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

LAWRENCE LUSTIG, MD

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

RULE 26 EXPERT REPORT OF LAWRENCE LUSTIG, MD

The following report is provided pursuant to Rule 26 of the Federal Rules of Civil 

Procedure. All opinions I offer in this Report 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 materials considered are attached as Exhibit C. The materials I 

have relied on in forming my opinions in this report are included in this report and included in 

my list of materials considered. 

Sections:

I. Qualifications

II. Background

III. The CAEv2 Ear Plug

I. Qualifications

I currently serve as the Howard W. Smith Professor and Chair of the Department of 

Otolaryngology – Head & Neck Surgery at Columbia University Irving Medical Center and New 

York Presbyterian Hospital in New York City, NY. 

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I obtained a Bachelor of Arts degree from the University of California Berkeley in 1987, 

and subsequently earned a Medical Degree from the University of California San Francisco 

(UCSF) in 1992. I subsequently completed an internship in General Surgery and then a 

residency in Otolaryngology-Head & Neck Surgery at UCSF, finishing in 1997. I then 

completed a fellowship in Neurotology and Skull Base Surgery at Johns Hopkins University in 

Baltimore, MD in 1999. Following the fellowship, I joined the faculty at Johns Hopkins as an 

Otologist and Neurotologist. I remained at Johns Hopkins through 2004, and subsequently 

returned to UCSF as the Division Chief of Otology, Neurotology and Skull Base Surgery, where 

I was the Francis A. Sooy MD Professor of Otology & Neurotology. In 2014 I became the

Howard W. Smith Chair of Otolaryngology-Head & Neck Surgery at Columbia University and 

New York Presbyterian Hospital. I remain in that position to this day.

I am Board Certified in Otolaryngology (1998) and Neurotology (2006). 

Throughout my career I have been extensively involved in hearing research, with 109 

peer-reviewed publications, review articles on hearing loss, 45 book chapters, and several online 

publications. I have also been the editor of a book, Clinical Neurotology (2003, Martin Dunitz). 

My research has focused on such areas as neuronal input to the inner ear, genetic causes of 

hearing loss, ototoxicity of chemotherapeutic agents, noise-induced hearing loss, and cochlear 

gene therapy to correct genetic deafness. 

I have been involved in research projects that have a direct impact on noise-induced 

hearing loss. This includes cochlear gene therapy to regrow auditory hair cells in the cochlea 

(sponsored by Novartis Corp). The goal of this research is to restore hearing in people with 

hearing loss from a variety of causes, including noise-induced hearing loss. Other research 

projects are tangentially related to noise-induced hearing loss, including those studying the 

efferent auditory system. Since the efferent neural auditory pathway is thought to protect against 

noise-damage to the inner ear, understanding the molecular pathways governing this system are 

critical for understanding how noise causes inner ear damage. This includes work on cochlear 

outer hair cells and nicotinic acetylcholine receptors, synucleins, saposins, and the protein 

Tmtc4, and how abnormalities of these proteins and pathways can lead to susceptibility to noise 

damage. I have also published research on mechanisms of ototoxicity due to chemotherapy 

compounds. I have studied how different genetic strains of mice have varying susceptibilities to 

noise damage. I have also studied the genetics of age-related hearing loss in large populations of 

individuals in an effort to determine the genetic causes of presbycusis (hearing loss with aging). 

I have published extensively on issues relating to hearing loss and cochlear implantation. 

I have received research awards from the American Academy of Otolaryngology and the 

National Institutes of Health (National Institute of Deafness and Communications Disorders) to 

study hearing loss. For a number of years, I was the administrative director of the research 

grants program of the American Academy of Otolaryngology, focusing on hearing and balancerelated research. I currently serve as a reviewer for hearing research grants to the National 

Institutes of Health, NIDCD. I also serve on an international research advisory board that 

oversees auditory research funding in France (Fondation Pour l’Audition). Many of the research 

proposals that come through these agencies are focused on noise-induced hearing loss.

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My clinical experience throughout my career has focused on disorders of hearing, 

balance, facial nerve disorders, and skull base tumors. I have maintained an active medical and 

surgical practice since completing my training. As part of this practice I routinely treat patients 

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

head trauma, ear infections, immune disorders, neoplastic disorders, and metabolic conditions, 

among others. It is routine in my practice to produce a differential diagnosis of a patient’s 

hearing loss and determine a cause of hearing loss in an individual. It is also a routine part of my 

practice to recommend treatment for hearing loss. Because treatment is often specific for the 

cause of hearing loss, arriving at the correct diagnosis is a critical part of this determination. 

Additionally, I routinely have recommended hearing protection to patients exposed to noise as 

part of their work or recreational activities. As part of my counseling I discuss with patients the 

various types of hearing protection available and include a discussion of noise reduction ratings 

(NRR) as a measure that should be evaluated when selecting hearing protection devices. This 

includes telling patients that a higher NRR means stronger noise protection, and that this is a 

measure that patients should rely on when selecting noise protection devices since it is 

scientifically derived. 

I treat patients with hearing loss who also have depression, which is a frequent 

comorbidity, and routinely involve psychiatry and psychology in the treatment planning of 

patients when both conditions co-exist. 

In addition to treating patients with hearing loss, I also routinely treat patients with 

tinnitus. As with hearing loss, it is routine for me to review the general causes of tinnitus, 

explain current understanding of the mechanisms that generate tinnitus, and explore possible 

causes of tinnitus in each specific patient. I then review tinnitus treatment options and make 

specific treatment recommendations to patients under my care. I also involve psychology or 

psychiatry in that treatment process when there are associated issues related to depression or 

anxiety associated with tinnitus. In my career I have diagnosed and treated patients with tinnitus 

from a number of causes, including (but not limited to) trauma from noise, trauma from impulse 

noise and explosive devices (including automobile air bag deployment), ototoxic drugs, 

infections, age related hearing loss, and other causes. Because patients suffering from tinnitus 

may also have depression, which is a frequent comorbidity, I routinely involve psychiatry and 

psychology in the treatment planning of patients when both conditions co-exist.

I have also treated military veterans during my career, having worked for a period of time 

at the Fort Miley Veterans Administration Hospital in San Francisco, CA (1992–1997). During 

this period, I diagnosed and treated many veterans with noise-induced hearing loss. These 

included veterans with exposure to impulse noise, blast exposure, and long-term noise exposure. 

I also diagnosed and treated patients with traumatic brain injury from blast exposure, including 

dizziness and post-traumatic stress disorder (PTSD). Many of these veterans also had tinnitus 

and depression. I also offered specific treatment(s) for the hearing loss in each individual 

patient. I routinely counseled veterans on the use of ear protection when exposed to loud noise. 

I routinely involved ancillary services such as psychiatry and psychology to help with 

comorbidities including depression and PTSD. 

I have clinical experience fitting some in-the-canal hearing aids. During the initial trials 

of the Lyric hearing aid (InSound Medical, prior to being acquired by Phonak), I was involved in 

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the initial fitting paradigms for this deep-seated hearing aid. I was also recently the lead 

investigator in a clinical trial studying a new in-office myringotomy procedure by Tusker Corp. 

(recently acquired by Smith-Nephew). As part of this trial, clinicians had to correctly size an inthe-canal iontophoresis device to allow delivery of lidocaine to the ear canal and ear drum.

I have served on the medical and surgical advisory committees of a number of hearingrelated companies and have advised a number of companies on hearing related commercial 

products. This includes three cochlear implant manufacturers (Advanced Bionics Corp., 

Cochlear Corp., Med-El Corp.), and a number of biomedical startup companies focusing on 

hearing restoration (Akuous, Rescue Hearing Inc., Decibel, Otonomy, and Sound Pharma). 

These activities include recommendations on product design and implementation, as well as 

surgical approaches to the inner ear. I have also served as a consultant to Roche Pharmaceuticals 

on recommendations for future research and developmental strategies in hearing-related product 

development. In this work I have also made recommendations to both the Federal Drug 

Administration (FDA) and Center for Medicaid Services (CMS) on behalf of manufacturers, 

including Novartis, Akuous and Decibel (cochlear gene therapy protocols), and Sonitus Medical 

(a bone conduction hearing aid). 

I have been extensively involved in leadership positions in national societies that deal 

with hearing loss, including serving as past president of the American Neurotology Society and 

the Association for Research in Otolaryngology. I have served on the senior leadership council 

of the American Auditory Society and currently serve on the senior council of the American 

Otological Society. I am also a senior examiner for the American Board of Otolaryngology, the 

governing body that ensures proper training and competence of otolaryngologists in the United 

States. In this role, I test recently graduated Otolaryngology trainees on their competency of 

hearing loss disorders, including noise-induced hearing loss. I am also one of the founding 

members of the International Society of Inner Ear Therapeutics and serve as Vice President, a 

society that is devoted to finding cures for hearing loss and other ear disorders. 

I have also been extensively involved in publications in our field. I serve as the Editorin-Chief of Otology & Neurotology, a journal focused on hearing related disorders and which 

has the highest impact factor of all otology-focused journals. In this role, I oversee all 

publications submitted to the journal, including those that focus on hearing loss and noiseinduced hearing loss. Through my work with Otology & Neurology, I have served as the 

supervising editor of hundreds of scientific manuscripts directly or indirectly relating to noise 

exposure and tinnitus in both humans and animals. This includes oversight of manuscripts 

relating specifically to noise and blast exposure in the military (seven manuscripts published 

since 2016 in the journal on this topic). 

I have given numerous talks nationally and internationally on hearing-related subjects. 

These include, among others, an endowed lecture on Presbycusis and Noise Induced Hearing 

loss at Harvard University, Massachusetts Eye and Ear Infirmary in 2013 (I refer to my CV for a 

full list of lectures given). I have also given talks on Hidden Hearing Loss and Cochlear 

Synaptopathy in New York City at an annual Otolaryngology Update Course. I have taught 

auditory anatomy and physiology to medical students and have given courses on the genetics of 

hearing loss to medical and graduate students throughout my career. I have mentored numerous 

medical students, residents and fellows in otology and neurotology who have gone on to 

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successful academic careers and have won teaching awards for this education at three different 

academic institutions. 

II. Background

A. Anatomy and Physiology of the Auditory System

Our current understanding of the underlying mechanism of hearing in humans is the 

result of several hundred years of study. At its most basic level, sound travels down the ear canal 

to the eardrum. The eardrum senses the sound pressure vibrations and transfers those sound 

waves through the three middle ear bones (ossicles) to the inner ear. Within the inner ear those 

sound waves are converted to an electrical impulse which is then sent along the auditory nerve to 

the brain. 

Within the inner ear, understanding the mechanism by which sound waves are converted 

to an electrical signal is critical to understanding how hearing loss occurs in a majority of people. 

This sound conversion occurs within a spiral shaped structure called the cochlea. Once sound 

waves arrive in the cochlea, its physical structure will cause high frequency sounds to vibrate one 

end (the base), while low frequency sounds will vibrate the other end (the apex). Thus, the 

cochlea is mechanically ‘tuned’ like a piano keyboard, with every location corresponding to a 

specific sound pitch, from low to high frequency. 

Once complex sounds are parsed to their frequency location within the inner ear, the next 

step occurs, converting the sound wave into the electrical impulse that will travel to the brain. 

This occurs in a structure within the cochlea called the Organ of Corti. This organ contains, 

among others, tiny cells called ‘hair cells’ (over 30,000 of them exist in a single ear). They are 

called hair cells because of small cilia that stick out of the top of the cells. These cells are bathed 

in a salt-rich fluid called endolymph. As a particular portion of the organ of Corti moves in 

response to sound, the hair cells will vibrate, causing the cilia to also vibrate. These cilia also 

contain a salt (potassium) channel that will open in response to this movement, allowing the 

potassium from the endolymph to rush into the hair cell. This change in the potassium levels 

within the hair cell will then trigger the synapse at the base of the hair cell to release a 

neurotransmitter (glutamate). After being released from the hair cell, the neurotransmitter is then 

picked up by an adjacent nerve, which in turn gets activated, and now sends the signal to the 

brain.

Thus, to summarize this process, sounds are transmitted down the ear canal, through the 

middle ear bones, to the inner ear. Within the inner ear, those sound waves vibrate particular 

regions of the cochlea depending on their frequency. As the specific region of the organ of Corti 

within the Cochlea moves, hair cells at that location sense those vibrations, open their salt 

channels which will then activate the synapse at the base of the hair cell, which then sends an 

electrical signal off to the brain via the nerve adjacent to that hair cell. 

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B. Hearing and Auditory System – Acoustics and Linguistics

1. Acoustics

Sound travels as a wave at approximately 1087 feet per second. Loudness of sound is 

due to the intensity of auditory sensation that is produced, and proportional to the logarithm of 

sound intensity: when the intensity is very small, the sound is not audible; when it is too great, it 

becomes painful and dangerous to the ear. The sound intensity that the ear can tolerate is 

approximately 1012 times greater than the amount that is just perceptible. This range varies from 

person to person and with the frequency of the sound. The decibel scale is an objective scale of 

intensity and is defined physically. Any intensity can be compared directly with the physically 

defined reference point. Tone is a sound that can be recognized by its regularity of vibration. A 

simple tone has only one frequency, though the intensity may vary. A complex tone consists of 

two or more simple tones, called overtones. The tone of lowest frequency is the fundamental 

frequency. 

An amazing feature of hearing is the enormous range that can be perceived by the human 

ear. Sound intensity varies by a factor of 1012, from the threshold of sound perception to a 

volume that causes damage to the ear in seconds. For every 10dB of sound increase, the 

intensity of sound increases by a factor of ten, and thus the dB scale is logarithmic in its growth 

in terms of sound intensity. As an example, an increase in 10dB (the difference between the 

rustle of leaves and a whisper at 1-meter distance) is a tenfold increase in the sound intensity (see

figure below). 

Sound Intensity Levels and Intensities1

Sound intensity 

level β (dB)

Intensity I(W/m2) Example/effect

0 1×10–12 Threshold of hearing at 1000 Hz

10 1×10–11 Rustle of leaves

20 1×10–10 Whisper at 1 m distance

30 1×10–9 Quiet home

40 1×10–8 Average home

50 1×10–7 Average office, soft music

60 1×10–6 Normal conversation

70 1×10–5 Noisy office, busy traffic

1 Paul Peter Urone, Roger Hinrichs, Sound Intensity and Sound Level, OpenStax (June 21, 2012), 

https://openstax.org/books/college-physics/pages/17-3-sound-intensity-and-sound-level.

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80 1×10–4 Loud radio, classroom lecture

90 1×10–3 Inside a heavy truck; damage from prolonged 

exposure.

100 1×10–2 Noisy factory, siren at 30 m; damage from 8 h per day 

exposure

110 1×10–1 Damage from 30 min per day exposure

120 1 Loud rock concert, pneumatic chipper at 2 m; 

threshold of pain

140 1×102 Jet airplane at 30 m; severe pain, damage in seconds

160 1×104 Bursting of eardrums

2. Signal Detection

Fundamentally, the purpose of hearing is for signal detection. Hearing sounds allows us 

to react to various environmental stimuli. Used in combination with our other senses (balance, 

smell, vision, touch, etc.), it allows us to perform such activities as to respond to another human 

speaking, listen for a predator that may harm us, or aid us in our attempt to locate a next meal. 

Inherent in this ability is to detect what we want to hear in a background of noise, a process 

called signal detection. As hunter-gatherers, this allowed humans to hear a predator in a 

background of forest sounds to prevent us from being eaten; today it allows us to hear a 

conversation in a crowded bar or a cocktail party. 

3. Linguistics

Communication through speech is an important aspect of our society. Speech is 

exquisitely complex and filled with information. Speech can be broken down into individual 

‘units’, termed phonemes. A phoneme is the smallest unit of speech that allows us to distinguish 

one word or word element from another (e.g., ‘rot’ vs. ‘rob’). In the English language, we have 

26 letters, but 42–44 different speech phonemes or sounds. Another interesting aspect of the 

English language is that meaning in words are often coded in consonants, which are high 

frequency sounds, vs. vowels, which are lower frequency sounds. For example, the words ‘cat’, 

‘bat’, ‘chat’, ‘mat’, and ‘rat’ all differ by single phonemes that are all consonants, yet each of 

these words mean very different things. 

4. Effects of Hearing Loss on Speech Understanding

Because a majority of people who lose hearing (e.g., age-related hearing loss, noiseinduced hearing loss) tend to lose higher frequencies, often the consonant-based phonemes may

be misheard or not heard, for example mistaking, ‘I left my cat out in the rain’ for ‘I left my hat 

out in the rain’ – a single phoneme substitution but a very different meaning. Such confusion 

can be a source of great frustration for people with hearing loss. Patients with hearing loss also 

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have difficulty hearing the appropriate signal in a noisy background, compounding these 

listening difficulties. This is the reason why people with age-related hearing loss and noiseinduced hearing loss have such difficulty hearing in complex listening environments such as 

restaurants or cocktail parties-not only do they have challenges hearing the appropriate signal 

within the noise, but also miss many of the critical phonemes that impart the meaning of speech. 

5. The Importance of Visual Cues

When confronted with complex listening environments, hearing impaired individuals will 

typically resort to additional cues for listening, including lip reading and focusing on facial 

motion, that will assist in determining what is being said. However there are a number of 

modalities where this may also be limited, including speaking on the telephone, listening to 

recordings, watching television, or listening to people with non-familiar accents. Further, 

hearing-impaired individuals who may work in an environment where facemasks are required 

will have difficulty. More recently, with the widespread use of facemasks during the COVID 

pandemic, hearing impaired individuals struggle especially hard since the face mask not only 

muffles speech, but prevents the listener from using facial cues and lip reading to assist in 

understanding what is being said.2

6. Single Sided Deafness Impairments

Patients with asymmetrical or unilateral hearing loss may have additional impairments. 

Hearing with two ears gives us the ability to localize where sounds are coming from, and also 

hear better in noisy backgrounds. This is because each ear provides different pieces of 

information to the brain. As the auditory signal comes in from both ears, they combine in the 

brainstem. The brainstem uses loudness differences between the two ears, and the time 

difference for the signal to reach the brain between the two ears, to determine where sounds 

come from. For example, if a sound from the left ear reaches the brainstem before the same 

sound reaches the brain stem from the right ear, it is because the sound is coming from the left 

side. Similarly, in most cases the side where the signal is louder is generally where the sound is 

coming from. 

Using differences in the auditory signals between the two ears, the brain can also filter 

out background noise to detect what is important (e.g., speech). Thus, when someone has lost 

hearing in one ear, the ability to localize sounds by hearing alone becomes impossible, and the 

ability to hear in a noisy background also degrades substantially.3

2 Moira McCarthy, Lip Reading, Facial Expressions: How Masks Make Life Harder for People with 

Hearing Difficulties, Healthline (July 27, 2020), https://www.healthline.com/health-news/covid19-facemasks-difficulties-people-hearing-impairments.

3 Hwa J. Son & Daniel Choo, Updated optimal management of single-sided deafness,127 Laryngoscope 

1731, 1731–32 (2017).

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C. Hearing Loss

1. Types of Hearing Loss: Conductive vs. Sensorineural Hearing Loss

Hearing loss can generally be defined as falling into three categories: Conductive, 

Sensorineural, or Mixed (a combination of Conductive and Sensorineural). 

Conductive hearing loss involves the outer or middle ear and is usually caused by 

something blocking sound from getting to the inner ear. This could be something as simple as 

ear wax, or a hole in the ear drum, fluid in the middle ear, or fixation of the middle ear bones. 

Sensorineural hearing loss (SNHL) occurs due to problems within the inner ear or along 

the auditory nerves in the brain. In most cases, SNHL occurs due to problems within the inner 

ear, and most commonly this is from loss of hair cells. Hair cells are quite fragile, and do not 

regrow once lost. This is why for the most part, SNHL is irreversible. We all lose hair cells as 

we age, though the rate by which we each lose hair cells (and hence hearing loss) differs for 

everyone. This rate is largely determined by genetics, and accounts for why some of us lose 

hearing more quickly as we age than others. However, environmental factors can also influence 

that rate of hearing loss. The number one environmental factor that influences the rate of hearing 

loss over time is loud noise. 

Other factors can also affect hearing over time, including certain medications (termed 

‘ototoxic’, mostly including some classes of antibiotics and chemotherapeutic agents), trauma, 

and some underlying diseases.

a. Conductive Hearing Loss

As noted, conductive hearing losses are due to anything that impedes the transmission of 

sound from the external environment to the cochlea. This can include such conditions as 

cerumen impaction, problems with the tympanic membrane, fluid in the middle ear, or fixation 

or erosion of the middle ear bones due to infection, trauma or neoplasia. 

In general, conductive hearing losses are distinguishable because they result in reduction 

in pure tone thresholds on a hearing test, but will not affect word understanding, frequency 

discrimination, dynamic range, or loudness perception. Conductive hearing loss is also different 

from SNHL in that it is potentially treatable. Treatment for conductive losses can involve 

correcting the cause of sound impairment (e.g., removing a blockage, repairing the eardrum or 

middle ear structures), or using conventional or implantable hearing aids.

b. Sensorineural Hearing Loss

In contrast to a conductive hearing loss, sensorineural hearing loss (SNHL) involves 

injury or damage to the cochlea or central auditory neural pathways within the brain. SNHL is 

usually permanent and not medically correctable. SNHL will raise thresholds and impair 

frequency and word discrimination, reduce the dynamic range of sound perception, and can alter 

loudness perception. 

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SNHL can itself be subdivided into two general categories – ‘sensory’ or cochlear, and 

‘neural’ or retrocochlear, involving the auditory nerve or auditory pathways within the brain. 

These can often be differentiated with an MRI scan to identify retrocochlear lesions such as 

benign or malignant tumors that impact the auditory nerve or auditory centers in the brain, or 

other central pathology such as stroke or multiple sclerosis. Overall, retrocochlear pathologies 

(e.g., tumors, stroke) are uncommon relative to cochlear causes of hearing loss (age, noise, 

genetics). 

i. Sensory Hearing Loss

‘Sensory’, or cochlear causes of SNHL are due to a variety of causes. These include age 

(the most common cause, also known as presbycusis), noise exposure, genetics, ototoxicity (most 

commonly from intravenous gentamicin or platinum chemotherapy compounds), industrial 

chemical exposure, infections (bacterial and viral), ‘idiopathic’ (unknown cause but presumed 

viral), autoimmune disorders, Meniere’s disease, and cochlear otosclerosis, to name the most 

common. Genetics also plays an important role in hearing loss. Not only can it lead to hearing 

loss by itself, though usually genetic forms of hearing loss begin at a young age, but genetics 

also affects the susceptibility to age-related hearing loss and noise-induced hearing loss. For 

example, the genes that make someone susceptible to age related hearing loss would also make 

them more likely to suffer from noise-induced hearing loss. In some cases, conductive and 

sensorineural hearing losses can co-exist, in what we term ‘mixed’ hearing losses. 

Differentiating between conductive and sensorineural hearing losses is typically 

straightforward with a standard audiogram (see below), which measures both types of hearing. 

Differentiating between the various types SNHL involves eliciting a detailed history of the 

patient's hearing loss, a physical exam, and assessing the audiometric profile. Imaging may also 

be required for diagnosis. 

ii. Noise Induced Hearing Loss

Noise trauma is the second-most common cause of sensory hearing loss after age-related 

hearing loss. Sounds exceeding 85 dB are potentially injurious to the cochlea, especially with 

prolonged exposure. Noise-induced hearing loss typically will initially manifest in the high 

frequencies, particularly from three to six kHz, where a typical ‘notch’ may be seen with 

audiometric testing. In contrast to presbycusis (age-related hearing loss), recovery is usually 

seen at eight kHz. Over time however the high frequencies may also decline. With repeated 

noise exposure, however, hearing loss extends to adjacent frequencies, which makes 

differentiation from presbycusis difficult in the elderly, but more straightforward in younger 

patients who should not be suffering from presbycusis. Noise exposure alone rarely produces a 

hearing loss greater than 75 dB in the higher frequencies and 40 dB in the lower frequencies. 

While it has traditionally been believed that hearing loss due to noise exposure does not progress 

once the exposure is discontinued, recent research suggests that early noise exposure predisposes 

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to more progressive age-related hearing loss and that even isolated noise exposure can lead to 

significant neural damage.4

Noise-induced hearing loss presents in two forms. 

(1.) Acoustic trauma is the sudden permanent hearing loss in response to a single, 

intense noise exposure, such as a blast or an explosion. Impulses typically range around 140 dB 

and cause direct mechanical injury to the hair cells of the cochlea. The degree of hearing loss is 

variable ranging from mild to profound and is often associated with new-onset tinnitus. Some 

improvement may be expected in the following days. Tympanic membrane perforation or 

ossicular disruption may cause a conductive hearing loss that accompanies the sensorineural loss 

for blast exposures.

(2.) Chronic noise-induced hearing loss, in contrast to blast or impulse trauma, 

represents the accumulation of cochlear neural damage from long-term exposure to lower-level 

noise. The principal mechanisms include occupational or industrial exposures, weapons, and 

excessively loud music.

The development of chronic noise-induced hearing loss is a two-stage process. First, the 

exposure to loud noise produces a ‘temporary threshold shift’, which is a brief hearing loss that 

completely resolves on pure-tone audiometry after a period of auditory rest, typically 16 to 48 

hours. A ‘permanent threshold shift’ occurs after repeated exposure to sufficiently intense noise. 

This second stage leads to an irreversible hearing loss through permanent hair cell damage. 

However, it should be noted that animal studies have documented that noise exposures that 

produce temporary threshold shifts can by themselves cause significant and permanent neural 

damage, which has recently been termed ‘hidden hearing loss’ or ‘cochlear synaptopathy’ (see

below for a more complete discussion).5

The Occupational Health and Safety Administration (OSHA) has set a permissible 

exposure limit for workers of 90 dB for eight hours per day.6

 The OSHA standard uses a fivedB exchange rate, meaning for each increase in noise level by five dB, time exposure must be cut 

in half (e.g., a worker can be exposed to 100 dB of noise for a maximum of two hours). To limit 

occupational noise exposure, OSHA recommends assessment of noise levels, administrating 

controls, engineering controls, and the use of personal hearing protection devices. Among the 

latter, proper fitting earmuffs and earplugs can dampen noise intensity by 45 and 30 dB, 

respectively.

4 Katharine A. Fernandez, Penelope W.C. Jeffers, Kumud Lall, M. Charles Liberman, & Sharon G. 

Kujawa, Aging after noise exposure: acceleration of cochlear synaptopathy in "recovered" ears, 35 J. 

Neuroscience 7509, 7509–20 (2015).

5 Katharine A. Fernandez, Penelope W.C. Jeffers, Kumud Lall, M. Charles Liberman, & Sharon G. 

Kujawa, Aging after noise exposure: acceleration of cochlear synaptopathy in "recovered" ears, 35 J. 

Neuroscience 7509, 7509–20 (2015); Jane Bjerg Jensen, Andrew C Lysaght, M Charles Liberman, Klaus 

Qvortrup & Konstantina M Stankovic, Immediate and delayed cochlear neuropathy after noise exposure in 

pubescent mice, PLoS One 10(e0125160 (2015), 

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0125160.

6 United States Department of Labor, Occupational Safety and Health Administration, Occupational Noise 

Exposure, https://www.osha.gov/SLTC/noisehearingconservation/.

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‘Temporary Thresholds Shifts’ are not Temporary

Recent research continues to shed light on the danger posed by exposure to loud noises, 

even in the absence of permanent threshold shifts. A number of animal studies have emerged 

that suggest that even noise exposures that produce “temporary” threshold shifts are associated 

with long-term neuronal damage that could further exacerbate age-related hearing.7 It is thus 

very possible that many of the standards developed will be needed to be revised as this research 

progresses in the coming years. 

A study by Gates and colleagues in 2000 demonstrates that ‘temporary thresholds shift’ 

(a temporary reduction in auditory thresholds following loud noise exposure that reverses within 

72 hours), in fact resulted in injury to the cochlea. Studying a patient population from the 

Framingham longitudinal research cohort, this group showed that patients with a history of noise 

exposure had more severe age-related hearing losses than those individuals without prior noise 

exposure.8

A series of animal studies by Liberman and Kujawa have unequivocally documented this 

relationship and support the findings of Gates, et. al.9

 These investigators exposed animals to 

low levels of sound to cause a temporary threshold shift (TTS) on audiometric testing, which 

then recovered. They then followed those animals for over a year, and compared the hearing in 

those animals to those that were not exposed to that sound. As compared to the animals that 

were not exposed to sound, the animals that had a TTS had a much faster rate of age-related 

hearing loss. When the investigators examined the hair cells of these noise-exposed animals 

under the microscope, there was a loss of the hair cell synapses and the nerve fibers going to 

those synapses, with minimal loss of the total number of hair cells. In these animals, the loss of 

the nerve fibers at the base of the hair cells (which signal the brain) and their associated hair cell 

synapse, led to a much more rapid age-related hearing loss in these animals. This occurred 

despite having ‘normalized’ their initial hearing tests after the noise exposure. This phenomenon 

was thus termed ‘Hidden Hearing Loss’ since one did not see it on the associated hearing test 

immediately after recovery from the noise exposure. It was also termed ‘Cochlear 

Synaptopathy’ since the pathology of the hearing loss was the loss of the hair cell synapse and 

associated nerve fibers adjacent to the synapse. 

Does a similar phenomenon occur in humans? Firstly, there is good data to show a 

similar process occurs in non-human primates (Valero et al 2017), which are closest to us on an 

evolutionary scale.10 One can obviously not repeat these same intensive series of experiments on 

a human, but some proxy studies have been carried out which do suggest a similar occurrence. 

In one study by Liberman and colleagues in 2016, a group of college students were queried 

7 Fernandez, supra note 4; Jensen, supra note 5.

8 George A.Gates, Pete Schmid, Sharon G. Kujawa, Byung-ho Nam & Ralph D’Agostino, Longitudinal threshold 

changes in older men with audiometric notches, 141 Hearing Research 220, 220–28 (2000).

9 M. Charles Liberman & Sharon G. Kujawa,Cochlear synaptopathy in acquired sensorineural hearing loss: 

Manifestations and mechanisms, 349 Hearing Research 138, 138–47 (2017).

10 Valero, M.D., Burton, J.A., Hauser, S.N., Hackett, T.A., Ramachandran, R., Liberman, M.C. 2017. Noise-induced 

cochlear synaptopathy in rhesus monkeys (Macaca mulatta). Hear Res 353, 213-223.

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whether or not they had been exposed to loud noise in their past.11 These two groups were then 

intensively studied for changes in hearing. While standard audiometry was identical in these two 

different groups, those that had admitted to prior loud noise exposure were shown to have more 

difficulty listening in noise, more annoyance to loud sounds, and had changes in electrical 

auditory measures of the inner ear. Another study by Viana and colleagues studied the inner ears 

of post-mortem patients, and showed that a similar ‘synaptopathy’ was seen in aging ears.12 

While neither of these human studies is considered definitive, the same changes seen in closely 

related animals are also seen in human ears, and there is every reason to believe that human ears 

behave similarly to sound trauma as do animal ears, in response to noise exposures that cause 

temporary threshold shifts and cochlear synaptopathy. 

It is unsurprising that there is a discrepancy between what is seen on audiometric testing 

and what is seen when studying the ear under the microscope. In my experience, the basic and 

most common measures of hearing and hearing loss are inadequate. If a simple pure tone 

audiogram may record normal hearing despite the observable presence of neuronal and cellular 

damage, then clearly that pure tone audiogram is not sufficient to capture the full scope of 

damage individuals can suffer due to noise exposure. This aligns with my experience 

diagnosing, evaluating and treating patients with hearing loss. As such, I almost never rely on a 

single test – but will instead perform a battery of qualitative and quantitative measures of a 

patient’s ability to hear not only pure tones but also complex sounds and real language. This is 

common practice in the medical community and can be readily understood when one considers 

how a pure tone audiogram is performed and what is measured. A patient sits in a sound-proof 

room without background noise, is asked to detect a frequency of sound, and is scored for the 

lowest volume that sound is detected. That patient is not asked what they are hearing, just if they 

hear any tone at that volume level. This in no way mimics how people use hearing in everyday 

life or provides sufficient insight into an individual’s ability to process language in complex 

noise environments. 

Unfortunately, our field has not yet come up with ‘definitive’ tests to clearly document 

cochlear synaptopathy, though it is an active area of research. However, there are a number of 

audiometric tests that do test more complex listening tasks, including word understanding in a 

noisy background. While this gets closer to documenting inner ear damage from sound damage 

and other insults to hearing, we are not yet at a place where we can definitively diagnose 

cochlear synaptopathy using existing testing paradigms. That will take research with large 

numbers of patients who have been exposed to noise, comprehensively tested, then followed for 

many years to see who develops more severe hearing loss, then determining which tests correlate 

most closely with those changes. 

11 Liberman, M.C., Epstein, M.J., Cleveland, S.S., Wang, H., Maison, S.F. 2016. Toward a Differential Diagnosis of 

Hidden Hearing Loss in Humans. PLoS One 2016, 11, e0162726.

12 Viana, L.M., O'Malley, J.T., Burgess, B.J., Jones, D.D., Oliveira, C.A., Santos, F., Merchant, S.N., Liberman, 

L.D., Liberman, M.C. 2015. Cochlear neuropathy in human presbycusis: Confocal analysis of hidden hearing loss in 

post-mortem tissue. Hear Res 2015, 327, 78-88.

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D. Tinnitus

The following discussion of tinnitus is adapted from a chapter written by me, “Medical and 

Surgical Treatment of Inner Ear Disease.”13

1. Tinnitus Definitions

Tinnitus is defined as the sensation of sound in the absence of an exogenous sound source. 

Tinnitus can accompany any form of hearing loss and its presence provides no diagnostic value in 

determining the cause of a hearing loss. Approximately 15 percent of the general population 

experience some type of tinnitus with prevalence beyond 20 percent in aging populations.14 

Simple forms of tinnitus include the low-pitch tinnitus that results from the accumulation of 

cerumen in the external ear canal, or that due to tympanic membrane perforation. Eustachian tube 

insufficiency manifesting a middle ear effusion can produce tinnitus, as can an abnormally patent 

Eustachian tube that produces a ‘blowing’ tinnitus that coincides with respiration. More complex 

presentations of tinnitus are categorized as either objective (heard or recordable by others) or 

subjective (reported by the patient and not heard or recordable by others). The most common 

presentation of tinnitus, however, is in the setting of sensorineural hearing loss. Sensorineural 

hearing loss has several psychophysical correlates. In addition to diminished hearing sensitivity, 

reduced frequency resolution, loudness recruitment, and tinnitus commonly associated with many 

forms of sensorineural hearing loss. Indeed, the vast majority of cases of clinical tinnitus are 

subjective and are associated with sensorineural hearing loss.15

Subjective tinnitus is a common clinical disorder characterized by auditory sensations 

without external stimulation. The sensation can last anywhere from several seconds to a lifelong 

affliction. The sensation itself can be one of a high-tone ring (most commonly), buzzing, humming, 

crickets, whistle, hissing, or roaring. In rare cases, patients can sometimes perceive actual musical 

melodies. Tinnitus can affect patients in many ways, ranging from mild annoyance to severe 

depression and suicide.16

2. Tinnitus Pathophysiology

Recent research identifies damage to the peripheral auditory system (outer ear, middle 

ear, and inner ear) as a basis for tinnitus. Following damage to the peripheral auditory system, 

13 Lawrence R. Lustig, Medical and Surgical Treatment of Inner Ear Disease, in Scientific Foundations of 

Audiology 131 (Anthony T. Cacace, Emile de Kleine, Avril Genene Holt, Pim van Dijk eds., 2016).

14 R.R.A. Coles, Epidemiology of tinnitus: (1) prevalence, 98 J. Laryngol & Otology (Issue S9) 7, 7–15 (1984); 

Dongmei Tang, Huawei Li, Lin Chen, Advances in Understanding, Diagnosis, and Treatment of Tinnitus, in 1130 

Hearing Loss: Mechanisms, Prevention and Cure. Advances in Experimental Medicine and Biology 109, 109–28 

(Huawei Li & Renjie Chai eds., 2019).

15 Aaron A. Esmaili & John Renton, A review of tinnitus, 47 Austl. J. General Practice 205, 205–08 (2018).

16 Coles, supra note 14; Robert A. Dobie, Depression and tinnitus, 36 Otolaryngol Clinics N. Am. 383, 383–88 

(2003); Esmaili, supra note 15; James A. Kaltenbach, Summary of evidence pointing to a role of the dorsal cochlear 

nucleus in the etiology of tinnitus, 126 Acta Oto-Laryngolica 20, 20–26 (2006) [hereinafter Kaltenbach 2006a]; 

James A. Kaltenbach, The dorsal cochlear nucleus as a participant in the auditory, attentional and emotional 

components of tinnitus, 216–17 Hearing Research 224, 224–34 (2006) [hereinafter Kaltenbach 2006b].

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central portions of the system change to try to adapt and/or compensate for the loss of input, i.e., 

neural plasticity.17

A variety of evidence implicates that following damage to the peripheral auditory system 

there are ensuing changes throughout the central auditory system, including new axonal growth, 

synaptogenesis and synapse degeneration, and changes in the structural properties of neurons.18 

Increased spontaneous neuronal activity in the dorsal cochlear nucleus (DCN) is one theory for 

chronic tinnitus, backed by data demonstrating cochlear damage altering outer hair cell afferent 

Type II fibers, which in turn leads to reduced inhibition of fusiform cells within the cochlear 

nucleus.19 Within the DCN, increased spontaneous neuronal activation has also been attributed to 

bursting discharges and neuronal synchrony following ototoxic drug exposure.20

Beyond the DCN, the auditory cortex has also been implicated in chronic tinnitus. As with 

the DCN, hyperactive spontaneous neuronal activity has been implicated along with neuronal 

synchronization.21 These theories of tinnitus mirror those changes seen in the somatosensory 

system in response to loss of sensory input due to amputation.22 Newer imaging modalities, 

including positron emission tomography (PET) and functional magnetic resonance imaging 

(fMRI), will hopefully shed new light onto some of the potential central causes of chronic 

tinnitus.23

Studies have shown that approximately one in seven tinnitus sufferers experience severe 

annoyance while four percent are severely disabled.24

3. Tinnitus and Depression

The potential concurrence of tinnitus and depression should be assessed in all patients with 

subjective tinnitus. Dobie has examined the simple notion that “tinnitus causes depression” and 

17 Haúla F Haider, T. Bojic, S. Ribeiro, João C. Paço, D. A. Hall & A. Szczepek, Pathophysiology of Subjective 

Tinnitus: Triggers and Maintenance12 Frontiers in Neuroscience (art. 866) 1, 1–12 (2018); J. Henry, L. Roberts, D. 

Caspary, S. Theodoroff & R. Salvi,. Underlying mechanisms of tinnitus: review and clinical implications, 25 J. Am. 

Acad. Audiology 5, 5–22 (2014).

18 James C. Saunders, The role of central nervous system plasticity in tinnitus, 40 J. Commc’n Disorders 313, 313–

34 (2007).

19 Kaltenbach 2006a, supra note 16. 20 David M. Baguley, Mechanisms of tinnitus, 63 British Medical Bulletin 195, 195–212 (2002); Saunders, supra 

note 18.

21 Saunders, supra note 18.

22 Josef P. Rauschecker,. Auditory cortical plasticity: a comparison with other sensory systems, 22 Trends in

Neuroscience 74, 74–80 (1999).

23 Berthold Langguth, Peter Eichhammer, Antje Kreutzer, Peter Maenner, Joerg Marienhagen, Tobias Kleinjung, 

Phillipp SandHajak, The impact of auditory cortex activity on characterizing and treating patients with chronic 

tinnitus--first results from a PET study, Acta Oto-Laryngolica (Issue sup556) 84, 84–88 (2006); Saunders, supra 

note 18; Marion Smits, Silvia Kovacs, Dirk de Ridder, Ronald R. Peeters, Paul van Hecke & Stefan Sunaert, 

Lateralization of functional magnetic resonance imaging (fMRI) activation in the auditory pathway of patients with 

lateralized tinnitus, 49 Neuroradiology 669, 669–79 (2007).

24 Tang, supra note 14.

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notes that many patients believe this to be the case.25 However, Dobie notes that it seems 

implausible that depression causes tinnitus, but it is likely that depression erodes the coping

process that probably develops for most patients with tinnitus, thus changing a normally 

insignificant symptom into one with high life impact. Depression can certainly amplify disability 

associated with chronic medical illness.26

4. Tinnitus Treatment

To date, both pharmacologic and surgical approaches have shown little to no efficacy 

toward tinnitus. Those treatments that have demonstrated benefit relate to the use of masking 

external inputs, in the form of an external masking27 or cochlear implantation.28 Behavioral 

adaptive methods may offer benefit in enhancing tolerance of the symptom and alleviating 

associated anxiety.

Treatment results using antidepressants in tinnitus sufferers are encouraging. 

Nortriptyline, a tricyclic antidepressant administered with careful dosing adjustments, appears to 

improve symptoms in several domains in depressed tinnitus patients. (Sullivan, M.D., Dobie, 

R.A., Sakai, C.S., Katon, W.J. 1989. Treatment of depressed tinnitus patients with nortriptyline. 

Ann Otol Rhinol Laryngol 98, 867-72.) Clearly, the largest treatment effect is a reduction in 

depressive symptoms. Further, however, not only did patients’ estimates of tinnitus severity (i.e., 

“How much does it bother you?”) decline as depression improved, but many patients also reported 

quieter tinnitus. Nonetheless, the authors of this study indicate that the major therapeutic benefit 

was in mood and coping ability, with less change in tinnitus.

Transcranial magnetic stimulation (TMS) is a newer modality being directed toward 

tinnitus and has shown early promise.29 Already in trials for such disorders as depression, TMS 

may offer tinnitus sufferers a nonpharmacologic, nonsurgical treatment.

E. Hearing Protective Devices (HPD) 

1. NIOSH and OSHA Standards30

Noise is a well-known risk factor for hearing loss and tinnitus. In the United States, 

occupational regulations and standards have been established to protect workers against the 

health effects of exposure to hazardous substances and agents when certain values (or limits) are 

reached. The National Institute for Occupational Safety and Health (NIOSH), has established 

25 R. Dobie, W. Katon, M. Sullivan & C. Sakai, C., Tinnitus, Depression and Aging, in Geriatric Otolaryngology 

45–49 (J. Goldstein, H. Kashima & C. Koopmann eds.,1989).

26 Kenneth B. Wells, & Cathy D.Functioning and utility for current health of patients with depression or chronic 

medical conditions in managed, primary care practices, 56 Archives General Psychiatry 897, 897–904 (1989).

27 Julian Savage & Angus Waddell, Tinnitus, Clinical Evidence Handbook (2014), 

https://www.aafp.org/afp/2014/0315/afp20140315p471.pdf.

28 F. J. Kloostra, J. Verbist, R. Hofman, R. Free, R. Arnold & P. van Dijk, A Prospective Study of the Effect of

Cochlear Implantation on Tinnitus. Audiology & Neurotology 356, 356–63 (2018).

29 Zhe Peng, Xiu-Qi Chen & Shu-Sheng Gong, Effectiveness of repetitive transcranial magnetic stimulation for 

chronic tinnitus: a systematic review, 147 Otolaryngol – Head & Neck Surgery 817, 817–25 (2012).

30 Center for Disease Control, Nat’l Inst. for Occupational Safety & Health, Noise and Hearing Loss Prevention, 

https://www.cdc.gov/niosh/topics/noise/choose.html.

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Recommended Exposure Limits (REL) for noise based on the best available science and practice. 

The NIOSH REL for noise is 85 decibels, using the A-weighting frequency response (often 

written as dBA) over an eight-hour average, usually referred to as Time-Weighted Average 

(TWA). Exposures at or above this level are considered hazardous. Similarly, the Occupational 

Safety and Health Administration (OSHA) sets legal limits on noise exposure in the workplace. 

These limits are based on a worker’s time weighted average over an eight-hour day. With noise, 

OSHA’s permissible exposure limit (PEL) is 90 dBA for all workers for an eight-hour day.

Occupational standards specify a maximum allowable daily noise dose, expressed in 

percentages. For example, a person exposed to 85 dBA per NIOSH or 90 dBA per OSHA over 

an eight-hour work shift, will reach 100 percent of their daily noise dose. The noise dose is 

based on both the sound exposure level and how long it lasts (duration) so for each increase or 3-

dB (NIOSH) or 5-dB (OSHA) in noise levels, the duration of the exposure should be cut in half 

(this is what’s referred to as exchange rates in standards). The following table illustrates the 

relationship between sound exposure levels and durations for both NIOSH and OSHA. 

For either standard, high impact noise above 120dB can result in injury to hearing 

without hearing protection for even a very brief exposure. 

2. Hearing Protective Device Types31

By physically blocking or reducing the sound pressure levels reaching the inner ear, 

hearing protection devices (HPD) can increase the amount of time that workers or soldiers can be 

exposed to injurious levels of sound without causing damage to the delicate structures of the 

inner ear. These devices come in several forms. Regardless of the type of HPD, it is common 

knowledge that the best hearing protector is the one that is comfortable and convenient, properly 

fit, and that will be worn whenever the user is in an environment with hazardous noise.

HPDs effectiveness are documented by a scientifically derived Noise Reduction 

Rating(NRR). These are also referred to as a ‘hearing protection rating.’ The higher the NRR, 

the greater the hearing protection afforded by the device. NRR is an estimate based on what will 

31 Center for Disease Control, Nat’l Inst. for Occupational Safety & Health, Noise and Hearing Loss Prevention, 

https://www.cdc.gov/niosh/topics/noise/choose.html.

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be achieved by 98 percent of the population if the hearing protection is properly fit. Because of 

variability in the population, there have been efforts by the EPA to change NRR ratings labels 

from a ‘one number’ approach to a range, from the minimally trained to the more proficient 

users, accounting for variability in usage and fit. 

a. Expandable Foam Plugs

These plugs are made of a formable material designed to expand and conform to the

shape of each person’s ear canal. To use them, you toll the expandable plugs into a thin, creasefree cylinder. Whether you roll plugs with thumb and fingers or across your palm doesn’t 

matter. What’s critical is the final result—a smooth tube thin enough so that about half the 

length will fit easily into your ear canal. Some individuals, especially women with small ear 

canals, have difficulty rolling typical plugs small enough to make them fit. 

b. Pre-molded, Reusable Plugs

Pre-molded plugs are made from silicone, plastic or rubber and are manufactured as 

either ‘one-size-fits-most’ or are available in several sizes. Many pre-molded plugs are available 

in sizes for small, medium, or large ear canals.

A critical tip about pre-molded plugs is that a person may need a different size plug for 

each ear. The plugs should seal the ear canal without being uncomfortable. This takes trial and 

error of the various sizes. Directions for fitting each model of pre-molded plug may differ

slightly depending on how many flanges they have and how the tip is shaped. Insert this type of 

plug by reaching over your head with one hand to pull up on your ear. Then use your other hand 

to insert the plug with a gentle rocking motion until you have sealed the ear canal.

Advantages of pre-molded plugs are that they are relatively inexpensive, reusable, washable, 

convenient to carry, and generally come in a variety of sizes. Nearly everyone can find a plug 

that will be comfortable and effective. In dirty or dusty environments, you do not need to handle 

or roll the tips.

c. Canal Caps

Canal caps often resemble earplugs on a flexible plastic or metal band. The earplug tips 

of a canal cap may be a formable or pre-molded material. Some have headbands that can be 

worn over the head, behind the neck or under the chin. Newer models have jointed bands 

increasing the ability to properly seal the earplug.

The main advantage canal caps offer is convenience. When it is quiet, users can leave the 

band hanging around their necks. They can quickly insert the plug tips when hazardous noise 

starts again. Some people find the pressure from the bands uncomfortable. Not all canal caps 

have tips that adequately block all types of noise. Generally, the canal caps tips that resemble 

stand-alone earplugs seem to block the most noise.

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d. Earmuffs

Earmuffs come in many models designed to fit most people. They work to block out 

noise by completely covering the outer ear. Muffs can be ‘low profile’ with small ear cups or 

large to hold extra materials for use in extreme noise. Some muffs also include electronic 

components to help users communicate or to block impulsive noises.

Users who have heavy beards or sideburns or who wear glasses may find it difficult to get 

good protection from earmuffs. The hair and the temples of the glasses break the seal that the 

earmuff cushions make around the ear. For these users, earplugs are best. Other potential 

drawbacks of earmuffs are that some people feel they can be hot and heavy in some 

environments.

e. Custom Ear Plugs

Custom ear plugs are created similar to a hearing aid mold. A soft material is injected 

into the canal that conforms to the canal shape then hardens. These custom plugs can then be 

fitted with various filters to provide different levels of sound attenuation. These are also known 

as ‘musician’s plugs’ since they provide a broader fidelity of sound. 

f. Hybrid HPDs

Manufacturers, recognizing the limits of these older HPDs, have developed new devices 

that are hybrids of the traditional types of hearing protectors. Because many people like the 

comfort of foam plugs, but do not want to roll them in dirty environments, a plug is available that 

is essentially a foam tip on a stem. You insert this plug much like a pre-molded plug without 

rolling the foam.

g. Tactical and Selective Attenuation Earplugs

Tactical earplugs are also reusable, available in a few sizes, and must initially be fitted by 

a medical professional. However, they can be used when effective communication and 

situational awareness is important. Using the toggle switch on each earplug, you can choose 

whether hearing protection is needed for unwavering noises (airplanes, generators) or sudden 

noises (gunfire, explosions). They must also be examined annually by a professional.

Selective attenuation earplugs, also termed ‘non-linear, level-dependent’ or ‘impulse’ ear 

plugs, are designed to block loud impulse noise, such as gunfire and explosions, through the use 

of an integrated noise filter. These plugs also allow the wearer to hear low amplitude nonimpulse sounds, including verbal commands or ambient noises. These plugs have the advantage 

of allowing soldiers to hear orders and be able to communicate in the field, while still offering 

protection against dangerous impulse noise such as gunfire. However, in order for these plugs to 

effectively protect against impulse noise, the plug needs to form an effective seal with the 

wearer’s ear canal. 

One example of a selective attenuation earplug is the 3M Combat Arms CAEv2. This 

plug has an attenuated ‘non-linear’ end (the open end or yellow end), and also has a ‘closed’ end 

(olive end) that is designed to operate like a traditional fully blocked earplug. 

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h. Helmets with Integrated HPDs

Lastly, specialized helmets are available that have integrated HPDs and communication 

capability. They are commonly used for aviators and their crew, flight and well-deck personnel, 

tank crew, and amphibious assault vehicle crew members. 

F. Audiometry testing 

The following is adapted from a chapter written by me, “Medical and Surgical Treatment 

of Inner Ear Disease”.32 

1. Auditory Testing Introduction

An accurate, objective and repeatable measure of one’s ability to hear is a critical initial 

step in the evaluation of someone with hearing loss. Hearing loss can occur at any stage of the 

auditory pathway, from the ear canal to the auditory cortex. While simple otoscopy can identify 

obvious pathology in the external and middle ear, the ability to determine the cause and nature of 

hearing loss is often limited by physical exam alone. Thus, subjective and objective measures of 

hearing have become paramount in the clinical evaluation of the cochlea. With contemporary 

techniques, it is now possible to evaluate the functional integrity of the entire auditory pathway, 

from the tympanic membrane to cerebral cortex. Such testing, including tympanometry, puretone threshold and speech testing, immittance testing, and auditory brainstem response testing, 

allows clinicians to characterize and localize the nature of hearing loss in most cases. An 

additional important electrical measure of auditory function, otoacoustic emissions, also has 

important and useful clinical applications.

2. Pure Tone Threshold Audiometry

Pure-tone threshold audiometry, the most fundamental of all diagnostic hearing tests, is a 

behaviorally based measure of hearing that is used to distinguish between sensorineural (cochlear 

and central auditory pathways) and conductive (external and middle ear) types of hearing loss, 

representing a critical clinical distinction. The primary goal of pure-tone testing is to obtain a 

representation of the softest sound intensities one can hear across the frequency spectrum. These 

data can then be compared to well-established normative population-based standards to 

determine the nature and degree of one’s hearing loss.

To obtain pure-tone thresholds, auditory stimuli are presented in a soundproof chamber to 

eliminate confounding background noise. In general, air conduction thresholds are obtained to 

determine actual levels of hearing while bone conduction thresholds are also obtained to 

determine true cochlear function; differences between these values represent conductive forms of 

hearing loss, caused by pathologic processes impeding sound transduction to the cochlea. With 

air conduction, stimuli consist of pure tones at octave levels presented most commonly from 25 

to 8,000 Hz while patients wear either an earphone or headphone. In some special circumstances 

32 Lawrence R. Lustig, Medical and Surgical Treatment of Inner Ear Disease, in Scientific Foundations of 

Audiology 131 (Anthony T. Cacace, Emile de Kleine, Avril Genene Holt, Pim van Dijk eds., 2016).

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(e.g., ototoxicity screens) higher frequencies are tested.33 The patient indicates whenever a 

stimulus is heard, allowing the audiologist to record the softest intensity the patient is able to 

hear for each frequency. Bone conduction testing is identical, except that instead of headphones, 

a bone oscillator is placed on the mastoid of the test ear (immediately behind the auricle) and 

results are recorded at only 500 Hz, 1,000 Hz, 2,000 Hz, and 4, 000Hz. Various methods have 

been developed for systematic tone presentations, such as the modified Hughson-Westlake 

technique, allowing an accurate and efficient recording of pure-tone thresholds.

For widespread clinical consistency, the results of an audiologic evaluation are 

commonly plotted on an audiogram, which depicts frequencies (represented in Hertz, Hz) on the 

x-axis and intensities (represented in decibels, dB) on the y-axis. This visual representation of an 

individual’s hearing allows a rapid assessment of a pattern of hearing loss and ability to readily 

compare one audiogram to another or monitor changes over time. To aid in standardization, 

graphic representation and symbols were recommended in 1974 by American Speech and 

Hearing Association and later revised by the American National Standards Institute.34 Hearing 

loss is also commonly described by degree of severity and in relation to the intensity or decibel 

level of the threshold response, allowing terms such as “severe” or “moderate” hearing loss to 

have consistent meanings across clinical settings.

3. Conductive vs. Sensorineural Hearing Loss

Hearing loss is grouped under two broad categories: Conductive and Sensorineural, 

determined by comparison of the air and bone conduction threshold results. The difference in 

thresholds between air and bone conduction is termed the air-bone gap and determines the 

degree of conductive hearing loss (CHL). CHL occurs when a pathologic process impedes 

sound transmission to the cochlea. In contrast, a sensorineural hearing loss (SNHL) is due to 

pathologic processes within the cochlea or central auditory pathways. A mixed hearing loss 

results when both air and bone conduction thresholds are elevated in the presence of an air-bone 

gap. There are some clinical conditions where these classic definitions break down, such as in 

cochlear otosclerosis, whereby a bony pathology results in a mixed or SNHL.

4. Audiometric Configurations

In addition to the type of hearing loss, there are several classic audiometric configurations 

that are commonly seen, essentially describing the shape or slope of the pure-tone thresholds. A 

down-sloping pattern implies worse high-frequency than low-frequency thresholds and is 

commonly seen with such conditions as age-related hearing loss (presbycusis), noise-induced 

hearing loss, and ototoxicity. A rising, or up-sloping pattern denotes poorer thresholds in the 

low-frequency range and is commonly seen in such pathologies as sudden sensorineural hearing 

loss, cochlear hydrops, and Meniere’s disease. Flat losses are indicative of equal threshold drops 

across the frequency range-causes may be ‘metabolic,’ genetic, or due to other medical disorders. 

Lastly, the ‘cookie-bite’ deformity demonstrates better preservation of low- and high-frequency 

33 Jane S. Gordon, David S. Phillips, Wendy J. Helt,, Dawn Konrad-Martin & Stephen A. Fausti, Evaluation of 

insert earphones for high-frequency bedside ototoxicity monitoring, 42 J. Rehabilitation Research & Dev. 353, 353–

61 (2005).

34 New Standards approved by ANSI and published by ASA—82 (1,3,5), 395 (N), 1099 (N), 1849 (N), 82 J. 

Acoustical Soc’y Am. 395, 395 (1987).

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thresholds with a greater drop in the mid-frequencies. The ‘cookie-bite’ pattern is classically 

seen in patients with congenital forms of hearing loss. 

5. Speech Audiometry 

While pure-tone thresholds give an indication of the cochlea’s ability to detect sounds 

and at what intensity levels, they do not provide important qualitative information regarding 

sound perception, and thus by itself, the pure-tone audiogram is an incomplete measure of 

hearing. A common refrain of patients with hearing loss is that “I can hear, but I cannot 

understand.” Speech audiometry provides this additional qualitative hearing assessment and 

offers a better view of how a patient with hearing loss is functioning.

6. Speech Reception Threshold

The speech reception threshold (SRT) is defined as the softest level at which a patient can 

repeat a word. Since this measure typically correlates closely with pure-tone thresholds, it is one 

objective way to determine the accuracy of the pure-tone audiometry results. In this test, words 

are presented either by live voice or a recording. The presented words are called ‘spondees,’ 

two-syllable words with an equal stress on each syllable (e.g., ‘baseball’). After the patients are 

familiarized with the words at an audible intensity level, the test proceeds as the intensity level is 

decreased until the words are no longer audible, and a threshold is determined. Differences 

between the SRT and the PTA (average of pure-tone thresholds at 500, 1,000, and 2,000 Hz) of 

more than 6 dB might suggest patient malingering or inaccurate measures of either score. 

7. Speech Discrimination Testing 

After determining the SRT, the next test is the speech discrimination score (SDS), 

calculated as the percentage of words a patient can repeat at a comfortable listening level. In 

contrast to spondees used in SRT, phonemes, phonetically balanced single syllable words, are 

used for SDS. The more challenging word list provides additional insight into patient 

functioning and is perhaps the best prognostic indicator of successful use of hearing aids.

8. Acoustic Immittance Testing

Acoustic immittance testing, in the broadest sense, objectively measures the ease with 

which sound is transmitted through the tympanic membrane and middle ear. Two principal tests 

are employed in immittance measurements: tympanometry and the acoustic reflex. The objective 

nature of immittance measures makes it a particularly valuable tool when testing those unable to 

give accurate responses, such as in infants and toddlers, and the medically infirm. 

9. Tympanometry

Tympanometry measures the changes that occur to the tympanic membrane and ossicles 

as a result of a change in air pressure in the ear canal. The test allows the measure of canal 

volume as well as peak compliance and middle ear pressure. Canal volume measures are useful 

for determining obstruction or tympanic membrane perforation. In contrast, peak compliance 

and middle ear air pressure are used to assess the status of the middle ear. Three widely 

recognized patterns of middle ear compliance or peak pressure are recognized, Type A, B, or 

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C.35 Type A tympanograms are characterized by a relatively sharp maximum at or near 0 mm, 

and are commonly seen ears with normal middle ear pressure. A subtype of the Type A 

tympanogram, termed As (s indicates ‘stiff’), can be seen in patients with otosclerosis. The type 

B tympanogram shows little or no maximum, with a flat peak. Type B tympanograms are 

typically found in ears with serous otitis media. In the Type C tympanogram, the maximum is 

shifted to the left of zero by negative pressure in the middle ear, and is commonly seen in cases 

of Eustachian tube dysfunction.

10. Acoustic Reflex Testing

The stapedius muscle reflex, or acoustic reflex, is another important component of 

immittance testing, and represents stapedius muscle contraction in response to a loud auditory 

signal.36 This reflex is tested using ipsilateral or contralateral stimulation, and the reflex 

measured when the stapedial muscle contracts (measured by sensing the altered compliance of 

the tympanic membrane). The acoustic reflex threshold is the lowest intensity level presented 

where a change in compliance can be observed. Testing is typically performed at 500, 1,000, 

2,000, and 4,000 Hz, with thresholds in the 70- to 100-dB range. Pathologies that reduce or 

abolish the acoustic reflex include any form of conductive hearing loss, severe SNHL, or 

retrocochlear lesions such as tumors of the auditory nerve or pathway. One example in which 

the acoustic reflex has gained contemporary relevance is the recently described entity of superior 

semicircular canal dehiscence. A common presenting finding in this condition is a conductive 

hearing loss; however, it is not a true conductive hearing loss but likely the presence of a third 

mobile window from the dehiscence that leads to an apparent CHL. The acoustic reflex can thus 

readily distinguish this entity (with intact responses) as compared to a true conductive hearing 

loss (absent acoustic reflex).

11. Auditory Brain Response Testing 

Auditory brain response testing (ABR; also referred to by terms such as BAER, 

brainstem auditory evoked response or BAEP, brainstem auditory evoked potential) is an 

important electrical test to measure cochlear and retrocochlear function.37 The ABR is an 

averaged surface-recording of the sound-activated auditory pathway beginning in the cochlea. 

The objective nature of this test, independent of a patient’s ability to respond, has made it an 

integral component of auditory testing in newborns, infants, and toddlers, as well any patient 

who might not be able to respond accurately to pure-tone testing. 

The ABR is measured with surface electrodes on the skull (usually mastoid process and 

vertex). Clicks or tone-pips are presented while neural electrical potentials are measured. 

Responses are averaged over large numbers of presentations to eliminate background noise. 

Normally, the first five positive measured peaks that can be recorded (termed Waves I through

V), occurring within a 10-ms timeframe, are used for clinical analysis. Waves I and II are felt to 

represent synchronized activity with the cochlea and cochlear nerve. Wave III is believed to be 

35 James Jerger, Clinical experience with impedance audiometry, 92 Archives Otolaryngology 311, 311–24 (1970).

36 Kim S. Schairer, Patrick M. Feeney & Chris A. Sanford, Acoustic reflex measurement, 34 Ear & Hearing 43S, 

43S–47S (2013).

37 Alan D. Legatt, Electrophysiology of Cranial Nerve Testing: Auditory Nerve, 35 J. Clinical Neurophysiology 25, 

25–38 (2018).

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due to activity within the cochlear nucleus, while Wave IV represents activation of the superior 

olivary complex. Wave V is thought to represent activity within the lateral lemniscus of the 

brainstem. It is Wave V that appears to be the most susceptible to hearing loss; Wave V latency 

has been shown to increase with increasing hearing loss, becoming absent in severe cases. In 

contrast, Wave I tends to be the most stable in sensorineural hearing loss. 

Because of its consistency across patients and its ability to measure the retrocochlear 

auditory pathways, the ABR has become an important tool in clinical diagnosis. The two 

principal electrical abnormalities that are analyzed on the ABR are wave amplitude and latency 

changes. Changes in peak amplitudes (as measured from the baseline to the wave peak), as well 

as changes in time interval between the similar contralateral wave (relative latency) or beyond 

accepted normative data (absolute latency) may indicate a form of retrocochlear (between the 

cochlea and auditory cortex) pathology, triggering the need for further evaluation with magnetic 

resonance imaging (MRI). However, ABR abnormalities are not absolutely indicative of central 

pathology, since a variety of other factors can influence ABR results.

12. Otoacoustic Emissions Testing

Additional tests for auditory function exit that measure outer hair cell function. These are 

called otoacoustic emissions.38 This is the test used in universal newborn hearing screenings. 

By playing a sound, and measuring sounds that the cochlea makes in response, this test measures 

contractility of the outer hair cells. This is not a common test performed in an audiometric 

battery but can be used when there are concerns about neuronal causes of hearing loss. There are 

several methods for performing the test, including measuring spontaneous otoacoustic emissions, 

or causing evoked otoacoustic emissions. 

G. Hearing Loss Diagnosis

1. Introduction

Diagnosis of a patient’s hearing loss involves multiple layers of evaluation that includes 

history, physical exam, testing (including audiometry), and possibly imaging. An initial 

assessment involves determining whether a hearing loss is unilateral vs. bilateral, or symmetrical 

vs. asymmetrical. A majority of hearing losses related to aging or genetics are bilateral and 

symmetrical (both ears hearing equally). Similarly, ototoxicity or other systemic causes of 

hearing loss will also typically result in bilateral and symmetrical hearing loss. In contrast, 

unilateral losses may be due to a variety of factors, including noise trauma, physical trauma or 

implosive injury, or any disease processes affecting only one ear. As a general rule, 

asymmetrical SNHL without an obvious cause warrants an MRI scan to rule out a retrocochlear 

lesion such as vestibular schwannoma. 

38 Lucretia Petersen, Wayne J. Wilson & Harsha Kathard, A systematic review of stimulus parameters for eliciting 

distortion product otoacoustic emissions from adult humans, 56 Int’l J. Audiology 382, 382–91 (2017).

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2. Hearing Severity

Determining the severity level of hearing loss is also important. As noted above, hearing 

loss is commonly described by degree of severity and in relation to the intensity or decibel level 

of the threshold response, allowing terms such as ‘severe’ or ‘moderate’ hearing loss to have 

consistent meanings across clinical settings. However, while convenient for comparing hearing 

losses among centers, such terms as ‘mild’ or ‘moderate’ may fail to take into account the 

patient’s difficulty or disability with their hearing loss.39 

3. Sensorineural vs. Conductive vs. Mixed Hearing Loss

The next step is to determine whether a hearing loss is sensorineural, conductive, or 

‘mixed’ (a combination of both). As noted above, this is accomplished by measuring both air 

conduction (AC - what a patient can hear when sound is presented into their ear) vs. bone 

conduction (BC -what is heard with a bone vibrator placed behind the ear). The ‘BC’ levels 

represent inner ear or cochlear function and constitute the degree of SNHL. Differences between 

AC and BC thresholds represent the degree of conductive hearing loss. 

4. Cochlear vs. Retrocochlear Hearing Loss

Determining the difference between ‘cochlear’ and ‘retrocochlear’ hearing loss is also 

routinely performed. For ‘cochlear’ SNHL, patients tend to have reduced speech understanding 

testing in proportion to the degree of hearing loss. Ancillary tests include otoacoustic emissions, 

which are usually abnormal or absent, and without evidence of retrocochlear lesions on imaging 

(CT or MRI). In contrast, retrocochlear pathology is often characterized by word understanding 

scores that are out of proportion to the pure tone threshold levels, poor testing in noise, abnormal 

acoustic brainstem response testing, and possibly a lesion identified on imaging. There are 

exceptions to all these rules. 

H. Noise-Induced Hearing Loss Diagnosis and Treatment

1. Noise-Induced Hearing Loss Characteristics

For noise exposure in particular, there are certain defining characteristics, though again, 

this is not universal.40 Firstly, there must be a documented noise exposure, and hearing loss 

should occur within the time frame of that noise exposure (however, as noted above under the 

discussion of cochlear synaptopathy and hidden hearing loss, progression of hearing loss can 

occur years after noise exposure). The hearing loss is defined as sensorineural, often symmetric, 

with high frequencies 2-8 kHz often most heavily affected, and appearing as a ‘cochlear’ loss on 

testing. The classic ‘noise notch’ at 4-6khz is highly characteristic, though not universal. 

However, the hearing loss may also be unilateral depending on the nature of the sound exposure. 

39 Benjamin W. Y. Hornsby,, Earl E. Johnson & Erin Picou, Effects of degree and configuration of hearing loss on 

the contribution of high- and low-frequency speech information to bilateral speech understanding, 32 Ear & 

Hearing 543, 543–55 (2011).

40 Trung N. Le, Louise V. Straatman, Jane Lea & Brian Westerberg, Current insights in noise-induced hearing loss: 

a literature review of the underlying mechanism, pathophysiology, asymmetry, and management options, 46 J. 

Otolaryngology - Head & Neck Surgery 41, 41 (2017).

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Often with rifle fire, depending on whether the shooter is right-handed or left-handed, there can 

be asymmetry with the opposite ear taking the brunt of sound damage as one ear is relatively 

‘protected’ against the butt of the rifle. With extremely loud sounds above 120dB, almost all 

configurations of hearing loss have been described. 

2. Differential Diagnosis

Because noise-induced hearing loss can present in so many different ways, taking a 

detailed history is important to arrive at a diagnosis of ‘noise-induced hearing loss.’ Since noiseinduced hearing loss is a form of sensorineural hearing loss, other causes of SNHL should be 

ruled out. 

Family history can provide a clue to both the presence of age-related hearing loss as well 

as susceptibility to noise-induced hearing loss based on genetics. Age can be used to rule out 

presbycusis as a cause of hearing loss. The timeline of the hearing loss is also important, when it 

started, and the nature of any progression of hearing loss over time. There should be a temporal 

relationship between the noise exposure, particularly if repeated, and the onset of hearing loss. 

The nature of the noise exposure is also an important part of the history – whether industrial, 

ammunition/guns, explosive, or machinery, including most importantly the duration and 

loudness of the noise exposure. Explosive exposures can be particularly injurious. The presence 

of associated recreational or hobby noise exposures including nightclubs, concerts, loud music, 

machines, or equipment (lawnmowers, shop tools, etc.) is also important to elicit. It is also very 

important to know whether a patient used hearing protective devices (HPD) with these 

exposures, and what type(s) of HPDs were used. A discussion of the various types of HPD are 

provided above. 

There are a number of other medical conditions that may lead to sensorineural hearing 

loss. These include infectious processes such as acute or chronic ear infections, herpes zoster 

oticus (ear herpes), and syphilis. Autoimmune disorders have been known to cause hearing loss, 

including ulcerative colitis. Meniere’s disease and otosclerosis are two additional medical 

conditions that lead to SNHL. Brain-related causes of SNHL include stroke, cardiovascular 

diseases, tumors of the central nervous system, dementia, head trauma/concussions, and 

migraines. Environmental toxins have also been shown to cause hearing loss, including mercury 

or lead ingestion/poisoning, or exposure to nitrogen mustard. Certain classes of medications are 

also known as ototoxic, and may lead to hearing loss, including most notably aminoglycoside 

antibiotics and platinum chemotherapy compounds. Prolonged use of certain other medications 

has also been associated with SNHL, including Tacrolimus, Percocet, and loop diuretics (e.g., 

Lasix). A detailed medical history and examination will help rule out these other possible causes 

of hearing loss, a majority of which are fairly obvious from the medical history. 

In summary, the diagnosis of noise-induced hearing loss requires identifying the noise 

exposure(s) responsible for the hearing loss, documenting the loss of hearing coincident with the 

noise exposure, and ruling out other medical causes of the hearing loss. Audiometric testing 

similarly reveals a hearing loss consistent with noise-induced hearing loss. Lastly, as discussed 

below, there may be telltale co-morbidities seen following noise-induced hearing loss, including 

tinnitus and/or hyperacusis. 

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3. Symptoms Commonly Associated with Noise-Induced Hearing Loss

In addition to features specific to the noise exposure, to make a diagnosis of noiseinduced hearing loss, it is important to know if there are other associated symptoms that 

commonly coexist with noise trauma, including tinnitus and hyperacusis, and whether there also 

associated anxiety or other psychological symptoms (e.g., depression) that accompany these 

symptoms.41 One should also rule out other potential causes of hearing loss, including a history 

of any of the following: presbycusis, ear infections, autoimmune disorders, Meniere’s disease, 

otosclerosis, vertigo, any ear-related issues, stroke, cardiovascular disease, tumors of the central 

nervous system, herpes zoster oticus (ear herpes), syphilis, dementia, head trauma/concussions, 

migraines, ulcerative colitis, or mercury or lead ingestion/poisoning. It should be noted that 

noise-induced hearing loss can co-exist with all these entities, and has been already discussed, 

there is some overlap between genetic hearing loss, age-related hearing and susceptibility to 

noise-induced hearing loss.

4. Noise-Induced Hearing Loss Treatment

Once a diagnosis of noise-induced hearing loss is rendered, the next step is treatment, 

which is similar for most forms of SNHL.42 These treatments generally include observation, 

hearing aids, or cochlear implants. Observation is an option for patients with mild losses, or 

those who feel their loss is not troublesome. Hearing aids are used for patients with moderate to 

severe SNHL, and with word recognition scores above 50–60 percent. When word recognition 

scores fall below 50 percent, hearing aids generally do not provide much benefit for patients 

since hearing aids do not improve word ‘clarity’, they simply provide amplification. Many 

patients with noise-induced hearing loss complain of lack of word ‘clarity’ and must be 

counseled that hearing aids may not improve this complaint. Another common challenge faced 

by patients with noise-induced hearing loss is hearing in a noisy environment. Again, hearing 

aids may provide partial improvement in certain situations, but sometimes the use of hearing aids 

in loud, crowded and complex acoustic environments may worsen this sensation as the aids 

amplify not just what the patient wants to hear, but also the background noise levels as well. 

Some features of hearing aids, including noise-cancelling technology and directional 

microphones can improve this, but hearing in noise remains a challenge for most hearing aid 

users. When a patient’s hearing is in the severe to profound range and accompanied by poor 

word understanding scores (below 60 percent), they may become a candidate for a cochlear 

implant. A cochlear implant is a surgically placed device that bypasses the damaged cells of the 

cochlea to directly stimulate the auditory nerve. Cochlear implants have revolutionized the 

treatment for patients with severe to profound hearing loss. While most patients who receive 

cochlear implants do quite well, far superior then they performed with conventional hearing aids, 

they do require extensive rehabilitation to use the device, and it is a far cry from ‘normal’ 

hearing. 

41 Tonghui Ding, Aihui & Ke Liu, What is noise-induced hearing loss?, 80 British J. Hospital Medicine 525, 525–

29 (2019); Lema Imam & S. Hannan, Noise-induced hearing loss: a modern epidemic?, 78 British J. Hospital 

Medicine 286, 286–90 (2017); Le, supra note 36.

42 Ding, supra note 41; Imam, supra note 41; Le, supra note 41.

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5. Treatment of Comorbidities

Patients with noise-induced hearing loss commonly have coexisting conditions of tinnitus 

and hyperacusis. The treatment of tinnitus is complex and dependent upon the individual and 

severity of symptoms. Sound suppression and masking represents the mainstay of treatment for 

tinnitus. This can be as simple as a sound machine that ‘masks’ noises in the ear to tinnitus 

retraining devices, which are worn like hearing aids. If there is associated hearing loss, 

conventional hearing aids are recommended, as this will also provide sound suppression of 

tinnitus. Many newer hearing aids also incorporate tinnitus masking programs as well. 

Biofeedback has also been used as a treatment for tinnitus. To date there are no medications that 

have been conclusively shown to improve tinnitus though there are anecdotal reports of 

lipoflavinoids and other supplements helping some individuals. As noted above, tricyclic 

antidepressants can be of benefit in patients with associated depression. Newer modalities 

include transcranial magnetic stimulation and deep brain stimulation though neither have gained 

widespread traction. Counseling, including cognitive behavioral therapy has also been shown to 

help patients with tinnitus. While these measures do not eliminate the tinnitus, they have been 

shown to help with coping mechanisms. 

Hyperacusis, when even normal levels of sound are perceived as pain, is another 

troubling symptom that often accompanies noise trauma. The pathophysiology of hyperacusis is 

poorly understood. Treatment consists of sound therapy to try to get the auditory system to adapt 

to normal levels of sound, psychological counseling, and occasionally medications such as 

benzodiazepines or tricyclic antidepressants. 

III. The Combat Arms Earplug, Version 2

I have reviewed extensive documents and testimony related to the Combat Arms Earplug, 

version 2 (CAEv2). This Section of my report discusses the development, marketing and sales 

of the CAEv2, as well as information about the testing of the product, the findings related to the 

fit, seal and other characteristics of the product, and the labeling and promotion of the product. 

Product Design, Development And Sales of the CAEv2 To The Military

The CAEv2 was a dual-ended earplug consisting of two Ultrafit type - one green and one 

yellow - attached to opposite ends of a plastic stem with a small opening in the middle. The 

olive end of the earplug worked like a traditional earplug and was to provide protection from 

continuous noise. The yellow end of the earplug was referred to as the “open end” of the earplug 

and was designed to provide “non-linear” protection, by allowing sound to travel into the 

opening and through a filter before entering the ear. The filter was supposed to allow low level 

sounds like speech to pass through while reducing higher level impulse noises from guns, for 

example. 

The CAEv2 was developed and designed by Aearo Technologies LLC, a personal 

protection equipment company headquartered in Indianapolis. 3M purchased Aearo 

Technologies LLC in 2008 (Aearo became a subsidiary of 3M) at which time 3M added the 

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CAEv2 to its product lines. I will generally refer to both Aearo Technologies LLC and 3M 

collectively herein as “3M” for ease of reference.

Throughout the 1990s, 3M collaborated with The French-German Institute in Saint-Louis 

(ISL) to research and design non-linear earplugs (ISL).43 ISL was the designer of the “non-linear 

filter” that was inserted in 3M’s single-ended Ultrafit earplug in the late 1990s.44 This Ultrafit 

with the non-linear filter was version one of the Combat Arms series of earplugs (CAE1).45 

CAEv1 was not widely used in the US, but it was in Europe, so it is sometimes referred to as the 

“European Non-linear Plug.” 46 CAEv1 was discontinued in the US in 2007 because of low 

sales.47

In 1997, ISL and 3M designed what would become the CAEv2. It was a single earplug 

that combined linear and non-linear functions and it was the first of its kind.48 The prototype had 

a non-linear plug on one end and a linear plug on the other.49 After changes were made to the 

size of the stem on the prototype, the CAEv2 was done being developed and was ultimately 

marketed and sold by 3M. 50

The US military, through Doug Ohlin, Program Manager at Hearing Conservation, U.S. 

Army Center for Health Promotion and Preventive Medicine (CHPPM), expressed an interest in 

3M’s design of an earplug that had linear and non-linear functions.51 3M was not, however, 

provided formal specifications from the military or anyone else for the CAEv2, and 3M, not the 

military, actually designed the earplug.52 3M developed the earplugs to be sold not only to the 

military, but also to consumers as a “shooter’s plug.”53

Shortly before 3M started selling the CAEv2 to the military, 3M considered shortening 

the earplug so that it could fit in soldiers’ carrying cases.54 Simultaneously, Ohlin explored the 

possibility of enlarging the carrying case to fit 3M’s prototype. 3M determined that it could 

redesign and shorten the stem and did so on its own at that point.55 Thereafter, Doug Ohlin 

recommended to the Department of Defense (DoD) working group that the CAEv2 be approved 

for military use and, thereafter, the group approved the recommendation.56

43 3M_MDL000712631

44 3M_MDL000188671; 3M_MDL000779978 

45 3M_MDL000005686 

46 Touhy00000298; 3M_MDL000259866 at 870

47 3M_MDL000692589

48 3M_MDL000013024

49 3M_MDL000006631

50 3M_MDL000006631

51 3M_MDL000425673

52 Ohlin Dep., Apr. 24, 2013, 130:6-131:14, 241:5-6; 3M_MDL000527305; 3M_MDL000425673; 

3M_MDL000434810; 3M_MDL 000277773; 3M_MDL000343622

53 3M_MDL000259188 at 196

54 Berger Dep., Dec. 10, 2019, 60:4-61:20, 104:5-106:4, 241:8-242:5. 

55 3M_MDL000393831

56 Ohlin Dep., Apr. 24, 2013, 130:6-131:5.

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3M’s first sales to the military were in July of 1999.57 There was not a procurement 

contract in place at the time.58 In 2000, Aearo started selling the CAEv2 to civilian consumers 

including hunters, shooters and welders in sporting goods stores and other retail stores.59 The 

consumer versions of the CAEv2 were identical other than different colored Ultrafit tips.60 

Most of 3M’s sales to the military were “bulk” sales, meaning the CAEv2 earplugs were 

shipped in boxes containing 100 earplugs (fifty pair) inside a zip lock bag.61 In late 2005, 3M 

also started selling the CAEv2 in “blister packs” in retail stores on and off military bases 

containing one pair of the earplugs, a package insert, and a carrying case.62

Then, suddenly, in October of 2015, 3M halted sales of the CAEv2. Brian Myers, a 

marketing executive at 3M, sent an internal email demanding that the CAEv2 be immediately 

discontinued.63 The stated reason for the discontinuation (from internal documents) was that 3M 

could no longer sell the CAEv2 with the listed NRR on the label. Myers further stated: “We 

cannot distribute this [product] with the current NRR on the package.”64 He told 3M employees 

to “dispose of” inventory and to cancel pending orders.65 No mention was made to the military, 

though, to immediately stop using the earplugs. Rather, 3M sent a letter in November of 2015 

that stated that 3M had made the decision to “discontinue” the earplugs.66 

3M sold millions of CAEv2s to the military and consumers for over 15 years without any 

design changes.

67

The Original Testing of the CAEv2

3M started selling the CAEv2 to the military without first testing the product to make 

sure it was safe. This is true even though EPA regulations require manufacturers of hearing 

protective devices (HPDs) to perform Real-Ear at Threshold Testing (REAT) testing on products 

in order to establish a Noise Reduction Rating (NRR) before “distributing the [HPD] in 

commerce.”68 An NRR is a measure of the HPD’s effectiveness in reducing noise. The higher 

57 Moses Dep., Oct. 17, 2019, 457:25-459:18.

58 Myers 30(b)(6), Dec. 13, 2019, 793:6-795:5.

59 Myers 30(b)(6), Oct. 18, 2019, 172:4-174:18; Myers Dep., Dec. 12, 2019, 161:4-19, 398:17-400:1.

60 Ohlin 30(b)(6), Oct. 17, 2019, 51:5-15, Myers 30(b)(6), Oct. 18, 2019, 61:14-65:6 (double ended earplugs the Arc 

earplug, Browning Duo, and AO Safety earplug were sold commercially); Myers Dep., Dec. 12, 2019, 399:5-11; 

Berger Dep., Dec. 11, 2019, 459:4-461:15 (“It’s essentially the same plug. The colors have been changed.”). 

61 Myers 30(b)(6), Oct. 18, 2019, 81:2-8, 85:14-19; Moses Dep., Dec. 5, 2019, 181:5-17.

62 Myers 30(b)(6), Oct. 18, 2019, 178:20-179:12, 200:17-202:12, 212:6-15; 3M_MDL000080183; 

3M_MDL000148609

63 3M_MDL000332111

64 3M_MDL000332061; 3M_MDL000332090

65 3M_MDL000332061–70

66 3M_MDL000013574–77; 3M_MDL000549104

67 Moses 30(b)(6), Oct. 17, 2019, 267:16-270:12; Murphy Dep., Jan. 29, 2020, 224:8-15; Fallon Dep., Sept. 3, 2020, 

293:10-16, 294:7-295:19.

68 See 42 U.S.C. § 4907(b) The Noise Control Act; 44 Fed. Reg. 56120 (Sept. 28, 1979) (codified at 40 C.F.R. part 

211 et seq.). Note: there is an exception to the requirements in the Act for products designed exclusively for combat 

use, but that exception doesn’t apply to the CAEv2, which is designed for civilian consumer use as well as for 

military use. 

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the number, the greater the effectiveness or, in other words, the greater the noise protection 

provided by the HPD. NRRs are required to be prominently placed on the label for the HPD.69 

It is important for consumers and those responsible for recommending and providing hearing 

protection to employees to be told the level of protection an HPD provides and to be able to rely 

on the manufacturer’s labeled NRR when purchasing a hearing protector for themselves or 

others. 

REAT testing is the gold standard for “fit testing” hearing protective devices. REAT 

testing involves a hearing test given to subjects in a quiet room. A minimum of 10 subjects are 

tested without the hearing protector and with the hearing protector (ears open and ears occluded) 

in order to get a measure of the protection provided by the hearing protector. Tones are played at 

various frequencies and each subject undergoes at least three trials for the complete test. The 

attenuation measurements for all subjects’ multiple tests are then input into a formula, and

additional corrections are made to generalize for a population, account for differences between 

laboratory test sounds and real-world noise, and other correction factors, to come up with a final 

NRR value. 

Because 3M failed to test the CAEv2 before selling it to the military, military personnel 

involved in the decision whether to approve the CAEv2 for use with soldiers and marines were 

unable to determine the amount of protection the CAEv2 would provide. 3M knew, however, 

that the military was expecting the CAEv2 to provide an NRR in the range of 3M’s Ultrafit plugs 

that advertised an NRR in the twenties.70 

The CAEv2 was sold to the military for almost six months before 3M realized that it was 

selling the CAEv2 without having tested it to know whether it was safe and without any data to 

know what level of hearing protection it would provide our troops.71 In December of 1999, 3M 

started performing REAT testing for the first time on the CAEv2.72 Both ends of the CAEv2 

were tested using “Experimenter Fit” REAT testing pursuant to ANSI S3.19. Ronald Kieper, 

Acoustical Lab Technician at 3M, was the expert fitter of the earplugs during the test. 

Mr. Kieper used “standard fitting instructions” to insert the earplug in subjects’ ears 

during the tests, meaning he held the stem of the earplug between his thumb and forefinger and 

pressed the plug into the ear canal without flipping back the flanges before inserting the plug.73 

He testified that he did not start the test until he was satisfied that he had a “best fit” with the 

earplug.74 He performed the tests under the direction of Elliott Berger, 3M’s Manager of the 

Acoustical Lab, and kept Mr. Berger informed of the results during the tests.75 

69 40 C.F.R. § 211.108.

70 Knauer Dep., Dec. 17, 2019, 117:10-17; Berger Dep., Dec. 11, 2019, 559:5-13.

713M_MDL000257805

72 3M_MDL000313390

73 Kieper Dep., Dec. 19, 2019, 91:17-92:25, 230:18-232:22.

74 Kieper Dep., Dec. 19, 2019, 105:18-21. 

75 3M_MDL000257805; Kieper Dep., Dec. 19, 2019, 111:25-113:1; 94:11-95:3

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Test 213016, the test on the open end of the CAEv2, resulted in a -2 NRR, but 3M 

rounded that value up to 0.76 Mr. Kieper testified that the data from Test 213016 showed “big” 

variances in some subjects’ attenuation levels.77 Nevertheless, 3M decided to accept the results 

of Test 213016 and to use the results to label the open end of the CAEv2 at all times while it was 

being sold by 3M with an NRR of 0.78

Test 213015, the test on the closed end of the CAEv2, was aborted after eight of the ten 

subjects were tested.79 The interim NRR at that time was 10.8, rounded to 11 by 3M.80 Mr. 

Berger ordered Mr. Kieper to stop the test because the projected NRR was too low.81 Several 

3M witnesses testified that the NRR achieved after eight subjects was below what was expected 

and was unacceptable.82 Richard Knauer, 3M’s Senior Technical Director for Passive Hearing 

Protection testified that the military expected an NRR in the range of 20.83 Jeffrey Hamer, 3M’s 

Global Laboratory Manager for Hearing Protection called an NRR of 11 “insufficient.”84 Mr. 

Kieper also found the results in this test “variable” among the individuals.85 

Mr. Berger and Mr. Kieper authored a report titled “How Folding the Flanges Back 

Affects REAT Results of the UltraFit Earplug End of the Combat Arms Plug” in order to 

“document that the current length of the UltraFit Earplug end of the Combat Arms Plug is too 

short for proper insertion, and how changing the fitting technique affected the results of real-ear 

tests of this plug.”86 This report, dated July 10, 2000, is often referred to as the “Flange Report” 

and it documents the problems Mr. Kieper faced with fitting and sealing the CAEv2 during 

testing as a result of the earplug being “too short for proper insertion,” as well as the results of 

the “retesting” Mr. Berger ordered on the closed end of the earplug.

87 Mr. Kieper described his 

difficulty with insertion of the earplug as follows:

For test 213015, the plugs were fit according to the standard plug's fitting Instructions, 

with no modifications. Because the stem of the green, solid end of the plug is so short; it 

was difficult for the experimenter to insert the plug deeply into some subjects'. ear canals, 

especially those subjects with medium and large ear canals. Additionally, the geometry of 

76 3M_MDL000188143; 3M_MDL000425527

77 Kieper Dep., Dec. 19, 2019, 191:25-193:23, 282:10-22 (“Not putting the actual NRR on a package 

would be, yeah, that would be a problem.”); Keiper Dep., Dec. 20, 2019, 492:17-22.

78 Kieper Dep., Dec. 20, 2019, 499:16-500:5. 

79 3M_MDL000313390; 3M_MDL000728812

80 3M_MDL000313390; 3M_MDL000728812

81 3M_MDL000313390; Kieper Dep., Dec. 19, 2019, 166:10-167:12, 196:12-197:25.

82 Berger 30(b)(6), Nov. 13, 2019, 276:3–277:4; Myers Dep., Dec. 12, 2019, 275:5–276:1; Fallon 

Dep., Sept. 3, 2020, 197:24–199:13.

83 Knauer Dep., Dec. 17, 2019, 117:10-17.

84 Hamer Dep., Oct. 17, 2015, 174:11-15.

85 3M_MDL000728811

86 3M_MDL000728811

87 3M_MDL000728811; 3M_MDL000005365; Kieper Dep., Dec. 19, 2019, 162:17-166:16; Kieper 

Dep., Dec. 20, 2019, 723:25-725:1.

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 33 of 226
33

the ear canal opening sometimes prevented the deep plug insertion required for maximum 

attenuation values.88

He also described a phenomenon he called “imperceptible loosening” of the earplug:

When the solid plug was fitted during the first test (015), the basal edge of the third 

flange of the yellow, level-dependent plug sometimes pressed against the subject's ear 

canal opening and folded up . . .When the inward pressure on the plug was released, the 

yellow plug's flanges tended to return to their original shape and this sometimes loosened 

the plug, often imperceptibly to the subject.89

The data from Test 213015 were attached to the report and Mr. Kieper confirmed that the 

“initial test 213015 was stopped after 8 subjects because the individual results were variable and 

the NRR was quite low (11).”90 

Mr. Berger sent a draft of the Flange Report to Brian Myers, 3M’s Vice President of 

Marketing to inform him of “problems” with the CAEv2 and stated: “Should I share this with 

Ohlin? It looks like the existing product has problems unless instructions are revised.”91 Mr. 

Ohlin was an employee of the DoD and 3M’s primary contact with the military about the 

CAEv2.92 

The retest of the closed end of the CAEv2 was four months later, in May of 2000.93 

During this test, the instructions for insertion were changed and Mr. Kieper noted that “[t]he 

yellow flanges were folded outward to allow a deeper insertion of the green plug.”94 Mr. Kieper 

described that folding back the flanges helped his ability to fit the plugs:

The folded-back flanges and the hard plastic stem provided a long, stiff quasi-stem for 

the experimenter to grasp and allowed for a deeper and more-consistent fit of the solid 

plugs for test 213017: When folded back in that way, the yellow flanges neither touched 

the subjects' conchae nor compromised the fit of the solid earplugs.95

Test 213017 resulted in an NRR of 21.7, rounded up to 22.96 Mr. Kieper’s test with the 

reconfigured earplug doubled the NRR from 11 in the initial Test 213015 to 22 in Test 213017. 

3M thereafter called Test 213017 its “labeling test” for the closed end of the CAEv2 and at all 

times labeled the closed end of the earplug with an NRR of 22.97 As discussed more fully below, 

88 3M_MDL000728811 at 2

89 3M_MDL000728811 at 2

90 3M_MDL000728811 at 2

91 3M_MDL000258590

92 Ohlin Dep., Apr. 24, 2013, 130:24-131:5; Berger Dep., Dec. 10, 2019, 76:7-11.

93 3M_MDL000728812

94 3M_MDL000728812 at 4; 3M_MDL000005366

95 3M_MDL000728812

96 3M_MDL000728812

97 3M_MDL000259866

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34

however, 3M did not change the instructions to reflect that the NRR of 22 was only obtainable if 

the flanges were folded back.98 

3M’s Additional REAT Testing Of The CAEv2

Experimenter Fit Testing 

3M continued testing both ends of the CAEv2 starting in June of 2004. The following is 

a listing of all the “experimenter fit” REAT tests on the CAEv2 from a Table in Mr. Keiper’s and

Mr. Berger’s report titled “The Development of the Combat Arms Earplug, Version 1 through 

Version 4.”99 

Table 1 - Listing of REAT Tests of 4 versions of the Combat Arms Earplugs

Test ID Date

Versio

n Position NRR

213016 Jan-00 2 open 0 (-2)**

213017 Jan-00 2 closed 22

215009 Jun-04 2 open 0 (-1)**

215507 Jun-05 2 open 4

215508 Jun-05 2 closed 15

215511 Jun-05 2 open 6

215512 Jun-05 2 closed 21

215515 Sep-05 2 open 5

215012 Apr-06 2 open 5

215516 Apr-07 2 closed 14

98 Berger Dep., 75:5-76:4, 77:15-80:9, 99:13-1011:6.

99 3M_MDL000259866

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35

** - Note that when the real-ear test results compute to a negative number for the 

NRR, we chose to label the device with a 0.

As can see, 3M performed five additional Tests on the open end of the CAEv2 between 

2004 and 2006. Test 215009 in June of 2004 was a test of 10 subjects resulting in an NRR of -1, 

which was rounded to 0 by 3M. This test, like the original labeling Test 213016, showed 

extensive variability of attenuation levels among subjects. The four additional tests on the open 

end, 215507, 215511, 215515, and 215012, all showed much higher attenuation (NRRs of 4, 6, 

5, and 5).100 These later tests on the open end of the CAEv2 led Mr. Kieper and Mr. Berger to 

comment in their July 2010 report as follows: “Comment: 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.”101

On the closed end of the CAEv2, 3M performed three additional tests - Tests 215508, 

215512, and 215516. These tests were also experimenter fit tests. All three of these tests 

resulted in low NRRs for a linear HPD - 215508 with an NRR of 14.8, rounded to 15, and 

215516 with an NRR of 14.2, rounded to 14.102 Test 215512 had an NRR of 21. All three Tests 

included less than 10 subjects each (5, 5, and 3, respectively). 3M acknowledged that it 

continued to see variable and inconsistent test data from test to test.103 

3M’s Subject Fit Testing

In 2001, 3M performed its first subject fit test on the CAEv2. This test was Method B 

testing pursuant to ANSI S12.6-1997.104 A subject fit REAT test is similar to an experimenter fit 

study, but the earplug is inserted by the subjects themselves. Subject fit REAT tests are thought 

to be more accurate as far as the noise protection a user of a HPD will get because it reflects 

results from the subjects insertion of the earplug, as would be the case in the real world. This 

test, 213024 was stopped for some reason after only 4 subjects, although Method B testing 

requires testing of 20 subjects.105 One of the four subjects had extremely variable results.106

In June of 2006, 3M performed another ANSI S12.6-1997 Method B subject fit test on 

the closed end of CAEv2.107 This test - Test 213030- was actually performed on the “Arc Plug” 

which is an identical commercial brand of the CAEv2 with the exception of the color of the 

flanges.108 This was another subject fit test and 20 subjects were tested pursuant to the ANSI 

100 Kieper Dep., Dec. 20, 2019, 494:17-500:23; Kieper Ex. 46, Kieper Ex. 47, Kieper 48, Kieper Ex. 49. 

101 3M_MDL000259866 at 78

102 3M_MDL000259866

103 3M_MDL000481953 

104 3M_MDL000534743

105 3M_MDL000534743

106 3M_MDL000534743

107 3M_MDL000313220

108 Berger Dep., Dec. 11, 2019, 459:4-461:15; Ohlin 30(b)(6), Oct. 17, 2019, 51:2-11. 

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 36 of 226
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guidelines.109 Test 213030 resulted in a very low NRR of 4.4 for the closed end.110 An NRR of 

4.4 represents a fraction of the NRR of 22 on the CAEv2 label.111 Several subjects had large 

variations in attenuations between tests.112 3M noted on the report one subject, “JSS failed the 

Extreme Range Test” at several frequencies and that without four other subjects, the results 

would have been higher.113

Testing By Third Parties

I have reviewed testing performed by the U.S. Army and the U.S. Air Force as well. The 

Air Force Research Laboratory tested both ends of the CAEv2 in 2009, pursuant to ANSI S12.6-

1997 (Method A Experimenter- Supervisor Fit) in 2009.114 The NRRs reported were 15 on the 

closed end and 3 on the open end of the CAEv2. Major Brian Hobbs testified that this study was 

not done for approval or disapproval of the CAEv2 and the testers had no knowledge of potential

“slippage of the device.”115 The U.S. Army Aearomedical Research Laboratory conducted 

testing on the CAEv2 in 2014.116 The testing was on the open and closed ends and done 

pursuant to ANSI S12.6-2008. This was “experimenter-supervised fit” testing, meaning the 

subject inserts the plug while getting help from the fitter on techniques for best fitting. This test 

included 20 subjects. 

In 2012, Michael & Associates Laboratory tested both ends of the CAEv2 pursuant to 

ANSI S3.19-1974.117 The test resulted in an NRR of 9 on the open end and 23 on the closed 

end. 

3M’s REAT Testing Practices 

Several documents and witnesses have addressed 3M’s REAT testing practices that are 

relevant to the issues in this case. 

109 3M_MDL000313220

110 3M_MDL000313220 (noting “NRR (SF) 4.4”).

111 3M_MDL000313220

112 3M_MDL000313220

113 3M_MDL000313220 (noting “w/o SLD, LLE, JEH and DJS the NRR (SF) is 10.5.”). 

114 (Hobbs, Hudson, McKinley and Brungart, AIR FORCE RESEARCH LABORATORY, “Wideband 

Hearing, Intelligibility, and Sound Protection (WHISPr): Tactical Headset Evaluation” (January 

2009)

115 Hobbs Dep., July 16, 2020, 277:14-21; 80:13-81:13.

116 Williams, Stefanson, Reeves, and Gordon, U.S. ARMY AEAROMEDICAL RESEARCH LABORATORY, 

“Assessment of Four Passive Hearing Protection Devices for Continuous Noise Attenuation, 

Impulse Noise Insertion Loss, and Auditory Localization Performance,” USAARL Report No. 

2015-01 (November 2014)

117 3M_MDL000005607

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 37 of 226
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Testing Panels

ANSI S3-19 standards require test subjects to satisfy certain hearing threshold levels to 

qualify to be a “listener” in a REAT test.118 3M has a practice of placing qualified subjects into 

“testing panels” rather than placing all qualified subjects in a pool of test subjects that can then 

be randomly selected for use in the testing.119 Specifically, ANSI S3-19 qualified subjects must 

complete several training sessions during which they are tested on specific HPDs including foam 

earplugs, premolded earplugs, push-in earplugs and earmuffs.120 Subjects are put into test panels 

based on their attenuation levels in prior testing. When 3M then selects subjects for testing on a 

particular device, they choose subjects from the test panel that have achieved higher attenuation 

levels in prior testing on that type of HPD.121 3M admits that by not using a randomized panel 

and using these test panels where subjects are chosen by prior performance, they typically get 

higher NRRs for their products.122 The NRR is supposed to represent the noise attenuation that 

98 percent of the population would receive if properly fitted with the HPD. 3M, however, only 

uses test subjects who show high levels of attenuation in tests and thereby may cause the results 

in NRR testing to be overstated. 

Bias In EARCAL Laboratory 

3M uses its own laboratory, EARCAL laboratory, when REAT testing 3M HPDs for 

labeling purposes. Documents and testimony from witnesses discuss potential bias in favor of 

obtaining higher NRRs as a result of 3M testing its own products in its own lab. 

It is well known and agreed upon that HPDs with higher NRRs lead to more sales for 

manufacturers of HPDs.123 Therefore, those in sales and marketing at a company like 3M desire 

the highest possible NRRs for HPDs, which can lead to pressure being put on those who are 

testing the devices. This is especially true when a company like 3M is testing its own devices. 

Documents reviewed reflect that EARCAL laboratory has had problems with inflating 

NRRs in the past. Cabot Safety Corporation, which was Aearo’s predecessor company before 

3M acquired Aearo, paid a $900,000 civil penalty handed down by the Department of Justice and 

118 For a candidate "listener" to qualify under ANSI S3. I 9, the listener must "have[ unoccluded] hearing 

threshold levels in either ear no higher than 10 dB at the 250-1000-Hz test frequencies and no higher than 

20 dB at any other test frequency as measured by a standard audiometer." ANSI S3-19 §3.2.1 ; In 

addition, no listener "whose variability for the open threshold of audibility ... is such that the range on 

three successive open threshold measurements at any test band between the 250- and 4000-Hz bands is 

greater than 6 dB" shall be selected as a test subject. ANSI S3-19 at §3.2.2. "Listeners who satisfy the 

other requirements of this standard and who do obtain an adequate fit with the test item [] may not be 

dismissed for reporting small amounts of protection." ANSI S3-19 §3.2.3.

119 Kieper Dep., Oct. 9, 2015, 46:12-17. 

120 Kieper Dep., Oct. 9, 2015, 27:12-37:25.

121 Berger Dep., Oct. 8, 2015, 81:19-82:10; 152:21-153:2; Kieper Dep., Oct. 9, 2015, 46:12-55:9.

122 Berger Dep., Oct. 8, 2015, 79:14- 82:10.

123 3M_MDL000259198-200 (“Users focus on NRR rating as an indicator of hearing protector 

performance. . . . Many users want higher NRRs”); Murphy Dep., Jan. 29, 2020, 153:18-154:19.

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 38 of 226
38

the EPA in 1993 for inflating NRRs on HPDs by as much as fifty percent.124 An internal email 

from Mr. Ohlin, who worked closely with 3M for many years, claimed that the marketing 

department often pressured Mr. Berger and other laboratory employees to use “every legal trick 

in the book” in order to try to boost NRRs.125 At relevant times, the marketing department was 

in charge and overseeing the EARCAL lab. In fact, Mr. Berger, the Acoustical Laboratory 

Manager, reported directly to Brian Myers, an executive in the marketing department for several 

years. 126 3M’s testing policy, states that “multiple testing attempts with the same product are 

not allowed because this is prohibited by the EPA.”127 3M witnesses and documents, however, 

confirm that the marketing department is routinely kept apprised of NRR results during tests and 

tests are halted if the desired NRR is not likely to be reached, with subsequent retesting of the 

HPD until the desired NRR is achieved.128 This practice violates 3M’s own testing 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.”129

According to Jeffrey Hamer, 3M’s Global Laboratory Director, 3M should not have 

terminated Test 213015 after 8 subjects simply because the NRR was too low and the results 

were variable.130 He also testified that 3M’s retesting of the CAEv2 with the flanges folded back 

was “improper.”131 

Disclosure of Test 213015 and the Flange Report

The Flange Report memorialized in writing the problems 3M discovered with the fitting 

and imperceptible loosening of the CAEv2. The Flange Report was never provided to the 

Military or anyone else until 2015. It was disclosed for the first time in October of 2015 during 

the course of a deposition in a lawsuit brought by Moldex against 3M.132 The very next day, 3M 

discontinued the sales of the CAEv2.133

3M never provided the military with the results of Test 213015 even though military 

representatives specifically asked for testing data on the CAEv2.134 Instead of providing all data, 

124 3M_MDL00024833, April 7, 1993 Dept. of Justice Civil Penalty Determination to Cabot.

125 3M_MDL000019705

126 Berger Dep., Dec. 10, 2019, 24:21-25:5; Myers Dep., Dec. 12, 2019, 62:12-14; 3M_MDL000321796 

(Berger email to Myers, June 2, 2006, with attachment updating test results). 

127 3M_MDL000332847; 3M_MDL000014573–639; Kieper Dep., Dec. 19, 2019, 253:14–255:8.

128 Cimino Dep., Dec. 11, 2019, 266:22-269:2, 270:3-271:4, 271:10-274:20; 3M_MDL000649705 (“please 

advise by the 8th-9th person what it looks like it will come out to.”); 3M_MDL000480086 (“Ok, keep going 

if you can get me a 25 NRR, it is the bare minimum I can accept....”); Berger Dep., Dec. 10, 2019, 

166:21–168:1; 3M_MDL000004550–52; 3M_MDL000434769; 3M_MDL000321562–63; 

3M_MDL000208205-06; Kieper Dep., Dec. 19, 2019, 351:14-353:6, 403:5-404:2. 

129 3M_MDL000332847; 3M_MDL000014573-639; Kieper Dep., Dec. 19, 2019, 253:14-255:8.

130 Hamer Dep., Oct. 7, 2015, 104:25-105:3, 136:10-12.

131 Hamer Dep., Oct. 7, 2015, 165:20-166:1.

132 Hamer Dep., Oct. 7, 2015, 149:13-152:5. 

133 Hamer Dep., Oct. 7, 2015, 149:18–157:8; 3M_MDL000332111; 3M_MDL000332061.

134 Myers Dep., Dec. 13, 2019, 489:6-490:13.

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 39 of 226
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Berger sent the military only a spreadsheet containing test results that 3M found acceptable --

Test 213016 and Test 213017 -- but concealing all testing data revealing problems with the 

CAEv2 -- Test 213015 and the Flange Report.135

3M also never provided the Flange Report to the military or anyone else.136 Mr. Berger

testified that that he informed Mr. Ohlin that folding back the flanges would be important for 

“some” people, but he never provided the report and doesn’t remember providing any more 

detail than that137 

The wallet card, which was developed in part by Mr. Ohlin, a military employee, does 

not provide evidence that 3M shared the Flange Report or the results of Test 213015 with Mr. 

Ohlin or the military. The wallet card only references folding back the flanges for “very large 

ear canals”, which is inconsistent with the findings documented in the Flange Report - that 

folding back the flanges is necessary for all users of the CAEv2.138 In fact, the military admits 

that it did not know that folding back the flanges was necessary for medium and larger or all ear 

canal sizes.139 Further, the wallet card does not mention the other problems revealed in Test 

213015 and the Flange Report, including that the earplug is too short for proper insertion, that 

fitting the plugs in most ear canals is difficult, that the flanges on the outward facing plug could 

cause imperceptible loosening, that the geometry of the ear canal can prevent fitting, or that the 

NRR of 22 was achieved by folding the flanges back.140 

In 2016 and 2017, the United States Department of Justice investigated 3M for False 

Claims Act violations.141 The allegations included that 3M manipulated testing of the CAEv2 in 

order to get a higher NRR on the closed end of the CAEv2.142 Several military witnesses were 

interviewed and all testified that they did not know about the testing with the folded back flanges 

or that the NRR was not as claimed.143 None of the military witnesses claimed they had been 

told about the CAEv2’s problems with fitting, seal and loosening imperceptibly.144 

135 3M_MDL000570063-69

136 Berger Dep., Oct. 8, 2015, 110:16-21; Berger Dep., Dec. 11, 2019, 544:18-545:22, 546:16-547:8; 

Fallon Dep., Sept. 3, 2020, 213:21.

137 Berger Dep., Oct. 8, 2015, 109:6-110:15; Berger 30(b)(6), Nov. 13, 2019, 337:8-18, 352:15-

25, 373:19-374:6.

138 3M_MDL000229332

139 Berger 30(b)(6) Nov. 12, 2019, 346:9-23, 373:12–374:6; McNamara Dep., Mar. 11, 2020, 

439:13-441:24.)

140 Murphy Dep., Jan. 29, 2020, 309:7–310:18; Berger Dep., Dec. 11, 2019, 545:8-19; Myers 

Dep., Dec. 12, 2019, 335:6–336:6, 338:18-339:13, 344:6-345:9; 3M_MDL000728812 

141 CID File0001-4

142 Complaint in United States ex rel. Moldex-Metric, Inc. v. 3M Co., 3:16-1533 (May 12, 2016)

143 E.g. CID File0240

144 E.g. CID File0038, 0039, 0214, 0225, 0234-0237

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 40 of 226
40

There is simply no evidence that 3M disclosed the results of Test 213015 or any of the 

findings of the Flange Report to the military or consumers at any time. 

Labeling, Instructions, and Warnings

EPA regulations require HPD manufacturers to affix a label containing an 

NRR as well as “instructions as to the proper insertion” to an HPD or, if the HPD 

is sold in bulk, to the bulk container.145 There is a military exception for 

“weapons or equipment” designed for combat use.146 The CAEv2, however, was 

designed for consumer use as well, and therefore the exception does not apply. 

3M’s Jason Jones and Doug Moses agree that an EPA label should be placed on 

the CAEv2 because “there is no exception for the US military.”147

Aearo/3M started selling the CAEv2 to the Military before testing it and 

without a label containing an NRR or instructions for the proper insertion of the 

earplug.148 3M witnesses testified that the CAEv2 was sold to the military 

without any instructions from 1999 to 2005.149 Most of the CAEv2 sales to the 

military were “in bulk”, meaning one hundred earplugs in a plastic bag were 

shipped to the military in a box.150 3M’s corporate representative testified that 

3M was unable to identify any label or any instructions ever provided with bulk 

shipments of the CAEv2.151

When selling the CAEv2 to the military, 3M only “affixed” a label with an 

NRR and instructions to “blister packs” containing a single pair of the plugs.152 

CAEv2 blister packs were sold on military bases as well as in retail stores, but 

were purchased by relatively few soldiers.153 In 2005, 3M developed a package 

insert to go inside the blister packs because soldiers were having difficulty 

understanding how the CAEv2 earplugs work.154 The purpose of the instruction 

145 Noise Control Act, 42 U.S.C. § 4907(b); 44 Fed. Reg. 56120 (Sept. 28, 1979) (codified at 40 C.F.R. part 211 et 

seq.); 40 C.F.R. 211.204-4; 40 C.F.R. 211.108. 

146 42 U.S.C. § 4902(3)(B)(i)

147 3M_MDL000446689

148 Moses 30(b)(6), Oct. 17, 2019, 457:17-458:5 (CAEv2 first sale July 22, 1999); Myers 30(b)(6), Oct. 18, 2019, 

132:10-133:16, 178:20-179:12, 183:3-10, 184:7-17, 193:4-20, 198:7-16; Berger 30(b)(6), Nov. 13, 2019, 80:21-24 

(no CAEv2 NRR labeling tests as of Nov. 19, 1999), 86:6-11.

149 Myers 30(b)(6), Oct 18, 2019, 178:20-179:12, 198:7-199:13; Berger Dep., Dec. 10, 2019, 224:6-226:12; 

3M_MDL000056553

150 Myers 30(b)(6), Nov. 18, 2019, 81:2-8, 85:14-19.

151 Myers 30(b)(6), Nov. 18, 2019, 196:23-197:2, 197:12-198:6, 198:7-199:15; Berger Dep., Dec. 10, 2019, 226:2-

12; Moses Dep., Dec. 5, 2019, 162:21-164:7.

152 3M_MDL000080183; Myers 30(b)(6), Oct. 18, 2019, 178:20-179:12, 212:6-15.) 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)

153 Myers 30(b)(6), Oct. 18, 2019, 200:17-202:12; 3M_MDL000148609

154 3M_MDL000620089

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 41 of 226
41

insert was to develop product education and to provide proper insertion technique, 

among other things.155 

The label on the blister packs listed an NRR of 22 for the closed end and 0 

for the open end. The blister pack contained instructions for use and a “fitting 

tip.” 156 The instructions for use tell users to “grasp the plug by the stem and 

insert it into the ear canal” and then “adjust the plug for best sealing 

performance.”157 The fitting tip states that “fitting is easier if 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.”158 This tip was 

provided for improved comfort and improved fit, not as a requirement to ensure a 

good fit and seal or to avoid loosening of the plug.159 For some reason, the 

fitting tip was removed from labeling and in 2012.160 There was not any 

reference to folding flanges from March of 2012 until the CAEv2 was 

discontinued in 2015.161 

Consumer versions of the CAEv2 were sold in retail stores starting in 2000.162

Consumer versions were identical to the version sold to the military with the 

exception that some consumer versions had different color flanges.163 Consumer 

versions of the CAEv2 were also sold in blister packs with an affixed label with 

an NRR, instructions and the above fitting tip as early as 2000.164 

3M’s labeling, including package inserts and other promotional materials, never warned the 

military or consumers about the results or findings in Tests 213015 or about the “problems” with 

155 3M_MDL000620089

156 Myers 30(b)(6), Oct. 18, 2019, 212:6-214:18; 3M_MDL000080183.

157 3M_MDL000042065

158 3M_MDL000425527; 3M_MDL000425680

159 Myers 30(b)(6), Oct. 18, 2019, 251:24–252:5, 405:8–406:11; Berger Dep., Dec. 10, 220:10-18; Hamer Dep., 

Dec. 18, 2019, 299:5-300:22; 318:24-321:11; 323:11-22; Myers Dep., Dec. 12, 2019, 338:18-25; Santoro Dep., Dec. 

3, 2019, 306:1-22.

160 3M_MDL000193296–301; Myers 30(b)(6), Oct. 18, 2019, 314:3–317:5.

161 Myers 30(b)(6), Oct. 18, 2019, 314:3–317:5.

162 3M_MDL000425527

163 Myers 30(b)(6), Oct. 18, 2019, 172:4-174:18; Myers Dep., Dec. 12, 2019, 161:4-19, 398:17-400:1.

164 3M_MDL000425526-7 (AOSafety Indoor/Outdoor Range EAR Plugs).

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the CAEv2 documented in the Flange Report.165 Specifically, 3M never warned the military or 

consumers that:

(1) testing showed that the CAEv2 was too short for proper insertion;

(2) the CAEv2 is difficult to insert in medium and larger ear canals;

(3) the geometry of some ear canals prevent proper insertion of the CAEv2;

(4) the dual-ended design could lead to imperceptible loosening caused by the flanges on the 

outward facing plug contacting and pressing against the user’s ear;

(5) the NRR obtained when inserting the CAEv2 according to the instructions for use was 

only 11; and 

(6) the 22 NRR was obtained by folding the flanges back, a post manufacturing alteration of 

the product that was not contemplated when the earplug was designed166 

Misrepresentations

First, 3M misrepresented the NRR for the closed end of the CAEv2 in its label,

advertisements and correspondence with the military.167 3M labeled and advertised the closed 

end of the CAEv2 as having an NRR of 22 “when used as directed.”168 3M knew that the NRR 

was obtained only when the flanges were folded back, yet 3M never “directed” users that folding 

back the flanges was required in order to obtain the stated NRR of 22. To the contrary, users 

were directed to insert the plug according to the standard instructions for earplugs - “grasp the 

plug by the stem and insert it into the ear canal” and then “adjust the plug for best sealing 

performance.169 A “fitting tip” was provided for improved comfort or fitting, but the tip was 

hardly a directive or a requirement to fold back the flanges. Nowhere did the label inform users 

that when used as 3M directed, the CAEv2 would only provide a NRR of 11, which is 90 percent 

less than the stated NRR of 22. 

In my practice as an ENT, I have regularly recommended hearing protection for my 

patients. I have regularly reviewed HPD labels and have done research on HPDs for patients in 

order to ensure that the HPD will provide adequate protection to my patients. I have to rely on 

manufacturers’ labeling and advertising to determine if it is safe for patients. Consumers also 

have to rely on the manufacturer’s representations about the protection afforded by the HPD and 

its safety. It is very important that manufacturers are honest and accurate in their labeling of 

NRRs. As stated previously, documents and testimony support that 3M has a history of inflating 

or manipulating NRRs. It is my opinion that 3M did so in this case and, as a result, 

servicemembers and consumers relied on the misrepresentations and suffered NIHL and tinnitus 

as a result. 

165 Berger Dep., Dec. 10, 2019, 206:7-14.

166 Berger 30(b)(6), Nov. 13, 2019, 295:14-25; Berger Dep., Dec. 12, 2019, 151:8-21; Berger Dep., Dec. 10, 2019, 

82:9-22, 83:3-18, 212:2-213:9; McNamara Dep., Mar. 11, 2019, 152:20-153:9; Myers Dep., Dec. 12, 2019, 352:16–

353:24.

167 E.g., 3M_MDL000425680; 3M_MDL000042067; 3M_MDL000002628; Moses 30(b)(6), Oct. 17, 2019, 216:8-

217:25; Santoro Dep., Dec. 3, 2019, 235:7-236:18; Warren Dep., Jan. 12, 2020, 174:9-25, 178:20-180:12; 

McNamara Dep., Mar. 11, 2020, 413:10-415:9.

168 3M_MDL000425527; 3M_MDL000573846

169 3M_MDL000042065

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Second, 3M also promoted the CAEv2 to the military and to consumers as providing 

adequate protection from gunshot noise when it did not have adequate proof that was the case 

and when it knew that, in fact, the open end of the CAEv2 was not safe for use on gun ranges or 

in battle with frequent gunfire.170 

3M informed the military that the earplugs would be designed to protect from impulse 

noises created by military firearms.171 3M further claimed that the CAEv2 was safe for use on 

gun ranges, and in fact, a consumer brand of the CAEv2 was called the “AO Safety 

Indoor/Outdoor Range” earplug.172 Promotional materials for the CAEv2 state that the open end 

provides “instant protection from high-level noises like weapons fire and explosions. It’s that 

easy. It’s that quick.”173 Another marketing brochure claimed that when needed, the earplugs 

would react to afford instant protection from impact noises such as weapons fire or improvised 

explosive devices.174 Testimony from 3M witnesses confirmed these misrepresentations.175

Meanwhile, inside the company, 3M’s employees with testing and sales experience with 

the CAEv2, confirmed that the open end of the CAEv2 should not be used on gun ranges. One 

marketing manager with extensive experience selling the CAEv2, concluded that the open end of 

the CAEv2 would “NOT” protect users on gun ranges if guns are “going off” every 30 

seconds.176 3M’s audiologist with extensive testing experience with the CAEv2, Mr. Elliott 

Berger, agreed that CAE earplugs are not an optimal choice for a gun range and, further, 

confirmed that 3M did not have data “one way or the other” about whether the CAE earplugs are 

safe for use on gun ranges.177 Ted Madison, 3M’s Technical Service Specialist, also agreed and 

said that use of the CAE earplug on a gun range “doesn’t make sense.”178 From the record, it is 

difficult to know when representatives of 3M first knew and concluded that the CAEv2 was not 

safe for use on gun ranges.179

In 2014, fourteen years after the CAEv2 was first sold to the military and consumers, 3M 

decided it needed to change the label and add an “impulse noise warning.” 180 3M did not add 

the warning to CAE labels until 2016, after the CAEv2 had already been pulled from the 

market.181 Therefore, the military and hundreds of thousands of users of the CAEv2 were never 

170 3M_MDL000000013 at 57

171 3M_MDL000000013 at 55 

172 3M_MDL000425526; Murphy Dep., Jan. 29, 2020, 98:6–99:13; 3M_MDL000619485; 

3M_MDL000716271

173 3M_MDL000005685; 3M_MDL000286137

174 3M_MDL000193307; 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”)

175 Murphy Dep., Jan. 29, 2020, 350:2-354:12; Jones Dep., June 19, 2020, 251:8-20. 176 3M_MDL000008470

177 3M_MDL000008470 at 473

178 3M_MDL000008470 at 471

179 Murphy Dep., Jan. 29, 2020, 349:20-354:12; 3M_MDL000473502 at 03 (“I would insert the word ‘infrequent’ 

before ‘gunshot’. A shooter should not go to the range and fire a box of shells with the yellow side in.”); 

3M_MDL000392992 (Sept. 2015 Peltor Sport brochure change to “Ideal for outdoor shooting and hunting where 

listening is primary use and gunshot noise is infrequent (yellow end).”).

180 3M_MDL000587314

181 3M_MDL000587314; Madison Dep., Dec. 10, 2019, 266:16-267:4. 

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warned that the open end was not safe for use on gun ranges. Various witnesses testified and 

confirmed that the military and consumers were never warned.182 

Discontinuation of the CAEv2

As stated above, sales of the CAEv2 were discontinued by 3M the day after Jeffrey 

Hamer, 3M’s Global Laboratory Manager, was confronted with the Flange Report in deposition 

in litigation brought by Moldex, a 3M competitor, against 3M.183 Mr. Hamer had never seen the 

Flange Report. The day after Mr. Hamer’s deposition, Brian Myers, 3M marketing executive, 

instructed 3M employees to immediately discontinue the sales of the CAEv2.184 Emails 

confirmed that the CAEv2 could not be sold with the “current NRR on the package”185 3M 

discontinued the sales and removed their inventory from its shelves, but never told the military to 

immediately stop using the earplugs.186 It was not until July of 2018, that the military was 

notified that the earplugs should no longer be used because “there is a risk of hearing loss” if 

individuals continue to wear that CAEv2.187 The Chief of Occupational Health Operations at the 

Office of the Surgeon General wrote that CAEv2 was “found to be defective and did not protect 

the wearer to the advertised level of protection.”188 

OPINIONS

Based on my education, training, experience, and review of the documents and testimony 

in this case, I offer the following opinions within a reasonable degree of medical and scientific 

certainty:

1. The CAEv2 Is Unreasonably Dangerous And Can Cause NIHL And Tinnitus

It is 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.

REAT Test Findings And The Flange Report

When 3M first tested the CAEv2 in January of 2000, it found that the earplug had several 

“problems.”189 Importantly, each of the “problems” identified led to the inability to properly fit 

and seal the earplugs. The ability to get a proper fit and to maintain a proper seal is a critical 

182 Babeu Dep., Mar. 10, 2020, 173:11-176:6, 391:15-18; Merkley Dep., Feb. 26, 2020, 426:6-11; Madison Dep., 

Dec. 10, 2019, 223:5-12; McNamara Dep., Mar. 11, 2020, 300:20-301:7, 303:1-305:21; Murphy Dep., Jan. 29, 

2020, 98:6-99:13, 349:19-352:11. 183 Hamer Dep., Oct. 7, 2015, 149:18–157:8.

184 3M_MDL000332111

185 3M_MDL000332061-63; Myers Dep., Dec. 12, 2019, 352:16-353:16.

186 Madison Dep., Dec. 10, 2019, 305:8-307:20; Myers Dep., Dec. 12, 2019, 362:25-363:21.

187 CTRL_3M_touhy00002253–55

188 CTRL_3M_touhy00002253–55

189 3M_MDL000258590.

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characteristic for an earplug.190 3M knows this.191 The inability to get a good fit and seal or to 

maintain a good seal makes an earplug ineffective and unable to protect the user. An earplug, 

like the CAEv2, which is difficult if not impossible to fit and to maintain an airtight seal on a 

consistent basis is unreasonably dangerous.

Test 213015, the original REAT test on the CAEv2, revealed the earplug’s defects. After the test 

was halted early, Mr. Berger and Mr. Kieper documented the CAEv2’s defects – all dealing with 

the difficulty of getting a good fit and seal - in the Flange Report. Their findings were as 

follows: 

● the CAEv2 is too short for proper insertion, which makes it difficult to insert deeply in 

order to get a good fit and seal, especially in medium and larger ear canals;

● the CAEv2 as designed, does not fit in the geometry of some ear canals;

● even if the CAEv2 is inserted deeply enough, the basal edge of the third flange on the 

non-inserted plug can press against the conchae (entrance to the ear canal) and loosen the 

earplug, “imperceptibly” to the user.192 

These defects stem from the design of the earplugs and make it difficult if not impossible 

to get a quality, consistent fit of the CAEv2. 

It is important to note that this test involved insertion of the CAEv2 by an expert fitter 

with years of experience fitting earplugs (Mr. Kieper), not the listener being tested. Yet, even 

the expert fitter was unable to consistently fit and seal this earplug. This did not bode well for 

the real-world use of the CAEv2, because in my opinion and according to the published 

literature, soldiers and civilians and other users who try to fit and maintain seal of the earplugs 

outside the laboratory, are unable to replicate the “best fit” achieved in the laboratory.193 This is 

true not only because an expert fitter is placing the earplug in the laboratory, but because the real 

world environment involves movement by the user, unlike in the laboratory, that can make the

fitting and maintaining the seal more difficult.

A review of the data from the initial REAT tests on the closed and open ends of the 

CAEv2 – Tests 213015 and 213016 – also supports that the CAEv2 was not able to be properly 

fit in a substantial number of subjects in the tests. Mr. Berger called the data from the CAEv2 

testing “more variable than [he] had ever observed for a solid plug that requires a good acoustical 

seal in the ear.”194 I reviewed the data and the analysis of Dr. John Franks, an expert in REAT 

testing and psychoacoustics with over 35 years of experience. The data from testing on both ends 

190 Berger, E.H., Custom Hearing Protection: Have it Your Way ...Maybe, Industrial Hygiene News, May/June 

2011 (“the degree of noise reduction depends on the quality of the fit”)

191 E.g., 3M MDL000416820 at slide 12; 3M_MDL000409110.

192 3M_MDL000728811

193 Berger, EARLOG5, 1980; (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.) (Scientific Basis of Noise-induced Hearing Loss, Chapter 29, 

International Review of Field Studies of Hearing Protector Attenuation at p. 375 (Berger, Franks and Lindgren 

(1996).

194 Berger10/8/2015 Depo at 106:9-14.

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of the CAEv2 show a high degree of variability among attenuation levels achieved by subjects in 

their own trials, and when compared as a group. Large variations in the attenuation levels for 

subjects from trial to trial are present in six out of the ten subjects tested in Tests 213015 and 

213016 (8 of the 10 subjects were used in both tests).195 Based on my review of the data and Dr. 

Franks’ report, it is my opinion that the extremely variable data from these tests supports that the 

CAEv2 is very difficult to consistently fit the earplug, even when it is being inserted in a 

laboratory, without the subject moving, by a professional fitter of earplugs.196 This data supports 

that the CAEv2 is defectively designed. 

Given these defects identified during Test 213015 and documented in the Flange Report, 

and for additional reasons stated below, it is my opinion to a reasonable degree of medical and 

scientific certainty that the CAEv2’s problems with being consistently fit and with maintaining 

its seal including imperceptible loosening among other things, that the CAEv2 was unreasonably 

dangerous and capable of causing or contributing to cause NIHL and tinnitus in users exposed to 

hazardous noise when wearing the earplug. 

 

Additional Testing Of The CAEv2

As outlined previously, 3M, the military, and Michael & Associates laboratory did 

further testing on the CAEv2 after the January of 2000 initial REAT testing. I have reviewed the 

data and information from those tests. When all of these tests are considered in the totality, the 

dramatically inconsistent results provide further support that it is very difficult to fit and maintain 

a seal on the CAEv2, leading it to provide extremely variable and inconsistent sound attenuation. 

As discussed above, 3M’s additional REAT experimenter fit tests on both ends of the 

earplug continued to reveal subjects who had extremely variable attenuation results indicative of 

a poor fit. In addition, the calculated NRR results for the closed end (15,16,17) all reflect 

protection much lower than the labeled NRR of 22. This is true despite the fact that 3M was 

using skewed test panels (as discussed above) in its own lab that has a history of inflating NRRs. 

The most informative test 3M performed on the CAEv2 was Test 213030, completed in 

2006. This test was 3M’s only complete “subject fit” ANSI S12.6-1997, Method B test of the 

CAEv2. This test was 3M’s largest test on the CAEv2, with 20 subjects, who all inserted the 

CAEv2 on their own, without the assistance of Mr. Kieper, the expert earplug fitter. As stated 

previously, this test is a more accurate reflection of the CAEv2’s real world attenuation, and the 

result was horrible for the CAEv2. The NRR in this test was 4.4, which equates to less than 10% 

of the protection that is listed on the label for the closed end – the NRR of 22. An NRR of 4.4 

provides almost no protection. Like most of the tests on the CAEv2, several test subjects had 

extremely variable attenuation levels in the trials indicative of a poor fit and seal. Because of the 

195 Expert Report of Dr. John Franks.

196 Mr. Kieper, 3M’s experimenter fitter agrees that large variations in the attenuation levels in the studies support 

that poor fits for some individuals. Kieper 10/9/2015 107:3-108:21); 109:20-110:7; 110:22-111:20.

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nature of this test (a more “real-world” test) and because of the extremely low NRR, this test 

should have been another red flag to 3M that its dual-ended CAEv2 was defective. Yet, the 

results of this test were never disclosed to the military or to consumers. 

The tests performed by the Army research laboratory as recently as 2014 also revealed 

variable results, which when considered with the other testing over the years is indicative of the 

inability to properly fit the earplug in as many as 6 subjects in this 20 subject ANSI S12.6-2008 

test. 

Michael & Associates ANSI S3.19-1974 testing in 2012 was essentially the only positive 

test of the CAEv2 from an attenuation standpoint. This single positive test in the context of the 

many tests that revealed that the CAEv2 is very difficult to fit and to maintain a seal in a 

substantial number of subjects, certainly does not negate the overwhelming evidence that the 

CAEv2 provides variable and inconsistent protection even in a laboratory setting.

 

In my opinion, the totality of the data from the CAEv2 tests, including the data from the 

test that is most representative of how the earplug will perform in the real world, strongly 

supports that the CAEv2 is defective and is capable of causing or contributing to cause NIHL and 

tinnitus if a user is exposed to hazardous noise while wearing the CAEv2. 

 Risk Benefit Analysis

In determining whether the CAEv2 is defective, I have tried to look at whether the 

benefits of using the earplugs outweigh the risks of using them. In my opinion, the risks to the 

servicemembers and consumers of using the CAEv2 far outweighed any potential benefits the 

earplugs could provide. The defective design of the CAEv2, leading to difficulty fitting the 

plugs, maintaining a seal, and to the ear plugs loosening without users knowing it, made it 

extremely risky to wear these earplugs.

The CAEv2 was designed to both protect the user from continuous noise while using the 

closed end, and to allow the ‘hear-through’ on the open end to maintain “situational awareness” 

while also providing protection from impulse noises. These desired characteristics, if achieved, 

would have been beneficial and an important safety protective measure for military personnel. 

Unfortunately, however, the design of the CAEv2 made it difficult if not impossible to fit and to 

maintain a protective seal for many of the users, so these aspirational benefits were never 

achieved. And, as a result, the CAEv2 exposes users to great risk of severe hearing damage if 

exposed to hazardous noise while wearing the earplugs. Consequently, it is my opinion that the 

risks of using the CAEv2 far outweighed any benefits received from using them. 

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2. 3M Acted Unreasonably With Respect to the CAEv2

3M Did Not Test The CAEv2 Before It Began Selling The Earplug

In reviewing the record, it is clear to me that 3M did not test the CAEv2 in any meaningful 

fashion before it began selling that earplug to the military. More specifically, 3M did not REAT 

test the CAEv2 before beginning these sales, which its own employees concede violated industry 

norms and was “wrong.”197 As a hearing professional, I certainly depend on manufacturers’ testing 

to understand the supposed protection HPDs provide, so 3M’s failure to REAT test before 

beginning sales is extremely surprising and disturbing.

But this failure does not just violate general industry norms; it also violates EPA 

regulations, which affirmatively require manufacturers to test an HPD before selling it.198 I and 

other hearing professionals rely on manufacturers' adherence to these regulations because they 

help promote safety and protect users. 3M’s failure to abide by these regulations was therefore 

unreasonable from the standpoint of a practitioner in the hearing protection field, a point that is all 

the more pressing given that the CAEv2’s dual-ended design was the first (and, to date, only) of 

its kind. 

3M Failed To Inform The Military And Consumers About The CAE’2s Problems And Did 

Not Stop Selling The Earplug Despite Those Problems

Even if 3M had not acted unreasonably in beginning to sell the CAEv2 before conducting

REAT testing, it did conduct that testing months later and, as I have discussed above, found at that 

time that the CAEv2 was a deeply defective product. More recent testing by Edens and Armstrong 

(also discussed above) have only confirmed these problems.

The tests 3M conducted showed without a doubt that it was not safe for market. 3M knew, 

for example, that the CAEv2 had problems with fit, seal and loosening, three of the most important 

features of an effective HPD. 3M also knew that the CAEv2 had, at best, a 10.8 NRR on the closed 

end, which would not provide adequate protection to the military or to civilians, because the 10.8 

NRR was achieved in a lab that did not approximate real world use. And I do not need to rely 

solely on my own professional expertise in this regard; 3M’s own employees—e.g., Berger—

stated that they knew pre-molded earplugs’ performance in the laboratory was considerably worse 

in the real world.199 What this meant is that the 10.8 NRR was a best case scenario, one that was 

far lower than the 22 NRR 3M actually advertised for the closed end.

197 Warren 1/23/2020 98:4-99:1; 3M_MDL000718635 (Berger stating that “[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.”

198 40 C.F.R. § 211.210-2.

199 Berger, EARLOG5, 1980 (laboratory tests “significantly overestimate the [real world] performance of HPDs, due 

to the unrealistic, optimized manner in which experimental subjects can wear these devices for short duration tests”). 

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: real-world performance of HPDs, especially 

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The reasonable course for 3M upon learning of these defects would have been to stop 

selling the earplugs, and to convey the problems to the military and to users who had already 

purchased the earplugs. It is as simple as that. Hearing professionals such as myself rely on 

truthful representations regarding an HPD’s supposed effectiveness (including the implicit 

representation it is safe through continued sales), as do consumers. A reasonable manufacturer in 

3M’s position therefore would have stopped selling the earplug because acting otherwise was 

wrong, as 3M’s own Global Laboratory Director admitted in this case.200

What the record shows is that 3M only stopped selling the CAEv2 when it was caught; 

specifically, when it discontinued the product the day after an opponent’s lawyers presented 3M 

with the Flange Report during a deposition in litigation. This is itself a concession of how 

unreasonable 3M was before, given that it knew it needed to discontinue the CAEv2, now that 

others had evidence of the product’s inherent defects.

Put differently, what would have been reasonable was to take corrective action after the 

Flange Report; not engage in testing tricks to discount the 10.8 NRR and report a much higher one 

than the product could actually achieve in real world situations. 3M chose a different course, and 

as a hearing professional who has reviewed 3M’s own concessions, I believe that was 

unreasonable.

3. 3M Did Not Warn About The CAEv2’s Defects And Risks Or Tell The Truth 

About Its Protection 

As I noted above, hearing professionals like myself review HPD’s warning labels to learn 

about them and their supposed efficacy. I also use those labels to determine whether I think the 

HPD in question is proper for various individuals with whom I treat. Along with warnings the 

most important is the NRR, which provides a general sense of the HPD’s ability to attenuate sound 

(and by how much). Although the NRR is not the only piece of information I need to assess an 

HPD’s appropriateness, it is certainly a critical information point, and one that I need to be correct 

in order to make an adequate assessment of the product’s protective ability.

40 C.F.R. Sec. 211.210-1(a), 211.10-2 required certain label contents for the CAEv2. 

Specifically, Part B of the Regulations, which applies to HPDs, requires that labels include an 

accurate NRR and that the product include “instructions as to the proper insertion or placement of 

the device.” More generally, it is also necessary for HPD manufacturers to warn about dangers 

associated with using an HPD, especially if the hazards are latent or otherwise unknowable to the 

user. Again, I do not need to just rely on my own professional experience to make this point; 3M’s 

senior executive and former President of North America Safety Products conceded that 3M was 

well aware of the duty to warn of known risks.

earplugs, demonstrates less attenuation and greater variability than currently standardized laboratory tests would 

predict.” (Scientific Basis of Noise-induced 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. 

200 Hamer 10/7/15 at 175:9-176:7. 

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But NRR is not the only piece of information I need when assessing HPDs. I also need to 

know if there are any other pieces of information (such as how to insert the product to achieve 

proper fit, or that the product has highly variable attenuation results), so I can assess the HPD’s 

reliability. If I have the option between two earplugs, one of which has a slightly lower NRR but 

is much more reliable, that is information I will use to make a decision on what product to select 

for my patients, and will most likely lead me to select the more reliable earplug. As I have 

previously discussed, an earplug with a high reported NRR is of little use to users that are unable 

to obtain good fit or a consistent seal. Yet, this is exactly the warnings 3M failed to provide on 

the CAEv2.

As I discuss in more detail below, it is my opinion that 3M failed to warn in several respects, 

including, but not limited to:

1. (regarding sales or samples before the REAT Tests were completed) the CAEv2 is a dualended plug that has never been tested to determine if it provided effective hearing 

protection as required by the EPA and industry standards;

2. The geometry of the ear canal opening in some individuals prevents the deep insertion 

necessary for a proper fit and seal of the CAEv2;

3. the CAEv2 is too short for proper insertion and, thus, obtaining a proper fit may be 

difficult if not impossible to achieve;

4. the dual-ended design of the CAEv2 can cause the earplug to imperceptibly loosen as a 

result of the outward facing earplug’s flanges contacting and compressing against the 

outer ear;

5. the CAEv2 achieved the labeled NRR (22) only by folding back the opposing flanges, 

which is a configuration that is not the manufacturer’s intended design of the product;

6. The CAEv2 was tested using the instruction for use (without folding the flanges back) 

and the testing resulted in an NRR of 11

7. Multiple tests of the CAEv2 have shown that it provides variable and inconsistent 

attenuation and may be difficult to get a proper fit; 

8. The CAEv2’s yellow end is not appropriate for use on gun ranges 

9. the CAEv2’s yellow end was designed to protect from infrequent impulse noise exposure 

in non-reverberant environments, and was not tested in human beings exposed to 

repeated, high intensity impulse noises (gunshots), and therefore there is no assurance 

that the yellow end provides adequate protection from such exposures

3M Failed To Warn The Military and Purchasers In 1999 And 2000 That The CAEv2 

Had Not Undergone The Required Testing

Above, I discuss how 3M began selling the CAEv2 in 1999 without first REAT testing 

the product. This clearly violated 3M’s duty to test its HPD before selling it and to provide 

adequate warnings to the military and other purchasers. Without that information, the military 

and other purchasers were unable to decide based on adequate information whether the CAEv2 

was safe. It is my opinion that 3M had a duty to warn the military and any others who purchased 

the CAEv2 before it was tested, that the CAEv2 was being sold without first being tested. The 

military and any others who purchased the device before it was tested needed to know that the 

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 51 of 226
51

EPA required testing and the testing required by industry norms, had not been done before those 

first purchases. 3M’s failure to do that, was a violation of the standard of care for an HPD 

manufacturer, as well as a violation of the EPA regulations. 

3M Never Warned About The CAEv2’s Defects Documented in the Flange Report

As I note above, 3M eventually learned from tests, codified in the Flange Report, that the 

CAEv2 suffered from multiple different problems and defects. Nevertheless, 3M never disclosed 

the Flange report nor its findings to the public or the military. Once 3M decided to keep selling 

the CAEv2 to the military and to consumers, however, it needed to disclose the fitting problems 

on the label or packaging of the product, in order for consumers and users to have enough 

information to assess the product’s safety. These necessary disclosures included that testing 

showed that the closed end was too short for proper insertion, making proper fit and seal difficult 

or not possible in some users. Further, 3M needed to warn purchasers that the “geometry of the 

earcanal opening” can “prevent” deep insertion of the CAEv2 and the inability to obtain a proper 

seal of the device; and 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. 3M also 

needed to actually warn about how this imperceptible loosening occurred (i.e., that the opposing 

flange could press against the earcanal opening, fold up and subsequently return to its original 

shape, causing the plug to loosen imperceptibly to the user). The fact that this defect was a 

hidden or latent defect that would be unknown to users, made it particularly important. 3M also 

needed to inform potential users that it only achieved the reported 22 NRR on the closed end by 

folding back the opposing flanges during the NRR testing, and that not folding them back often 

led to far less protection. The military and other purchasers should also have been told that 

folding back the flanges was not the manufacturer’s intended design of the device. Failing to 

disclose this information, as I discuss above, greatly misrepresented the product’s protective 

abilities, because users did not know how to use the product in a way that 3M used to maximize 

its NRR capabilities.

3M’s failure to provide these various warnings made the CAEv2 even more unreasonably 

dangerous because hearing professionals like myself would not have recommended its use, had 

they known about its defects and that the only way to achieve potential fit and seal was to use it 

in a way that was not its intended use. This information also was critical because there were 

other safer alternatives available that users and intermediaries could have chosen instead and 

protected their hearing where the CAEv2 could (and did) not. It is my opinion that 3M’s 

omission of these warnings to the military and other purchasers resulted in Service Member’s 

and consumers suffering severe hearing damage from hazardous noise. 

3M Sold the CAEv2 Without Adequate Labels Or Warnings Of The Product’s Risks, And 

Without Adequate Instructions For Safe Use

Above, I discuss how 3M did not label the CAEv2 in a way that provided adequate instructions 

for use, nor warnings of its fit, seal, and loosening problems. (30(b)(6) 10/18/19 178:20-179:12, 

198:7-199:13; Berger 12/10/19 224:6-226:12; 3M_MDL000056553; 30(b)(6) 10/18/19 200:17-

202:12, 212:6-15) Users needed this information to determine the safety and effectiveness of the 

CAEv2, yet they could not do so due to 3M’s failure to include that information on its labels or 

in its instruction. 

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3M Never Warned That The 22 NRR Was False

For the vast majority of the product’s life, 3M claimed that the CAEv2’s closed end had a 

22 NRR. I have discussed above how and why the 22 NRR was always inaccurate. 3M should 

not have labeled the CAEv2’s closed end in that way, because that result was achieved via a test 

where the researchers folded back the opposing flanges. However, the CAEv2’s instructions 

never stated that users needed to fold back the opposing flanges in order to ensure a proper fit 

and seal, and achieve the intended NRR. Given that ordinary users could not have similar 

knowledge regarding folding back the opposing flanges, listing the 22 NRR without providing 

disclosures about how 3M obtained those results deprived users of the ability to assess how they 

could use the earplugs—or whether to use the earplugs safely. The 22 NRR was misleading, and 

3M had a duty to inform users of the actual estimated NRR of 11. As stated above, hearing 

professionals like myself and others rely on what manufacturers tell us about the protection 

provided by their HPDs. When that information is false or misleading, I can’t make safe 

recommendations and users of the earplug are at risk of suffering severe hearing damage. It is 

my opinion that the military and other purchasers of the CAEv2 relied on 3M’s 

misrepresentation of the protection of the CAEv2, and suffered severe NIHL and tinnitus as a 

result. 

3M Falsely Promoted The Open End Of The CAEv2 As Safe For Use On Gun Ranges, 

When It Should Have Warned That Using The Open End On Gun Ranges Was Dangerous

As discussed above, 3M promoted use of the open end of the CAEv2 on gun ranges from 

the time it was first sold. In fact, 3M told the military in brochures and other promotional 

materials, that the CAEv2 would provide “instant protection” against weapons fire. As a result, 

service members and other purchasers of the consumer versions of the CAEv2 were worn on gun 

ranges for more than 15 years. 

 

Internally, though, the scientists most knowledgeable about the CAE products (which 

share the same filter), had concluded that wearing the CAEv2 and the other CAE earplugs on a 

gun range was dangerous. 3M even went so far as to change the label for CAE products, albeit 

too little too late for those users of the CAEv2 because it had already been suddenly discontinued 

before 3M got around to the label change. 

 

3M was well aware that servicemembers and consumers were wearing the open end of 

the CAEv2 to gun ranges and into battle with frequent gunfire. These users were doing so 

because 3M said it was the “ideal” earplug for ranges. 3M had a duty, though, to tell the military 

and other users that use of the open end on ranges was unsafe. Rather they continued to 

misrepresent the CAE2 as safe in these situations. As a result of 3M’s misrepresentations that 

the CAEv2 was safe on ranges and as a result of its failure to warn to the contrary, service 

members and consumers all over the country were unprotected on ranges and suffered NIHL and 

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tinnitus. 

3M Did Not Provide Appropriate Training or Instructions

I have discussed above that 3M realized the CAEv2 was inherently difficult to fit and use, 

but this fact was never disclosed to users. Given 3M knew that the CAEv2 was difficult to fit 

and seal, it needed to train and instruct the military and users about what Berger himself called 

an “unusual” earplug, especially because 3M knew users did not understand how to use the 

CAEv2.201 As a result of 3M’s failures to train and provide adequate disclosures, thousands of 

service members and consumers never learned about the CAEv2’s problems or how to use the 

earplugs safely.

There was nothing preventing 3M from providing service members, audiologists, hearing 

health professionals and other users detailed instructions and training and warnings about 

the CAEv2’s problems with fit, seal, and imperceptible loosening. There was nothing 

preventing 3M from instructing the military and other users that folding back the 

opposing flanges in testing helped achieve higher NRRs in a laboratory setting, but that 

the product’s other design problems (fit, seal, imperceptible loosening) persist in the realworld setting. Nevertheless, 3M chose not to provide these instructions, which meant 

that hundreds of thousands of users never had a chance to learn about the CAEv2’s

dangers.

3M’s Bare Minimum Warnings Did Not Adequately Inform Users About The CAEv2’s 

Dangers

I understand 3M has claimed that the “fitting tip” in some of its instructions and 

marketing materials, as well as the wallet card it helped develop for the military, adequately 

warned users about the CAEv2’s design defects and dangers. I wholeheartedly disagree. As I 

noted above, the first problem with this claim is that there is no evidence I have seen that the 

“fitting tip” was provided to military users until at least five years after 3M first started selling 

the earplug to the military. Similarly, the wallet card was not provided until 2004, and there is no 

evidence of which I am aware that either the wallet card or materials with the fitting tip were 

widely circulated or received by military users of the CAEv2.

Regardless, neither of these materials adequately warned users about the CAEv2’s 

dangers and defects. The fitting tip was not identified as an instruction; it was a “tip” only, and 

it said only that fitting could be “improved” if the opposing flanges were rolled back. It did not 

say that rolling back the opposing flanges was necessary in order to obtain proper fit and ensure 

an adequate seal. Nor did it say that the closed end’s 22 NRR could only be achieved if the 

flanges were rolled back. Nor does the tip provide any information about the fitting difficulties 

201 3M_MDL000620089 (3M acknowledging years after it began selling the CAEv2 to the military that “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); Santoro 12/3/19 301:4-302:14 (3M “continue[d] to hear that the soldiers don’t understand how 

the plugs should be used or how to properly wear them.”)

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arising from the earplug’s short stem; that the earplug would simply not fit in certain ear canal 

geometries; or that the earplug could imperceptibly loosen. The instructions and “tips” needed 

all that information in order to properly warn potential users.

The same is true for the wallet card, but that document is even worse, because it limited 

its tip regarding the opposing flange to “very large” ear canals. The Flange Report noted that the 

fit, seal, and imperceptible loosening problems applied to users with medium and larger 

earcanals; i.e., the vast majority of users in the country.

For these reasons, the fitting tip and the wallet card—even if someone ever saw them—clearly 

failed to adequately warn of the CAEv2’s dangers. Moreover, because rolling back the opposing 

flanges did not, in any event, actually fix the defects inherent in the CAEv2, the fitting tip and 

wallet card were deficient because they did not warn that the product was unreasonably 

dangerous.

4. There Were Safer Alternatives Than The CAEv2

In my opinion, there were existing safer alternative earplug designs available, which were 

able to effectively and substantially reduce or eliminate the risk of noise-induced hearing loss 

and tinnitus in the military environment. These earplugs lacked the inherent design flaws of the 

CAEv2, which are well documented in my Opinions discussed above. First, because the CAEv2 

is uniquely dual-sided, when it is inserted deeply enough to get a good seal, the opposing side of 

the plug will provide force to push the plug out. Secondly, the CAEv2, has a stiff and wide stem, 

forwardly positioned, which again needs to be inserted deeply into the earcanal. Both of these 

design shortcomings make the CAEv2 an earplug that tends to be difficult to fit and one that can 

lose its seal which unfortunately can be “imperceptible” to the user

Some safer alternative designs are earplugs which have similar nonlinear functionality, 

but which lack the CAEv2 design shortcomings. In fact, nonlinear filters like the one inserted 

into the CAEv2, were also inserted into the single-sided, Aearo’s “version one” CAE earplug,202

which had a flexible stem and was commonly sold in Europe and to the DOD . This ear plug was 

for “impulse noise” protection only, but it could be paired with a traditional linear earplug, such 

as commonly used foam earplug or the 3M UltraFit, which provide excellent “steady state” noise 

reduction. Although the user would have to carry around two pairs of plugs, overall this is a safer 

alternative than the CAEv2, which compromised the dual-mode functionality by combining two 

plugs into one. 

Other examples of safer alternative designs are the Surefire “Sonic Defender” (versionsEP3, 4, and 7), which also have flexible stems and nonlinear filters. The Sonic Defender also can 

be “closed” and “opened,” so that it can be used for both “steady state” and gunfire or impulse 

noise environments. This provides the dual-mode benefit of the CAEv2 but without the dualended design and opposing flange problem. 

More examples of this same dual-use functionality in a single plug, are the Aearo/3M 

“Combat Arms” version 3, 4, and 4.1, and the Moldex “Battleplugs.” All of these can be found 

202 2012- CAE version 1-EU label 370-1400-3M_MDL000453589.

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in the publicly released, DOD’s, Hearing Center of Excellence poster on the “selection of passive 

hearing protection”.203 There are also custom earplugs from a variety of vendors, some of which 

contain nonlinear filters. All of the above models lack a dual-ended design with opposing flanges 

that push against ear anatomy that cause loosening. Nor do they have a thick, rigid, forwardpositioned stem, all of which create fitting problems and ultimately can cause the plug to break a 

good seal, leading to inadequate attenuation- which is “imperceptible” to the user.

Dated: October 9, 2020

_____________________________________

Lawrence Lustig, M.D.

203 2018-DOD’s HCE- Selection of passive hearing protection, downloadedhttps://pueblo.gpo.gov/DOD/pdfs/HCE-856.pdf

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CURRICULUMVITAE

Name: Lawrence Lustig, MD

Positions: Howard. W. Smith Professor & Chair, Dep’t of Otolaryngology-Head & Neck Surgery

Columbia University Medical Center, New York Presbyterian Hospital

Address: Columbia University Medical Center

180 Fort Washington Avenue, Harkness 8-850

New York, NY 10032

Email: l.lustig@columbia.edu

Office: 212-305-5820

EDUCATION

1982 - 1987 University of California, Berkeley BA Microbiology

1987 - 1992 University of California, San Francisco MD Honors with Thesis

1992 - 1993 University of California, San Francisco Intern General Surgery

1993 - 1997 University of California, San Francisco Resident Otolaryngology

1997 - 1998 Johns Hopkins University Fellow Otology, Neurotology

LICENSES,CERTIFICATION

1993 State of California Medical License (G078418)

1993 Drug Enforcement Agency

1993 Advanced Cardiac Life Support Certification 1993

1993 Advanced Trauma Life Support Certification 1993

1993 National Board of Medical Examiners

1997 State of Maryland Medical License

1998 American Board of Otolaryngology - April 10, 1998, #15525.

2006 American Board of Otolaryngology-Neurotology Subspecialty Certification 06/05/2006

PRINCIPALPOSITIONSHELD

1998 - 1999 Johns Hopkins University, Baltimore, MD Clinical Professor Otolaryngology

1999 - 2002 Johns Hopkins University, Baltimore, MD Assistant Professor Otolaryngology

2002 - 2004 Johns Hopkins University, Baltimore, MD Associate Professor Otolaryngology

2004 - 2008 University of California San Francisco Associate Professor Otolaryngology

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2008 – 2014

2014-

University of California San Francisco

Columbia University /

New York Presbyterian Hospital

Francis A. Sooy, MD

Endowed Professor

Howard W. Smith

Professor & Chairman

Otolaryngology

Otolaryngology

OTHERPOSITIONSHELD

2008 - 2014 University of California San Francisco Francis A. Sooy, MD

Endowed Chair

Otolaryngology

2008 - 2014 University of California San Francisco Professor Neurosurgery

2004 - 2014 University of California San Francisco Division Chief-Otology,

Neurotology, Skull Base

Surgery

Otolaryngology

2004 - 2014 University of California San Francisco Director, UCSF Cochlear

Implant Program

Otolaryngology

2004 - 2014 University of California San Francisco Co-Director-UCSF Center

for Balance and Falls

Otolaryngology

2004 - 2014 University of California San Francisco Clinical Director, Parnassus

Campus

Otolaryngology

HONORSANDAWARDS

1980 Eagle Scout, Boy Scouts of America

1987 UC Berkeley, graduation with Honors and Distinction in Scholarship

1988 Dean's Summer Prize in Medical Student Research, UC San Francisco

1992 UC San Francisco School of Medicine, Graduation with Honors

1996 First Place Clinical Presentation, Bay Area Resident Research Association

1996 American Academy of Otolaryngology-Head & Neck Surgery Foundation,

Inc. Foundation Grant Award

1999 Herbert Silverstein Award for Otologic Research - $10,000 - AAO-HNS

Foundation

2001 George T. Nager MD Award for Excellence in Teaching, Department of

Otolaryngology, JHU

2006 The Roger Boles, MD Award for Excellence in Clinical Faculty Teaching

2006 Award for Excellence in Innovative Curricular Design and Program

Development and Teaching

2009 American Academy of Otolaryngology-Distinguished Service Award

2011-Present US News and World Report-America’s Top Doctors – Otolaryngology-Head &

Neck Surgery

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2016

2017

Maxwell Abramson Award for Excellence in Teaching and Service, New York

Presbyterian Resident Award

American Academy of Otolaryngology-Head & Neck Surgery Foundation

Distinguished Service Award

KEYWORDS/AREASOFINTEREST

Otology, neurotology, skull base surgery, cochlear implants, vestibular schwannoma,

otosclerosis, molecular otology, history of otolaryngology, genetics of hearing loss, efferent

auditory inhibition, hair cell physiology, cochlear gene therapy

PROFESSIONALACTIVITIES

Administrative

Chair-Department of Otolaryngology-Head & Neck Surgery. I oversee all aspects of Otolaryngology-Head &

Neck Surgery at Columbia University Medical Center and New York Presbyterian Hospital and serve as the

Otolaryngologist in Chief at NYP on the Columbia campus. As Chair I am responsible for oversight of all clinical

and financial aspects of the department, including strategic planning, financial planning, and clinical

development.

SUMMARY OF CLINICAL ACTIVITIES

My clinical focus includes all disorders of the ear and skull base. This includes surgery for chronic ear infections,

hearing loss, and tumors of the ear and skull base. Common surgeries performed include cochlear implantation

for profound deafness, tympanoplasty and mastoidectomy for chronic ear infections and cholesteatoma,

stapedectomy for otosclerosis, and assistance with the neurosurgical team for resection of skull base tumors

(vestibular schwannoma most commonly). I also see patients with a variety of balance disorders relating to the

ear.

PROFESSIONALORGANIZATIONS

Memberships

1993 - present American Academy of Otolaryngology-Head & Neck Surgery

1999 - present Association for Research in Otolaryngology

2001 - present North American Skull Base Society - Member

2001 - present American Neurotology Society, Fellow

2003 - present Society of University Otolaryngologists

2004 - present Society for Neuroscience

1997 - present Otolaryngology History Society

2002 - present American Neurotologic Society

2006 - present American Otologic Society

2006 - present Fellow of the American College of Surgeons

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2007 - present

2014 – present

2015 - present

American Auditory Society

New York Otologic Society

Fellow-New York Academy of Medicine

Service to Professional Organizations

2000 - present History and Archives Subcommittee,AAO-HNS Foundation

2000 - 2005 Research Liaison Subcommittee- AAO-HNS Foundation, Inc.

2001 - 2003 Instructional Course Advisory Committee, AAO-HNS Foundation, Inc.

2002 - present Research Education Subcommittee-AAO-HNS Foundation, Inc.

2003 - 2006 Task Force on New Materials-American Board of Otolaryngology.

2003 - 2007 Education Subcommittee, Association for Research in Otolaryngology

2004 - 2007 President- Otolaryngology History Society

2005 - 2014 Program & CME Committee- American Neurotology Society Spring Meetings.

2006 - 2012 CORE Co-Director, American Academy of Otolaryngology-Head & Neck Surgery.

2006 - 2008 Chair, Media Relations Committee, Association for Research in Otolaryngology

2006 - 2007 Home Study Course Committee, AAO-HNS Foundation

2007 - present Otology-Neurotology Education Subcommittee, AAO-HNS Foundation

2007 - 2013 American Otological Society-Research Advisory Board

2013 - 2013 Chair, American Otological Society-Research Advisory Board

2008 - 2016 American Auditory Society Executive Board, (Elected position by AAS membership)

2008 - 2009 President-UCSF Medical Alumni Association

2009 - 2009 American Otological Society Program Advisory Committee

2009 - 2009 American Otological Society Audit Committee

2009 - 2014 American Neurotologic Society Continuing Medical Education

Chair

2010 - present American Otological Society Membership Committee - Chair

2011 - 2014 Association for Research in Otolaryngology - Program Committee Chair

2012 - 2013 American Board of Otolaryngology- Guest Examiner

2014 - present American Board of Otolaryngology – Senior Examiner

2015 – 2016

2016 - 2017

Association for Research in Otolaryngology – President

American Neurotologic Society - President

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SERVICETOPROFESSIONALPUBLICATIONS

1999 - 2016 Otology & Neurotology - Associate Editor

1999 - present Archives of Otolaryngology-Head & Neck Surgery-ad hoc Reviewer (~2 papers

/ year)

1999 - present Laryngoscope-ad hoc Reviewer (1-2 papers/year)

1999 - present Otology & Neurotology-(2-3 papers/year)

2000 - present Annals of Neurology- ad hoc Reviewer (1 paper in last 3 years)

2000 - present Journal of Neuroscience - ad hoc Reviewer (2 papers in last 5 years)

2003 - present Neurology - ad hoc Reviewer (~1 paper/year)

2003 - present Otology, Neurotology and Skull Base surgery Editor for e-edition of

Otolaryngology-Head & Neck Surgery, Cummings et al, Eds.

2011 – present

2016-

Faculty of 1000, Editor, Otology Subsection (www.1000biology.com)

Editor-in-Chief, Otology & Neurotology

COURSEDIRECTOR

2009 – 2009

2014

2016

The Future of Medicine is Now. San Francisco, CA. CME course for returning

Alumni at UCSF, May 2009

New York Otolaryngology Update, New York NY, October 2014

New York Otolaryngology Update, New York NY, October 2016

INVITEDPRESENTATIONS

INTERNATIONAL

2004 Arab Health Congress 2004, Dubai UAE. January 18-22. Invited Speaker

2004 Egyptian ORL Society Otolaryngology Update, Cairo,

Egypt, January 22-24.

Invited Speaker

2006 Guest Speaker, "Advanced Course on Temporal Bone

Dissection, Neurotological Surgery, and Implantable

Auditory Prostheses. March 2006, Bogota, Columbia.

Invited speaker

2011 Tissue Engineering in the Cochlea, London, UK.

"Cochlear Gene Therapy"

Invited Speaker

2011 Hearing Preservation Workshop, London, UK. October

2011. "Cochlear Gene Therapy"

Invited Speaker

2011 Pasteur Institute, Paris, France. December 2011.

"Restoration of hearing in the VGLUT3 knockout mouse"

Invited Speaker

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2013 Medical Hospital of Hannover, Germany-Otology Update

2013-"Cochlear Gene Therapy" and "Cochlear Implants

2013 Update" invited lectures, March 2013

Invited Faculty

2013 University D'Auvergne-The Clermont Symposium,

Claremont-Ferrand, France. "Cochlear Gene Therapy"

and "Cochlear Implants 2013 update" invited lecturers

Invited Faculty

2013 Congress of French Audioprothesists, Keynote Speaker.

"Cochlear Gene Therapy 2013", April, 2013, Paris, France

Keynote Speaker

2014

2016

2017

2017

Korean Otologic Society. "Cochlear Gene Therapy."

Seoul, South Korea, March 2014

Frontiers in Otolaryngology-Queensland, Australia,

September 2016

Hallym University Joint Symposium on Cochlear

Implantation, Seoul, South Korea, March 2017

International Federation of Otolaryngology Societies

(IFOS)-Paris, France. Session moderator-The Facial

Nerve. Panelist on Journal Editors.

Invited Speaker

Keynote Speaker

Keynote Speaker

Panelist and moderator

NATIONAL

1995 House Ear Institute - Los Angeles, CA. Invited speaker

2001 Oregon Health Sciences University - Department of

Otolaryngology & Hearing Sciences Center. October

2001 Annual Meeting of the American Academy of

Otolaryngology-Head & Neck Surgery, Denver, CO.

Committee on History and Archives Plenary Session.

Podium Presentation.

2002

2002

University of Cincinnati Department of Otolaryngology -

Grand Rounds. Invited speaker - November 13, 2002

Boston University Department of Oto-HNS Grand Rounds

Invited speaker April 15, 2002

2003 University of California San Francisco, Department of

Oto-HNS - Grand Rounds. Invited speaker, October.

2003 CI2003: Pediatric Cochlear Implantation, Washington DC,

April 23-26. Session Chair and Podium Presentation

2004 University of Michigan Department of Otolaryngology.

Invited Lecturer. April 21-22

2005 Stanford University Department of Otolaryngology.

Invited Lecturer. January 13, 2005.

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2005 University of California Davis, Department of

Otolaryngology, Grand Rounds Speaker, April 2005.

2006 University of California Davis, Department of

Otolaryngology, Grand Rounds Speaker, May 2006.

2007 Sisson Otolaryngology Workshop, Vail CO, Feb 2008.

2007 Vanderbilt University Department of

Otolaryngology-Michael Glasscock Lecturer, Oct 2007.

2008 University of Colorado Otolaryngology Update, Vail CO,

Feb 2008.

2008 Commonwealth Club-San Francisco, May 2008.

2008 Northwestern University, "The David G Hanson MD

Lecturer", Chicago IL, June 27.

2008 Stanford University Department of Otolaryngology-Grand

Rounds Speaker, November.

2009 University of Colorado Otolaryngology Update, Vail CO,

Feb 2008.

2010 National Institutes of Health-Consensus Development

Conference on Fibrous Dysplasia, Oct 4, 2010

2010 Washington University Senturia lecturer, Oct 26, 2010. Endowed Lecturer

2010 St Louis Otolaryngology Society, invited lecturer, Oct 25,

2010

Invited Speaker

2011 University of Pennsylvania Department of

Otolaryngology. January 2011

Invited Speaker

2011 Medical University of South Caroline, Department of

Otolaryngology, December 2011

Invited Speaker and

temporal bone instructor

2012 University of Texas Southwestern Department of

Otolaryngology. "Noise-induced hearing loss and

Presbycusis: Old Problems, New Paradigms." March

2012

Invited Professorship

2012 University of Colorado Otoalryngology Update, Vail CO

Feb 2012.

Course Faculty, Invited

Speaker

2012 American Academy of Otolaryngoloyg-Head & Neck

Surgery Annual Meeting. Advances in Molecular Otology

Miniseminar

Miniseminar organizer and

panelist

2013 American Otological Society Annual Meeting, Orlando,

FL, April 2013. "Cochlear Gene Therapy" talk in the

Advances in Molecular Otology Panel

Panelist

2013 Triological Society Spring Meeting, Orlando, FL, april

2013. "Cochlear Implants-Which Device Would You

Choose?"

Panelist

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2013 American Society of Gene and Cell Therapy, Annual

Meeting. "Cochlear Gene Therapy-Where Are We Now

and Where Are We Going?" Invited Speaker, May 2013

Invited Speaker

2013 Biology of the Inner Ear Course, Woods Hole, MA.

"Cochlear Implants and Cochlear Gene Therapy."

August 2013

Invited Speaker

2013 Harold Schuknecht Lecturer-Massachusetts Eye and Ear

Infirmary. "Presbycusis and Noise-Induced Hearing

Loss-Old Problems and New Paradigms." December

2013

Endowed Lecture

2013

2014

2014

2014

2014

2015

2015

2015

2015

2015

2016

Eaton Peabody Labs, Massachusetts Eye and Ear

Infirmary. "Cochlear Gene Therapy: Is It Time?"

December 2013

American Auditory Society-Translational Research

Lecturer. "Cochlear Gene Therapy" March 2014,

Scottsdale, AZ

Fernandez Lecturer – University of Chicago. "Cochlear

Gene Therapy: Is It Time?" May 2014, Chicago, IL

Annual Morris J. Bender Lecturer – Long Island Jewish

Hospital. "Cochlear Gene Therapy: Is It Time?"

September 2014, New Hyde Park, New York

New York University Grand round lecture, December

2014.

Atlantic Otolaryngology Update, San Juan, Puerto Rico

February 2015.

Mt Sinai-New York Eye and Ear Department of

Otolaryngology-Grand Rounds, Feb 2015

University of Utah, Department of Otolaryngology-End of

Year Graduation Speaker

Biology of the Inner Ear-Woods Hole, MA

National Institutes of Health-NIDCD

Austrian-American Foundation Otology Course

Salzberg, Austria

Inivted Speaker

Invited Lecturer

Endowed Lecturer

Endowed Lecturer

Invited Speaker

Invited Speaker

Invited Speaker

Invited Speaker

Course Instructor

Invited Lecturer

Course Instructor

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2016

2016

2016

2016

2016

2017

2017

2017

2017

2017

East Virginia Medical School-Temporal Bone Course

Invited Speaker

Saunder’s Lecturer – The Ohio State University

Case Western Reserve-UH System Otolaryngology

Graduation Speaker

Stanford Otology Update, November 2016

Johns Hopkins University Center for Hearing Sciences

Medical College of Wisconsin – Resident Research Day

University of Arizona- Grand Rounds Speaker

Triological Society-Winter Meeting. New Orleans, Feb

2017. Panelist-Endoscopic Ear Surgery Pro and Con.

University of Iowa – Resident Research Day and

Graduation Speaker

Virginia Commonwealth University - Resident Research

Day and Graduation Speaker

Invited Lecturer

Endowed Lecture

Invited Lecturer

Invited Lecturer

Invited Lecturer

Endowed Lecturer

Invited Lecturer

Panelist

Endowed Lecturer

Endowed Lecturer

REGIONAL AND OTHER INVITED PRESENTATIONS

1999 The Maryland Academy of Audiology- Annual Meeting,

October 21, 1999. Invited Speaker

2000

2000

Conjoint Clinic, Department of Internal Medicine, Johns

Hopkins University Invited speaker - March 18, 2000

Maryland School for the Deaf. Invited speaker -

September 26, 2000

2001 5th Annual 2001 Mid-Atlantic Hearing Exposition, Hunt

Valley, MD - Keynote Speaker. March 03, 2001

2001 Maryland Academy of Audiology Annual Meeting, Hunt

Valley, MD. Invited speaker - October 11, 2001.

2003 Mid-Atlantic Hearing Expo, Hunt Valley, MD, March 03.

Keynote Speaker.

2003 Maryland Society for Otolaryngology-Head & Neck

Surgery Nursing, Baltimore, MD, March 23,

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2003 Maryland Academy of Audiology Annual Meeting,

Annapolis, MD. October 2003.

2004 Maryland Society for Otolaryngology-Head & Neck

Surgery Nurses. Spring Symposium, Baltimore, MD.

Invited speaker.

2005 Audiology Update, UCSF, October 2005, invited speaker.

2005 Otolaryngology Update, UCSF, November 2005, invited

speaker.

2006 Novato Community Hospital, Novato, CA, July 2006,

invited speaker

2007 Bernstein Otolaryngology Update, Honolulu Hawaii, Feb

2007, invited speaker

2007 Kaiser Permanente Department of Pediatric Grand

Rounds, Oakland, CA, July 2007, invited speaker.

2007 From Institute Medical lecture series, University of San

Francisco, September 2007, invited speaker.

2008 Kaiser Permanente Department of Pediatric Grand

Rounds, Oakland, CA, Oct 2008, invited speaker.

2009 2nd International Conference in Advanced in

Orthopaedic Osseointegration. San Francisco, CA,

invited speaker.

2010 Pacific Coast Oto-Ophthalmological Society, Monterey

CA, June 2008, invited speaker.

2010 Stanford Otology Update, November 2010, invited

speaker.

2011 UCSF Otolaryngology Update Invited Speaker & Course

Faculty

2012 UC Berkeley Bioengineering Undergraduate

Course-invited speaker

Invited Speaker

2012 California Academy of Audiology Annual Meeting

-"Cochlear Gene Therapy: Is It Time?", Invited speaker,

Berkeley, CA

Invited Speaker

2012 State Senior Injury Prevention Conference 2012, "Doc

I'm Dizzy". Invited Speaker, June 2012

Invited Speaker

2012 Osher Lifelong Learning Institute, Berkeley, CA.

"Cochlear Implants: 2012"

Invited Speaker

2013

2014

California Senior Injury Prevention Partnership (SIPP)

Conference . "Doc I'm Dizzy". Invited Speaker, May

2013

Invited Speaker

Invited Speaker

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2015

2016

San Francisco State University-Hearing and Speech

Sciences. “Cochlear Implants: Past, Present and

Future.”

The New York Head & Neck Institute-Implantable

Auditory Devices Conference. “Bone Anchored Hearing

Aids.” March 2015

New York Otolaryngology Update – “Hidden Hearing

Loss”. October 2015

Invited Speaker

Course director and

speaker

POST-GRADUATECOURSESATTENDED

2015 Program for Clinical Chiefs, Harvard School of Public Health, January 2015.

GOVERNMENTANDOTHERPROFESSIONALSERVICE

2000 - 2004 National Institutes of Health, Small Business

Innovation Research Grant Review Study

Section, ad hoc reviewer

2001 - 2001 Deafness Research Foundation Grant Review

committee

2005 - 2005 NIH-NIDCD Temporal Bone Consortium Grant

Review Panel

2007 - present NIH-NIDCD Temporal Bone Consortium Advisory

Committee

2007 - 2007 NIH-NIDCD Tinnitus Collaborative Research

Grant RFA Grant Review Committee

2009 - 2010 NIH-NIDCD AUD Study Section ad-hoc reviewer

2010 - 2010 NIH Consensus Development Conference on

Fibrous Dysplasia and Cherubism, Oct 2010.

2011 - 2011 NIH-NIDCD R24 Grant Review Panel Grant Reviewer

2012 - 2012 NIH-NIDCD R24 Grant Review Panel Grant Reviewer

2013 - 2017 NIH-NIDCD ZDC1 SRB-R (32) Grant Review

Panel

Grant Reviewer

2013 NIH-NIDCD P30 Grant Review Panel Grant Reviewer

2013 NIH-NIDCD P50 Grant Review Panel Grant Reviewer

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UNIVERSITYANDPUBLICSERVICE

UNIVERSITYSERVICE

SCHOOL OF MEDICINE

2004 - 2014 Operating Room Committee

2004 - 2008 Contracts Committee

2006 - 2014 UCSF Medical Alumni Association Board of Directors

2008 - 2014 Moffitt Long Blocktime Committee

2008 - 2014 Ambulatory Surgery Center Blocktime Committee

2009 - 2010 UCSF Medical Alumni Association President

2010 - 2014 Allocation Committee

2011 - 2011 5-year Stewardship Review Committee,

Department of Ophthalmology

Chair

2013 – 2014

2015

2017

Moffitt-Long Surgical Chairs Committee

Chair Search Committee-CUMC

Department Radiation Oncology

Columbia School of Medicine Liaison to

Westchester Country

Member

DEPARTMENTAL SERVICE

1999 - 2004 Johns Hopkins University, Department of

Otolaryngology-Head & Neck Surgery

Residency Selection Committee

Member

2002 - 2004 Johns Hopkins University, Department of

Otolaryngology-Head & Neck Surgery

Clinical Credentials Committee

Chair

2002 - 2004 Johns Hopkins University, Department of

Otolaryngology-Head & Neck Surgery

Performance Improvement Committee

Chair

2004 - 2014 UCSF Department of Otolaryngology-Head &

Neck Surgery

Division Chief of Otology,

Neurotology, Skull Base

Surgery

2004 - 2014 UCSF Department of Otolaryngology-Head &

Neck Surgery

Director - UCSF Cochlear

Implant program

2004 - 2014 UCSF Department of Otolaryngology-Head &

Neck Surgery

Director - UCSF Center for

Balance and Falls

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2006 - 2014 UCSF Department of Otolaryngology-Head &

Neck Surgery

Clinical Chief, Moffitt-Long

Hospital, Parnassus

campus

2006 - 2014 UCSF Department of Otolaryngology-Head &

Neck Surgery-Finance Committee

Member

2013 – 2014

2014-

UCSF Department of Otolaryngology-Head &

Neck Surgery-Advancement Committee

Department of Otolaryngology-Head & Neck

Surgery, Columbia University Medical Center/New

York Presbyterian Hospital

Member

Chair

PUBLICSERVICE

2008 - 2014 Hearing and Speech Center of Northern California Board of Directors

2009 - 2013 Ronald Wornick Jewish Day School Board of Directors

TEACHINGANDMENTORING

TEACHING

FORMAL SCHEDULED CLASSES - UCSF

Qtr

Academic

Yr

Course Number and Title Teaching Contribution Units Class Size

4th 2009 -

2014

Brain, Mind and Behavior Auditory Anatomy &

Physiology

Entire

1st year

medical

class

2009 -

2014

Logitudinal Clinical Experience Weekly clinic with 3rd

year medical student

LCE

Student

(1 at a

time)

2006 -

2014

Otol 140.01 - Introduction to

Otolaryngology

Meet with students

rotating through OHNS

5-7

2009 -

2014

Advanced Medical Genetics Genetics of Hearing

Loss lecture

~20

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FORMAL SCHEDULED CLASSES – Columbia University Medical Center

2014 – present Anatomy and Physiology of the Inner ear. First year medical student class

POSTGRADUATE AND OTHER COURSES

2011 – 2012

2013, 2015

BioE 192 Senior Bioengineering

Design-University of California Berkeley

undergraduate course

Biology of the Inner Ear

Woods Hole MA

Lecture: Cochlear Implants, an

Update

Course faculty

INFORMAL TEACHING

1998 - present Otology resident education; I meet monthly with the residents for didactic

sessions.

TEACHING NARRATIVE

Teaching constitutes a significant portion of my duties within academic medicine. In the clinic

(one day per week), I typically have a medical student or resident with me who I guide through

the evaluation of various Otologic problems. In the operating room I also have a resident who

I will lead through surgical cases. This also involves pre- and post-surgical care teaching with

the residents and fellows. In addition to these activities, I meet with the residents on a weekly

basis who rotate through the otology service to discuss a topic of the resident's choosing.

There are also teaching opportunities during the temporal bone dissection course in winter

each year (a 6 week course).

MENTORING

POSTDOCTORAL FELLOWS AND RESIDENTS DIRECTLY SUPERVISED OR MENTORED

Dates Name Fellow Faculty Role Current Position

2001 - 2002 Charles

DellaSantina

Otology Fellowship Advisor Professor, JHU

2002 - 2003 Charles Limb, MD Otology Fellowship Advisor Assoc Professor, JHU

2002 - 2003 Timothy Hullar, MD Otology Fellowship Advisor Assoc Professor, Wash U, St. Louis

2003 -

present

Elizabeth Redd, MD Otology Fellowship Advisor Otolaryngology, New York

2000 - 2004 Brian Dunham Otolaryngology Career Advisor Assoc Professor, University of

Pennsylvania, Department of Oto-HNS

2003 -

present

Omar Akil, PhD Post-Doc Research Supervisor Research specialist, UCSF

2003 - 2003 Erik Waldman, MD Resident Research supervisor Ass't Professor, Columbia University

Dep't OtoHNS

2004 - 2004 Kevin Leahy, MD,

PhD

Resident Research Supervisor Ass't Professor, University of

Pennsylvania, Dep't OtoHNS

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2005 - 2006 Kalpesh Valkharia,

BS

Med Student Research Supervisor Resident, Mass Eye and Ear Infirmary,

Dep't OtoHNS

2005 - 2006 Jolie Chang, MD Med Student and

Resident

Research Supervisor Ass't Professor, UCSF Dep't OtoHNS

2006 - 2008 Katherine

McLaughlin

Med Student Research Supervisor Pediatrics private practice, California

2007 - 2008 Shi-Nae Park, MD Physician Research Supervisor Professor, Catholic University, Dep't

OtoHNS, Seoul Korea

2007 - 2008 Theresa Kim, MD Resident Research Supervisor Otolaryngology private practice, San

Francisco, CA

2008 - 2008 Betty Tsai, MD Resident Research Supervisor Ass't Professor, Dep't OtoHNS, Univ

Oklahoma

2010 - 2010 Wesley Chin, MS Medical Student Research Supervisor Med Student - UCSF

2010 - 2010 Andrew Wang, MS Medical Student Research Supervisor Med Student - VCU

2010 - 2010 Mohammad Shaikh,

MS

Medical Student Research Supervisor Med Student-UC Irvine

2011 - 2012 Aurash Alemi, MS Medical Student Research Supervisor Med Student-UC Irvine

2012 - 2013 Chi-Kyou Lee, MD Physician Research Supervisor Research Associate UCSF

2012 - 2013 Kevin Burke Resident Research Supervisor Resident-UCSF

2013 - 2014 Ruwan Kiringoda,

MD

Resident Research Supervisor Resident-UCSF

2911 - 2012 Yoon Hee Cha, MD Fellow K08 Mentor Fellow, UCLA

MENTORING NARRATIVE

Mentoring activities constitute an important part of my academic life. In addition to serving as the

chair, and hence ‘Mentor-in-Chief’ for the Department of Otolaryngology, I also am continually

mentoring students, post-docs and residents. In the lab, I have mentored high school and

undergraduate students, in addition to residents and post-docs whom I host throughout the year. In

the clinic and hospital, I am always mentoring the residents through surgery and clinical cases.

OTHER

See book (Lustig LR and Niparko JK) published in 2003, which updates the field of Otology & Neurotology and

used by residents in the U.S. and Europe as a teaching reference.

TEACHINGANDMENTORINGAWARDSANDNOMINATIONS

2001 George T. Nager MD Award for Excellence in Teaching, Department of

Otolaryngology, Johns Hopkins University. This is an annual award given to a

faculty member by residents for teaching.

2006 The Roger Boles, MD Award for Excellence in Clinical Faculty Teaching, UCSF.

This is an annual award given to a single faculty member by OHNS residents for

teaching.

2006

2014

Award for Excellence in Innovative Curricular Design and Program Development

and Teaching, from the Haile Debas Academy of Medical Educators, UCSF.

The Roger Boles, MD Award for Excellence in Clinical Faculty Teaching, UCSF.

This is an annual award given to a faculty member by OHNS residents for

teaching

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2016 Maxwell Abramson Award for Teaching and Service, New York Presbyterian

Hospital. This is an annual award given to a faculty member from the combined

New York Presbyterian/Columbia and Cornell Otolaryngology Residency

Program, for excellence in teaching and having a significant impact in residency

training.

SUMMARYOFTEACHINGANDMENTORINGHOURS

2012 - 2013 420 total hours of teaching (including preparation)

Formal class or course teaching hours: 20 hours

Informal class or course teaching hours: 200 hours

Mentoring hours: 200 hours

Other hours:

2013 - 2014 420 total hours of teaching (including preparation)

Formal class or course teaching hours: 20 hours

Informal class or course teaching hours: 200 hours

Mentoring hours: 200 hours

2014 - 2015 Total anticipated hours of teaching: 420 hours

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RESEARCHANDCREATIVEACTIVITIES

RESEARCHAWARDS

CURRENT

(PI) 02/01/2013 - 01/30/2015

The Usher IIIa Initiative $100,000 direct/yr1

Virally mediated gene therapy in the Clarin-1 Trangenic

Mouse

$100,000 total

R01 (co-PI with Patricia Leake, PhD) 01/01/2014 - 12/30/2017

NIH-NIDCD $340,000 direct/yr1

AAV-Mediated Neurotrophin Expression in the Deafened

Cochlea

$1,900,000 total

Novartis – FDA Phase I trial (PI Columbia site) 01/01/15 -

A three-part, multi center, open label, single dose study to assess the safety, tolerability, and efficacy

of intra-labyrinthine (IL) CGF166 in patients with severe-to-profound hearing loss. FDA Phase I study

studying gene therapy for cochlear hair cell regeneration.

PAST

1R21DC012118-01 (PI) 12/16/2011 – 12/15/2013

NIH-NIDCD $275,000 direct/yr1

Virally Mediated Gene Therapy for Genetic Hearing Loss $550,000 total

(PI) 02/01/2013 - 02/01/2014

Giannini Foundation $200,000 direct/yr1

CI Interconnect: A Multidisciplinary Approach to Pediatric

Cochlear Implantation

$200,000 total

(Mentor) 07/01/2011 - 06/30/2012

American Otological Society $50,000 direct/yr1

Virally-mediated gene therapy for genetic hearing loss $50,000 total

(PI) 07/01/2010 - 06/30/2011

American Hearing Research Foundation $20,000 direct/yr1

The Role of Synucleins in the Mammalian Cochlea $20,000 total

K08 DC00189 (PI) 08/01/2001 - 07/30/2006

NIH NIDCD $505,000 direct/yr1

The Characterization of the human hair cell nicotinic

acetylcholine receptor

$101,000 total

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(PI) 01/20/2001 - 01/19/2002

National Organization for Hearing Research $10,000 direct/yr1

Nicotinic Acetylcholine Receptor Function in Human

Lymphocytes: A New Model for Studies of alpha9 and

alpha10 - Containing Nicotinic Acetylcholine Receptors

$10,000 total

(PI) 01/01/1999 - 12/30/2000

American Academy of Otolaryngology-Head & Neck

Surgery and the American Neurotologic Society

$10,000 direct/yr1

The Characterization of Alpha-9, the Hair Cell

Acetylcholine Receptor, in Human Inner Ear

Neuroepithelium

$10,000 total

(PI) 07/01/1997 - 06/30/1999

American Otolgoical Society $80,000 direct/yr1

The Characterization of Alpha-9, the Hair Cell

Acetylcholine Receptor, in Human Inner Ear

Neuroepithelium

$40,000 total

(PI) 06/01/1996 - 12/01/1996

American Academy of Otolaryngology-Head & Neck

Surgery

$10,000 direct/yr1

The Efficacy of Direct and Adeno-associated Virus

Mediated Introduction of Neurotrophin-3 in Preventing

Neural Degeneration Following Aminoglycocide-induced

Ototoxicity in the Guinea Pig

$10,000 total

PEERREVIEWEDPUBLICATIONS

1. Kurtzman, G.J., Platanias, L., LUSTIG,L., Frickenhofen, N., Young, N.S. Feline Parvovirus

Propagates in Cat Bone Marrow Cultures and Inhibits Hematopoietic Colony Formation in vitro. Blood

1989, 74(1): 71-81.

2. Parker DA, Schindler RA, Amoils CP, LustigLR, Hradek GT. Hyaluronan synthesis in the adult

guinea pig endolymphatic sac. Laryngoscope. 1992 Feb; 102(2):152-6.

3. Amoils CP, Jackler RK, LustigLR. Repair of chronic tympanic membrane perforations using

epidermal growth factor. Otolaryngol Head Neck Surg. 1992 Nov; 107(5):669-83.

4. LustigLR, Leake PA, Snyder RL, Rebscher SJ. Changes in the cat cochlear nucleus following

neonatal deafening and chronic intracochlear electrical stimulation. Hear Res. 1994 Apr;

74(1-2):29-37.

5. LUSTIGLR, Cheung SW, Lee K. Lemiere's Syndrome: 2 Cases of Postanginal Sepsis.

Otolaryngol Head Neck Surg 1995; 112(6):767-772.

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6. LustigLR, Cusick BC, Cheung SW, Lee KC. Lemierre's syndrome: two cases of postanginal

sepsis. Otolaryngol Head Neck Surg. 1995 Jun; 112(6):767-72.

7. LustigLR, Jackler RK, Chen DA. Contralateral hearing loss after neurotologic surgery.

Otolaryngol Head Neck Surg. 1995 Sep; 113(3):276-82.

8. LustigLR, Jackler RK. Neurofibromatosis type I involving the external auditory canal. Otolaryngol

Head Neck Surg. 1996 Feb; 114(2):299-307.

9. LUSTIGLR, Jackler RK. Contralateral Hearing Loss Following Neurotologic Surgery. Otolaryngol

Head Neck Surg 1996, 113(3):276-82.

10. Deschler DG, LustigL, Singer MI. Gelcap-assisted fiberoptic nasogastric feeding tube placement.

Ear Nose Throat J. 1996 Feb; 75(2):102-3.

11. LUSTIGLR, Jackler RK. Neurofibromatosis Type-1 of the External Auditory Canal. Otolaryngol

Head Neck Surg 1996; 114(2):299-307.

12. LustigLR, Jackler RK. The variable relationship between the lower cranial nerves and jugular

foramen tumors: implications for neural preservation. Am J Otol. 1996 Jul; 17(4):658-68.

13. Ahn MS, Jackler RK, LustigLR.The early history of the neurofibromatosis. Evolution of the

concept of neurofibromatosis type 2. Arch Otolaryngol Head Neck Surg. 1996 Nov; 122(11):1240-9.

14. LustigLR, Jackler RK, Lanser MJ. Radiation-induced tumors of the temporal bone. Am J Otol.

1997 Mar; 18(2):230-5.

15. LustigLR, Lalwani A. The history of Meniere's disease. Otolaryngol Clin North Am. 1997 Dec;

30(6):917-45.

16. LUSTIGLR, Deschler D, Kingdom TK, Murr A, Lee K. Doxycycline Injection of Benign

Lymphoepithelial Cysts. Laryngoscope 1998, 108(8 part I): 1199-205.

17. LustigLR, Jackler RK, Mandelcorn R. The history of otology through its eponyms I: anatomy. Am

J Otol. 1998 May; 19(3):371-89. PMID: 9596191

18. LustigLR, Jackler RK. The vulnerability of the vein of labbé during combined craniotomies of the

middle and posterior fossae. Skull Base Surg. 1998; 8(1):1-9.

19. LustigLR, Rifkin S, Jackler RK, Pitts LH. Acoustic neuromas presenting with normal or

symmetrical hearing: factors associated with diagnosis and outcome. Am J Otol. 1998 Mar;

19(2):212-8.

20. LUSTIGLR, Jackler RK. "The Vulnerability of the Vein of Labbe During Combined Craniotomies

of the Middle and Posterior Fossae," Skull Base Surg. 1998;8(1):1-9.

21. Spiegel JH, LustigLR, Lee KC, Murr AH, Schindler RA. Contemporary presentation and

management of a spectrum of mastoid abscesses. Laryngoscope. 1998 Jun; 108(6):822-8.

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22. LUSTIGLR, Jacker RK. "The History of Otology Through Eponyms I: Anatomy." Am J Otol 1998,

19(3): 371-89.

23. LustigLR, Lee KC, Murr A, Deschler D, Kingdom T. Doxycycline sclerosis of benign

lymphoepithelial cysts in patients infected with HIV. Laryngoscope. 1998 Aug; 108(8 Pt 1):1199-205.

24. LustigLR, Cheung SW, Jackler RK. Subcochlear petrous cholesterol granuloma involving the

infratemporal fossa. Otolaryngol Head Neck Surg. 1998 Dec; 119(6):685-9.

25.LustigLR, Hiel H, Fuchs PA. Vestibular hair cells of the chick express the nicotinic acetylcholine

receptor subunit alpha 9. J Vestib Res. 1999; 9(5):359-67.

26. LustigLR, Jackler RK. The history of otology through eponyms II: the clinical examination. Am J

Otol. 1999 Jul; 20(4):535-50.

27. Resto VA, LustigLR. Hemangioblastoma of the internal acoustic canal in a patient with von

Hippel-Lindau disease: a case report and review of the literature. Arch Otolaryngol Head Neck Surg.

2000 Jan; 126(1):85-8.

28. Lee MP, Ravenel JD, Hu RJ, LustigLR, Tomaselli G, Berger RD, Brandenburg SA, Litzi TJ,

Bunton TE, Limb C, Francis H, Gorelikow M, Gu H, Washington K, Argani P, Goldenring JR, Coffey

RJ, Feinberg AP. Targeted disruption of the Kvlqt1 gene causes deafness and gastric hyperplasia in

mice. J Clin Invest. 2000 Dec; 106(12):1447-55.

29. Lin D, Goldstein JA, Mhatre AN, LustigLR,Pfister M, Lalwani AK. Assessment of denaturing

high-performance liquid chromatography (DHPLC) in screening for mutations in connexin 26 (GJB2).

Hum Mutat. 2001; 18(1):42-51.

30. LustigLR, Peng H, Hiel H, Yamamoto T, Fuchs PA. Molecular cloning and mapping of the human

nicotinic acetylcholine receptor alpha10 (CHRNA10). Genomics. 2001 May 1; 73(3):272-83.

31. LustigLR, Arts HA, Brackmann DE, Francis HF, Molony T, Megerian CA, Moore GF, Moore KM,

Morrow T, Potsic W, Rubenstein JT, Srireddy S, Syms CA, Takahashi G, Vernick D, Wackym PA,

Niparko JK. Hearing rehabilitation using the BAHA bone-anchored hearing aid: results in 40 patients.

Otol Neurotol. 2001 May; 22(3):328-34.

32. LustigLR, Holliday MJ, McCarthy EF, Nager GT. Fibrous dysplasia involving the skull base and

temporal bone. Arch Otolaryngol Head Neck Surg. 2001 Oct; 127(10):1239-47.

33. Chu EA, Mhatre AN, LUSTIGLR, Lalwani AK. Implication of mutations in Connexin 31 in cochlear

implant outcome. Gene Funct Dis 2001, 2(5-6):214-20.

34. LustigLR, Peng H. Chromosome location and characterization of the human nicotinic

acetylcholine receptor subunit alpha (alpha) 9 (CHRNA9) gene. Cytogenet Genome Res. 2002;

98(2-3):154-9.

35. Limb CJ, LustigLR. Hearing loss and the invention of the phonograph: the story of Thomas Alva

Edison. Otol Neurotol. 2002 Jan; 23(1):96-101.

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36. O'Donoghue G, Balkany T, Cohen N, Lenarz T, LustigL, Niparko J. Meningitis and cochlear

implantation. Otol Neurotol. 2002 Nov;23(6):823-4. No abstract available.

37. Eisen MD, LustigLR. Otolaryngologic aspects of the Lewis & Clark Expedition, 1803-1806.

Laryngoscope. 2002 Jun; 112(6):1065-71.

38. Raz Y, LustigL. Surgical management of conductive hearing loss in children. Otolaryngol Clin

North Am. 2002 Aug; 35(4):853-75.

39. Niparko JK, Cox KM, LustigLR. Comparison of the bone anchored hearing aid implantable

hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral

deafness. Otol Neurotol. 2003 Jan; 24(1):73-8.

40. Minor LB, Carey JP, Cremer PD, LustigLR, Streubel SO, Ruckenstein MJ. Dehiscence of bone

overlying the superior canal as a cause of apparent conductive hearing loss. Otol Neurotol. 2003 Mar;

24(2):270-8.

41. LustigLR, Yeagle J, Niparko JK, Minor LB. Cochlear implantation in patients with bilateral

Ménière's syndrome. Otol Neurotol. 2003 May; 24(3):397-403.

42. Blevins NH, LustigLR. Current digital imaging for the otolaryngologist. Curr Opin Otolaryngol

Head Neck Surg. 2003 Jun; 11(3):166-72.

43. Hullar TE, LustigLR. Paget's disease and fibrous dysplasia. Otolaryngol Clin North Am. 2003

Aug; 36(4):707-32.

44. Ohlroggen M, LustigL. A translation of: The scientific progress of otology in the past decennium

(until late 1862) by Hermann Schwartze: pathology and therapy of the external ear. Otol Neurotol.

2003 Nov; 24(6):952-7.

45. LustigLR, Lin D, Venick H, Larky J, Yeagle J, Chinnici J, Polite C, Mhatre AN, Niparko JK,

Lalwani AK. GJB2 gene mutations in cochlear implant recipients: prevalence and impact on outcome.

Arch Otolaryngol Head Neck Surg. 2004 May; 130(5):541-6.

46. LustigLR. The history of intratympanic drug therapy in otology. Otolaryngol Clin North Am. 2004

Oct; 37(5):1001-17.

47. Peng H, Ferris RL, Matthews T, Hiel H, Lopez-Albaitero A, LustigLR. Characterization of the

human nicotinic acetylcholine receptor subunit alpha (alpha) 9 (CHRNA9) and alpha (alpha) 10

(CHRNA10) in lymphocytes. Life Sci. 2004 Dec 3; 76(3):263-80.

48. Waldman EH, Desantis E,LustigLR, Tunkel DE. Pathology quiz case. Diagnosis: Glial

choristoma of the middle ear. Arch Otolaryngol Head Neck Surg. 2005 Apr; 131(4):363-4.

49. Streubel SO, LustigLR. Cochlear implantation in patients with osteogenesis imperfecta.

Otolaryngol Head Neck Surg. 2005 May; 132(5):735-40.

50. Limb CJ, Francis HF, LustigLR, Niparko JK, Jammal H. Benign positional vertigo after cochlear

implantation. Otolaryngol Head Neck Surg. 2005 May; 132(5):741-5.

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51. Waldman EH, LustigLR. Sir Charles Alfred Ballance: contributions to otology and neurotology.

Otol Neurotol. 2005 Sep; 26(5):1073-82.

52. Lee DJ, LustigL, Sampson M, Chinnici J, Niparko JK. Effects of cytomegalovirus (CMV) related

deafness on pediatric cochlear implant outcomes. Otolaryngol Head Neck Surg. 2005 Dec;

133(6):900-5.

53. LustigLR. Nicotinic acetylcholine receptor structure and function in the efferent auditory system.

Anat Rec A Discov Mol Cell Evol Biol. 2006 Apr; 288(4):424-34.

54. LustigLR, Yeagle J, Driscoll CL, Blevins N, Francis H, Niparko JK. Cochlear implantation in

patients with neurofibromatosis type 2 and bilateral vestibular schwannoma. Otol Neurotol. 2006 Jun;

27(4):512-8.

55. Akil O, Chang J, Hiel H, Kong JH, Yi E, Glowatzki E, LustigLR. Progressive deafness and altered

cochlear innervation in knock-out mice lacking prosaposin. J Neurosci. 2006 Dec 13; 26(50):13076-88.

56. LustigLR, Sciubba J, Holliday MJ. Chondrosarcomas of the skull base and temporal bone. J

Laryngol Otol. 2007 Aug; 121(8):725-35.

57. LustigLR. Anesthesia, antisepsis, microscope: the confluence of neurotology. Otolaryngol Clin

North Am. 2007 Jun; 40(3):415-37, vii.

58. Spankovich C, LustigLR. Restoration of brain stem auditory-evoked potential in maple syrup

urine disease. Otol Neurotol. 2007 Jun; 28(4):566-9.

59. Seal RP, Akil O, Yi E, Weber CM, Grant L, Yoo J, Clause A, Kandler K, Noebels JL, Glowatzki E,

LustigLR,Edwards RH. Sensorineural deafness and seizures in mice lacking vesicular glutamate

transporter 3. Neuron. 2008 Jan 24; 57(2):263-75.

60. Osman AA, Schrader AD, Hawkes AJ, Akil O, Bergeron A, LustigLR, Simmons DD. Muscle-like

nicotinic receptor accessory molecules in sensory hair cells of the inner ear. Mol Cell Neurosci. 2008

Jun; 38(2):153-69.

61. Akil O, Weber CM, Park SN, Ninkina N, Buchman V, LustigLR. Localization of synucleins in the

mammalian cochlea. J Assoc Res Otolaryngol. 2008 Dec; 9(4):452-63.

62. Ali MJ, Orloff LA, LustigLR, Eisele DW. Botulinum toxin in the treatment of first bite syndrome.

Otolaryngol Head Neck Surg. 2008 Nov; 139(5):742-3.

63. Hwang HS, Glastonbury CM, Grenert JP, LustigLR. Expansile bone cyst and cholesteatoma of

the temporal bone. Otol Neurotol. 2009 Feb; 30(2):170-3.

64. Mong S, Goldberg AN, LustigLR. Fallopian canal meningocele: report of two cases. Otol

Neurotol. 2009 Jun; 30(4):525-8.

65. Posner D, Scott A, Polite C, LustigLR. External magnet displacement in cochlear implants:

causes and management. Otol Neurotol. 2010 Jan; 31(1):88-93.

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66. More SS, Akil O, Ianculescu AG, Geier EG, LustigLR, Giacomini KM. Role of the copper

transporter, CTR1, in platinum-induced ototoxicity. J Neurosci. 2010 Jul 14; 30(28):9500-9.

67. Chang JL, Brauer DS, Johnson J, Chen CG, Akil O, Balooch G, Humphrey MB, Chin EN, Porter

AE, Butcher K, Ritchie RO, Schneider RA, Lalwani A, Derynck R, Marshall GW, Marshall SJ, LustigL,

Alliston T. Tissue-specific calibration of extracellular matrix material properties by transforming growth

factor-ß and Runx2 in bone is required for hearing. EMBO Rep. 2010 Oct; 11(10):765-71.

68. Del Signore A, Murr AH, LustigLR, Platt MP, Jalisi S, Pratt LW, Spiegel JH. Claim validity of print

advertisements found in otolaryngology journals. Arch Otolaryngol Head Neck Surg. 2011 Aug;

137(8):746-50.

69. Park SN, Back SA, Choung YH, Kim HL, Akil O, LustigLR, Park KH, Yeo SW. a-Synuclein

deficiency and efferent nerve degeneration in the mouse cochlea: a possible cause of early-onset

presbycusis. Neurosci Res. 2011 Nov; 71(3):303-10.

70. LustigLR, Akil O. Cochlear gene therapy. Curr Opin Neurol. 2012 Feb; 25(1):57-60.

71. Akil O, LustigLR. Severe vestibular dysfunction and altered vestibular innervation in mice lacking

prosaposin. Neurosci Res. 2012 Apr; 72(4):296-305.

72. Friedmann DR, Amoils M, Germiller JA, LustigLR, Glastonbury CM, Pramanik BK, Lalwani AK.

Venous malformations of the temporal bone are a common feature in CHARGE syndrome.

Laryngoscope. 2012 Apr; 122(4):895-900.

73. Lee JS, FitzGibbon EJ, Chen YR, Kim HJ, LustigLR, Akintoye SO, Collins MT, Kaban LB.

Clinical guidelines for the management of craniofacial fibrous dysplasia. Orphanet J Rare Dis. 2012

May 24; 7 Suppl 1:S2.

74. Akil O, Seal RP, Burke K, Wang C, Alemi A, During M, Edwards RH, LustigLR. Restoration of

hearing in the VGLUT3 knockout mouse using virally mediated gene therapy. Neuron. 2012 Jul 26;

75(2):283-93.

75. Lambert PR, Nguyen S, Maxwell KS, Tucci DL, LustigLR, Fletcher M, Bear M, Lebel C. A

randomized, double-blind, placebo-controlled clinical study to assess safety and clinical activity of

OTO-104 given as a single intratympanic injection in patients with unilateral Ménière's disease. Otol

Neurotol. 2012 Sep; 33(7):1257-65.

76. Teschner M, Polite C, Lenarz T, LustigL. Cochlear implantation in different health-care systems:

disparities between Germany and the United States. Otol Neurotol. 2013 Jan; 34(1):66-74.

77. Kiringoda R, LustigLR. A Meta-analysis of the Complications Associated With Osseointegrated

Hearing Aids. Otol Neurotol. 2013 Jul; 34(5):790-4. PMID: 23739555

78. Pross SE, Layton A, Tong K, LustigLR. Cost of Placement and Complications Associated With

Osseointegrated Bone-Conducting Hearing Prostheses: A Retrospective Analysis of Medicare Billing

Data. Otol Neurotol. 2013 Sep 27. PMID: 24080981

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79. Jethanamest D, Channer GA, Moss WJ, LustigLR, Telischi FF. Cochlear implant fixation using

a subperiosteal tight pocket without either suture or bone-recess technique.. Laryngoscope. 2013 Oct

1.PMID: 24114870.

80. Akil O, LUSTIGLR. Mouse Cochlear Whole Mount Immunofluorescence. Bio Protoc 2013 Mar 5;

3(5). PMID 27547786.

81. Park SN, Back SA, Park KH, Seo JH, Noh Hi, Akil O, LustigLR, Yeo SW. Comparison of

functional and morphologic characteristics of mice models of noise-induced hearing loss. Auris Nasus

Larynx 2013 Feb; 40(1):11-7. PMID 22364846.

82. Akil O, Hall-Glenn F, Chang J, Li A, Chang W, LustigLR, Alliston T, Hsiao EC. Disrupted bone

remodeling leads to cochlear overgrowth and hearing loss in a mouse model of fibrous dysplasia.

PLoS One. 2014 May 5, PMID: 24788917

83. Kram YA, LustigLR, McDermott MW, Cheung SW. Transcanal Blind Sac Closure of the External

Auditory Canal After Skull Base Surgery to Treat CSF Leak: Technique and Results. Otol Neurotol.

2014 Jun 4. PMID: 24901670

84. Akil, O., Sun, Y., Vijayakumar, S., Zhang, W., Ku, T., Lee, C., Jones, S.M., Grabowski, G.A.,

LUSTIG,L.R. Spiral Ganglion Degeneration and Hearing Loss as a Consequence of Satellite Cell

Death in Saposin B deficient Mice. J Neurosci 2015, Feb 18; 35(7):3263-75. PMID: 25698761

85. Akil O, Rouse SL, Chan DK, LustigLR. Surgical method for virally mediated gene delivery to the

mouse inner ear through the round window membrane. J Vis Exp. 2015 Mar 16;(97). PMID: 25867531

86. LustigLR, Alemi S, Sun Y, Grabowski G, Akil O. Role of saposin C and D in auditory and

vestibular function. Laryngoscope. 2015 Jul 21. PMID:26198053

87. Amoils M, Crisham Janik M, LustigLR. Patterns and Predictors of Sensorineural Hearing Loss in

Children With Congenital Diaphragmatic Hernia. JAMA Otolaryngol Head Neck Surg. 2015 Sept.

PMID: 26356130

88. Tamplen M, Schwalje A, LustigL, Alemi AS, Miller ME. Utility of preoperative computed

tomography and magnetic resonance imaging in adult and pediatric cochlear implant candidates.

Laryngoscope. 2015 Sep 11. PMID: 26360798

89. Jáuregui EJ, Akil O, Acevedo C, Hall-Glenn F, Tsai BS, Bale HA, Liebenberg E, Humphrey MB,

Ritchie RO, LustigLR, Alliston T. Parallel mechanisms suppress cochlear bone remodeling to protect

hearing. Bone 2016 April 13; 89:7-15. PMID: 27085457

90. Kasi SK, Kim HJ, Bashram RP, Cunningham ET, Sy A, LUSTIGLR, Kerten RC. Idiopathic Orbital

Inflammation Associated with Necrotizing Scleritis and Temporal Bone Inflammation. Ophthal Plast

Reconstr Surg 2016 Jul-Aug; 32(4);e77-9. PMID: 25126771.

91. Hoffmann TJ, Keats BJ, Yoshikawa N, Schaefer C, Risch N, LustigLR. A Large Genome-Wide

Association Study of Age-Related Hearing Impairment Using Electronic Health Records. PLoS Genet.

2016 Oct 20;12(10):e1006371. PMID 2776409

92. Korver AM, Smith RJ, Van Camp G, Schleiss MR, Bitner-Glindzicz MA, LustigLR, Usami SI,

Boudewyns AN. Congenital hearing loss. Nat Rev Dis Primers. 2017 Jan 12;3:16094. PMID:

28079113.

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93. Akil O, Oursler AE, Fan K, LustigLR.Mouse Auditory Brainstem Response Testing. Bio Protoc.

2016 Mar 20;6(6). pii: e1768. PMID: 28280753.

94. Emptoz A, Leili A, Akil O, Monvel B, Lahlou G, Meyer A, Doupont MA, Mouaille S, Ey E, de Barros

F, Beraneck M, Dulon D, Hardelin JP, LUSTIGL, Avan P, Petit C, Safieddine S. Local gene therapy

durably restores vestibular function in a mouse model of Usher syndrome type 1G. PNAS 2017,

114(36):9695-0700. PMID: 28835534.

95. Geng R, Akil O, Gopal SR, Chen DH, Dinculescu A, Furness D, Saperstein D, Hauswirth W, Lustig

LR, Alagramam K. Modelling and Preventing Progressive Hearing Loss in Usher Syndrome III.

Scientific Reports (Nature), 2017, 7:13480, PMID: .

ReviewArticles

1. LUSTIG, L. Cochlear Implants: A Review. UCSF Medical Student Journal, 1991.

2. LUSTIG LR, Lalwani A. The History of Meniere's Disease. Otolaryngol Clin N A, 30(6), 917-45,

1997.

3. LUSTIG LR, Niparko J. Osseo-Integrated Implants in Otology. Advances in Otolaryngology-Head

and Neck Surgery, Vol 13, 1998.

4. LUSTIG LR, Tunkel D. Sensorineural Hearing Loss in Children. Current Opinions in

Otolaryngology, Vol 6(6), Dec 1998.

5. Raz Y, LUSTIG LR. Surgical Management of Conductive Hearing Loss in Children. Otolaryngol

Clin N A, 35:853-75, 2002.

6. Friedland D, LUSTIG LR. Osteoradionecrosis of the temporal bone. Current Opinion in Otolaryngol

Head Neck Surgery, 10:366-70, 2002.

7. O'Donoghue G, Balkany T, Cohen N, Lenarz T, LUSTIG L, Niparko J. Meningitis and cochlear

implantation. Otol Neurotol 2002 Nov;23(6):823-4. Editorial

8. Blevins NH, LUSTIG LR. Current digital imaging for the otolaryngologist. Curr Opin Otolaryngol

Head Neck Surg. 2003 Jun;11(3):166-72.

9. Hullar TE, LUSTIG LR. Paget's disease and fibrous dysplasia. Otolaryngol Clin North Am. 2003

Aug;36(4):707-32. Review.

10. LUSTIG LR. The history of intratympanic drug therapy in otology. Otolaryngol Clin North Am.

2004 Oct;37(5):1001-17.

11. LUSTIG LR, Wackym PA: Bilateral cochlear implantation. In: Cochlear and Brainstem

Implantation. Wackym PA (Guest Editor), Oper Tech Otolaryngol Head Neck Surg 2005; 16(2):

125-130.

12. LUSTIG LR, Gantz B. Imminent Inventions in Otology and Neurotology. ENTNews, Sept 2006.

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13. LUSTIG LR. Anesthesia, antisepsis, microscope: the confluence of neurotology. Otolaryngol Clin

North Am. 2007 Jun;40(3):415-37, vii.

14. Tremblay JP et al. Translating the genomics revolution: the need for an international gene therapy

consortium for monogenic diseases. Mol Ther 2013 Feb; 21(2):266-8. PMID 23369965.

15. LUSTIG LR. Letter from the New Editor-in-Chief. Otol Neurotol 2016 Oct; 37(9):1206. PMID:

27631652.

BooksandChapters

1. LUSTIG LR, Jackler RK. "Benign Lesions of the Temporal Bone," a chapter in Clinical Otology,

Hughes G and Pensak M, Eds, Thieme Medical Publishers, Inc., NY, 1996, pp. 313-334.

2. LUSTIG LR. Radiation-induced Tumors of the Temporal Bone. A chapter in Tumors of the Ear

and Temporal Bone, Jackler RK and Droscoll C, Eds. Lippincott-Raven Publishers, 2001.

3. LUSTIG LR. Neurofibramatosis Type I. A chapter in Tumors of the Ear and Temporal Bone,

Jackler RK and Droscoll C, Eds. Lippincott-Raven Publishers, 2001.

4. LUSTIG LR. "Historical Overview of Otology and Neurotology through the Nineteenth Century," a

chapter in Clinical Neurotology. Lustig LR and Niparko JK, Eds. Martin Dunitz, 2003

5. LUSTIG, LR. "Anatomy of the Facial Nerve," a chapter in Clinical Neurotology. Lustig LR and

Niparko JK, Eds. Martin Dunitz, 2003

6. LUSTIG, LR. "Developmental Disorders of the Ear," a chapter in Clinical Neurotology. Lustig LR

and Niparko JK, Eds. Martin Dunitz, 2003

7. Limb CJ, LUSTIG, LR, Niparko JK. "Infections of the ear: Acute and Chronic Disease," a chapter

in Clinical Neurotology. Lustig LR and Niparko JK, Eds. Martin Dunitz, 2003

8. LUSTIG, LR, Niparko JK. "Sensorineural Hearing Loss," a chapter in Clinical Neurotology. Lustig

LR and Niparko JK, Eds. Martin Dunitz, 2003

9. LUSTIG, LR. "Fibroosseous disorders of the temporal bone," a chapter in Clinical Neurotology.

Lustig LR and Niparko JK, Eds. Martin Dunitz, 2003

10. LUSTIG, LR. "Neoplasms of the temporal bone," a chapter in Clinical Neurotology. Lustig LR and

Niparko JK, Eds. Martin Dunitz, 2003

11. Minor L, Carey J, LUSTIG, LR. "Disorders of Balance," a chapter in Clinical Neurotology. Lustig

LR and Niparko JK, Eds. Martin Dunitz, 2003

12. LUSTIG LR, Blevins N. "Graphics and Digital Imaging for Otolaryngologists," a chapter in

Otolaryngology-Head & Neck Surgery, 4th Ed., Cummings C. et al, Eds. Mosby, 2003-4

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13. LUSTIG LR, DellaSantina C. "Surgically Implantable Hearing Aids," a chapter in

Otolaryngology-Head & Neck Surgery, 4th Ed., Cummings C. et al, Eds. Mosby, 2003-4

14. LUSTIG LR. "The History of Neurotology and Skull Base Surgery," a chapter in Neurotology, 4th

Ed., Jackler RK. et al, Eds. Mosby, 2003-4.

15. Niparko, JK and LUSTIG LR, "Transcochlear extension of the translabyrinthine approach," a

chapter in An atlas of Skull Base Surgery, Long DM et al, Editors. The Parthenon Publishing Group,

New York, 2003

16. Ng M, Lee DJ, LUSTIG LR, Niparko JK, "Complications in skull base surgery: avoidance and

management," a chapter in An atlas of Skull Base Surgery, Long DM et al, Editors. The Parthenon

Publishing Group, New York, 2003

17. LUSTIG LR, Niparko JK, "Anatomy, Physiology and Testing of the Facial Nerve," a chapter in

"Current Concepts in Otolaryngology-Head & Neck Surgery, Lalwani A, Ed. McGraw Hill, 2006.

18. LUSTIG LR, Niparko JK, "Disorders of the Facial Nerve," a chapter in "Current Concepts in

Otolaryngology-Head & Neck Surgery, Lalwani A, Ed. McGraw Hill, 2006

19. LUSTIG LR, Jackler RK. "Benign Lesions of the Temporal Bone," a chapter in Clinical Otology,

2

nd Ed, Hughes G and Pensak M, Eds, Thieme Medical Publishers, Inc., NY, 2007

20. LUSTIG LR. "Complications in Cochlear Implantation." A chapter in Complications in

Otoalryngology-Head & Neck Surgery, Eisele D, Ed. Elsevier, 2008

21. LUSTIG LR. "Temporal Bone and Skull Base Tumors." A chapter in Vertigo and Imbalance:

Clinical Neurophysiology of the Vestibular System, Eggers S and Zee D, Eds. Elsevier, 2010

22. Yeung A, Vance K, LUSTIG LR. "Vestibular Testing," a chapter in Textbook of Otology,

Brackmann D, Kirtane MV and Borkar, Eds., 2010

23. Schindler J, LUSTIG LR. "Otolaryngology-Head & Neck Surgery." A chapter in Current Medical

Diagnosis and Therapy (CMDT), Tierney LM, McPhee SJ, and Papadakis MA, Eds. McGraw Hill Co,

yearly updates since 2008-present

24. Hullar T, LUSTIG LR, "Otology & Neurotology," a chapter in Differential Diagnosis in

Otolaryngology-Head & Neck Surgery, Thieme, 2010

25. Lustig LR. "The Clinical Cochlea," a chapter in Auditory Science: The Ear, Fuchs PA, Ed. Oxford

University Press, 2010

26. LUSTIG LR, DellaSantina C. "Surgically Implantable Hearing Aids," a chapter in

Otolaryngology-Head & Neck Surgery, 5th Ed., Cummings C. et al, Eds. Mosby, 2010

27. LUSTIG LR. "Complications in Cochlear Implantation," a chapter in Complications in

Otolaryngolgy-Head & neck Surgery. Eisele DW and Smith RV, Eds. Mosby-Elsevier, Philadelphia,

2009.

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28. Hullar T, LUSTIG LR. “Otology,” A chapter in Differential Diagnosis in Otolaryngology-Head &

Neck Surgery, Steward M, Selesnick S, Eds. Thieme Publishers, 2011

29. Kangelaris G, LUSTIG LR. “Sensorineural Hearing Loss in Adults.” A chapter in Springer

Encycopledia of Otolaryngology-Head & Neck Surgery. Springer, New Delhi, India. 2012

30. Alemi A, LUSTIG LR. “Genetic Hearing Loss.” A chapter in Springer Encycopledia of

Otolaryngology-Head & Neck Surgery. Springer, New Delhi, India. 2012

31. Tsai B, LUSTIG LR. “Physiology of the Vestibular System.” A Chapter in ENT, Thieme

International, Stuttgart, Germany, 2012

32. Tsai, B, LUSTIG LR. “ Tests to Evaluate Vestibular Function.” A Chapter in ENT, Thieme

International, Stuttgart, Germany, 2012

33. Clinical Neurotology. LUSTIG LR, Niparko JK, Eds. Martin Dunitz Medical Publishers, London,

2003, 2014.

34. LUSTIG LR, Carey JC. Intratympanics treatment of inner ear disease. Otolaryngol Clin North

Am. 2004 Oct;37(5). Edited volume of Otolaryngologic Clinics of North America

35. Santa Maria PL , LUSTIG LR, Jackler RK. "Benign Lesions of the Temporal Bone," a chapter in

Clinical Otology, 4th Ed, Hughes G and Pensak M, Eds, Thieme Medical Publishers, Inc., NY, 2013

36. Lustig LR. The History of Neurotology. Otology, Neurotology and Skull Base Surgery, Plural

Publishing, 2015.

37. Pross S, Della Santina C, Lustig LR. Implantable Hearing Aids. A Chapter in

Otolarygnology-Head & Neck Surgery, Elsevier, 2015.

38. Kiringoda R, Niparko JK, Lustig LR. Anatomy and Physiology of the Facial Nerve. A chapter in

Sataloff’s Textbook of Otolaryngologic Surgery. Wolters Kluwer, 2015.

39. Gruss C, El-Sayed I, Lustig LR. Squamous Cell Cancer of the External Auditory Canal, Chapter

133. Head & Neck Surgery, 2

nd Ed. Jaypee Brothers Medical Publishers, New Delhi, 2016.

40. Lustig LR. “Medical and Surgical Treatment of Inner Ear Disease,” a chapter in Scientific

Foundations of Audiology, Plural Publishing Inc., San Diego, 2016.

Editorials

Lustig LR. Letter From the New Editor-in-Chief. Otol Neurotol. 2016 Oct;37(9):1206. PMID:

27631652

OnlinePublications

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1. Kim T and LUSTIG LR. "Skull Base: Petrous Apex Infections," a chapter in eMedicine on-line

textbook of Medicine. Myers A, Chief Editor. www.emedicine.com

2. Yeung A and LUSTIG LR. "Middle Ear: Benign Tumors," a chapter in eMedicine on-line textbook

of Medicine. Myers A, Chief Editor. www.emedicine.com

3. Limb C and LUSTIG LR. "Acute Otitis Media in Adults." www.UpToDate.com , 2009-present

4. Limb C and LUSTIG LR. "Complications of Acute and Chronic Otitis Media."

www.UpToDate.com, 2009-present

5. Lustig LR. Inner Ear Disorders. The Merck Manual. Online reference, www.merck.com,

2012-present.

6. Lustig LR. Hearing Loss – Non-Medical Management: Hearing Aids, Bone Anchored Hearing

Implants, and Cochlear Implants. Nature Reviews Disease Primers. 2015

7. Lin K, Lustig LR. Risks of Untreated Acute Otitis Media in Adults. Postgraduate Institute for

Medicine (PIM), an online, non-industrucy funded education library.

OTHERCREATIVEACTIVITIES

1. Mythbusters - December 28, 2009. Mini Myth Mayhem - Can you make a candle out of ear wax?

Discovery Channel. Assisted with production and appeared in the episode.

2. Hearing Loss in the Elderly. Interviewed for San Mateo County Public Access Television, "Living

Longer, Living Better." November 2012

3. “Revolutionary Treatment for Hearing Loss. Fox National News interview, aired February 02, 2015.

http://www.foxnews.com/health/2015/02/02/revolutionary-treatments-for-hearing-loss.html

4. Science Friday – National Public Radio. Radio interview for cochlear gene therapy and hearing

loss. November 2015

RESEARCHPROGRAM

SignificantResearchPublications-Past5years:

More SS, Akil O, Ianculescu AG, Geier E, LUSTIG LR, Giacomini KM. Role of the copper transporter,

CTR1, in platinum-induced ototoxicity. J Neurosci 2010 Jul 14;30(28):9500-9.

Akil O, Seal RP, Burke K, Wang C, Alemi A, During M, Edwards RH, LUSTIG LR. Restoration of

hearing in the VGLUT3 knockout mouse using virally mediated gene therapy. Neuron. 2012 Jul

26;75(2):283-93. PMID: 22841313

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Akil O, Hall-Glenn F, Chang J, Li A, Chang W, Lustig LR, Alliston T, Hsiao EC. Disrupted bone

remodeling leads to cochlear overgrowth and hearing loss in a mouse model of fibrous dysplasia.

PLoS One. 2014 May 5, PMID: 24788917

Akil, O., Sun, Y., Vijayakumar, S., Zhang, W., Ku, T., Lee, C., Jones, S.M., Grabowski, G.A., LUSTIG,

L.R. Spiral Ganglion Degeneration and Hearing Loss as a Consequence of Satellite Cell Death in

Saposin B deficient Mice. J Neurosci 2015, Feb 18; 35(7):3263-75. PMID: 25698761

RESEARCHNARRATIVE

My research currently has several focuses. The current principle focus in the lab is the exploration of

cochlear gene therapy for genetic forms of hearing loss. This work stems from an initial study in which

we demonstrated that the inner hair cell glutamate transporter VGLUT3 is integral in the development

of hearing, while a mutation of this transporter causes an early profound hearing loss. In a follow-up

series of studies, we demonstrated that virally-mediated gene therapy can successfully restore the

hearing phenotype in this mouse model of genetic deafness (Akil et al, 2012), and are currently

exploring additional models of genetic deafness to see if we can duplicate these results. One of these

projects has just been awarded an NIH R01 Grant, in collaboration with the lab of Dr. Patricia Leake,

exploring virally-mediated gene therapy for spiral ganglion regeneration in a cat model of deafness

(Co-PI with Patricia Leake).

We also continue to study outer hair cell function and synaptic transmission within the mammalian

cochlea. The family of nicotinic acetylcholine receptors supports chemical synaptic transmission

throughout the nervous system, including efferent, or centrifugal regulation of the inner ear. While

cholinergic innervation of the inner-ear has been studied in several animal models, our understanding

of cholinergic transmission within the human inner ear is quite limited. Initial work led to the

identification of a novel nAChR subunit to produce the cochlear outer hair cell cholinergic response.

This work was followed up with a thorough genomic characterization of the human nAChR alpha9, as

well as a complete functional analysis of the human nAChR alpha9 and alpha10 subunits. Additional

work studying protein interactions with these subunits led to the identification of synucleins within the

mammalian cochlea, a protein thought to be integral in several neurodegenerative disorders, including

Parkinson's disease and Alzheimers disease. We are currently studying the role of synucleins within

the mammalian cochlea.

Another series of investigations in our lab are in collaboration with Dr. Tamara Alliston of the UCSF

Department of Orthopedic surgery, exploring cochlear bone development. Using transgenic mice and

sophisticated molecular techniques applied to bone growth and development, we are now studying

how the material properties of otic capsule bone contributes to hearing. Studies from this work have

demonstrated how TGF-beta and Runx-2, critical in the pathway of bone development, are important

for otic capsule development, and alterations of these pathways leads to hearing loss. These studies

will be important to our understanding of how bony metabolic abnormalities cause hearing loss,

including otosclerosis, Padget's disease and other osteodystrophies.

A final series of studies in our lab are in collaboration with Kathy Giacomini in the UCSF department of

Pharmacology. Dr. Giacomini's lab is developing novel chemotherapeutics based upon platinum

compounds. Platinum-based compounds have known ototoxic potential yet the mechanism of that

ototoxicity is unknown. In a series of studies (to be published in the Journal of Neuroscience), we

have demonstrated that cisplatinum enters auditory hair cells through the copper transporter CTR1.

Further, and perhaps more importantly, we have shown that blockage of the transporter with copper

prevents uptake of cisplatinum into the hair cell and ameliorates the hearing loss caused by this drug.

These studies will have important implications for both the development of new platinum-based

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chemotherapeutic drugs, as well as in the development of therapies to prevent the hearing loss

associated with cisplatinum use in clinical practice.

SIGNIFICANTPUBLICATIONS

1. LUSTIG LR, Peng H, Hiel H, Fuchs, P. Identification of the nicotinic acetylcholine receptor

alpha-10 from human inner-ear and tonsillar tissue. Genomics 2001, 73(3):272-83.

In this study, I was the PI and the lead author. I performed a majority of the experiments and directed

the remainder, which led to the identification of a novel nicotinic acetylcholine receptor in human inner

ear tissue.

2. LUSTIG LR, Peng H. Chromosome location and characterization of the human nicotinic

acetylcholine receptor subunit alpha (a) 9 (CHRNA9) gene. Cytogenet Genome Res,

2002;98(2-3):154-9.

This study, in which I was the PI and lead author, characterized the genomic structure and location of

the alpha9 nicotinic acetylcholine receptor subunit gene. I performed or directed all the experiments.

3. LUSTIG LR, Hiel H, Fuchs, P. Vestibular Hair Cells of the Chick express the Nicotinic

Acetylcholine Receptor Subunit alpha-9 . J Vestib Res 1999, 9(5):359-367.

This study, in which I was the lead author and performed all the experiments, led to the identification of

nicotinic acetylcholine receptor subunit alpha9 in vestibular hair cells in the chicken.

4. Lee MP, Ravenel JD, Hu RJ, LUSTIG LR, Tomaselli G, Berger RD, Brandenburg SA, Litzi TJ,

Bunton TE, Limb C, Francis H, Gorelikow M, Gu H, Washington K, Argani P, Goldenring JR, Coffey

RJ, Feinberg AP.. Targeted disruption of the Kvlqt1 gene causes deafness and gastric hyperplasia in

mice. J Clin Invest, 2000 106(12):1447-55.

In this study, I collaborated with lab of Dr. Andrew Feinberg to characterize the Otologic findings in a

knock-out mouse that was a model for Jervell and Lange-Nielsen syndrome. I directed all the

experiments relating to the ear, including hearing tests and inner-ear histologic characterization.

5. Chu EA, Mhatre AN, LUSTIG LR, Lalwani AK. Implication of mutations in Connexin 31 in cochlear

implant outcome. Gene Funct Dis 2001, 2(5-6):214-20.

This study was a collaboration between my lab and Anil Lalwani's lab (formerly UCSF), examining the

relationship between connexin 26 mutations and clinical outcome following cochlear implantation. This

is the first in a series of manuscripts relating to this collaboration

6. Akil O, Chang J, Hiel H, Kong JH, Yi E, Glowatzki E, LUSTIG LR. Progressive Deafness and

Altered Cochlear Innervation in Knock-Out Mice Lacking Prosaposin. J Neurosci 2006,

26(50):13076-13088.

This study, representing the most significant work to date from my lab, describes a new protein within

the cochlea, prosaposin, and its potential relationship to the hair cell nicotinic acetylcholine receptor.

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As such it ascribes a novel function for the hair cell receptor, and opened up new avenues for

research for our lab

7. Seal RP, Aki O, Yoo J, Webeber C, Claus A, Kandler K, Noebels L , LUSTIG LR, Edwards RH.

Seizures and Sensororineural Deafness in Mice Lacking Vesicular Glutamate Transporter. Neuron.

2008 Jan 24;57(2):263-75.

This was a significant publication documenting the role of vesicular glumatate transporters in the

auditory system, and their potential role in some forms of deafness. My lab performed all the auditory

studies, and was the basis for it's impact in the journal Neuron.

8. Akil O, Weber CM, Park SN, Ninkina N, Buchman V, LUSTIG LR. Localization of synucleins in the

Mammalian cochlea. J Assoc Res Otolaryngol. 2008 Dec;9(4):452-63.

This publication was the first to describe the presence of synucleins in the mammalian cochlea and

potentially link such disparate disorders as Parkinson's disease and age-related hearing loss through

common molecular pathways.

9. More SS, Akil O, Ianculescu AG, Geier E, LUSTIG LR, Giacomini KM. Role of the copper

transporter, CTR1, in platinum-induced ototoxicity. J Neurosci 2010 Jul 14;30(28):9500-9

This publication explores the mechanism by which the ototoxic compound cisplatinum gets into

auditory hair cells. After demonstrating that the copper transporter CTR1 is integral to ciplatinum

uptake, we demonstrate that this uptake, and consequently the ototoxicity of cisplatinum, can be

blocked by using an inhibitor of the transporter.

10. Akil O, Seal RP, Burke K, Wang C, Alemi A, During M, Edwards RH, LUSTIG LR. Restoration of

hearing in the VGLUT3 knockout mouse using virally mediated gene therapy. Neuron. 2012 Jul

26;75(2):283-93. PMID: 22841313

This publication described our work using virally-mediated gene therapy to rescue the deafness

phenotype in a mouse model of congenital, genetic hearing loss. This work represents the first

successful attempt at hearing rescue in a model of genetic deafness.

11. Akil O, Hall-Glenn F, Chang J, Li A, Chang W, Lustig LR, Alliston T, Hsiao EC. Disrupted bone

remodeling leads to cochlear overgrowth and hearing loss in a mouse model of fibrous dysplasia.

PLoS One. 2014 May 5, PMID: 24788917

This publication extended our work on understanding how bone remodeling related to bone

abnormalities as seen in a mouse model of fibrous dysplasia. Patients with fibrous dysplasia develop

trabecular bone overgrowth resulting in hearing loss if the lesions affect the temporal bones. The

findings in this work suggest that factors regulating bone remodeling, including peri-lacunar remodeling

by osteocytes, may be useful targets for treating the bony overgrowths and hearing changes of fibrous

dysplasia and other bony pathologies.

12. Akil, O., Sun, Y., Vijayakumar, S., Zhang, W., Ku, T., Lee, C., Jones, S.M., Grabowski, G.A.,

LUSTIG, L.R. Spiral Ganglion Degeneration and Hearing Loss as a Consequence of Satellite Cell

Death in Saposin B deficient Mice. J Neurosci 2015, Feb 18; 35(7):3263-75. PMID: 25698761

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In this work we extend our understanding of the role of saposins in auditory and vestibular function.

This study demonstrates that loss of Saposin B function leads to progressive sulfatide accumulation in

satellite cells surrounding the SG neurons, leading to satellite cell degeneration and subsequent spiral

ganglion degeneration with a resultant loss of hearing. Relative sparing of the efferent auditory and

vestibular neurons suggests that alternate glycosphingolipid metabolic pathways predominate in these

other systems.

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ADDITIONALRELEVANTINFORMATION:

RESEARCH​ ​&​ ​CLINICAL​ ​SYMPOSIUM​ ​PRESENTATIONS

1987 Department of Microbiology and Immunology, University of California, Berkeley. Honors thesis

presentation, June 1987.

1990 Coleman and Epstein Laboratories, UC San Francisco Laboratory Seminar, December 1990. Oral

Presentation

1991 UCSF Department of Neurosurgery Grand Rounds, August 1991. Oral Presentation

1991 UCSF Department of Otolaryngology Grand Rounds, March 1991. Oral Presentation

1992 Association for Research in Otolaryngology, St. Petersburg, Florida, Feb 1992. Poster presentation.

1993 American Academy of Otolaryngology-Head and Neck Surgery Fall Meeting, Minneapolis, MN,

September 1993. Poster presentation.

1994 International Society for the History of Otolaryngology, American Academy of Otolaryngology Fall

Meeting, San Diego, CA, Sep 1994. Oral Presentation

1994 American Academy of Otolaryngology, San Diego, CA, Sept 1994. Podium Presentation

1994 Bay Area Residents Research Symposium, Berkeley, CA, May 1994. Podium Presentation

1994 The San Francisco Otology Update, October 1994. Oral Presentation

1995 Bay Area Residents Research Symposium, Berkeley, CA, May 1995. Podium Presentation

1995 International Society for the History of Otolaryngology, American Academy of Otolaryngology Fall

Meeting, New Orleans, LA, Sept 1995. Oral Presentation

1995 Combined Otolaryngology Spring Meeting, American Otologic Society, Palm Desert, CA, May 1995.

Podium Presentation

1996 Bay Area Residents Research Symposium, Berkeley, CA , May 1996. Podium Presentation

1996 Combined Otolaryngology Spring Meeting, American Otologic Society, Orlando, FL, May, 1996. Podium

Presentation

1996 UCSF Department of Otolaryngology Grand Rounds, October 1996.

1997 American Academy of Otolaryngology-Head & Neck Surgery Annual Meeting, September 1997. Poster

Presentation

1997 Combined Otolaryngology Spring Meeting, American Otologic Society, Phoenix, AZ, May 1997. Podium

Presentation

1997 The Triologic Society, Western Section Meetings, Tuscon, AZ, January 1997. Podium Presentation

1997 2nd International Skull Base Congress / North American Skull Base Society, June 1997. Podium

Presentation

1998 Johns Hopkins University Department of Otolaryngology-Head & Neck Surgery Grand Rounds

Presentation, November 30 + December 7, 1998

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1998 The Molecular Biology of Hearing and Deafness Meeting, Bethesda, MD. October 8-11, 1998. Podium

1999 Association for Research in Otolaryngology, St. Petersburg, Florida, Feb 1999. Podium Presentation

1999 North American Skull Base Society, Xth International Symposium, Chicago, IL. Podium Presentation

1999 North American Skull Base Society, Xth International Symposium, Chicago, IL. Podium Presentation

1999 The Otolaryngology Historical Society American Academy of Otolaryngology-Head & Neck Surgery

Annual Meeting, September 1999, New Orleans. Charles Limb, MD, Presenter, L Lustig Senior

Author

1999 The Center for Hearing Sciences Research Seminar, Johns Hopkins University. December 1999

2000 Association for Research in Otolaryngology, St. Petersburg, Florida, Feb 2000. Poster Presentation

2000 Joint Workshop-Comparative and Evolutionary Biology of Hearing, University of Maryland and Johns

Hopkins University. April 28, 2000

2000 The Annual Meeting of the American Otologic Society - COSM, Orlando, FL, May 14, 2000. Podium

Presentation

2000 Synaptic Function in Hearing and Balance Symposium, Baltimore, MD. June 10, 2000. Poster

Presentation

2000 Annual Meeting of the American Academy of Otolaryngology, Washington DC. September 23,

2000,Podium

2001 Association for Research in Otolaryngology, St. Petersburg, Florida, Feb 4-8, 2001. Poster Presentation

2001 IXth International Facial Nerve Symposium, San Francisco, CA, July 29-Aug 1. Podium Presentation

2001 IXth International Facial Nerve Symposium, San Francisco, CA, July 29-Aug 1. Podium Presentation

2001 Annual Meeting of the American Academy of Otolaryngology-Head & Neck Surgery, Denver, CO.

Podium

2002 The Annual Meeting of the American Neurotologic Society - COSM, Palm Beach, FL, May 2002. Podium

2002 Annual Meeting of the American Academy of Otolaryngology-Head & Neck Surgery, San Diego, CA.

Poster Presentation. Sven Streubel, MD, presenter, L Lustig PI

2002 Annual Meeting of the American Academy of Otolaryngology-Head & Neck Surgery, San Diego, CA.

Poster Presentation. Joshua Schinder, MD, presenter, L Lustig PI

2002 Annual Meeting of the American Academy of Otolaryngology-Head & Neck Surgery, San Diego, CA.

Poster Presentation. Daniel J. Lee, MD, presenter, L Lustig PI.

2002 San Francisco Otology & Neurotology Update, Oct 31-Nov 1. Three podium talks

2003 Association for Research in Otolaryngology (ARO), Daytona Beach FL, Feb 23, 2003. Lustig LR and

Peng HP. Poster Presentation.

2003 CI2003: Pediatric Cochlear Implantation, Washington DC, April 23-26. Podium Presentation

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2003 Research Symposium, Annual Meeting of the American Academy of Otolaryngology-Head & Neck

Surgery, Orlando, FL. Erik Waldman, MD, presenter, L Lustig PI.

2003 Society for the History of Otolaryngology. Annual Meeting of the American Academy of

Otolaryngology-Head & Neck Surgery, Orlando, FL. Erik Waldman, MD, presenter, L Lustig, PI

2004 Association for Research in Otolaryngology (ARO), Daytona Beach FL, Feb 2004. Simmons DD, Akil O,

Lustig LR.

2004 Association for Research in Otolaryngology (ARO), Daytona Beach FL, Feb 2004. Akil O,

Paramathewan S, Hiel H, Lustig LR (PI).

2004 CI2004 International Cochlear Implant Symposium, Indianapolis, IN, May 12, 2004. Rivas A, Chinnici J,

Francis HW, Lustig LR, Niparko JK (Poster, Rivas presenter)

2004 Stanford Otology Update, San Francisco, CA, November 4-6, 2004. Presenter L Lustig

2005 Lustig LR. Cholesteatoma-A Clinical Panel. Trialogic Society Western Section meeting, Las Vegas NV,

February 4, 2005.

2005 Lustig LR-Moderator. Intratympanic Therapy: A Clinical Forum. Annual Meeting of the American

Neurotologic Society, Boca Raton, Florida, May 2005.

2005 Lustig LR-EAR Club Meeting, UC Berkeley Auditory Neuroscience Research Seminar, September.

2006 Ali J, Vakharia K, Rebscher S, Lustig LR. Trauma profile and Electrode Positioning in Two Newly

Designed Cochlear Implants. (Poster Presentation) Triological Society Western Section meeting,

San Diego, CA, February 2-4, 2006.

2006 Gurney T, Lustig LR. Pachymeningitis presenting as Gradenigo's syndrome. (Poster presentation)

Trialogic Society Western Section meeting, San Diego CA, February 2-4, 2006.

2006 Vakharia K, Lin D, Glastonbury C, Polite C, Lustig LR. Management of an Obstructing Jugular Bulb

During Cochlear Implantation (Poster Presentation) Triological Society Western Section meeting,

San Diego, CA, February 2-4, 2006.

2006 Lustig LR. Association for Research in Otolaryngology. Presbycusis and Age-Related Hearing Loss,

Podium Presentation. Feb 2005, Baltimore, MD.

2006 Vakharia K, Akil O, Schneider R, Butcher K, Lustig LR. Expression and localization of

Chondromodulin-1 in the Cochlea. Association for Research in Otolaryngology Poster presentation,

Feb 2006, Baltimore, MD.

2006 Akil O, Chang J, Lustig LR. The Role of Prosaposin in Organ of Corti Maturation. Association for

Research in Otolaryngology Poster presentation, Feb 2005, Baltimore, MD.

2006 Chang J, Johnson J, Balooch G, Stern R, Lalwani A, Lustig LR, Alliston T. TGF-b and Runx2 control of

Bone Matrix Mechanical Properties in Bone Disease-Associated Hearing Loss. Association for

Research in Otolaryngology Poster presentation, Feb 2006, Baltimore, MD.

2007. Chang J, Johnson J, Balooch G, Stern R, Lalwani A, Lustig LR, Alliston T. TGF-b and Runx2 control of

Bone Matrix Mechanical Properties in Bone Disease-Associated Hearing Loss. Association for

Research in Otolaryngology Podium presentation, Feb 2007, Denver, CO.

2007 Akil O, Weber C, Lustig L. Co-localization of prosaposin with nAChR a10 in the organ of Corti.

Association for Research in Otolaryngology, podium presentation, Feb 2007.

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2007 Sisson Workshop in Otolaryngology. Panel Presentation. Vertigo. Vail, CO, Feb 2007

2007 Bernstein Otolaryngology Update. 6 podium presentations spanning the gamut of otology, Feb 2007,

Hawaii

2007 UCSF Otolaryngology Update, November 2007. Podium presentations

2008 University of Colorado Otolaryngology Update, Vail CO, Feb 2008.

2008 Weber C, Akil O, Park SN, LUSITG L. Silencing Prosaposin in Mouse Cochlea by RNAi. Association for

Research in Otolaryngology Poster presentation, Feb 2008, Phoenix AZ

2008 Akil O, Weber C, Park SN, Buchman V, LUSTIG L. Localization of Synuclein proteins in the mice and rat

cochlea. Association for Research in Otolaryngology Poster presentation, Feb 2008, Phoenix AZ

2008 Seal R et al. Role of vesicular glutamate transporters in the cochlea. Association for Research in

Otolaryngology Poster presentation, Feb 2008, Phoenix AZ

2008 Stanford Otology Update, November , San Francisco, CA. 3 Podium presentations: Hybrid Cochlear

Implants, an update; Superior Semicircular Canal Dehiscence; Age-Related Hearing Loss.

2009 Akil O et al. Alteration of the Vestibular System function in the Prosaposin KO Mice. Association for

Research in Otolaryngology Poster presentation, Feb 2009, Baltimore, MD

2009 Park, SN et al. Early Onset Hearing Loss and Efferent Auditory Deficits in Mice Lacking α-Synuclein.

Association for Research in Otolaryngology Poster presentation, Feb 2009, Baltimore, MD

2009 Swati SS et al. Role of Copper Transporter CTR1 in Platinum-induced Ototoxicity. Association for

Research in Otolaryngology Poster presentation, Feb 2009, Baltimore, MD

2010 Akil O, Sun Y, Grabowski, G, LUSTIG LR. Cochlea Spiral Ganglion Cells Degeneration and Hearing

Loss as a Consequence of Schwann Cells Death in the Saposin B KO Mice. Association for

Research in Otolaryngology Poster presentation, Feb 2010, Anaheim, CA

2010 Park SN et al. Comparison of Cochlear Morphology and Apoptosis in Mice Models of Presbycusis.

Association for Research in Otolaryngology Poster presentation, Feb 2010, Anaheim, CA

2010 Park SN et al. Efferent Nerve Degeneration Associated with Alpha-Synuclein Expression in Mouse

Cochlea: a Possible Cause of Early Onset Presbycusis. Association for Research in Otolaryngology

Poster presentation, Feb 2010, Anaheim, CA

2010 LUSTIG LR et al. TheRole of CTR1 in Platinum-Induced Ototoxicity. Association for Research in

Otolaryngology Poster presentation, Feb 2010, Anaheim, CA

2010 LUSTIG LR et al. Otolaryngology During Wartime-A Symposium. World War 2. A symposium.

AAO-HNS Annual Meeting, Boston, September 2010.

2010 LUSTIG LR et al. Evidence-Based Medicine in Otology Symposium. Combined Therapy for Sudden

Sensorineural Hearing Loss. AAO-HNS Annual Meeting, Boston, September 2010.

2011 Assoc for Research in Otolaryngology-Annual Meeting. MMP-13 deficiency causes mineralization

defects in cochlear capsule bone matrix and hearing loss, Feb 2011.

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2011 Assoc for Research in Otolaryngology-Annual Meeting. Restoration of VGLUT3 KO Mice Hearing

Using Different Methods of Introducing the Gene Therapy Vector Into the Cochlea, Feb 2011.

2011 Assoc for Research in Otolaryngology-Annual Meeting. Estimation of the Optimum Insertion Depth for

the HiFocus 1J Electrode Array Based on High Resolution CT Images. Baltimore, MD Feb 2011.

2011 Association for Research in Otolaryngology Annual Meeting. Noise Induced Permanent Hearing Loss

in CBA and C57 Mice: Comparison of Their Morphology and Hearing, . Baltimore, MD Feb 2011.

2011 Association for Research in Otolaryngology Annual Meeting. Restoration of Hearing in VGLUT3

Knockout Mice Using Virally-Mediated Gene Therapy. Baltimore, MD Feb 2011.

2011 Colorado Mid-Winter Otolaryngology Update. The Role of Synucleins in the Cochlea. Vail, CO Feb

2011.

2011 American Neurotologic Society Annual Meeting COSM. Migraine Associated Dizziness and Positional

Vertigo: is there a correlation? Chicago, IL, March 2011.

2011 Tissue Engineering in the Cochlea. Restoration of Hearing in the VGLUT3 Knockout Mouse using

Virally-mediated Gene Therapy. London, UK, June 1, 2011.

2012 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2012, San Diego. Mechanical

Characteristics of Cochlear Implant Electrodes Affect the Incidence of Intracochlear Trauma, Oral

Presenatation.

2012 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2012, San Diego.Identification of

Conductive Hearing Loss in Transgenic Mouse Models of Hearing Loss Using Implantable Hearing

Aid Stimulation of Round Window Membrane. Poster Presentation

2012 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2012, San Diego. Auditory

Characterization of a Mouse Model of Fibrous Dysplasia. Poster Presentation

2012 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2012, San Diego.Changes in Efferent

Nerve Endings and Alpha- Synuclein Within the Mice Cochleae After Noise Exposure, Poster

Presentation.

2012 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2012, San Diego. Elevated Hearing

Thresholds and Noise Protection in a Mouse Over-Expressing Alpha Synuclein. Poster Presentation

2013 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2013, Baltimore, MD. Restoration of

Hearing in VGLUT3 Knock Out Mice using Virally-Mediated Gene Therapy (P1-3 Injection), Poster

Presentation.

2013 The Molecular Biology of Hearing and Deafness-BiAnnual Meeting, Stanford, CA. Loss of cochlear

innervation and hearing loss in the Saposin B knockout mouse. Podium Presentation

2014 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2014, San Diego, CA. Clinical Indications

for Bone Conduction Hearing. Symposium Presentation. The Role of the Medial Olivocochlear

Efferent Pathway in Noise Induced Hearing Loss in the VGLUT3 Knockout Mouse. Poster

Presentation.

2014 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2014, San Diego, CA. A Mouse Model

With Fibrous Dysplasia of the Bone Exhibits Progressive Hearing Loss Caused by Cochlear

Overgrowth. Poster Presentation

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2015 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, Baltimore, MD. Effects of musical

characteristics and processing strategy on music perception in cochlear implant users. Poster

presentation.

2015 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, Baltimore, MD. Feasibility of

AAV-mediated neurotropin gene therapy in the cochlea. Poster presentation.

2015 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, Baltimore, MD. Functional analysis

of clarin-1 using a transgenic mouse model of hearing loss in Usher syndrome III and preservation of

hearing in that model by AAV-mediated gene therapy. Podium presentation.

2015 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, Baltimore, MD. AAV5 mediated

expression of GDNF in the mouse. Poster presentation.

2016 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, San Diego, CA. Gene Therapy for

Hearing and Balance defects: How close are we? Podium presentation.

2016 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, San Diego, CA. A multi-ethnic

genome-wide association study of age-related hearing impairment. Poster presentation.

2016 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, San Diego, CA. Unilateral cochlear

delivery of virally mediated gene therapy demonstrates bilateral expression in VGLUT3 knockout mice.

Poster presentation.

2016 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, San Diego, CA. AAV-mediated

neurotrophin gene therapy promotes improved spiral ganglion survival in the deafened cochlea. Poster

presentation.

2016 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, San Diego, CA. Restoration of

auditory thresholds in the VGLUT3 knockout mouse by fetal gene transfer to the developing inner ear.

Poster presentation.

2016 Assoc for Research in Otolaryngology-Annual Meeting, Feb 2015, San Diego, CA. Gene therapy

restores auditory and vestibular function in a mouse model for Usher syndrome. Poster presentation.

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EXHIBIT B

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 96 of 226
LAWRENCE R. LUSTIG, MD 

TESTIMONIAL HISTORY

Kenji Mercadeo (as parent of Nya Acevedo) plaintiffs vs New YorkCity Health and Hospitals 

Corporation. Expert review for the defense.

Garces v Walmart. Expert review for the plaintiff

Sophia Levasseur (as the mother of LL) vs Jose Temitope and other defendants. Expert review for the 

Defense, Office of the New York Attorney General

Dabniel Luciuk (plaintiff) v. The United States of America (US District Court, District of Connecticut). 

Expert review for plaintiff

Jeanine Tansey (plaintiff) v. Andrea Vakbutas MD and Long Island Jewish Medical Center. Expert review 

for Defense.

In re: 3M Combat Arms Earplug Products Liability Litigation, USDC NDFL Case No. 3:19-md-2885

Deposition – General and re Lewis Keefer, 7:20-cv-00104 - December 20, 2020; 

Deposition – re William Wayman, 7:20-cv-00149 - January 26, 2021

Trial – April 15, 2021 (Estes, 7:20cv137; Keefer, 7:20cv104; Hacker, 7:20cv131); June 10, 2021 (Baker, 

7:20-cv-39)

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 97 of 226
EXHIBIT C

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 98 of 226
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 NonLinear Plug3M_MDL000712631 3M_MDL000712631

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

1

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 99 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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 NonLinear Filter3M_MDL000425674 3M_MDL000425674

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) 

2

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 100 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

3/24/1998 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

3

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 101 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

4/9/1999 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

4

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 102 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

6/30/1999 Kalb, Garinther, Golden, Price (1999) ARLHRED 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

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

5

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 103 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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 Short-Stemmed 

UltraFit Plug Tests

3M_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

6

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 104 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

5/11/2000 EAR Memo re Results of Short-Stemmed 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

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

7

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 105 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

8/1/2001 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

8

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 106 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

11/27/2002 McLain Ltr to Moldex re Aearo's Position re NRR 

Testing (Multiple Re-testing 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 Indoor-Outdoor 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 LevelDependent HPD3M_MDL000012358 3M_MDL000012371

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

9

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 107 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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 A-Weighting 

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 Non-Linear (SingleEnded and Double-Ended) Military Earplugs 3M_MDL000010369 3M_MDL000010385

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

10

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 108 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

11

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 109 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

12

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 110 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

13

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 111 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

10/30/2005 Schulz to Aearo re SOW for CAE Training (AearoUSACHPPM Agreement)3M_MDL000430792

11/1/2005 MAJ Eric Fallon PPT re Painting the Hearing 

Conservation Picture

FALLON00294

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

14

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 112 of 226
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

03/06/2006 Thread re Article - Seeking the Right Amount of 

Sound in the Fury of Combat

3M_MDL000236980 3M_MDL000236983

15

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 113 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

6/30/2006 Improved Combat Arms Earplug QRI Status 3M_MDL000003006 3M_MDL000003026

7/1/2006 CAEv2 Blister Pack Insert 3M_MDL000000142 3M_MDL000000143

16

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 114 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

1/1/2007 CAEv2 Blister Pack Card 3M_MDL000000001 3M_MDL000000001

1/11/2007 Moses and Warren re Approving CAEv1 

Discontinuation Due to Low NAI-Military 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

17

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 115 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

18

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 116 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

19

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 117 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

20

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 118 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

21

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 119 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

22

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 120 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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 Field-MIRE 

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

23

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 121 of 226
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

24

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 122 of 226
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

5/9/2011 Gavin to Cimino re Centurion Positioning for 

Army and USMC Markets

3M_MDL000363896

25

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 123 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

26

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 124 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

3/23/2012 Grantham Impulse Testing 3M_MDL000094185

3/28/2012 Michael & Associates Letter re Testing Procedure 

and Results of CAEv2 Steady-state 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

27

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 125 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

28

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 126 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

29

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 127 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

30

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 128 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

31

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 129 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

32

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 130 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

33

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 131 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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)

34

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 132 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

10/17/2017 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

35

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 133 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

7/26/2018 DoJ Press Release re 3M Company Agrees to Pay 

9.1MM

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

36

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 134 of 226
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

AutoCAD Drawing 3M_MDL000605248

Berger (2003) Noise Manual 5th edition

Berger Call Notes Printout 3M_MDL000022661 3M_MDL000022664

37

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 135 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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 HighIntensity 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

DRAFT White Paper -Sound Localization with 

Passive Level-Dependent 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, 1F-065505

3M_MDL000198795

EP4-Sonic-Defenders-Plus-71-01-907

EPA Regulation Part 211 - Product Noise 

Labeling

3M_MDL000023319 3M_MDL000023336

38

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 136 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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

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

39

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 137 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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 

10/9/2020 Rule 26 Expert Report and Exhibits of Mark 

Packer

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 

40

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 138 of 226
DOCUMENTS 

Date Description Bates Beg Bates End

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 

11/19/2020 Rebuttal Report Re: Expert Report of John G. 

Casali - David Eddins 

41

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 139 of 226
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 

42

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 140 of 226
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 

43

Case 7:20-cv-02945-MCR-HTC Document 20-7 Filed 08/09/22 Page 141 of 226
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 

44

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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 

45

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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 (30(b)(6)) and Exhibits of Elliott Berger, 

M.S.

Berger, Elliott 12/12/2019 Deposition Transcript 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 

46

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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

47

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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

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

McGinley, Brian 12/20/2019 Deposition Transcript and Exhibits of Brian McGinley

48

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DEPOSITIONS-TESTIMONY

Witness Date Description 

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 

Ohlin, Douglas 4/24/2013 Deposition Transcript and Exhibits of Douglas Ohlin, Ph.D.

49

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DEPOSITIONS-TESTIMONY

Witness Date Description 

Packer, Mark 12/17/2020 Deposition Transcript and Exhibits of Mark Packer, MD 

Packer, Mark 12/18/2020 Deposition Transcript and Exhibits of Mark Packer, MD 

Packer, Mark 4/12/2021 Trial Testimony of Mark Packer, April 12, 2021

Packer, Mark 4/13/2021 Trial Testimony of Mark Packer, April 13, 2021

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 

4/7/2021 Trial Testimony of Christopher Spankovich, April 7, 2021

Spankovich, 

Christopher 

4/8/2021 Trial Testimony of Christopher Spankovich, April 8, 2021

Spankovich, 

Christopher 

12/10/2020 Deposition Transcript and Exhibits of Christopher Spankovich

Spankovich, 

Christopher 

12/11/2020 Deposition Transcript and Exhibits of Christopher Spankovich

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 

50

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DEPOSITIONS-TESTIMONY

Witness Date Description 

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) 

51

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LITERATURE 

Author Title Citation

3M 3M E-A-R Double-End Combat Arm Ear Plugs 3M Technical Datasheet 2012

3M Lab Attenuation Data for 3M HPDs 3M (2015)

3M Technical Data Bulletin 234 Hearing 

Protection for Impulse Noise 

3M (2015)

A. Dancer, et al Noise Limiting Factor for the Use of Modern 

Weapon Systems?

NSTITUT FRANCOALLEMAND DE 

RECHERCHES SAINT-LOUIS 

(FRANCE) 2005. 

A. Dancer, et al Study and production of nonlinear perforated 

earplugs

Saint-Louis Franco-German 

Research Institute-Tr. Ed. 1994 

Report, R 128/97

A. Dancer, P. Hamery A New Nonlinear Earplug for Use in High 

Level Impulse Noise Environment

The Journal of the Acoustical 

Society of AmericaÊ1998; 5 

(1103): 2878-2878.

A. Donahue, D. Ohlin Best Practices in Hearing Loss Prevention Textbook of Military Medicine: 

Occupational health: the Soldier 

and the Industrial Base. 

Washington, DC: Borden 

Institute, Office of The Surgeon 

General, US Dept of the Army, 

207-252.

A. Hunter, et al Elements of Morphology - Standard 

Terminology for the Ear

American Journal of Medical 

Genetics Part A 2009;Ê1(149): 

40-60.

A. Nakashima Overview of Tactical Headsets Defense Research and 

Development Toronto 2010;

AA Scharine, et al An Evaluation of Selected Communications 

Assemblies and Hearing Protection Systems: A 

Field Study Conducted for the Future Force 

Warrior Integrated Headgear Integrated 

Process Team

ARMY RESEARCH LAB 

ABERDEEN PROVING 

GROUND MD HUMAN 

RESEARCH AND 

ENGINEERING 

DIRECTORATE 2005

Abel S, Nakashima A An Investigation of the attenuation provided by 

the Surefire EP3 Sonic Defender Earplug 

DRDC Toronto TR 2008-040

Abel S, Powlesland C Laboratory Performance of the Single-Sided EA-R Combat Arms Hearing Protective EarplugCan Accoust 2010; (38) 2

52

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LITERATURE 

Author Title Citation

Abel SM, Nakashima A An investigation of the attenuation provided by 

the Surefire EP3 Sonic Defender earplug

DRDC Toronto TR 2008-040 

Abel, S. Noise-Induced Hearing Loss and Hearing 

Protective Devices

Can J of Public Health 1986; 

77(1): 104-107

Abramas, Harvey Using Hearing Aid Signal Processing for 

Hearing Protection

Innovations 2013; 3 (3):42-45 

Abrams H, Chisolm TH, 

McArdle R

A cost-utility analysis of adult group 

audiologic rehabilitation: Are the benefits 

worth the cost? 

J Rehabil Res Dev. 2002 SepOct;39(5):549-58

Abrams TE, Barnett MJ, Hoth 

A, Schultz S, Kaboli PJ

The Relationship Between Hearing Impairment 

and Depression in Older Veterans

J Am Geriatr Soc. 2006 

Sep;54(9):1475-7

Adams ME, Huang TC, 

Nagarajan S, Cheung SW

 Tinnitus Neuroimaging Otolaryngol Clin North Am. 

2020 Aug;53(4):583-603

Aedo C, Aguilar E Cochlear synaptopathy: new findings in 

animal and human research

Rev Neurosci. 2020 Aug 

27;31(6):605-615

Ahroon WA, Hill ME, Goodes 

DP

Analysis of army-wide hearing conservation 

database for hearing profiles related to crewserved and individual weapon systems

Noise Health. 2011 JanFeb;13(50):76-83

Akil O, Blits B, Lustig LR, 

Leake PA

Virally Mediated Overexpression of GlialDerived Neurotrophic Factor Elicits Age- and 

Dose-Dependent Neuronal Toxicity and 

Hearing Loss

Hum Gene Ther. 2019 

Jan;30(1):88-105

Akil O, Chang J, Hiel H, Kong 

JH, Yi E, Glowatzki E, Lustig 

LR

Progressive deafness and altered cochlear 

innervation in knock-out mice lacking 

prosaposin

J Neurosci. 2006 Dec 

13;26(50):13076-88

Akil O, Lustig LR Gene Therapies. A Chapter in “Function and 

Dysfunction of the Cochlea: From Mechanisms 

to Potential Therapies.”

Petit C and Richardson G, Eds. 

Cold Spring Harbor, 2018. 

Akil O, Sun Y, Vijayakumar 

S, Zhang W, Ku T, Lee CK, 

Jones S, Grabowski GA, 

Lustig LR

Spiral ganglion degeneration and hearing loss 

as a consequence of satellite cell death in 

saposin B-deficient mice

J Neurosci. 2015 Feb 

18;35(7):3263-75

53

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LITERATURE 

Author Title Citation

Akil O, Weber CM, Park SN, 

Ninkina N, Buchman V, 

Lustig LR

 Localization of synucleins in the mammalian 

cochlea

J Assoc Res Otolaryngol. 2008 

Dec;9(4):452-63

Alali K, Casali J Auditory backup alarms: distance-at-firstdetection via in-situ experimentation on alarm 

design and hearing protection effects

Work. 2012;41 Suppl 1:3599-607

Alali K, Casali J The challenge of localizing vehicle backup 

alarms: effects of passive and electronic 

hearing protectors, ambient noise level, and 

backup alarm spectral content

Noise Health. 2011 MarApr;13(51):99-112

Alamgir H, Tucker DL, Kim 

SY, Betancourt JA, Turner 

CA, Gorrell NS, Wong NJ, 

Sagiraju HK, Cooper SP, 

Douphrate DI, Whitworth 

KW, Marko D, Gimeno D, 

Cornell J, Hammill TL, 

Senchak AJ, Packer MD

Economic Burden of Hearing Loss for the U.S. 

Military: A Proposed Framework for 

Estimation

Mil Med. 2016 Apr;181(4):301-6

Alamgir H, Turner CA, Wong 

NJ, Cooper SP, Betancourt JA, 

Henry J, Senchak AJ, Hammill 

TL, Packer MD

The impact of hearing impairment and noiseinduced 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

Aldag M, Armstrong RC, 

Bandak F, Bellgowan PSF, 

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 RC 3rd, 

Leggieri MJ Jr, Marion D, 

Mazzoli R, McCrea M, 

O'Donnell J, Packer M, Petro 

JB, Rasmussen TE, SammonsJackson W, Shoge R, Tepe V, 

Tremaine LA, Zheng J

The Biological Basis of Chronic Traumatic 

Encephalopathy following Blast Injury: A 

Literature Review

J Neurotrauma. 2017 

Sep;34(S1):S26-S43

54

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LITERATURE 

Author Title Citation

Alemi A, Lustig LE “Genetic Hearing Loss.” A chapter in Springer 

Encyclopedia of Otolaryngology-Head & Neck 

Surgery

Springer, New Delhi, India 2012

Alice H. Suter EPA (2003) Workshop on Hearing Protector 

Devices

US Environmental Protection 

Agency 2003 Workshop on 

Hearing Protector Devices Papers 

and Proceedings

Al-Omari AS, Al-Khalaf HM, 

Hussien NFM

Association of Flying Time with Hearing Loss 

in Military Pilots

Saudi J Med Med Sci. 2018 SepDec;6(3):155-159

Alster J, Shemesh Z, Ornan M, 

Attias J

Sleep Disturbance Associated with Chronic 

Tinnitus

Biol Psychiatry 1993;34:84-90

Altschuler RA, Halsey K, 

Kanicki A, Martin C, 

Prieskorn D, DeRemer S, 

Dolan DF

Small Arms Fire-like noise: Effects on Hearing 

Loss, Gap Detection and the Influence of 

Preventive Treatment

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?

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