Affects 

REAT Results of Ultrafit End of CAEv2 

(v1.2)

3M_MDL000019514 3M_MDL000019519

8/24/2000 AOSafety Indoor-Outdoor EAR Plugs 

Blister Pack Card - Front and Back

3M_MDL000425526 3M_MDL000425527

10/25/2000 Falco Research Notebook No. 5722 3M_MDL000724035 3M_MDL000724346

10/25/2000 Robert Falco's Cabot Lab Research 

Notebook

3M_MDL000724035 3M_MDL000724346

11/21/2000 U.S. Patent No. 6,148,821 3M_MDL000338061 3M_MDL000338063

11/30/2000 Cover email - performance reviews for 

Kieper & Kladden 

3M_MDL000259134 3M_MDL000259140

01/12/2001 Knauer to Myers re UltraFit Flange 

Complaint and Missing Instructions

3M_MDL000258631 3M_MDL000258631

3/1/2001 Berger-Casali Thread re Test Study and 

EAR's "No" Vote on Canadian Standard 

Adopting ANSI S12.6-1997 Method B

3M_MDL000596227 3M_MDL000596236

6/1/2001 Aearo-EAR Product Management Org 

Chart

3M_MDL000014897 3M_MDL000014897

6/6/2001 Partial EARCAL CAEv2 Attenuation 

Test Data (Open - 213023)

3M_MDL000534630 3M_MDL000534630

6/7/2001 Individual (Partial) Subject Data (Closed 

- 213024)

3M_MDL000534460 3M_MDL000534460

8

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 140 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

8/1/2001 Babeu (2001) The effects of Antioxidant 

Chloroquine and Noise Exposure on 

Auditory Brainstem Response Threshold 

and DPOEA in Guinea Pigs

8/20/2001 Major Little to Berger re CAEv2 Testing 3M_MDL000018428 3M_MDL000018428

9/18/2001 Berger Letter to Little re CAEv2 Info for 

NIOSH

3M_MDL000008624

9/18/2001 Military Noise Conf. Abstracts 2001.doc 3M_MDL000478880

9/20/2001 Army Hospital James Wax Email to 

Ohlin re CAEv2 Report

3M_MDL000017328 3M_MDL000017328

9/25/2001 Berger to Mark Little re No Instructions 

in Orders of 50 and Fit Questions

3M_MDL000018429 3M_MDL000018430

10/23/2001 CDC Email to 3M re Impulse Peak 

Level Preliminary Testing w ISL ATF 

3M_MDL000024875 3M_MDL000024875

12/11/2001 NATO (2001) Reconsideration of the 

Effects of Impulse Noise

3m_mdl000514846

02/13/2002 Babeu, et al. Project re Detection, 

Recognition, and Sound Localization 

Using Different HPDs and Related 

Documents

CTRL_3M_TOUHY00

00786

3/25/2002 Email Thread Saleem re retesting of 

Ultrafit

3M_MDL000581654

4/16/2002 Ohlin to Myers re Fold Flanges for 

Excessively Large Ear Canals

3M_MDL000017329 3M_MDL000017329

4/18/2002 Thread re Marketing CAEv2 to Military 

and Instruction Notes from Ohlin

3M_MDL000017371 3M_MDL000017372

4/19/2002 Thread re Addressing Ohlin's 

Dissatisfaction re Taking CAEv2 

through Distributors

3M_MDL000257843 3M_MDL000257844

10/31/2002 Hickey Email re Army CAEv2 

Complaint (1st Rog Response)

3M_MDL000257846 3M_MDL000257847

9

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 141 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

11/27/2002 McLain Ltr to Moldex re Aearo's 

Position re NRR Testing (Multiple Retesting Prohibited)

3M_MDL000332847 3M_MDL000332847

01/15/2003 Babeu PPT to Dancer re CAE 

Localization Study Plan

CTRL_3M_TOUHY00

002469

CTRL_3M_TOUHY00

002500

1/22/2003 CAEv2 Spec Sheet Draft (Edits by 

Myers)

3M_MDL000254134 3M_MDL000254137

02/01/2003 AMC-FAST Tracks Monthly Digest 

Articles re CAEv2

CTRL_3M_touhy0000

7880

CTRL_3M_TOUHY00

007885

3/28/2003 US EPA Workshop On Hearing 

Protector Devices Proceedings

3M_MDL000084199 3M_MDL000084409

4/9/2003 Medical Procurement Item Description 

(MPID) #1 

CTRL_3M_Touhy000

00952

CTRL_3M_TOUHY00

000954

5/7/2003 Email re Problem with Existing Product 

Unless User Instructions are Revised 

3M_MDL000570611 3M_MDL000570613

5/7/2003 McNamara to Myers re Newly Created 

CAEv2 PPT

3M_MDL000570625 3M_MDL000570626

8/4/2003 Klun, Knauer (2003) Aearo Company 

Product Development Process HPD

3M_MDL000235472 3M_MDL000235477

9/30/2003 EARCal September Monthly Report 

(Cimino Apprised of Marketing Claim 

Problems)

3M_MDL000434798 3M_MDL000434798

11/1/2003 Noblitt-Hetrick AOSafety Indoor 

Outdoor Range EAR Plugs Press 

Release

3M_MDL000702930 3M_MDL000702930

11/3/2003 Noblitt to Salon attaching Media 

Clippings including AOSafety IndoorOutdoor Range Plugs

3M_MDL000635084 3M_MDL000635091

12/31/2003 Performance Improvement Review 

Feedback Form for Bob Falco FY04

3M_MDL000340727 3M_MDL000340759

1/1/2004 Babeu (2004) Localization Wearing 

Level-Dependent HPD

3M_MDL000012358 3M_MDL000012371

10

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 142 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

1/1/2004 Readiness thru Hearing Conservation - 

Technical Guide 250 

1/8/2004 Cimino to Berger re Advising Cimino 

Non-CAE NRR After 8 Subjects to Hit 

Target NRR

3M_MDL000649705 3M_MDL000649705

1/19/2004 Berger and Cimino re Contemplating 

Continuing Non-CAE Testing for 

Desired NRR and CSA Class

3M_MDL000480086 3M_MDL000480087

2/12/2004 USACHPPM CAE Just the Facts 

Pamphlet (Colored)

CTRL3M000000134

2/12/2004 USACHPPM CAE Just the Facts 

Pamphlet (Colored)

3M_MDL000364235 3M_MDL000364235

02/21/2004 A New Hearing Protector Rating - the 

Noise Reduction Statistic for Use with AWeighting 

3M_MDL000233556

3/5/2004 DODI 6055.12 DoD Hearing 

Conservation Program (HCP)

6/15/2004 EARCAL CAEv2 (NRR of -1.1) Test 

Report (Open - 215009)

3M_MDL000004536 3M_MDL000004540

6/15/2004 EARCAL CAEv2 (NRR of -1.1) Test 

Report (with Colored Graph) (Open - 

215009) 

3M_MDL000319275 3M_MDL000319279

07/09/2004 Email re Good News on Combat Arms – 

they work great in this environment 

3M_MDL000478130

8/3/2004 Aearo Company Analytical Laboratory 

Report re Nonlinear Filter (4047-A)

3M_MDL000755095 3M_MDL000755100

08/25/2004 Myers and Ohlin re Increase for 

Individual Packaging 

3M_MDL000569256

9/1/2004 Reduction of Wind Noise for NonLinear (Single-Ended and DoubleEnded) Military Earplugs 3M_MDL000010369 3M_MDL000010385

11

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 143 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

9/2/2004 Aearo and Ohama (Army) re Improving 

CAEv2 Due to Negative Military 

Feedback and Individual Packaging

3M_MDL000569279 3M_MDL000569279

9/2/2004 Myers to CPT Ohama re Disc with 

Ohlin to Get Individual Packaging

3M_MDL000569279 3M_MDL000569279

09/13/2004 Email re Babeu Call re CAE Discomfort 

within Test Subjects and Discussion re 

Improving Comfort

3M_MDL000236156 3M_MDL000236156

9/27/2004 McNamara and Ohlin re Stock Count by 

Channel and Surgeon General Request 

re Wallet Card

3M_MDL000570163 3M_MDL000570164

9/29/2004 Work Order Request for Creation of 

CAEv2 Wallet Card

CTRL_3M_Touhy000

00712

CTRL_3M_Touhy0000

0715

9/30/2004 Blown Up Laminated CAEv2 Wallet 

Card

3M_MDL000084664 3M_MDL000084665

9/30/2004 Ohlin to Myers re Internal USACHPPM 

Disc re Wallet CAEv2 IFU Cards

3M_MDL000017330 3M_MDL000017330

10/4/2004 Army CAEv2 Feedback Report 3M_MDL000229334 3M_MDL000229334

10/4/2004 Blown Up Laminated CAEv2 Wallet 

Card (Colored)

3M_MDL000229331 3M_MDL000229332

10/4/2004 Ohlin to Army re Comments on CAEv2 

Wallet Cards

3M_MDL000013298 3M_MDL000013300

10/28/2004 Myers re Sidor to Provide Labeling 

Requirements

3M_MDL000569426

11/15/2004 Berger to Ohlin re Comfort Issues & 

Plastic Filter

3M_MDL000192859 3M_MDL000192860

11/15/2004 Thread re Draft Email Response to Plug 

Flanges and Shape Comfort Complaints 

3M_MDL000236202 3M_MDL000236202

11/29/2004 Myers re Military-Exclusive CAEv2 Is 

Not Labelled as HPD (''Separate 

Instructions Given by Trainer'')

3M_MDL000602157 3M_MDL000602157

12

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 144 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

11/29/2004 Ohlin Email re CAEv2 Feedback and 

Attached CAEv2 Laminated Cards

3M_MDL000013301 3M_MDL000013303

11/30/2004 Berger to 3M re Iraq CAEv2 Feedback 

Report and Wallet Card (Colored) Sent 

by Ohlin

3M_MDL000321549 3M_MDL000321553

1/1/2005 Aearo CAEv1 and CAEv2 Brochure 

(BW)

3M_MDL000005685 3M_MDL000005687

1/1/2005 Aearo CAEv1 and CAEv2 Brochure 

(Colored)

3M_MDL000569204

1/1/2005 Aearo Technologies Corporate 

Overview PPT for 2006 (by Pete 

Murphy)

3M_MDL000617679 3M_MDL000617681

1/1/2005 Reading This Could Save Your Life 

CAEv2 IFUs

3M_MDL000425597 3M_MDL000425600

01/20/2005 White Paper re DPOAE Study 3M_MDL000229593 3M_MDL000229605

2/2/2005 EARCal January Monthly Report (by 

Berger)

3M_MDL000321562 3M_MDL000321563

3/1/2005 Brock Sales CAEv2 Ad Comic Strip

3/4/2005 Berger EARCal Memo re Comparing 

Hearing Protector Ratings - NRR, SNR, 

SLC80, and Others

3M_MDL000556247 3M_MDL000556253

3/14/2005 Berger Email to Hamery re Miniaturized 

Filter Prototype Testing

3M_MDL000008582 3M_MDL000008582

3/18/2005 Babeu (2005) Level Dependent Hearing 

Protection and DPOAE After Small 

Arms Fire 

3M_MDL000393650 3M_MDL000393650

3/24/2005 Email and attachments: Singe s. Dual 

CAE 

3M_MDL000570063-

69

3/24/2005 Email re REAT Data for Single and 

Dual Ended CAE

3M_MDL000018817 3M_MDL000018817

3/25/2005 Email Thread 3M_MDL000016913

13

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 145 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

3/29/2005 Myers to Ohlin re Breaking CAEv2 in 

Half

3M_MDL000569081 3M_MDL000569081

4/1/2005 Thread re CAEv3 Development - From 

ISL Testing to Army White Paper 

Submission

3M_MDL000502733 3M_MDL000502749

4/1/2005 Thread re CAEv3 Development - From 

ISL Testing to Army White Paper 

Submission

3M_MDL000527216 3M_MDL000527310

5/23/2005 Spahn Email re Revised CAEv2 

Brochure Back with Santoro Edits

3M_MDL000286137 3M_MDL000286139

05/25/2005 Hetrick to Myers-Santoro re Military PR 

Initiative Proposal and Invoice Estimate

3M_MDL000552288 3M_MDL000552291

6/8/2005 215007 HPDA Report Screenshot 3M_MDL000319672 3M_MDL000319673

6/8/2005 215508 HPDA Report screenshot 3M_MDL000319672

6/8/2005 CAE Attenuation Test Report (215505 - 

215508) 

3M_MDL000534749 3M_MDL000534749

6/8/2005 CAEv2 Testing Database Entry (Closed - 

215508)

3M_MDL000018620 3M_MDL000018620

6/8/2005 CAEv2 Testing Database Entry (Open - 

215507)

3M_MDL000018619 3M_MDL000018619

6/30/2005 215511 HPDA Report Screenshot 3M_MDL000319672 3M_MDL000319673

6/30/2005 CAE Attenuation Test Report (215509 - 

215512) 

3M_MDL000534753 3M_MDL000534753

6/30/2005 CAEv2 Testing Database Entry (Closed - 

215512)

3M_MDL000016445 3M_MDL000016445

7/3/2005 Berger (1993) Establishing the 'True' 

Laboratory 

3M_MDL000237667

7/5/2005 CAEv2 Yellow End Clicker Test IFU 

(Colored)

3M_MDL000478736 3M_MDL000478736

7/12/2005 Santoro and Myers re Combat Arms 

Offense Plan

3M_MDL000569267 3M_MDL000569267

14

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 146 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

7/26/2005 Email re Answers to CAE Offense Plan 

Questions

3M_MDL000570155 3M_MDL000570156

7/29/2005 Salon attaching Operation Cobra 

Marketing Offense Plan Draft

3M_MDL000570157 3M_MDL000570158

8/11/2005 Email re firing range use of CAE 3M_MDL000569317

8/14/2005 Stars and Stripes (2005) Iraq Moving 

Toward Finalizing Constitution

3M_MDL000010738 3M_MDL000010770

08/16/2005 Myers-Military Exchange re CAEv2 

Feedback and Response

3M_MDL000257999 3M_MDL000258001

8/17/2005 Myers-Military Exchange re CAEv2 

Feedback and Response

3M_MDL000258009 3M_MDL000258012

8/22/2005 Email attaching Questionnaires from 

Soldiers re CAE

3M_MDL000285546 3M_MDL000285556

8/30/2005 Aearo EAR-Peltor Passive Hearing 2006 

Business Plan

3M_MDL000018819 3M_MDL000018855

9/15/2005 Fitting tip to flanges in a EAR ARC 

earplug (commercial)

3M_MDL000013927 3M_MDL000013927

9/22/2005 215515 HPDA Report Screenshot 3M_MDL000319672 3M_MDL000319673

9/22/2005 CAEv2-v3 Attenuation Test Report 

(215513 - 215515) 

3M_MDL000535898 3M_MDL000535898

10/12/2005 Safety Products Lab Analytical Report 

re CAEv2 Heat Resistance

3M_MDL000010349 3M_MDL000010349

10/27/2005 Santoro and Charton re Acknowledging 

Lack of CAEv2 Education and 

Elaborating Offense Plan

3M_MDL000619705 3M_MDL000619705

10/30/2005 Schulz to Aearo re SOW for CAE 

Training (Aearo-USACHPPM 

Agreement)

3M_MDL000430792

11/1/2005 MAJ Eric Fallon PPT re Painting the 

Hearing Conservation Picture

FALLON00294

15

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 147 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

11/1/2005 Performance Improvement Review 

Feedback Form for Elliott Berger

3M_MDL000578447 3M_MDL000578447

11/1/2005 Prevention of Hearing Loss - Forbes 

Slide Deck 

FALLON00318 FALLON00346

11/01/2005 Santoro to Myers re Hetrick CAE 

Graphic and Schulz Article

3M_MDL000570021 3M_MDL000570023

11/2/2005 CAE Attenuation Test Report (215516 - 

215518) 

3M_MDL000534754 3M_MDL000534754

11/7/2005 2005 Email re developing new 

instruction guide for CAE

3M_MDL000620089

11/7/2005 Schulz Email to Ohlin re Editing CAE 

Training Statement of Work (SOW)

3M_MDL000570024

11/8/2005 Thread re Troops Aren't Understanding 

Purpose or Mechanism of CAEv2

3M_MDL000285486 3M_MDL000285486

11/16/2005 Berger to Santoro re CAEv2 Instruction 

Edits (Colored)

3M_MDL000321675 3M_MDL000321680

11/16/2005 Berger to Santoro re CAEv2 Instruction 

Edits

3M_MDL000056553 3M_MDL000056558

11/21/2005 Thread re Sales of Indoor Outdoor 

Range EAR Plug

3M_MDL000362155 3M_MDL000362156

11/30/2005 Draft Aearo-US ARL Prototype 

Agreement re CAEv3 Development 

(Attachment)

3M_MDL000689903 3M_MDL000689903

11/30/2005 Myers to Klun re Proposed Army 

Agreement re CAEv3 Development But 

Keep IP

3M_MDL000738814 3M_MDL000738815

12/2/2005 Thread re Updating Wallet Card for 

CAEv3

3M_MDL000258039 3M_MDL000258039

12/8/2005 Santoro to Dumelie re Answering 

Workers Compensation Board 

Audiologist CAEv2 Questions

3M_MDL000619485 3M_MDL000619485

16

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 148 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

12/13/2005 Spahn Email to Santoro re CAEv2 

Blister Pack Instructions (Colored)

3M_MDL000362770 3M_MDL000362773

12/13/2005 Spahn Email to Santoro re CAEv2 

Blister Pack Instructions

3M_MDL000042065 3M_MDL000042068

12/31/2005 Aearo Company Performance 

Assessment for Bob Falco FY06

3M_MDL000340724 3M_MDL000340759

12/31/2005 Robert Falco FY06 Goals and 

Objectives

3M_MDL000687720 3M_MDL000687745

1/5/2006 Knauer to Warren re Acoustical 

Impedance Testing During CAEv2 

Product Assembly

3M_MDL000258044 3M_MDL000258044

1/11/2006 Santoro Email re Marine Approval of 

CAEv2 Uniform Requirement and 

CAEv2 Business Opportunity in 

Marines

3M_MDL000569905 3M_MDL000569906

1/17/2006 Myers to Warren re Discussion with 

Ohlin re Army Reducing Deployment 

and Potential CAE Standard Issue

3M_MDL000617981 3M_MDL000617981

2/1/2006 Peltor CAE Blister Card and Package 

Insert

3M_MDL000193307

2/22/2006 New CAE Single Pair Blister Pack Ad 3M_MDL000573846 3M_MDL000573846

3/1/2006 Army Fitting Protocol (USACHPPM 

TG41) - Personal HPDs Fitting, Care, 

and Use (Colored)

3M_MDL000345123 3M_MDL000345124

3/3/2006 Memo re Call with Ohlin re Current 

Status and Agreements for CAEv3

3M_MDL000019811 3M_MDL000019812

03/06/2006 Myers Fwd. Article from Ohlin re 

Misuse CAE for Lack of Instruction

3M_MDL000285609 3M_MDL000285615

3/6/2006 Myers to Warren re Ohlin Gets Rapid 

Fielding Initiative Approved

3M_MDL000286513 3M_MDL000286521

3/6/2006 Ohlin Email re Military Acceptance of 

CAEv2 Use

3M_MDL000013977 3M_MDL000013980

17

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 149 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

03/06/2006 Thread re Article - Seeking the Right 

Amount of Sound in the Fury of Combat

3M_MDL000236980 3M_MDL000236983

3/7/2006 Falco to Berger Memo re CAEv3 

Measurements and Results (Attachment)

3M_MDL000569853 3M_MDL000569853

3/7/2006 Falco to Berger, et. al re Comments to 

Development of the CAE Memo 

(Parent)

3M_MDL000569852 3M_MDL000569853

3/31/2006 Challis Labs 2826-306 AKA 015012 

Method B CAEv2 Test Report 

3M_MDL000401604 3M_MDL000401604

04/01/2006 Aearo Growth Investments Strategy PPT MURPHYSUBPOEN

A0063

MURPHYSUBPOENA

0131

4/1/2006 CAEv2 Blister Pack Brochure 3M_MDL000320257 3M_MDL000320257

4/1/2006 CAEv2 Instructions for Use 3M_MDL000362795 3M_MDL000362796

4/20/2006 215012 HPDA Report Screenshot 3M_MDL000319672 3M_MDL000319673

4/20/2006 EARCAL CAEv2 (NRR of 5.1) Test 

Report (Open - 215012)

3M_MDL000006960 3M_MDL000006965

04/28/2006 Thread re CEP Earbud Potentially 

Killing CAE Sales if It Becomes 

Standard Issue

3M_MDL000569871 3M_MDL000569872

5/9/2006 McNamara to Santoro and Army re 

CAEv2 Instructional Materials

3M_MDL000703461 3M_MDL000703462

6/1/2006 Aearo Development Project Summary 

Sheets

3M_MDL000019978 3M_MDL000019982

6/2/2006 Method B Master Testing Spreadsheet 3M_MDL000321796 3M_MDL000321798

6/15/2006 Email re Berger sending CAE samples 

to sniper instructor 

3M_MDL000606241

6/15/2006 Spreadsheet re EAR Patents for 

Premolded Earplugs (Attachment)

3M_MDL000622242 3M_MDL000622242

6/27/2006 213030 Test Report 3M_MDL000473611 3M_MDL000473619

6/27/2006 EARCAL CAEv2 Unsigned Attenuation 

Test Data (Closed - 213030)

3M_MDL000313220 3M_MDL000313221

18

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 150 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

6/30/2006 Improved Combat Arms Earplug QRI 

Status

3M_MDL000003006 3M_MDL000003026

7/1/2006 CAEv2 Blister Pack Insert 3M_MDL000000142 3M_MDL000000143

7/5/2006 June Monthly EarCal Lab Memo 3M_MDL000002598 3M_MDL000002600

7/7/2006 Myers-Sidor Thread re CAE Testing and 

Triple Flange Concerns

3M_MDL000018856 3M_MDL000018857

7/31/2006 2007 EAR-Peltor Passive-Hearing 

Business Plan 

3M_MDL000327086 3M_MDL000327086

8/4/2006 Solicitation For Commercial Items 3M_MDL000000078 3M MDL000000141

8/7/2006 DLA to Myers re Solicitation Contract 

Offer

3M_MDL000000013 3M_MDL000000077

08/17/2006 Ohlin to Berger re Binseel's Iraq Field 

Study 

3M_MDL000258133

09/18/2006 Aearo-Army re Status of CAE Training 

Video

3M_MDL000259376 3M_MDL000259378

9/26/2006 Ohlin and Myers re CAEv2 Case and 

Instructions Feedback

3M_MDL000013973 3M_MDL000013974

9/26/2006 Ohlin-Myers Thread re New CAEv2 

Case Interferes w Uniform and 

Changing Cases

3M_MDL000013975 3M_MDL000013976

11/12/2006 PPT- Myers and Santoro- earfit-Custom 

announced

3M_MDL000334581

12/12/2006 Moses re Dated PSS CAEv3 Description 

and Proposed Description with CAEv2 

Complaints

3M_MDL000362403 3M_MDL000362404

12/15/2006 Gov't IDIQ Contract with Aearo (1st 

Rog Response)

3M_MDL000109405 3M_MDL000109409

1/1/2007 CAEv2 and CAEv3 Brochure (Colored) 3M_MDL000348518 3M_MDL000348524

1/1/2007 CAEv2 and CAEv3 Brochure w FAQs 3M_MDL000002065 3M_MDL000002070

1/1/2007 CAEv2 Blister Pack Card (Colored - 

Front and Back)

3M_MDL000345402 3M_MDL000345402

19

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 151 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

1/1/2007 CAEv2 Blister Pack Card 3M_MDL000000001 3M_MDL000000001

1/11/2007 Moses and Warren re Approving CAEv1 

Discontinuation Due to Low NAIMilitary Sales

3M_MDL000692589 3M_MDL000692590

2/19/2007 OHESD Gate Prep and Execution 

Handbook

3M_MDL000025836

3/1/2007 Lovejoy (2007 - Colored) Hearing 

Protection Evaluation for CAE at Idaho 

National Lab

3M_MDL000357176

3/5/2007 Australian Acoustical testing 3m_mdl000320272

3/11/2007 The Importance of Hearing 

Conservation / Unit Hearing Health 

Briefing

3M_MDL000028371 

3/15/2007 2006 IDIQ Contract File List and 

Contents

CTRL_3M_Touhy000

00397

CTRL_3M_Touhy0000

0708

3/19/2007 Kladden to Johnson attaching H140 

CAE Extensions Project Summary Sheet

3M_MDL000481358 3M_MDL000481403

04/10/2007 Aearo Thread re NRR Labelling and 

Pillow Packs

3M_MDL000089631 3M_MDL000089631

4/16/2007 Memo re CAEv2 and CAEv3 Military 

Testing

3M_MDL000002584 3M_MDL000002585

4/26/2007 215516 HPDA Report screenshot 3M_MDL000319672

4/26/2007 EARCAL CAEv2 Attenuation 

Measurements (Closed - 215516)

3M_MDL000195585 3M_MDL000195585

4/27/2007 Thread re Current CAE Development 

Status in Testing Before Sending Off to 

Production

3M_MDL000683454 3M_MDL000683995

4/27/2007 Thread re Delay in CAE Launch Date 

Due to Testing

3M_MDL000265980 3M_MDL000265980

5/8/2007 Quick Reference Guide (Internal) - 

Tactical Hearing Protection for the 

Warfighter

3M_MDL000004470 3M_MDL000004478

20

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 152 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

5/9/2007 Thread re NRR Testing for CAEv3 

Launch

3M_MDL000066875 3M_MDL000066876

5/14/2007 Falco to Berger re CAE Patent for New 

Packaging

3M_MDL000321280 3M_MDL000321280

5/14/2007 Hamer to Michaels re New Technical 

Director and Discontinuing Testing if 

Not Attaining the Expected NRR: 

Hamer 12/18/2019 Deposition Exhibit 

26

5/14/2007 Thread re Getting the NRR Specified by 

Myers

3M_MDL000066877 3M_MDL000066878

5/16/2007 Kieper Email re Stopping customEAR 

Labeling Test

3M_MDL000627217 3M_MDL000627218

5/16/2007 Kladden to Knauer re Adding Patent 

Numbers for CAEv3 Packaging (Parent)

3M_MDL000622240 3M_MDL000622242

6/18/2007 AFRL Hearing Protector Evaluation 

Report - Closed End 

ctrl_3m_touhy0000148

8

CTRL_3M_TOUHY00

001489

6/18/2007 AFRL Hearing Protector Evaluation 

Report - Open End 

CTRL_3M_TOUHY00

001245

CTRL_3M_TOUHY00

001246

6/22/2007 Berger Email re Stopping EARHookz 

Testing for Testing with a New 

Modified Part

3M_MDL000599946 3M_MDL000599946

6/22/2007 Thread re Interim report to avoid 

unacceptable NRR 

3M_MDL000599945 3M_MDL000599945

6/29/2007 Berger & Hamery published impulse 

test with 2008 date

3M_MDL000009240

07/24/2007 Aearo Management PPT re Current 

Status, Business Plans, etc.

3M_MDL000423338 3M_MDL000423338

9/1/2007 2007 Peltor Eyewear and Hearing 

Shooters Catalog

3M_MDL000716257 3M_MDL000716397

9/24/2007 Berger (2007) The Noise Stops Here - 

Experimental HPD Fitting Workshop

3m_mdl000464853

10/29/2007 Sizing Survey for CAEv2 and deploy 3M_MDL000204296

21

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 153 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

11/16/2007 Blown Up Laminated CAEv2 Wallet 

Card

3M_MDL000008279 3M_MDL000008281

12/11/2007 Falco to Berger re Testing Closed and 

Open Ends of Low Profile CAE 

Prototypes

3M_MDL000533349 3M_MDL000533349

12/12/2007 Ohlin Email re Army Considers EPs to 

be Medical Devices but CAE Not 

Mentioned 

3M_MDL000320189

1/1/2008 3M-Aearo Integration Action Plan 3M_MDL000335858 3M_MDL000335858

1/1/2008 Aearo-ISL Amplitude-Sensitive 

Attenuating Earplugs

3M_MDL000016506 3M_MDL000016577

1/1/2008 Hobbs (2008) Wideband Hearing, 

Intelligibility, and Sound Protection 

(WHISPr Report) 

ctrl_3m_touhy0000192

7

CTRL_3M_TOUHY00

002039

2/1/2008 Army Hearing Program ST 4-02.501

3/10/2008 Berger Email re Previous Lack of 

Instructions for Marines

3M_MDL000533262 3M_MDL000533263

3/26/2008 Email - Distributor Registration 

Requests for EAR Clinics

3M_MDL000362493

5/1/2008 Aearo Technology - Hearing Protection 

with Special Features PPT

3M_MDL000340477 3M_MDL000340487

5/1/2008 Peltor Sporting Goods Market - 2008 

Wholesale Price List

3M_MDL000568474 3M_MDL000568474

5/5/2008 Email attaching Paper re Combat Arms 

for ASA meeting

3M_MDL000019712 3M_MDL000019718

5/14/2008 Project Scope re CAEv4 (H145 Low 

Profile CAE)

3M_MDL000612663 3M_MDL000612664

7/11/2008 Falco Research Notebook No. 5594 3M_MDL000683454 3M_MDL000683995

8/6/2008 Email Myers to Helen Foo 3M_MDL000254318

22

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 154 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

8/7/2008 CAE v. SureFire - Arm decision not to 

use SureFire

3M_MDL000254320

8/20/2008 Combat Arms Plug and + Com Tac II 

Muff Test ID 268124 

3M_MDL000535243 3M_MDL000535243

8/22/2008 CAE Background Presentation 3M_MDL000313359

8/26/2008 Email Berger to Jimmy Wong 3M_MDL000314786

8/27/2008 Email re Hot Topics in Hearing 

Protection Q&As

3M_MDL000285244 3M_MDL000285246

9/3/2008 ANSI-ASA S12.6-2008

9/4/2008 Email thread re military opposition to 

the deep plugs 

3M_MDL000426573

10/8/2008 Early on-linear plug design 3M_MDL000571997

10/22/2008 Claims Substantial Worksheet with CAE 

Label

3M_MDL000163130

12/1/2008 HSE (2008) Epidemiological Evidence 

for the Effectiveness of Noise at Work 

Regulations

3m_mdl000322497

12/7/2008 Superior EarPro Hearing Protection 

Enhancement from SureFire

1/1/2009 3M Business Conduct Policies - 

Harassment Policy: Falco 2/12/2020 

Deposition Exhibit 34

1/1/2009 WHISPr Report - Wideband Hearing, 

Intelligibility, and Sound Protection - 

Tactical Headset Eval

3M_MDL000005379 3M_MDL000005430

1/23/2009 Berger Email with Kieper re Concerns 

Over Additional 4th CAEv2 Testing

3M_MDL000004558 3M_MDL000004558

1/23/2009 Thread admitting issues with CAEv2 

NRR testing

3M_MDL000034390 3M_MDL000034390

23

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 155 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

2/16/2009 Thread re CAEv3 Problem and Ill Fit of 

Regular Size CAE for Smaller Ear 

Canals

3M_MDL000201975 3M_MDL000201979

2/19/2009 Test ID 215019. CAE v4, Open. NRR 3M_MDL000535045

2/22/2009 Brochure re benefits of Ultrafit 3M_MDL000460155

2/27/2009 Berger to Doyle re ARC Plug Questions 

and Blocks Some Speech Frequencies

3M_MDL000004559 3M_MDL000004569

3/1/2009 Casali (2009) A field investigation of 

hearing protection and hearing 

enhancement in one device: For soldiers 

whose ears and lives depend upon it

3M_MDL000021166 3M_MDL000021188

3/19/2009 Email attaching Slides for Meeting at 

Fort Bragg re Issuing CAEv3 and 

CAEv4

3M_MDL000020020 3M_MDL000020025

4/6/2009 Aearo Company Performance 

Assessment - Robert Falco

FALCOSUBPOENA_

00001

FALCOSUBPOENA_0

0009

4/7/2009 Moses Email to Tucker re One Size Fits 

All Slide

3M_MDL000011968 3M_MDL000011971

4/27/2009 Email attaching CAE Branding 

Discussion Slides

3M_MDL000456240 3M_MDL000456248

5/21/2009 Kladden to Madison attaching 213016 

and 213017 CAEv2 Tests and 214049 

Pistonz Test

3M_MDL000010416 3M_MDL000010419

5/28/2009 Thread re "Biases" and "Every Legal 

Trick in the Book" for HPD Testing

3M_MDL000019705 3M_MDL000019711

5/29/2009 Cimino and Moses re Won't Be 

Launching CAEv4 with NRR 

Discussion

3M_MDL000363600 3M_MDL000363601

5/29/2009 Moses and Ohlin re Computation of 

NRR for New CAE

3M_MDL000019526 3M_MDL000019526

06/08/2009 Email from D. Ohlin to Brocksalesco re 

VA Medical attaching an article 

3M_MDL000364234

6/9/2009 Aearo Strategic Military Planning 

Session PPT and Notes

3M_MDL000048948 3M_MDL000048991

24

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 156 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

6/10/2009 Thread re Berger "Intense Pressure" to 

"Match Attenuation Values"

3M_MDL000188593 3M_MDL000188597

6/15/2009 3M Email re EPA Label Requirements 

for Moses

3M_MDL000024796 3M_MDL000024799

9/9/2009 Calendar Entry for Meeting re 

Discussing CAE, Skull Screws, and 

Peltor Muffs w New Dynamics 

3M_MDL000018895 3M_MDL000018895

9/29/2009 Thread re Buying Bulk CAEv2 in CHIM 

Side

3M_MDL000148608 3M_MDL000148617

9/30/2009 Thread re Stem Splitting in New CAE 

Assembly and Falco's Response

3M_MDL000166027 3M_MDL000166028

11/2/2009 Combat Medic Skills (Ch. 18) Force 

Health Protection - Hearing Protection

11/10/2009 Emails discussing problems with the 

Surefire plug

3M_MDL000450231

11/20/2009 Thread re Nominating Falco for 2009 

Circle of Technical Excellence and 

Innovation Award

3M_MDL000264002 3M_MDL000264004

11/23/2009 CAE v4 rocker stem design drawing 3M_MDL000825699

1/1/2010 3M Business Conduct Policies - 

Electronic Resources Policy: Falco 

2/12/2020 Deposition Exhibit 35

1/1/2010 3M CAEv2 Brochure (Colored) 3M_MDL000351438 

1/1/2010 3M CAEv2 Tri-Fold Brochure (Colored) 3M_MDL000400759 3M_MDL000400759

1/1/2010 3M Military Applications Catalog 3M_MDL000331024 3M_MDL000331025

1/1/2010 ANSI-ASA S12.42-2010 3M_MDL000015146 3M_MDL000015210

1/7/2010 Berger to Rice re Attached Lit on LD 

HPDs and CAEv2 Not for Indoors

3M_MDL000010065 3M_MDL000010084

25

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 157 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

1/11/2010 ANSI S12.42-2010 Methods - for the 

Measurement of Insertion Loss of HPDs 

in Continuous or Impulse Noise Using 

MIRE or ATF Procedures

3M_MDL000204212 3M_MDL000204277

1/13/2010 OH&ESD US Military Market Center 

Briefing

3M_MDL000094732 3M_MDL000094794

1/22/2010 Development and Validation of a FieldMIRE Approach for Measuring Hearing 

Protector Attenuation

3M_MDL000233892 3M_MDL000233926

1/26/2010 Thread re Making a Shorter Stemmed 

ISL Plug

3M_MDL000400961 3M_MDL000400970

2/5/2010 Update on the Combat Arms Earplug 

(V2.0)

3M_MDL000002628 3M_MDL000002677

2/9/2010 Thread re Questionable Johnson Blast 

Study

3M_MDL000153468 3M_MDL000153470

2/9/2010 Thread re Questionable Johnson Blast 

Study

3M_MDL000153464 3M_MDL000153467

2/9/2010 Tremblay to Berger re Revisiting 193dB 

Claim in CAE Brochure

3M_MDL000338039 3M_MDL000338043

2/16/2010 Fitting Instructions 3M_MDL000494968

2/18/2010 The Development of the Combat Arms 

Earplug, Version 1 through Version 4 

(V2.2)

3M_MDL000627180 3M_MDL000627180

4/1/2010 Berger T6 Div. Scientist Proposal with 

Recommendation Letters

3M_MDL000343622 3M_MDL000343623

4/10/2010 EAR Passive Hearing Brainstorming 

Session ''The Next Big Thing'' PPT

3M_MDL000724927 3M_MDL000724927

4/19/2010 Madison Email to 3M Japan re CAEv2 

Impulse Noise and Range Use

3M_MDL000135802 3M_MDL000135803

4/27/2010 McGinley to Moses re Thank You for 

Your Hard Work in CAEv4 Order

3M_MDL000263773 3M_MDL000263775

26

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 158 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

4/28/2010 Hamer to Moses re CAEv4 Launch 

Update and Gratitude to Team

3M_MDL000608132 3M_MDL000608134

07/08/2010 Email from D. Moses to D. Ohlin re 

Your July EHS Today Article 

3M_MDL000269903

7/23/2010 Development of the Combat Arms 

Earplug, Versions 1-4 (V2.4) (Colored)

3M_MDL000259866 3M_MDL000259918

7/23/2010 Development of the Combat Arms 

Earplug, Versions 1-4 (V2.4)

3M_MDL000002737 3M_MDL000002794

7/23/2010 Development of the Combat Arms 

Earplug, Versions 1-4 (V2.4)

3M_MDL000019281 3M_MDL000019338

7/23/2010 The Development of the Combat Arms 

Earplug, Version 1 through Version 4

3M_MDL000006619

8/16/2010 Doug to Gates 3M_MDL000142378

8/16/2010 Michael & Associates Letter re Impulse 

Testing of CAEv2 and Moldex 

Battleplug MICHAELASSOC_483

9/19/2010 Thread re Removal of Open Position 

NRR Info from Wallet Card

3M_MDL000188750 3M_MDL000188750

10/26/2010 CAD Drawing of UltraFlex Short 3M_MDL000724817 

11/5/2010 Berger Email to Hamer re Development 

of CAE V2.4 Doc

3M_MDL000006618

11/6/2010 Ohlin and Moses 3M_MDL000346495

11/9/2010 LtC Marjorie Grantham provides D. 

Moses with competitor (Surefire) 

information

3M_MDL000338354

11/15/2010 Moss to Moses re Approval for Routing 

Attached CAEv2 Insert

3M_MDL000346536 3M_MDL000346537

12/1/2010 certificate of results of testing performed 

by Gordon Jarvis Consulting on the 

CAE

3M_MDL000401064

27

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 159 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

12/15/2010 3M Product Advisory Notice re 

Potential Increase in Attenuation 

Following Repeated Use of Large Size 

CAEv4

3M_MDL000499202 3M_MDL000499202

12/22/2010 Email attaching comparison of EARcal 

and INSPEC Data 

3M_MDL000162848

2/17/2011 Binseel Poster - Three Variants of the 

Dual Mode Combat Arms Earplug 

ctrl_3m_touhy0000183

7

CTRL_3M_TOUHY00

001837

2/18/2011 Thread re Moses taking credit for new 

recruit strategy & upcoming conferences 

he will attend

3M_MDL000270892 3M_MDL000270893

3/7/2011 Thread re New CAE Competitor from 

Moldex 

3M_MDL000020030 3M_MDL000020032

3/7/2011 Ultra-Fit sales; price data 2012 3M_MDL000416681

3/14/2011 Ohlin to Moses - Recommendations for 

5th generation plugs

3M_MDL000364204

3/15/2011 Email attaching Moldex Filter Technical 

Drawing and Patent No. 6,068,079

3M_MDL000187926 3M_MDL000187931

3/19/2011 McGinley Email to Werken re Ohlin 

Report on Moldex Military Approval

3M_MDL000021836 3M_MDL000021838

3/19/2011 McGinley Email to Werken re Ohlin 

Report on Moldex Military Approval

3M_MDL000373258 3M_MDL000373261

3/21/2011 IL Tests of Combat Arms Earplug 

(CAE) and Moldex Combat Earplug 

Using KEMAR

3M_MDL000326276

3/24/2011 Thread re Reasons to Bring Casali In 3M_MDL000271330 3M_MDL000271334

4/11/2011 Cimino Email re Leaving Decision to 

Consult Casali with Indy Lab and Moses

3M_MDL000271421 3M_MDL000271424

4/21/2011 3M Thread re Using Situational 

Awareness Limitations of the CAE 

Article to Preempt Casali Study Report

3M_MDL000026687 3M_MDL000026691

28

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 160 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

5/9/2011 Gavin to Cimino re Centurion 

Positioning for Army and USMC 

Markets

3M_MDL000363896

5/21/2011 Documents re 3M's involvement in 

South East Asia

3M_MDL000029894

6/1/2011 Paper re_ Custom molded HPDs 3M_MDL000369525

6/22/2011 Caev.4 inspec testing closed 3M_MDL000318715

6/27/2011 Rick Morris, Mike Cimino's supervisor, 

asks for full ramifications of allowing 

New Dynamics

3M_MDL000286681

7/1/2011 EARCal June Monthly Report (by 

Berger)

3M_MDL000208204 3M_MDL000208208

8/3/2011 2010 CAE Blister Pack Insert and 

Diagrams

3M_MDL000010058 3M_MDL000010064

8/11/2011 3M Thread re Stem Splits Due to CAE 

Filter Being Too Large

3M_MDL000158218 3M_MDL000158226

10/7/2011 Email attaching Currently Used 

Promotional Materials

3M_MDL000349009 3M_MDL000349013

10/17/2011 Info on development of the 4.1 3M_MDL000275394

10/24/2011 INSPEC Test Report No. 1.11.09.62 - 

CAEv2 CLOSED 

3M_MDL000796805

10/24/2011 Ohlin CAEv2 Briefing PPT to Gischia 3M_MDL000010514 3M_MDL000010529

10/24/2011 Ohlin Email to Gischia with Attached 

CAEv2 Briefing PPT (1st Rog 

Response)

3M_MDL000011927 3M_MDL000011943

11/17/2011 Cimino and LaValle re Army Approval 

of "Functional Testing" for TCAPS

3M_MDL000634753 3M_MDL000634754

11/23/2011 Impulse Noise Test of 3M-Aearo 

CAEv1 and v2 w INSPEC Witness

3M_MDL000009215 3M_MDL000009239

12/9/2011 UK 3m technical file 3M_MDL000782760

29

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 161 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

1/11/2012 Thread re CAEv2 Material Construction 3M_MDL000012131 3M_MDL000012136

2/8/2012 Thread re Attached CAEv3 FAQs/Sell 

Sheet 

3M_MDL000162710 3M_MDL000162712

2/9/2012 CAE 4.1 Year Sales Projection - New 

CAE 4.1 will resolve Marine Corp 

issues and result

3M_MDL000276015

2/13/2012 Moses 2011 Performance Review 3M_MDL000567811 3M_MDL000567811

2/23/2012 NHCA 2012 - Summary of Activity 3M_MDL000019735 3M_MDL000019744

2/27/2012 Clasing & Casali (2012) Hearing 

Protection Devices and TCAPS: Can the 

Soldier Detect and Identify Gunshots 

and other Threats?

3M_MDL000019745 3M_MDL000019760

3/2/2012 Email attaching Casali Slide deck 

critical of CAE claims 

3M_MDL000182537

3/4/2012 Casali Presentation and 3M Response 3M_MDL000088230 3M_MDL000088250

03/05/2012 Moses and McGinley re 2013 Troop 

Level Assumptions and VA Accepting 

Tinnitus Compensation

3M_MDL000293781 3M_MDL000293784

3/6/2012 3M Marketing Thread re Response to 

Casali Slides

3M_MDL000276276 3M_MDL000276280

3/6/2012 Email attaching "CAE Trends - 

Opportunities" Memo

3M_MDL000018935 3M_MDL000018939

3/9/2012 Raw test results for lab 3M_MDL000002916

3/12/2012 CAEv4.1 PowerPoint slide re product 

development and sales forecast.

3M_MDL000358291

3/15/2012 Kladden and Berger Edits to CAEv2 

Packaging

3M_MDL000193296 3M_MDL000193305

3/23/2012 Additional US Army information 3M_MDL000395008

3/23/2012 Email from Bev Peck (Fred Little's 

assistant) to Little

3M_MDL000555323

30

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 162 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

3/23/2012 Grantham Impulse Testing 3M_MDL000094185

3/28/2012 Michael & Associates Letter re Testing 

Procedure and Results of CAEv2 Steadystate End

3M_MDL000023366 3M_MDL000023368

3/28/2012 Michaels and Associates Ltr re CAEv2 

and CAEv3 Testing Data

3M_MDL000005607 3M_MDL000005618

04/13/2012 Evaluation of the Surefire Sonic 

Defenders Plug 

3M_MDL000198782

5/7/2012 CAEv2 Package Insert 3M_MDL000349564 3M_MDL000349564

5/7/2012 Email attaching CAEv2 Blister Card and 

Paper Insert

3M_MDL000349562 3M_MDL000349564

5/7/2012 Spahn Email attaching CAEv2 Blister 

Card and Paper Insert

3M_MDL000014332 3M_MDL000014335

5/17/2012 Email re Lab Personnel with Photos and 

Testing Facility Synopsis

3M_MDL000314375 3M_MDL000314376

5/30/2012 Moses to Military re Incorrect NRR for 

CAEv2

3M_MDL000277069 3M_MDL000277071

5/30/2012 Spreadsheet re "Published Attenuation 

and Trademarks for Hearing Protection 

Products"

3M_MDL000039506

6/14/2012 AFRL Hearing Protector Evaluation 

Report - Closed End 

CTRL_3M_TOUHY00

002047

CTRL_3M_TOUHY00

002048

6/14/2012 AFRL Hearing Protector Evaluation 

Report - Open End 

CTRL_3M_TOUHY00

001249

CTRL_3M_TOUHY00

001250

7/3/2012 Objective Hearing Tests to assess in situ 

in vivo New Generation Earplugs

3M_MDL000096722

7/10/2012 Jason Jones thinks the data about the Ear 

canal size differences

3M_MDL000416818 3M_MDL000416820

8/7/2012 Madison to Liu (3M China) re Warping 

Change of UltraFit Flange Shape

3M_MDL000589320

31

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 163 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

08/16/2012 Military Hearing Protection Swarm 

Initiative PPT (Attachment)

3M_MDL000373403 3M_MDL000373403

8/28/2012 WestPoint Army-Navy Ad 3M_MDL000281765 3M_MDL000281766

09/06/2012 Thread re Grantham Military Update 

Meeting on CAE Prototype

3M_MDL000082348 3M_MDL000082351

9/11/2012 Program Manager Meeting Debrief 3M_MDL000277926

9/19/2012 2013.01.23 Jacob Ely emails 

Mohammed Saleem with drawings for 

the Ultrafit tips of the CAEv4.0 tips

3M_MDL000774780

10/11/2012 Hearing Protection Solutions - HPDs 

and HCPs PPT

3M_MDL000586984 3M_MDL000586984

10/15/2012 3M Thread re Grantham Mtg Notes and 

Filling in CAE Sales Gap

3M_MDL000038008 3M_MDL000038024

11/14/2012 McGinley Fwd. Email re Details from 

3M France re French Tender and CAE 

Feedback

3M_MDL000373480 3M_MDL000373482

11/30/2012 Houck to Berger re Substantiating 

190dB Claim

3M_MDL000016969 3M_MDL000016970

1/1/2013 New Dynamics Co-branded brochure 3M_MDL000012087 3M_MDL000012096

1/23/2013 Jacob Ely emails Mohammed Saleem 

with drawings for the Ultrafit tips of the 

CAEv4.0 tips

3M_MDL000774782

2/22/2013 Casali (2013) Implications if Your Life 

Depends upon Your Hearing: The NRR 

vs. the ASAF

3M_MDL000573630

2/23/2013 3M to Sempra Utilities with Attached 

Madison Article re Custom EPs and 

CAEv2 and ARC Plug Data Sheets

3M_MDL000322302

4/10/2013 3M-New Dynamics Meeting Minutes 3M_MDL000499602

6/7/2013 Email from Vasilios Brachos with 

attached EAR CAL attenuation tests for 

CAE v4

3M_MDL000060791

32

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 164 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

6/11/2013 Thread with Matsumura (3M Japan) re 

CAEv2 Tests 213016 and 213017 and 

Quality Systems Info for HGRA

3M_MDL000008420 3M_MDL000008424

6/12/2013 Berger emails Ron Berardino at New 

Dynamics with comparisons

3M_MDL000675626

6/12/2013 Email attaching Memos re Similarity of 

Moldex Battleplugs and CAE

3M_MDL000019806 3M_MDL000019809

7/12/2013 1974 ANSI S3.19-1974 3M_MDL000015129 3M_MDL000015145

8/5/2013 Email CFR Needed 3M_MDL000342409 3M_MDL000342410

9/5/2013 Madison Email re Variability of NRR 

Results

3M_MDL000008430 3M_MDL000008431

10/14/2013 Hearing Loss Prevention Programs 3M_MDL000495299

10/24/2013 3M Noise Control & Hearing 

Conservation Manual v6f

3m_mdl000440682

12/3/2013 U.S. Patent No. 8,596,279 B2: Falco 

2/12/2020 Deposition Exhibit 68

12/16/2013 Redacted doc discussing CAEv4.1 3M_MDL000804573

1/1/2014 CAEv2 Blister Pack Insert 3M_MDL000057677 3M_MDL000057678

01/01/2014 CAOHC Hearing Conservation Manual 

(Fifth Edition): Ted Madison 

12/10/2019 Deposition Exhibit 13 

1/1/2014 Peltor CAEv2 Package Insert 3M_MDL000019680 3M_MDL000019680

1/1/2014 US Marine Level-Dependent Hearing 

Protector Assessment (1st Rog 

Response)

3M_MDL000012099 3M_MDL000012130

1/2/2014 Jones to Moses re Howald Soldier 

Complaint

3M_MDL000096159 3M_MDL000096163

1/2/2014 Thread re Responding to Howald 

Soldier Complaint 

3M_MDL000815332 3M_MDL000815336

33

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 165 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

1/8/2014 3M PSD Release Specification Form 

DRAFT - UltraFit with Through Hole

3M_MDL000342929 3M_MDL000342930

1/8/2014 3M PSD Release Specification Form 

DRAFT - UltraFit with Through Hole

3M_MDL000342929 3M_MDL000342930

1/24/2014 Inspec caev4.1 testing 3M_MDL000318714

1/26/2014 Thread - 370-1018 New Dynamics plug 3M_MDL000453589

2/25/2014 Thread re HPDs for shooter study - CAE 

not recommended for indoor ranges

3M_MDL000243859 3M_MDL000243860

3/7/2014 Michael & Associates Testing MICHAELASSOC_00

000585

3/10/2014 Marketing Planning Template 3M_MDL000089665

3/17/2014 Fallon to Army re Howald Soldier 

Complaint is due to Army Fitting

3M_MDL000082841 3M_MDL000082841

4/8/2014 3M Thread re CAE Sales Review and 

Strategy for April 2014

3M_MDL000277770 3M_MDL000277774

4/10/2014 3M Marketing Thread re CAE Sales 

Context

3M_MDL000277811 3M_MDL000277816

4/11/2014 CAE Sales Review Discussion Guide 3M_MDL000756149 3M_MDL000756153

4/11/2014 Gavin re CAE Sales Observations 3M_MDL000360414 3M_MDL000360415

4/26/2014 Thread attaching Edits to Marketing 

Inserts (ARC Plug has folding back tip 

IFU)

3M_MDL000425481 3M_MDL000425503

4/30/2014 07.16.2006 Excerpt of what appears to 

be a spec sheet for CAE double-ended, 

circulated in 2014

3M_MDL000002017

4/30/2014 Pawlowski to Moses and Jones attaching 

MPID

3M_MDL000002024 3M_MDL000002032

5/5/2014 Thread re Moses thinks Posters are 

effective

3M_MDL000358867 3M_MDL000358869

34

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 166 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

5/7/2014 Jones Email attaching Importance of 

Hearing to the War Fighter (Merkley 

Slide Deck)

3M_MDL000028370 3M_MDL000028418

5/23/2014 Thread re Fitting Instruction Changes 

After Legal Review

3M_MDL000584247

6/13/2014 Review of CAE Film prepared for the 

UK MOD -Fallon-Berger re v4.1 fit 

video

3M_mdl000818359 3M_MDL000818359

7/1/2014 Readiness through Hearing Loss 

Prevention - Technical Guide 250 

ctrl3m000001127

7/9/2014 Thread re Use of CAE at the Firing 

Range

3M_MDL000005528 3M_MDL000005534

7/10/2014 Moses to Fallon re CAEv4.1 Sell Sheet 

with Comments

3M_MDL000359112 3M_MDL000359113

7/11/2014 Berger to Madison re CAE Info for 

National Lab

3M_MDL000010140 3M_MDL000010154

7/12/2014 Dick Email to Madison and Berger re 

CAE Info for National Lab

3M_MDL000008470 3M_MDL000008478

7/14/2014 CAEv4.1 Sell Sheet Draft with Edits 3M_MDL000359112 3M_MDL000359113

7/14/2014 Thread re Vote to Proceed with Testing 

After Receiving NRR of 23.3

3M_MDL000336479 3M_MDL000336479

8/11/2014 Mohammed Saleem emails Melissa 

Moss, Ian Foslien and Divinder Bains

3M_MDL000783336

8/27/2014 3M PSD Release Specification Form - 

UltraFit with Through Hole

3M_MDL000655833 3M_MDL000655834

10/1/2014 Policies and Procedures Manual for 3M 

EARCAL Acoustical Lab (V13.2) 

3M_MDL000019374 3M_MDL000019449

10/2/2014 CAE 4.1 Brochure and FAQ 3M_MDL000352049

35

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 167 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

11/17/2014 Williams (2014) USAARL Assessment 

of Four Passive Hearing Protection 

Devices for Continuous Noise 

Attenuation, Impulsive Noise Insertion 

Loss, and Auditory Localization 

Performance 

11/20/2014 Nov. 20, 2014 email from Eric Fallon re 

Military Labeling

3M_MDL000865702

12/9/2014 Fletcher re Marketing Claim Language 

''Infrequent Gun Shot Noise'' Cause for 

Concern

3M_MDL000473502 3M_MDL000473504

12/9/2014 Thread re CHIM CAEv2 Opportunity 

and Changing Marketing Claims re Hear 

Through and Indoor Range Use

3M_MDL000473499 3M_MDL000473501

12/11/2014 Clasing, Casali (2014) Warfighter 

Auditory Situation Awareness

3M_MDL000324634 3M_MDL000324635

12/15/2014 CAE 4.1 testing feedback 3M_MDL000336730

12/31/2014 Fallon 2014 Performance Review 3M_MDL000823910 3M_MDL000823914

1/8/2015 Army Hearing Program (DAP 40-501)

3/18/2015 Marine Corps Order 6260.3 - Marine 

Corps Hearing Conservation Program 

3M_MDL000024844

04/01/2015 July 1990 to May 2

015 Monthly Test Reports

3M_MDL000006966 3M_MDL000007281

4/17/2015 3M Combat Arms 4.1 Ear Plugs - 

Overview Video 

5/13/2015 EARCAL CAEv2 Attenuation Test 

Report (Open - 215027) 

3M_MDL000476636 3M_MDL000476640

5/13/2015 New Dynamics Weekly Meeting Notes 3M_MDL000085624 3M_MDL000085625

5/20/2015 Inspec report 1.10.05.78 3M_MDL000782757

5/28/2015 written by E. Berger_ _CAE arose out of 

collaboration between the 3M

3M_MDL000523220

36

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 168 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

06/04/2015 Hamery, Dancer PPT 3M_MDL000003173 3M_MDL000003244 

7/15/2015 Myers to Fallon re Can't Tell if CAEv2 

is Working

3M_MDL000398074 3M_MDL000398075

7/17/2015 Thread re Sensation that the CAE isn't 

Working

3M_MDL000398074 3M_MDL000398075

08/15/2015 Madison to Quality Compressed Air, Inc 

re Instructions for ARC Plug

3M_MDL000588462 3M_MDL000588464

8/18/2015 Email Fallon Comtac UI 3M_MDL000718635

9/1/2015 Peltor Sports Campaign PPT 

(Infrequent gunshot noise)

3M_MDL000392992 3M_MDL000392993

10/8/2015 Berger email re EARCal Attenuation 

Test Templates and Measurements (Test 

IDs 213009, 213015, and 2130179)

3M_MDL000319274

10/8/2015 Myers Email re CAEv2 Put on Indefinite 

Hold (One Day After Depo)

3M_MDL000332111 3M_MDL000332111

10/12/2015 Berger Revisits Rolling Back of Flanges 

Fitting Tip

3M_MDL000425680 3M_MDL000425680

10/16/2015 Ex. 5302 Aearo Development Process 

Hearing Protection Products

3M_MDL000019669 3M_MDL000019673

10/23/2015 Test Report - CAEv4 - Closed. Test ID 

215022

3M_MDL000581132

10/28/2015 Myers re We Should Not Ship This 

Product (CAEv2)

3M_MDL000332090 3M_MDL000332092

10/28/2015 Thread re Guns & Ammo Gift Guide 

Marketing Opportunity attaching Peltor 

Background PPT and Trade Schedule

3M_MDL000392990 3M_MDL000392993

10/29/2015 Ex 5630. Memo from Moses to 

McGinley following up on whether 3M 

should enforce CAE

3M_MDL000189996

10/30/2015 Jones-Davis (Army) Thread re CAEv2 

Photo in Combat Medic Textbook

3M_MDL000281278 3M_MDL000281283

37

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 169 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

11/3/2015 3M Thread re CAEv2 Not to Be Sold 

with Current Labelling

3M_MDL000332061 3M_MDL000332066

11/3/2015 3M Thread re Cancelling and Disposing 

the CAEv2 Order

3M_MDL000332067 3M_MDL000332070

11/3/2015 ND to SourceAmerica re Ref Freight 

and ETS Info for BCA

3M_MDL000023134

11/17/2015 Jones re Discontinuation of CAEv2 and 

Attached Letter

3M_MDL000549104 3M_MDL000549105

11/17/2015 Kowalsky Discontinuation Notice Letter 

of CAEv2 and ARC Plug

3M_MDL000574437 3M_MDL000574437

11/18/2015 New Dynamics Weekly Meeting Notes 3M_MDL000013554 3M_MDL000013556

1/1/2016 USMC Ranking of Passive Hearing 

Devices

1/5/2016 Expert Report of John r. Franks in 3M v 

Moldex

3M_MDL000023232 3M_MDL000023298

1/15/2016 Berger Email to Nick Pierce re CAEv2 

Discontinuation

3M_MDL000013574 3M_MDL000013577

1/25/2016 Kieper Email re Classic HearPlug with 

PelTip6 (OK to Finish?)

3M_MDL000629986 3M_MDL000629986

1/28/2016 Email re removing CAEv2 from New 

Dynamics product brochure

3M_MDL000356128

3/25/2016 Wells PPT re Hearing Protector 

Attenuation

3M_MDL000440368 3M_MDL000440370

5/12/2016 Complaint in United States ex rel. 

Moldex-Metric, Inc. v. 3M Co., 3:16-

1533 (May 12, 2016)

5/12/2016 Complaint in United States ex rel. 

Moldex-Metric, Inc. v. 3M Co. , 3:16-

1533 (May 12, 2016)

7/11/2016 Fallon Response re Madison Edits to 

Impulse Noise Warning Label

3M_MDL000280956 3M_MDL000280958

38

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 170 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

7/11/2016 Madison Demonstrative re Added 

Impulse Noise Warning During Review; 

Deposition Exhibit 25

7/11/2016 Thread re Adding Impulse Noise 

Warning

3M_MDL000587314 3M_MDL000587314

8/2/2016 Berger to Jones re NRR Required per 

ANSI S3.19 Standard and Kladden 

Memo re Legal Labelling Requirements

3M_MDL000446687 3M_MDL000446689

10/25/2016 Contact Log 3M_MDL000018429

2/15/2017 Kieper Memo to Berger re E-A-R 07-25 

CAE Update

3M_MDL000481953 3M_MDL000481953

10/10/2017 Limited Ltr Recall for CAEv4 3M_MDL000616416

10/17/2017 CAE 4.1 FAQ's 3M_MDL000289962

1/1/2018 3M PSD Technical Bulletin - Tinnitus 

and Hearing Protection - Fiction and 

Fact

1/23/2018 3M Hearing Protection Internal Training 

(Edits by Berger)

3M_MDL000696203 3M_MDL000696203

4/3/2018 Jones to Vastola attaching 3M 

Presentation re EARfit System Setup 

and Other Products (Jones's Name on 

PPT)

3M_MDL000409110 3M_MDL000409111

5/9/2018 Fallon says 3M does not want warning 

to audiologists 

3M_MDL000676599 3M_MDL000676602

6/19/2018 Thread re Open Mode of CAE does not 

create perceptible seal 

3M_MDL000716855 3M_MDL000716857

7/18/2018 email re CAEv4.1 SKU; Access (f/k/a 

New Dynamics) plans launch of 

CAEv4.1 at trade shows in fall of 2018

3M_MDL000490754

7/26/2018 DoJ Press Release re 3M Company 

Agrees to Pay 9.1MM

39

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 171 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

7/30/2018 DoJ Press Release re 3M Company 

Agrees to Pay 9.1MM

7/31/2018 U.S. Patent No. 10,034,798: Falco 

2/11/2020 Deposition Exhibit 24

8/2/2018 CAEv4.1 brochure 3M_MDL000278456

12/12/2018 NRR changed from 7 and 23 to 8 and 20 

from the CAEv4.0 to CAEv4.1

3M_MDL000367814

12/13/2018 CID Investigation Report (Unredacted) CID_FILE0001 CID_FILE00260

12/15/2018 Email re LE firing range use of CAE 4 3M_MDL000351335

12/19/2018 What is Your Favorite Sound Video 3M_MDL000559467 3M_MDL000559467

4/1/2019 FOIA Response by US Army Criminal 

Investigation Command [Qui Tam 

Investigation Report

4/12/2019 U.S. Army Garrison Hawaii Article - 

''Service Members Should File Claims 

about Faulty Combat Arms Earplugs 

with Private Counsel''

7/30/2019 Air Force Memo re Removal of CAE 

from Inventory

CTRL_3M_touhy0000

2040

CTRL_3M_TOUHY00

002040

10/15/2019 Air Force Thread re CAEv2 Verified 

Not in Use

CTRL_3M_touhy0000

2253

CTRL_3M_TOUHY00

002255

10/17/2019 Moses Binder re Sales and Business 

Plans: Deposition Exhibit 10

12/11/2019 Deposition Transcript Clip of Elliott 

Berger (30(b)(1)) re Falco as the 

Conceiver of CAEv2: Falco 2/12/2020 

Deposition Exhibit 40

12/12/2019 Deposition Transcript Clip of Elliott 

Berger (30(b)(6)) re Falco as the 

Designer of CAEv2: Falco 2/12/2020 

Deposition Exhibit 39

40

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 172 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

12/17/2019 Deposition Transcript Clips of Richard 

Knauer (30(b)(1)) re Falco as the One 

Who Shortened the Stem: Falco 

2/12/2020 Deposition Exhibit 41

1/10/2020 Air Force Thread re Searching for 

CAEv2s in AF Inventories 

ctrl_3m_touhy0000211

4

CTRL_3M_TOUHY00

002120

1/24/2020 Second Amended Notice to Take the 

Oral and Videotaped Deposition of 

Robert Falco

2/11/2020 Demonstrative re Falco's Family Tree 

and EARCAL Testing: Falco 2/11/2020 

Deposition Exhibit 26

7/24/2020 Docket - Document 1280 Order on GKD 

MSJ

12/29/2020 Ltr from Dept. of Defense in Response 

to Touhy Requests re: HHA noise data 

of M1126 Stryker Vehicle

03/xx/2014 CAEv2 Insert New Dynamics 3M_MDL000005445 

7/00/2015 Quality Manual for Michael & 

Associates, NIST , NVLAP

3M List of CAEv1-4 REAT Tests 3M_MDL000004550 3M_MDL000004552

A Discussion of S12-WG11's 

Anthropometric Data with a Comparison 

to Other Available Databases

3M_MDL000701185 3M_MDL000701185

AHCP Ft. Stewart Winn Army 

Community Hospital CAE Presentation

ANSI (2016) Methods for measuring 

the real-ear attenuation of hearing 

protectors

Army Earplug Reference - Darnall Army 

Community Hospital Fort Hood, TX 

Attenuation Test Report #213027 for 

Ultrafit

3M_MDL000451184

41

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 173 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

AutoCAD Drawing 3M_MDL000605248

Berger (2003) Noise Manual 5th edition

Berger Call Notes Printout 3M_MDL000022661 3M_MDL000022664

Brock Sales Bulk Packaged CAE 

Instructions 

BROCK_00000083 BROCK_00000083

CAE Filter Technical Drawings 4047 3M_MDL000481954 3M_MDL000481954

CAEv2 and Ultrafit with Hole Technical 

Drawings

3M_MDL000449441 3M_MDL000449444

CAEv2 Assembly Technical Drawings 

2041-3

3M_MDL000340512 3M_MDL000340512

CAEv2 Sales Bar Graph from 1999 to 

2010

3M_MDL000393647 3M_MDL000393647

CAEv2 Sales Spreadsheet (1999 - 2010), 

SKUs, and Delivery Information

3M_MDL000393647 3M_MDL000393647

CAEv4.1 Sell Sheet with Comments 3M_MDL000359113

Dancer Effectiveness of Earplugs in 

High-Intensity Impulse noise 

3M_MDL000319051

Design blueprint of non-linear earplug 3M_MDL000696516

DOD Hearing Center of Excellence 

Video - Hearing Loss and Quality of 

Life

DoD Memo re CAE NSN and Purchase 

Request 

3M_MDL000188689 3M_MDL000188693

DoD Memo re CAE NSN and Purchase 

Request

3M_MDL000013920 3M_MDL000013924

Draft Justification for Ohlin's DoD 

Memo

3M_MDL000033933 3M_MDL000033935

Draft Report re CAEv2 Wind Noise ctrl_3m_touhy0000029

8

42

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 174 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

DRAFT White Paper -Sound 

Localization with Passive LevelDependent Earplugs 

CTRL_3M_TOUHY00

002526

Draft White Paper with Berger 

Comments

3M_MDL000008610 3M_MDL000008621

E.A.RCAL Attenuation Test Report Per 

ANSI S3.19-1974 Test ID

3M_MDL000475915

EP4 samples from Jeff Hamer, April 10, 

2012, Model EP4-BK-MPR-BULK, 1F065505

3M_MDL000198795

EP4-Sonic-Defenders-Plus-71-01-907

EPA Regulation Part 211 - Product 

Noise Labeling

3M_MDL000023319 3M_MDL000023336

Ex. 5401 CAE EARCAL Attenuation 

Test Report May 2000 - NRR 21.7

3M_MDL000019897 3M_MDL000019933

Fallon PPT re Hearing Protection 

Devices

FALLON00025

Hearing Center of Excellence 811 

(HCE811) Poster - I Waited 9 Months to 

Hear ''Mommy''

Humana Pharmacy BROCK00000085

Image of CAEv2 in Blister Pack 3M_MDL000080183 3M_MDL000080183

Instructions EP3 Sonic Defenders

Method B Test Data 213024 3M_MDL000534743

Microsoft Excel 2000 Frequency (Hz) 

Real-ear Attenuation - REAT 

Compilation

3m_mdl000535878

Moldex NSN Product List

New UltraFit 2007 test subjects 3M_MDL000452976

Ohlin and Army Emails through Years 

re CAE 

3M_MDL00045117

43

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 175 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

Passive Hearing Protection for the 

Warfighter

CTRL_3M_Touhy000

00021

Photo of Custom Earplug Drawers in 

EARCal Lab

EARCal_lnspect_0000

0114

Photo of EARCAL Lab Interior with 

ATF Mannequin, Custom Earplug 

Boxes, and Headset Box

EARCal_lnspect_0000

0134

Premolded plug testing 7.2.2004 3M_MDL000451192

Readiness Through Hearing 

Conservation - A Commander's Guide 

PPT

REAT Compilation of all testing CAE 

Versions 

3m_mdl000535879

Sound Localization with the Combat 

Arms Earplug 

ctrl3m000000117

Test Report - CAEv4 open - Test ID 

215021

3M_MDL000535049

Test Report - CAEv4 Open. Test ID 

215013

3M_MDL000535052

UltraFit Plus NRR

UltraFit stem specs 3M_MDL000605263

UltraFlex

10/9/2020 Rule 26 Expert Report and Exhibits of 

David Eddins

10/9/2020 Rule 26 Expert Report and Exhibits of 

David Madigan

10/9/2020 Rule 26 Expert Report and Exhibits of 

General Timothy J. Edens

10/9/2020 Rule 26 Expert Report and Exhibits of 

John R. Franks, PHD 

44

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 176 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

10/9/2020 Rule 26 Expert Report and Exhibits of 

Lawrence Lustig 

10/9/2020 Rule 26 Expert Report and Exhibits of 

Moises Arriaga

10/9/2020 Rule 26 Expert Report and Exhibits of 

Rear Admiral Allie Coetzee Leslie 

10/9/2020 Rule 26 Expert Report and Exhibits of 

Richard McKinley

10/9/2020 Rule 26 Expert Report and Exhibits of 

Steve Armstrong 

11/9/2020 Expert Report and Exhibits of Gregory 

A. Flamme, PH.D & Mark Stephenson, 

Ph.D. 

11/9/2020 Expert Report and Exhibits of Harri 

Kytomaa, Ph.D., P.E., CFEI

11/9/2020 Expert Report and Exhibits of James V. 

Crawford, MD 

11/9/2020 Expert Report and Exhibits of Jennifer 

Sahmel 

11/9/2020 Expert Report and Exhibits of John G. 

Casali, Ph.D., CPE 

11/9/2020 Expert Report and Exhibits of Richard 

Neitzel

11/9/2020 Expert Report and Exhibits of Vickie 

Tuten

11/19/2020 Rebuttal Report Re: Expert Report of 

Harri Kytomaa - Steve Armstrong 

45

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 177 of 265
DOCUMENTS 

Date Description Bates Beg Bates End

11/19/2020 Rebuttal Report Re: Expert Report of 

John G. Casali - David Eddins 

46

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 178 of 265
TRIAL EXHIBITS

Trial Exhibit No. Case Info 

D-ESTES-120 Luke Estes, No. 7:20-cv-00137

D-ESTES-146 Luke Estes, No. 7:20-cv-00137

D-ESTES-270 Luke Estes, No. 7:20-cv-00137

D-ESTES-284 Luke Estes, No. 7:20-cv-00137

D-ESTES-313 Luke Estes, No. 7:20-cv-00137

D-ESTES-33 Luke Estes, No. 7:20-cv-00137

D-ESTES-573 Luke Estes, No. 7:20-cv-00137

D-ESTES-7 Luke Estes, No. 7:20-cv-00137

D-ESTES-77 Luke Estes, No. 7:20-cv-00137

D-GEN-108 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1111 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1122 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1139 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1159 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1363 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1371 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-146 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1461 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1477 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-158 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1689 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1806 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1807 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-1836 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-195 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-243 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-268 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-272 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-348 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-356 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-363 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-389 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-43 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-44 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-518 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-539 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-565 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-567 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-568 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-628 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-645 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-788 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-792 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-802 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-83 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-GEN-956 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

D-HACKER-254 Stephen Hacker, No. 7:20-cv-00131

D-HACKER-93 Stephen Hacker, No. 7:20-cv-00131

D-KEEFER-169 Lewis Keefer, No. 7:20-cv-00104 

D-KEEFER-190 Lewis Keefer, No. 7:20-cv-00104 

D-KEEFER-206 Lewis Keefer, No. 7:20-cv-00104 

D-KEEFER-208 Lewis Keefer, No. 7:20-cv-00104 

47

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 179 of 265
TRIAL EXHIBITS

Trial Exhibit No. Case Info 

D-KEEFER-217 Lewis Keefer, No. 7:20-cv-00104 

D-KEEFER-292 Lewis Keefer, No. 7:20-cv-00104 

D-KEEFER-295 Lewis Keefer, No. 7:20-cv-00104 

D-KEEFER-324 Lewis Keefer, No. 7:20-cv-00104 

P-ESTES-11019A Luke Estes, No. 7:20-cv-00137

P-ESTES-11028 Luke Estes, No. 7:20-cv-00137

P-ESTES-11068 Luke Estes, No. 7:20-cv-00137

P-ESTES-11084 Luke Estes, No. 7:20-cv-00137

P-GEN-00001 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00009 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00018 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00026 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00031 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00045 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00051 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00052 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00057 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00058 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00085 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00092 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00093 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00098 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00099 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00103 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00107 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00108 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00109 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00122 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00128 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00129 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00131 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00233 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00235 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00251 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00253 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00311 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00313 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00353 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00384 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00412 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00419 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00464 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00481 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00495 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00505 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00547 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00551 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00583 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00621 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00683 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00744 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00745 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

48

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TRIAL EXHIBITS

Trial Exhibit No. Case Info 

P-GEN-00782 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-00954 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-01065 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-01140 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-01185 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-01218 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-01262 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-01296 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-01701 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02219 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02270 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02403 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02489 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02523 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02565 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02586 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02602 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02717 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02732 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02848 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02858 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-02883 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-03084 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-03172 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-05111 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-05286 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-05314 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-05401 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-05843 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-0585 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-06076 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-06085 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-06119 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-06126 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-06226 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-09001 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-GEN-13123 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

P-HACKER-12091 Stephen Hacker, No. 7:20-cv-00131

P-HACKER-12108 Stephen Hacker, No. 7:20-cv-00131

P-HACKER-12130 Stephen Hacker, No. 7:20-cv-00131

P-HACKER-12143 Stephen Hacker, No. 7:20-cv-00131

P-HACKER-12178 Stephen Hacker, No. 7:20-cv-00131

P-HACKER-12206 Stephen Hacker, No. 7:20-cv-00131

P-HACKER-12208 Stephen Hacker, No. 7:20-cv-00131

P-KEEFER-13067 Lewis Keefer, No. 7:20-cv-00104 

P-KEEFER-13086 Lewis Keefer, No. 7:20-cv-00104 

S-ESTES-0036 Luke Estes, No. 7:20-cv-00137

S-GEN-0001 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0002 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0006 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0009 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0014 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

49

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TRIAL EXHIBITS

Trial Exhibit No. Case Info 

S-GEN-0016 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0017 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0018 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0019 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0022 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0025 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0027 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0029 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0033 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0034 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0039 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0040 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0045 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0049 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0051 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0054 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0055 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0057 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0066 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0070 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0071 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0076 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0082 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0083 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0085 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0087 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0090 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0092 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0096 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0099 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0100 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0102 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0103 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0105 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0108 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-GEN-0109 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-Gen-108 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-HACKER-0002 Luke Estes, No. 7:20-cv-00137;Stephen Hacker, No. 7:20-cv-00131;Lewis Keefer, No. 7:20-cv-00104 

S-HACKER-0025 Stephen Hacker, No. 7:20-cv-00131

S-HACKER-0028 Stephen Hacker, No. 7:20-cv-00131

S-HACKER-0029 Stephen Hacker, No. 7:20-cv-00131

S-KEEFER-0018 Lewis Keefer, No. 7:20-cv-00104 

S-KEEFER-0020 Lewis Keefer, No. 7:20-cv-00104 

S-KEEFER-0025 Lewis Keefer, No. 7:20-cv-00104 

S-KEEFER-0026 Lewis Keefer, No. 7:20-cv-00104 

S-KEEFER-0028 Lewis Keefer, No. 7:20-cv-00104 

S-KEEFER-0029 Lewis Keefer, No. 7:20-cv-00104 

S-KEEFER-0031 Lewis Keefer, No. 7:20-cv-00104 

S-KEEFER-0037 Lewis Keefer, No. 7:20-cv-00104 

50

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DEPOSITIONS-TESTIMONY

Witness Date Description 

Armstrong, Steven 12/3/2020 Deposition Transcript and Exhibits of Steven Armstrong

Arriaga, Moises 12/12/2020 Deposition Transcript and Exhibits of Moises Arriaga, MD 

Arriaga, Moises 12/19/2020 Deposition Transcript and Exhibits of Moises Arriaga, MD 

Babeu, Lorraine 3/10/2020 Deposition Transcript and Exhibits of Lorraine Babeu, Ph.D.

Barza, Harold A. 12/1/2015 Deposition Transcript and Exhibits of Harold A. Barza, Esq.

Battler, Leanne 9/10/2020 Deposition Transcript and Exhibits of LTC Leanne Battler

Berger, Elliott 4/2/2013 Deposition Transcript and Exhibits of Elliott Berger, M.S.

Berger, Elliott 10/8/2015 Deposition Transcript and Exhibits of Elliott Berger, M.S.

Berger, Elliott 11/13/2019 Deposition Transcript (30(b)(6)) and Exhibits of Elliott 

Berger, M.S.

Berger, Elliott 12/10/2019 Deposition Transcript and Exhibits of Elliott Berger, M.S.

Berger, Elliott 12/11/2019 Deposition Transcript and Exhibits of Elliott Berger, M.S.

Berger, Elliott 12/12/2019 Deposition Transcript and Exhibits of Elliott Berger, M.S.

Berger, Elliott 12/12/2019 Deposition Transcript (30(b)(6)) and Exhibits of Elliott 

Berger, M.S.

Berger, Elliott 9/25/2020 Deposition Transcript (30(b)(6)) and Exhibits of Elliott 

Berger, M.S.

Berger, Elliott 12/18/2020 Deposition Transcript and Exhibits of Elliott Berger, M.S.

Berger, Elliott 4/19/2021 Trial Testimony of Elliot Berger, April 19, 2021

Berger, Elliott 4/20/2021 Trial Testimony of Elliot Berger, April 20, 2021

Berger, Elliott 4/21/2021 Trial Testimony of Elliot Berger, April 21, 2021

Birkner, Jeffrey 10/26/2015 Deposition Transcript and Exhibits of Jeffrey Birkner

Brock, Charles 9/10/2020 Deposition Transcript and Exhibits of Charles Brock, Jr. 

Bushman, Julie 10/20/2015 Deposition Transcript and Exhibits of Julie Bushman 

Casali, John 12/18/2020 Deposition Transcript and Exhibits of John Casali, Ph.D

Cave, Kara 3/11/2021 Deposition Transcript and Exhibits of Kara Cave 

51

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DEPOSITIONS-TESTIMONY

Witness Date Description 

Childress, Annette 9/23/2020 Deposition Transcript (30(b)(6)) and Exhibits of Annette 

Childress

Childress, Annette 9/23/2020 Deposition Transcript and Exhibits of Annette Childress 

Cimino, Mike 12/11/2019 Deposition Transcript and Exhibits of Mike Cimino

Coatzee Leslie, Althea 12/2/2020 Deposition Transcript and Exhibits of Althea Coatzee Leslie 

Coleman, Jennifer 3/3/2020 Deposition Transcript and Exhibits of Special Agent Jennifer 

Coleman

Crawford, James 12/28/2020 Deposition Transcript and Exhibits of James Crawford, MD 

Dix, Daniel 11/30/2015 Deposition Transcript and Exhibits of Daniel Dix

Doty, Marc 7/28/2020 Deposition Transcript and Exhibits of Marc Doty

Eddins, David 12/15/2020 Deposition Transcript and Exhibits of David Eddins 

Edens, Timothy 12/3/2020 Deposition Transcript and Exhibits of Timothy Edens

Falco, Robert 2/11/2020 Deposition Transcript and Exhibits of Robert Falco

Falco, Robert 2/12/2020 Deposition Transcript and Exhibits of Robert Falco

Fallon, Eric 9/3/2020 Deposition Transcript and Exhibits of Eric Fallon, Volume I

Fallon, Eric 9/4/2020 Deposition Transcript and Exhibits of Eric Fallon, Volume II

Fallon, Eric 12/22/2020 Deposition Transcript and Exhibits of Eric Fallon

Fallon, Eric 4/27/2021 Trial Testimony of Eric Fallon, April 27, 2021

Flamme, Gregory 12/22/2020 Deposition Transcript and Exhibits of Gregory Flamme, Ph.D 

Franks, John 12/7/2020 Deposition Transcript and Exhibits of John Franks

Franks, John R. 2/17/2016 Deposition Transcript and Exhibits of John R. Franks, Ph.D.

Gates, Kathy 5/29/2020 Deposition Transcript and Exhibits of Col. (Ret.) Kathy Gates

Gavin, Frank C. 1/29/2020 Deposition Transcript and Exhibits of Frank C. Gavin

Grimsley, Terry 10/26/2015 Deposition Transcript and Exhibits of Terry Grimsley

Hamer, Jeffrey L. 12/18/2019 Deposition Transcript and Exhibits of Jeffrey L. Hamer

52

Case 7:20-cv-02945-MCR-HTC Document 20-5 Filed 08/09/22 Page 184 of 265
DEPOSITIONS-TESTIMONY

Witness Date Description 

Hamer, Jeffrey Lee 10/7/2015 Deposition Transcript and Exhibits of Jeffrey Lee Hamer

Harri, Kytomaa 1/4/2021 Deposition Transcript and Exhibits of Harri Kytomaa, Ph.D 

Hobbs, Brian 7/16/2020 Deposition Transcript and Exhibits of Dr. Brian Hobbs

Hornstein, James E. 9/25/2015 Deposition Transcript and Exhibits of James E. Hornstein

House, John 4/26/2021 Trial Testimony of John House, April 26, 2021

Jones, Derek 4/22/2021 Trial Testimony of Derek Jones, April 22, 2021

Jones, Jason 6/19/2020 Deposition Transcript and Exhibits of Jason Jones

Jones, Jason 9/24/2020 Deposition Transcript (30(b)(6)) and Exhibits of Jason Jones

Kieper, Ronald 10/9/2015 Deposition Transcript and Exhibits of Ronald Kieper

Kieper, Ronald 12/19/2019 Deposition Transcript and Exhibits of Ronald Kieper 

Kieper, Ronald 12/20/2019 Deposition Transcript and Exhibits of Ronald Kieper 

Kladden, Cynthia 1/31/2020 Deposition Transcript and Exhibits of Cynthia Kladden

Klun, Robert 6/24/2020 Deposition Transcript and Exhibits of Robert Klun

Knauer, Richard 12/17/2019 Deposition Transcript and Exhibits of Richard Knauer

Laborde, Jennifer 4/21/2021 Trial Testimony of Jennifer Laborde, April 21, 2021

Laborde, Jennifer 4/22/2021 Trial Testimony of Jennifer Laborde, April 22, 2021

Levinson, Eric D. 9/30/2015 Deposition Transcript and Exhibits of Eric D. Levinson, Esq.

Little, Frank 12/1/2015 Deposition Transcript and Exhibits of Frank Little

Lovejoy, James 6/24/2020 Deposition Transcript and Exhibits of James Lovejoy

Lustig, Lawrence 12/20/2020 Deposition Transcript and Exhibits of Lawrence Lustig, MD 

Madigan, David 12/11/2020 Deposition Transcript and Exhibits of David Madigan, Ph.D 

Madison, Ted 12/10/2019 Deposition Transcript and Exhibits of Ted Madison

Magidson, Mark 10/6/2015 Deposition Transcript and Exhibits of Mark Magidson

53

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DEPOSITIONS-TESTIMONY

Witness Date Description 

McGinley, Brian 12/20/2019 Deposition Transcript and Exhibits of Brian McGinley

McGinley, Brian S. 4/2/2013 Deposition Transcript and Exhibits of Brian S. McGinley

McGinley, Brian S. 4/3/2013 Deposition Transcript and Exhibits (30(b)(6)) of Brian S. 

McGinley

McKinley, Richard 12/9/2020 Deposition Transcript and Exhibits of Richard McKinley 

McKinley, Richard 3/30/2021 Trial Testimony of Richard McKinley, March 30, 2021

McKinley, Richard 3/31/2021 Trial Testimony of Richard McKinley, March 31, 2021

McKinley, Richard 4/1/2021 Trial Testimony of Richard McKinley, April 1, 2021

McNamara, Timothy 3/11/2020 Deposition Transcript and Exhibits of Timothy McNamara

Merkley, John A. 2/26/2020 Deposition Transcript and Exhibits of LTC John A. Merkley

Michael, Kevin L. 10/29/2015 Deposition Transcript and Exhibits of Kevin L. Michael, 

Ph.D.

Mishkin, Bernard 10/5/2015 Deposition Transcript and Exhibits of Bernard Mishkin

Moses, Douglas 10/21/2015 Deposition Transcript and Exhibits of Douglas Moses

Moses, Douglas 10/17/2019 Deposition Transcript (30(b)(6) and Exhibits of Douglas 

Moses

Moses, Douglas 12/6/2019 Deposition Transcript and Exhibits of Douglas Moses

Moses, Douglas 12/5/2019 Deposition Transcript and Exhibits of Douglas Moses

Moses, Douglas H. 4/4/2013 Deposition Transcript and Exhibits of Douglas H. Moses

Murphy, Peter Joseph 1/29/2020 Deposition Transcript and Exhibits of Peter Joseph Murphy

Myers, Brian 9/29/2015 Deposition Transcript and Exhibits of Brian Myers

Myers, Brian 10/18/2019 Deposition Transcript (30(b)(6)) and Exhibits of Brian Myers

Myers, Brian 12/12/2019 Deposition Transcript and Exhibits of Brian Myers

Myers, Brian 12/13/2019 Deposition Transcript and Exhibits of Brian Myers

Neitzel, Richard 12/16/2020 Deposition Transcript and Exhibits of Richard Neitzel, Ph.D 

Ohama, Daniel 11/17/2020 Deposition Transcript and Exhibits of Daniel Ohama, MD 

54

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DEPOSITIONS-TESTIMONY

Witness Date Description 

Ohlin, Douglas 4/24/2013 Deposition Transcript and Exhibits of Douglas Ohlin, Ph.D.

Pawlowski, Walter C. 10/23/2015 Deposition Transcript and Exhibits of Walter C. Pawlowski

Robinette, Martin 9/16/2020 Deposition Transcript and Exhibits of CNA Lt. Col. Martin 

Robinette

Salon, Martin 1/29/2020 Deposition Transcript and Exhibits of Martin Salon

Santoro, Marc A. 12/3/2019 Deposition Transcript and Exhibits of Marc A. Santoro

Schubach, William J. 10/22/2015 Deposition Transcript and Exhibits of William J. Schubach

Shamel, Jennifer 12/14/2020 Deposition Transcript and Exhibits of Jennifer Shamel 

Smith, Norman 12/1/2015 Deposition Transcript and Exhibits of Norman Smith

Spankovich, 

Christopher 

12/10/2020 Deposition Transcript and Exhibits of Christopher 

Spankovich

Spankovich, 

Christopher 

12/11/2020 Deposition Transcript and Exhibits of Christopher 

Spankovich

Spankovich, 

Christopher 

4/7/2021 Trial Testimony of Christopher Spankovich, April 7, 2021

Spankovich, 

Christopher 

4/8/2021 Trial Testimony of Christopher Spankovich, April 8, 2021

Stephenson, Mark 12/30/2020 Deposition Transcript and Exhibits of Mark Stephenson, Ph.D 

Todor, Stephen 8/24/2020 Deposition Transcript and Exhibits of Stephen Todor

Toyama, Andy 11/24/2020 Deposition Transcript and Exhibits of Andy Toyama 

Tremblay, Julie 12/9/2019 Deposition Transcript and Exhibits of Julie Tremblay

Tuten, Vickie 12/23/2020 Deposition Transcript and Exhibits of Vickie Tuten 

Van Densen, Mark 12/4/2020 Deposition Transcript and Exhibits of Mark Van Densen

Warren, D. Garrad 1/23/2020 Deposition Transcript and Exhibits of D. Garrad Warren, III

Zielinski, Robert 6/22/2020 Deposition Transcript and Exhibits of Robert Zielinski

1/8/2021 Transcript: Evidentiary Hearing on COL (Doc. 1602) 

55

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LITERATURE 

Author Title Citation

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3M Lab Attenuation Data for 3M HPDs 3M (2015)

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LITERATURE 

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Abrams TE, Barnett MJ, Hoth 

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Virally Mediated Overexpression of GlialDerived Neurotrophic Factor Elicits Ageand Dose-Dependent Neuronal Toxicity 

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LITERATURE 

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Spiral ganglion degeneration and hearing 

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J Neurosci. 2015 Feb 

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Alali K, Casali J The challenge of localizing vehicle backup 

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Mil Med. 2016 Apr;181(4):301-6

Alamgir H, Turner CA, Wong 

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The impact of hearing impairment and 

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Mil Med Res. 2016 Apr 12;3:11

58

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LITERATURE 

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The Biological Basis of Chronic Traumatic 

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J Neurotrauma. 2017 

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Alemi A, Lustig LE “Genetic Hearing Loss.” A chapter in 

Springer Encyclopedia of OtolaryngologyHead & Neck Surgery

Springer, New Delhi, India 2012

Alice H. Suter EPA (2003) Workshop on Hearing 

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US Environmental Protection 

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Hearing Protector Devices Papers 

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Al-Omari AS, Al-Khalaf HM, 

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Association of Flying Time with Hearing 

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Saudi J Med Med Sci. 2018 SepDec;6(3):155-159

Alster J, Shemesh Z, Ornan M, 

Attias J

Sleep Disturbance Associated with Chronic 

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Biol Psychiatry 1993;34:84-90

Altschuler RA, Halsey K, 

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Small Arms Fire-like noise: Effects on 

Hearing Loss, Gap Detection and the 

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Neuroscience 2019 May 

21;407:32-40

Alvarado JC, FuentesSantamar’a V, Juiz JMAntioxidants and Vasodilators for the 

Treatment of Noise-Induced Hearing Loss: 

Are They Really Effective?

Front Cell Neurosci. 2020 Jul 

22;14:226

Alvarado JC, FuentesSantamaria V, Juiz JMAntioxidants and Vasodilators for the 

Treatment of Noise-Induced Hearing Loss: 

Are They Really Effective? 

Front Cell Neurosci 

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Alvord, L. and Farmer, B. Anatomy and orientation of the human 

external ear

J Am Acad Audiol 1997; 8: 383-

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59

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LITERATURE 

Author Title Citation

Alvord, L., et al. Anatomy of an earmold-a formal 

terminology

J AM Acad Audiol 1997; 8: 100-

103

Amanat S, Gallego-Martinez 

A, Lopez-Escamez JA

Genetic Inheritance and Its Contribution to 

Tinnitus

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Jul 24

Amanat S, Gallego-Martinez 

A, Lopez-Escamez JA. 

Abstract Genetic Inheritance and Its 

Contribution to Tinnitus

Curr Top Behav Neurosci. 2020 

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American Academy of 

Audiology

Position Statement Preventing NoiseInduced Occupational Hearing LossLOSS, PREVENTING NOISEINDUCED OCCUPATIONAL 

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Amrein B, Letowski T High Level Impulse Sounds and Human 

Hearing: Standards, Physiology, 

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ARL-TR-6017; 2012 May

Amy Donahue, et al Noise and the Impairment of Hearing Textbook of Military Medicine: 

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and the Industrial Base. 

Washington, DC: Borden 

Institute, Office of The Surgeon 

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Andrew J. MacGregor, et al Co-occurrence of Hearing Loss and 

Posttraumatic Stress disorder Among 

Injured Military Personnel A Retrospective 

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BMC public health 2020; 1 (20): 

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Ann Nakashima A comparison of metrics for impulse noise 

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Defence Research and 

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Arias E., Xu J. U.S. State Life Tables, 2018. Natl Vital Stat Rep. 2020 Nov; 

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Army FOIA Response Criminal Investigation 

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Dept. of the Army 2019 Mar.

Army in Europe Army Hearing Program-Europe AE Reg. 40-501 2018 Jun.

Associated Industries DH-132s and DH-132AS CVC Helmets Associated Industries 

60

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LITERATURE 

Author Title Citation

Associated Press Soldiers in Iraq praise quick, quiet Stryker Ass. Press 2005 Apr. 6

https://tdn.com/news/soldiers-iniraq-praise-quick-quietstryker/article

Azam N Noise induced hearing loss: profile in 

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PAFMJ 2010 Dec 31

B. Kaushik, et al A Review of the Role of Acoustic Sensors 

in the Modern Battlefield

11th AIAA/CEAS Aeroacoustics 

Conference(p. 2997)

B.K Bohnker, et al U.S. Navy and Marine Corps Hearing 

Conservation Program 1995-1999: Mean 

Hearing Thresholds for Enlisted Personnel 

by Gender and Age Groups

Military MedicineÊ2020; 2 

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Babeu LA, Binseel MS, 

Mermagen TJ, Letowski TR

Sound Localization with the Combat Arms 

Earplug

ARL 2004

Babeu, LA, Binseel MS, 

Mermagen TJ, Letowski TR

Sound Localization With the Combat Arms 

Earplug (CAE)

US Army Research Lab. Human 

Eng. and Research Directorate 

Visual & Auditory Processes 

Branch

Baguley DM Mechanisms of tinnitus Br Med Bull. 2002;63:195-212

Baguley, David McFerran, 

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Tinnitus Seminar 2013; (382): 1600-1607

Baiduc RR, Poling GL, Hong 

O, Dhar S

Clinical Measures of Auditory Function - 

The Cochlea and Beyond

Dis Mon. 2013 Apr;59(4):147-56

Baigi A, Oden A, AlmlidLarsen V, Barrenas M-L, 

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Tinnitus in the General Population with a 

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Ear & Hearing 2011;(32)6:787-

789

Bakay WMH, Anderson LA, 

Garcia-Lazaro JA, McAlpine 

D, Schaette R

Hidden hearing loss selectively impairs 

neural adaptation to loud sound 

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Nat Commun. 2018 Oct 

16;9(1):4298

Balatsouras DG, Homsioglou E Extended high-frequency audiometry in 

patients with acoustic trauma

Clin Otolaryngol. 2005 

Jun;30(3):249-54

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LITERATURE 

Author Title Citation

Barbee CM, James JA, Park 

JH, Smith EM, Johnson CE, 

Clifton S, Danhauer JL

Effectiveness of Auditory Measures for 

Detecting Hidden Hearing Loss and/or 

Cochlear Synaptopathy: A Systematic 

Review

Semin Hear. 2018 May;39(2):172-

209

Barbee CM, James JA, Park 

JH, Smith EM, Johnson CE, 

Clifton S, Danhauer JL

Effectiveness of Auditory Measures for 

Detecting Hidden Hearing Loss and/or 

Cochlear Synaptopathy: A Systematic 

Review

Semin Hear. 2018 May;39(2):172-

209

Barbee CM, James JA, Park 

JH, Smith EM, Johnson CE, 

Clifton S, Danhauer JL

Effectiveness of Auditory Measures for 

Detecting Hidden Hearing Loss and/or 

Cochlear Synaptopathy: A Systemic 

Review

Semin Hear. 2018 May;39(2):172-

209

Bartels H, Middel B, van der 

Laan B, Staal M, Albers F

The additive effect of co-occurring anxiety 

and depression on health status, quality of 

life and coping strategies in help-seeking 

tinnitus sufferers

Ear Hear. 2008 Dec;29(6):947-56

Bauer CA Animal Models of Tinnitus Otolaryngol Clin North Am 

2003;(36):267-85, vi

Benjamin Sheffield, Douglas 

Brungtart, Amy Blank

The Effects of Hearing Impairment on Fire 

Team Performance in Dismounted Combat

Proceedings of the Human 

Factors and Ergonomics Society 

Annual Mtg. Sage Publications 

2016; 1 (60): 1509-1513 

Berger E Why Can't I Measure Sound Exposures 

from MP3 Players (iPod or equivalent) or 

from a Peltor Worktunes, style earmuff, 

with a simple microphone?

E-A-RCAL Laboratory 2008 Feb

Berger E Custom Hearing Protection Have It Your 

Way Maybe

IHN 2011 May/June

Berger E Hearing through the Protectors IHN 2010 July/August

Berger E Noise and Hearing Conservation Manual Amer Indus. Hyg. Assn 1986

Berger E What is a Personal Attenuation Rating 

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E-A-RCAL 07-21/HP; 2010 

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LITERATURE 

Author Title Citation

Berger E Review of the 2016 Edition of ANSI S12.6 

and its place in the panoply of standards on 

the measurement of real-ear attenuation at 

threshold since 1957

J Acoust Soc Am. 2018 

Oct;(140)4

Berger E, Casau J Hearing Protection Devices Encyclopedia of Acoustics, 

Chapter 81: 967-981

Berger E, Hamery P Empirical Evaluation using Impulse Noise 

of the level-dependency of various passive 

earplug design

J. Acoust. Soc. Am. 2008 June; 

Berger E, Lindren F, Kleper 

RW

Establishing the "True" Laboratory NRR - 

An Experimental Dilemma

18th Annual Conference of the 

National Hearing Conservation 

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Spectrum Vol. 10, Suppl. 1, p. 19 

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Berger E, Voix J Hearing Protection Devices In The Noise Manual, 6th Ed.; 

Chapt. 11, Am Ind Hygn Assoc. 

2017

Berger E, Voix J, Hager L Methods of Fit Testing Hearing Protectors, 

with representative field test data

Hearing Loss (ICBEN) 2008

Berger E, Voix J, Kieper R, Le 

Cocq C

Development and validation of a field 

microphone-in-real-ear approach for 

measuring hearing protector attenuation

Noise Health. 2011 MarApr;13(51):163-75

Berger E, Voix J, Kieper, R Methods of Developing and Validating a 

Field -MIRE Approach for Measuring 

Hearing Protector Attenuation

Spectrum 2007 Feb; (24) Suppl 

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Berger E, Wells L, Hager L, 

Myers B

The Noise Stops Here: An Experimental 

Hearing Protection Fitting Workshop

33rd Annual Conference of the 

National Hearing Conservation 

Association, Portland, OR, 

Spectrum Vol. 25, Suppl. 1 

Berger EH Bibliography on Hearing Protection, 

Hearing Conservation, and Aural Care, 

Hygiene and Physiology 1831-2004

E.A.R. 82-6/HP

Berger EH Hearing Protector Performance: How They 

Work - and - What Goes Wrong in the Real 

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LITERATURE 

Author Title Citation

Berger EH Hearing Protector Testing – Lets Get Real 

[Using the New ANSI Method-B Data and 

the NRR(SF)]

E.A.R. LOG 1999 Dec.

Berger EH Noise and Military Service: Findings From 

the Institute of Medicine

Berger EH, Franks JR, Behar 

A, Casali JG, Dixon-Ernst C, 

Kieper RW, Merry CJ, Mozo 

BT, Nixon CW, Ohlin D, 

Royster JD, Royster LH

Development of a new standard laboratory 

protocol for estimating the field attenuation 

of hearing protection devices. Part III. The 

validity of using subject-fit data.

J Acoust Soc Am. 1998 

Feb;103(2):665-72

Berger, Elliot Kieper, Ronald Evaluation of Variability in real-ear 

attenuation testing using a unique 

databaseÑ35 years of data from a single 

laboratory

The Journal of the Acoustical 

Society of America 2014; 4 

(136): 2134

Bezandry M, Raglin A, Noble 

J

Effects of hearing protection device 

attenuation on unmanned aerial vehicle 

(UAV) audio signatures

ARL-TR-7639 2016 Mar 

Bharadwaj HM, Mai AR, 

Simpson JM, Choi I, Heinz 

MG, Shinn-Cunningham BG

Non-Invasive Assays of Cochlear 

Synaptopathy - Candidates and 

Considerations

Neuroscience 2019 May 

21;407:53-66

Bhatt IS, Dias R, Washnik N, 

Wang J, Guthrie O, Skelton 

M, Lane J, Wilder J

Association Analysis of Candidate Gene 

Polymorphisms and Audiometric Measures 

of Noise-Induced Hearing Loss in Young 

Musicians

Otol Neurotol. 2020 

Jun;41(5):e538-e547

Bhatt JM, Bhattacharyya N, 

Lin HW

Relationships between tinnitus and the 

prevalence of anxiety and depression

Laryngoscope. 2017 

Feb;127(2):466-469

Bhatt JM, Lin HW, 

Bhattacharyya N 

Epidemiology of Firearm & Other Noise 

Exposures in the United States

Laryngoscope. 2017 

Oct;127(10):E340-E346

Bielefeld EC, Harrison RT, 

Riley DeBacker J

Pharmaceutical otoprotection strategies to 

prevent impulse noise-induced hearing loss

J Acoust Soc Am. 2019 

Nov;146(5):3790

Bielefeld, Eric Protection from noise-induced hearing loss 

with Src Inhibitors

Drug Discov Today. 2015; 6 

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64

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LITERATURE 

Author Title Citation

Binseel M, Cave K, Kalb J, 

Letowski T

A Comparison of the single-sided (Gen II) 

and a double-sided (Gen I) Combat Arms 

Earplugs (CAE): Acoustic properties, 

human performance, and used acceptance.

ARL-TR-6270 2012 Dec.

Binseel M, Cave K, Kalb J, 

Letowski T

A Comparison of the Single-sided (Gen II) 

and Double-sided (Gen I) Combat Arms 

Earplugs (CAE): Acoustic Properties, 

Human Performance, and User Acceptance

ARL-TR-6270 2012 Dec.

Binseel M, Kalb J, Cave K, 

Price R

Using the Auditory Hazad Assessment 

Algorithm for Humans (AHAAH Software, 

ARL-TR-4987 2009 Sep.

Blackwell DL, Lucas JW, 

Clarke TC

Summary Health Statistics for U.S. Adults - 

National Health Interview Survey, 2012

Vital Health Stat 10. 2014 

Feb;(260):1-161

Blair M Retrospective Cohort Study of Pure Tone 

Audiometry Threshold Shifts from Ototoxic 

Substance, Continuous Noise, and Impulse 

Noise Exposures at Tinker Air Force Base 

from 2005 to 2019

Air Force Institute of 

Technology. Theses and Diss. 

2020 (3226)

Blioskas S, Tsalighopoulos M, 

Psillas G, Markou K

Utility of otoacoustic emissions and 

olivocochlear reflex in predicting 

vulnerability to noise-induced inner ear 

damage

Noise Health. 2018 MayJun;20(94):101-111

Bramhall N Characterizing noise-induced hidden 

hearing loss in veterans

J. Acoust. Soc. Am. 2019 Mar; 

3(145) Pt. 2:1907

Bramhall N, Beach E, Epp B, 

Le Prell C, Lopez-Poveda E, 

Plack C, Schaette R, Verhulst 

S, Canlon B

The search for noise-induced cochlear 

synaptopathy in humans: Mission 

impossible?

Hear Res. 2019 Jun; 377:88-103

Bramhall NF, McMillan GP, 

Kujawa SG, Konrad-Martin D

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