eAudiology

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Bopanna Ballachanda, PhD, Academy President
Colleen Le Prell, PhD, ARC 2023 Program Chair

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Colleen Le Prell, PhD, University of Texas at Dallas 

Major efforts targeting the development of inner ear medicines are being made by academic labs and pharmaceutical and biotechnology companies, leveraging support from government, industry, and venture capital sources.  With increasing information available to the public regarding efforts to develop medicines for auditory indications, and the wide availability of dietary supplements marketed with names suggesting auditory benefits, audiologists may receive questions from patients.  To facilitate those conversations, this session will begin with an introduction to the regulatory process overseen by the US Food and Drug Administration for both medicines seeking approval of medical claims and dietary supplements for which medical claims are not allowed.  An overview of the different phases of clinical trials completed during the development of a new medicine will be provided.  Then, the design and findings from recent clinical trials assessing the possible prevention of noise- and ototoxin-induced hearing loss will be reviewed.  The inclusion of sound-evoked physiological responses and deficits “beyond the audiogram” that can be measured in clinical and research settings will be discussed. Although supra-threshold functional deficits have been termed “hidden” because they are not captured by the audiogram, hearing-in-noise difficulties and tinnitus are common patient complaints, not-so-hidden to either the patient or the audiologist when the appropriate test battery is completed.

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Lisa Cunningham, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)

Cisplatin is among the most widely used and effective anti-cancer drugs, and it is used to treat a variety of solid tumors in both pediatric and adult cancer patients. Cisplatin is the most ototoxic drug in clinical use, and approximately 50% of patients treated with cisplatin will experience a significant permanent hearing loss. I will describe a series of basic science studies by which we identified heat shock proteins (HSPs) as a class of protective molecules that reduce cisplatin-induced hair cell death in vitro and hearing loss in vivo in animal models. In order to begin to translate this basic science information into a therapy to reduce cisplatin-induced hearing loss, we next asked if there are FDA-approved drugs that are known inducers of these protective proteins. Our data showed that the widely-used cholesterol-lowering drug atorvastatin reduced cisplatin-induced hearing loss in mice. We conducted an observational study of patients undergoing cisplatin-based chemotherapy to treat head and neck cancer and asked if those taking atorvastatin had reduced cisplatin-induced hearing loss compared to those not taking a statin drug. Our data indicate that atorvastatin users have reduced cisplatin-induced hearing loss compared to individuals not taking a statin drug at the time of cisplatin therapy. We are now conducting a randomized controlled interventional study to definitively determine whether atorvastatin can be used to reduce cisplatin-induced hearing loss in patients with head and neck cancer. I will discuss how this study fits into the existing clinical data on preventing cisplatin-induced hearing loss and remaining questions and needs in the field.

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Karen Avraham, PhD, Tel Aviv University

While deafness already presents a significant global public health concern, with approximately 1 in 500 newborns, its prevalence is projected to escalate markedly. About 50% of congenital hearing loss cases can be attributed to genetic causes. These genetic factors can lead to the condition manifesting either at birth or later in life, exhibiting a range of severity levels. The imperative need to find biological treatments for genetic deafness has spurred a global undertaking of gene identification and development of cell and molecular therapy. Genetic therapy is a research field that aims to modify, replace, or repair the genetic factors responsible for genetic abnormalities. The first step in the development of gene therapy is to determine the spectrum of pathogenic variants contributing to hearing loss. Our group has discovered genes associated with hearing loss in order to lay the groundwork for gene therapy, when it will become available. A second step is to develop techniques for gene therapy using models. We have successfully implemented gene therapy on mice models for human hearing loss. Challenges remain for implementing gene therapy in humans. Clinical trials are now beginning for one specific gene, providing hope that gene therapy will be further developed for a multitude of genes.

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Gayla Poling PhD, ARC 2023 Program Committee Co-Chair

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COL Samuel Spear MC USAF. Chief, DOD Hearing Center of Excellence, Defense Health Agency. Joint Base San Antonio, TX

LTC Isaac Erbele MC USA. Chief of Neurotology, Associate Program Director, Brooke Army Medical Center, Joint Base San Antonio, TX

Noise-induced hearing loss (NIHL) is defined as a temporary or permanent sensorineural hearing loss form high-intensity continuous or impulse acoustic insults. In the military population, routine exposure to blast or firearms discharge during training and/or combat makes hearing loss one of the most prevalent Department of Defense (DoD) disabilities.  More broadly, NIHKL is the most common occupational disability, impacting 16% of the world’s population.  Tinnitus and cognitive impairment are secondary effects, which can cause substantial disruption to the patient.  Despite hearing protection device requirements within occupational hearing loss prevention programs, the prevalence of NIHL remains stubbornly high. This session will discuss and review acute NIHL and how it relates to miliary members and populations routinely exposed to acoustic trauma.  We will review how standard hearing conservation surveillance programs characterize hearing changes by capturing auditory changes in noise-exposed populations.  In addition, we will review the development of therapeutics for NIHL.

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Angela Garinis, PhD, National Center for Rehabilitative Auditory Research (NCRAR)

Aminoglycoside antibiotics have well-known adverse events such as tinnitus, hearing and balance issues. Monitoring for ototoxicity is not commonplace for patient populations receiving these therapies, partly due to gaps in evidence-based research supporting feasible and effective monitoring protocols. Emerging evidence has shown that susceptibility to ototoxicity may vary across patients based on certain patient and clinical characteristics. This talk will provide a discussion on the latest clinical research in this area, recommendations for establishing ototoxicity management protocols and advancements in technology aiding in the early detection and prevention of ototoxicity.

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Victoria Sanchez, AuD, PhD, University of South Florida

Although there are no available medicinal treatments for permanent hearing loss, significant contributions to the state of the science have been made at the drug discovery level and with first-in-kind clinical trials. With significant resources being allocated in the pursuit of more options for those with hearing loss, there will be continued progress towards discovery of novel therapies and drug delivery systems.   This session will present an overview of otology-related clinical trials with an emphasis on the outcome measures selected in these studies. We will review groundbreaking clinical trials completed, in progress, and on the horizon. The studies reviewed will include gene therapies along with preventative, enhancement, and regenerative medicine approaches. These landmark trials present with challenges, requiring unique and rationalized study designs and appropriate selection of outcome measures to determine safety and efficacy. Often the success of a clinical trial will be placed on an outcome measure that is beyond the audiogram.

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Angela Shoup, PhD, Callier Center for Communication Disorders/University of Texas-Dallas

Precision medicine, as discussed by Hood (2019), focuses on the P4 framework:  predictive, preventive, personalized and participatory.  Advances in hearing health strategies, including inner ear therapeutics, are increasing the precision of hearing healthcare and will have a broad impact on the profession of audiology.  These advances inform research, clinical practice, and education.  Research into advanced therapeutic approaches has identified the need for more precise diagnostic and outcomes measurements to identify appropriate candidates for precision treatments and to evaluate targeted therapeutic approaches.  The need for greater precision in diagnostic and outcomes measurements for clinical trials will also lead to more precise tools being introduced into clinical practice.  Further, more precise diagnosis of hearing loss, including genotyping and deep phenotyping, will allow for more personalized treatment approaches.  

Audiologists are involved in clinical trials and are also integral in the adoption of new treatments into general clinical practice, ensuring access to advanced treatments for all populations.  The role of the audiologist in clinical trials and adoption of new protocols and procedures to support and implement advanced diagnostic and treatment options will be discussed in the context of current themes in medicine, including precision/P4 medicine, implementation science and development of core outcome sets (COS).

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Colleen Le Prell, PhD, ARC 2023 Program Committee Chair