The ARCT Lab is dedicated to advancing knowledge at the intersection of auditory science, technology, and patient‑centered care. Our research spans collaborative national initiatives, cutting‑edge clinical trials, and translational investigations that directly inform and elevate clinical practice. By integrating artificial intelligence, cognitive neuroscience, and clinical expertise, we strive to improve diagnostics, treatment approaches, and long‑term outcomes for individuals with hearing and communication disorders.
Research at the Auditory Rehabilitation & Clinical Trials Laboratory
Hearing Loss & Cognition
Our research program investigates how evidence‑based hearing interventions can influence healthy aging, cognitive outcomes, and brain health across the adult lifespan. Through a series of multi‑site randomized controlled NIH trials—including every ACHIEVE study and related pilot studies—we evaluate the effects of hearing care on cognitive decline, brain organization, everyday functioning, and long‑term wellbeing. These studies span early to late stages of age‑related hearing loss and compare best‑practice hearing interventions with health education or standard care models. Across all projects, the ARCT Lab plays a central role in designing interventions, ensuring quality control, and advancing translational approaches that move from mechanistic understanding to real‑world clinical impact.
Pilot Study to Evaluate the Long-term Chronic Care of Patients who could or do utilize an Osseointegrated Device (OID)
Sponsor: Oticon Medical Inc. Clinicaltrials.gov: NCT04899037
This is a pilot study that is based on the ACHIEVE model. The purpose of this study is to evaluate the long-term cognitive, physical, and psycho-social effects of OID hearing intervention among patients who could vs. do utilize an OID.
Early-Stage Age Related Hearing Loss Investigation (EARHLI)
NIH/NCDID: R01AG075083; Clinicaltrials.gov: NCT06174038
The EARHLI study aims to evaluate the mechanisms linking early Age-Related Hearing Loss (ARHL) and Alzheimer’s disease and related dementias (AD/ADRD). EARHLI focuses on middle and older adults with ARHL and mild cognitive impairment, which is a critical time for AD/ADRD prevention. EARHLI is a Phase II 1:1 RCT of a hearing aid-based intervention vs. a comparator (health education program) conducted over 12 months, with focus on changes in brain organization/connectivity. The ARCT Lab will not participate in this study in the form of subject enrollment. Instead, the we will provide the hearing intervention protocol and quality control of its implementation.
Enrollment ONLY open at Columbia University - see the link above for their contact information
Early-Stage Age Related Hearing Loss Investigation - Pilot Study (PEARHLI)
NIH/NCDID: R01AG075083; Clinicaltrials.gov: NCT06174038
The EARHLI Pilot study aims to evaluate the protocol for use in the larger trial, EARHLI. The EARHLI trial will investigate mechanisms linking early Age-Related Hearing Loss (ARHL) and Alzheimer’s disease and related dementias (AD/ADRD). EARHLI focuses on middle and older adults with ARHL and mild cognitive impairment, which is a critical time for AD/ADRD prevention. EARHLI is a Phase II 1:1 RCT of a hearing aid-based intervention vs. a comparator (health education program) conducted over 12 months, with focus on changes in brain organization/connectivity. The ARCT Lab performed the pilot study for fidelity and will provide the hearing intervention protocol and quality control of its implementation in the larger trial.
ACHIEVE Successful Aging Group Follow-Up Study (ACHIEVE-SAFU), Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study with new hearing aid users
NIH/NIDCD: R01 DC019408-01; Clinicaltrials.gov: NCT05070429
A multi-site randomized trial comparing conventional in-person hearing health care (HHC) versus in-person HHC plus telehealth audiology sessions among new hearing aid users. Participants will be recruited from the ongoing Aging & Cognitive Health Evaluation in Elders (ACHIEVE). From 2021-2022, as participants in the successful aging control group complete the pre-specified three years of follow-up in the ACHIEVE trial, the investigators will recruit these new hearing aid users and randomize the participants 1:1 to receive continued conventional clinic-based delivery of hearing care services versus a model that incorporates telehealth. We provide the hearing intervention protocol and quality control of its implementation in the larger trial.
ACHIEVE Brain Health Follow-Up Study (ACHIEVE-BHFU), Long-Term Effects of Hearing Intervention on Brain Health in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study
NIH/NCDID 1R01AG076518-01; Clinicaltrials.gov: NCT05532657
The ACHIEVE Brain Health Follow-Up Study is a 3-year follow-up to the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study to determine the long-term effect of hearing intervention vs. successful aging/delayed hearing intervention on rates of cognitive decline and incident mild cognitive impairment or dementia. The ARCT Lab designed the hearing interventions (telehealth and conventional sessions), completed pilot studies, and was responsible for study quality assurance and control for this trial.
ACHIEVE Hearing Intervention Follow-Up Study (ACHIEVE-HIFU), Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study with Hearing Aid Users
NIH/NIDCD: R01DC019408; Clinicaltrials.gov: NCT05070429
This study is a multi-site randomized controlled trial comparing conventional in-person hearing health care (HHC) vs. in-person HHC plus telehealth audiology sessions among existing hearing aid users with mild-to-moderate hearing loss. The ARCT Lab designed the hearing interventions (telehealth and conventional sessions), completed pilot studies, and was responsible for study quality assurance and control for this trial.
Aging and Cognitive Health Evaluation in Elders (ACHIEVE)
NIH/NIA: R01AG055426; Clinicaltrials.gov: NCT03243422
This study is a multi-site randomized controlled trial, where older adults with hearing loss are randomized to either a hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging intervention (individual sessions with a health educator covering healthy aging topics), and assessed semi-annually for 3 years. The ARCT lab designed the hearing intervention provided in the ACHIEVE Study and was responsible for intervention quality assurance and quality control.
Aging and Cognitive Health Evaluation in Elders Fidelity Study (ACHIEVE-F)
NIH/NIA: R01AG055426; Clinicaltrials.gov: NCT03243422
This pilot study was conducted to evaluate the fidelity of the intervention procedures planned for a larger NIH‑funded clinical trial. In the full trial, older adults with hearing loss are randomized to either a hearing intervention—consisting of a hearing needs assessment, fitting of hearing devices, and education/counseling—or a successful aging intervention, which includes individualized sessions with a health educator on healthy aging topics. The ARCT Lab developed the hearing intervention protocol and assessed its fidelity during the pilot phase prior to its implementation in the full ACHIEVE trial. In the larger study, the ARCT Lab is responsible for overseeing intervention quality assurance and quality control to ensure consistent and accurate delivery of all intervention components.
Hearing Rehabilitation
Our research in hearing aid trials and rehabilitation focuses on improving access, validating emerging technologies, and enhancing real‑world hearing health outcomes. This work includes clinical validation of new devices to ensure they meet performance and safety standards in diverse listening environments. We also investigate innovative delivery models, including the use of community pharmacies as accessible points of care for over‑the‑counter hearing aids, capturing stakeholder perspectives to guide best practices. In addition, our team leads the hearing intervention components of the ACHIEVE trials, all of which utilize hearing aids to support auditory wellness and overall healthy aging. Together, these efforts advance evidence‑based, patient‑centered approaches to hearing rehabilitation and broaden equitable access to effective hearing care solutions.
Clinical Validation Study of the BHA100 Series Braun Clear Hearing Aid
Sponsor: Braun Inc.
The objective of Phase 1 of this clinical investigation is to demonstrate the effectiveness of the self-fitting hearing test of the BHA100 Series Braun® Clear™ Hearing Aid through quantitative measures.
Community Pharmacies as sites for Over-the-Counter Hearing Aid Delivery: Stakeholder Opinions
Principal Investigator-Initiated Research Study
To determine what is acceptable for primary stakeholders (pharmacists, audiologists, adults with age-related hearing loss) in terms of a community pharmacy-based OTC hearing aid delivery program.
All ACHIEVE trials have used Phonak Hearing Aids. The intervention protocol using these hearing aids has shown improvement in patient Auditory Wellness & Overall Wellness.
Innovative Treatments
Our innovative treatments portfolio advances the development of emerging therapeutics and diagnostic approaches for hearing loss. Through collaborations with leading biopharmaceutical and biotechnology partners, we contribute to clinical trials that span early‑phase safety studies to large‑scale evaluations of novel treatment strategies. Current and recent projects include investigations of regenerative and neurotrophic intratympanic therapies, assessments of pharmacologic interventions for age‑related hearing, genetic‑marker–based characterization of early‑onset presbycusis, efforts to reduce chemotherapy‑related ototoxicity in pediatric patients, and hyperbaric oxygen chamber affects. These collaborations accelerate the translation of innovative scientific discoveries into potential real‑world treatments for individuals with hearing and auditory‑related conditions.
Cross sectional and prospective study to characterize early-onset presbycusis (SONG)
Sponsor: Sensorion; Clinicaltrials.gov: NCT06354010
This is a multicenter, international, low-interventional, cross-sectional and prospective study that aims to characterize patients with adulthood-onset of bilateral sensorineural hearing loss (“early presbycusis”) likely due to a genetic cause rather than an underlying medical condition. No medicinal products or devices are administered or used, as the purpose is to assess the evolution of hearing loss in those carrying mutations in GJB2 gene through audiological and medical evaluations.
Hyperbaric Oxygen Treatment (HBOT) for Veterans with Traumatic Brain Injury
Clinicaltrials.gov: NCT06581003
The primary objective is to determine HBOT can decrease symptoms associated with chronic traumatic brain injury (TBI) as measured by the Neurobehavioral Symptom Inventory (NSI) compared to placebo/sham. Barotrauma is a sufficient pressure differential across tissue/air interface to cause tissue damage, including to the head and neck. It can affect the middle ear. The symptoms are a combination of hearing loss, tinnitus, and vertigo. Diagnosis should be considered in anyone with sensorineural hearing loss within 72 hours of diving or other hyperbaric exposure. The ARCT Lab is providing the audiological assessments for this trial.
Intratympanic Injection in Subjects with Speech-in-Noise Impairment
Sponsor: Otonomy, Inc.; Clinicaltrials.gov: NCT04129775
This study is a randomized, double-blind, placebo-controlled phase ½ study of OTO-413, given as a single intratympanic injection in subjects with speech-in-noise impairment. The purpose is to test the safety of the investigational product, OTO-413, compared to placebo (no active ingredient) in people with speech-in-noise impairment. OTO-413 contains the active ingredient brain-derived neurotrophic factor (BDNF). BDNF is a protein that is found in the body and helps nerve cells grow and survive. When OTO-413 is injected into the ear, OTO-413 turns into a gel and allows the BDNF to stay in the ear for several weeks. The ingredient that turns OTO-413 into a gel is called poloxamer 407.
Single Intratympanic Injection Medication in Adults with Acquired Sensorineural Hearing Loss
Sponsor: Frequency Therapeutics; Clinicaltrials.gov: NCT05086276
This study is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study. The aim is to evaluate the efficacy of FX-322-208, administered by intratympanic injection in adults with acquired sensorineural hearing loss. As there is currently no drug treatment or cure for sensorineural hearing loss, Frequency Therapeutics, Inc. has begun a research study to gather additional information about an investigational drug called FX-322-208. FX-322 is a combination of two small molecule drugs that has been developed to potentially restore inner ear hair cells and thus possibly improve hearing abilities.
Four Intratympanic Injection Medications in Adults with Acquired Sensorineural Hearing Loss
Sponsor: Frequency Therapeutics; Clinicaltrials.gov: NCT05086276
This study is a Phase 2, prospective, randomized, double-blind, placebo-controlled, four-dose, multicenter study. The aim is to evaluate the efficacy of FX-322-202, administered by intratympanic injection in adults with acquired sensorineural hearing loss. As there is currently no drug treatment or cure for sensorineural hearing loss, Frequency Therapeutics, Inc. has begun a research study to gather additional information about an investigational drug called FX-322-202. FX-322 is a combination of two small molecule drugs that has been developed to potentially restore inner ear hair cells and thus possibly improve hearing abilities
A Balanced, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss [CLARITY-1 Study]
Sponsor: Autifony Therapeutics; Clinicaltrials.gov: NCT02345031
To demonstrate a clinically significant improvement in the signal-to-noise ratio threshold in a speech in noise (SIN) test after repeat dosing in subjects with age related hearing loss and SIN deficit. To explore the effects of Kv3 channel modulation on parameters of hearing performance in subjects with age related hearing loss and SIN deficit.
Health Disparities
Our health disparities research aims to ensure that hearing healthcare is accessible, culturally responsive, and effective for diverse communities. We develop and evaluate tools, educational materials, and intervention models that address gaps in knowledge, care access, and clinical outcomes among underrepresented groups. These efforts include creating Spanish‑language self‑management resources, examining hearing‑health beliefs among Black women, and studying how everyday auditory environments influence intervention success across diverse populations. We also apply health behavior frameworks to better understand and predict healthcare decision‑making. Collectively, this work advances equitable hearing healthcare by centering the experiences, needs, and strengths of the communities we serve.
Development and Assessment of Spanish-Language Toolkit for Hearing Loss Self-Management
NIH/NIDCD R21DC018655; Clinicaltrials.gov: NCT04534387
The purpose of the study is to develop and test Spanish-language patient education materials for hearing loss. Using focus groups, education materials will be developed, and then assessed with Spanish-speaking participants.
Hearing Health Knowledge, Attitudes, and Beliefs among Black Women: A Multi-Method Analysis
USF Health Internal Award
The purpose of the study is to identify knowledge gaps regarding hearing loss and hearing healthcare among Black women and to determine whether the Health Belief Model (HBM) is an appropriate framework for exploring knowledge, attitudes, and beliefs about hearing loss and hearing healthcare among Black adults, particularly women.
Auditory Ecology and its Relationship to Audiologic Intervention Outcomes in Diverse Population Pilot Study
Principal Investigator-Initiated Research Study
Pilot study to characterize auditory ecology and factors related to auditory ecology in a diverse sample. Gain insight on real-world communicative mass (e.g., speech understanding, listening effort) and how auditory ecology may influence hearing aid outcomes
Application of Health Behavior Models to Predict Healthcare Outcomes
The overarching goal of this study is to use health behavior theory to understand the factors underlying hearing healthcare behavior so that in our future research we can develop evidence-based counseling and education programs that will modify attitudes, beliefs and readiness for change. In this way, a greater proportion of people with hearing loss will seek help and engage in auditory rehabilitation.
Evaluation of Clinical Protocols
Our research program is committed to strengthening the evidence base behind widely used audiological and otologic clinical practices. These studies examine how well current protocols identify auditory disorders across diverse patient groups and whether emerging measures offer meaningful improvements in diagnostic accuracy. Our work includes evaluating high‑frequency air‑bone gaps in both normal‑hearing and hearing‑impaired listeners, assessing extended high‑frequency auditory physiology as a feasible clinical tool, and analyzing the performance of commonly used speech‑in‑noise tests across varying levels of hearing ability. These projects support the refinement of clinical standards, promote more precise diagnostic pathways, and help ensure patients receive the most effective and reliable assessments possible.
High-Frequency Air-Bone Gaps in Normal-Hearing and Hearing-Impaired Listeners
Principal Investigator Initiated Research Study
Pure‑tone audiometry is the gold‑standard test for measuring air‑ and bone‑conduction hearing sensitivity, and accurate thresholds are essential for diagnosing hearing pathology. However, clinical reports and prior studies show that bone‑conduction thresholds above 2000 Hz often appear artificially better than air‑conduction thresholds, creating false air‑bone gaps. At 4 kHz, this artifact increases with the degree of hearing loss. These false gaps represent a significant clinical concern and highlight the need to re‑evaluate current standards, which was based on older technology and data from only normal hearing subjects. Using current technology, this study includes both normal‑hearing and sensorineural hearing loss (SNHL) participants to develop updated normative reference data and improve diagnostic sensitivity. The study also examines how bone‑conduction sensitivity relates to the magnitude of hearing loss at each test frequency.
The evaluation of extended high frequency auditory physiology as feasible clinical audiology measures
Sponsor: Frequency Therapeutics Inc.
Describe and quantify auditory performance using extended high‑frequency (EHF) acoustic stimuli. Establish normative performance ranges for normal‑hearing volunteers (NHVs) and general performance ranges for volunteers with sensorineural hearing loss. Evaluate whether EHF‑elicited auditory measures are feasible for clinical use and for assessing efficacy in future trials of new interventions or therapeutics.
Evaluation of the Speech in Noise tests on normal and hearing loss listeners
Sponsor: Otonomy Inc.
Our study aimed to evaluate the performance between three speech-in-noise tests with varying linguistic cues currently available for clinical implementation: the Digits in Noise test (DIN; Wilson & Weakley, 2004),the Words in Noise test (WIN; Wilson, 2003), and the American EnglishMatrix Test (AEMT; Kollmeier et al., 2015).To our knowledge, the AEMT, has yet to be compared to other clinically available speech-in-noise tests. Understanding correlational relationships on these tests will both allow for standardization of degrees of speech-in-noise hearing loss and determine if these tests can be used interchangeably in clinic.
Speech Perception
Our speech perception research aims to improve how speech understanding is measured, supported, and optimized for listeners with and without hearing loss. We examine factors that influence word and sentence recognition—including microphone directionality and noise‑reduction algorithms, the role of carrier phrases in word recognition accuracy, and bilingual speech‑in‑noise performance. Additionally, we investigate innovative approaches to clinical speech testing, such as adaptive protocols designed to better capture performance across the full dynamic range of speech. Together, these projects advance more precise assessment methods and enhance our understanding of how individuals process speech in both quiet and challenging listening environments.
Optimizing Clinical Word Recognition Testing through an Adaptive Protocol that Measures Across the Dynamic Range of Speech Pilot Study
USF Internal Award
Assess the clinical feasibility of the 25-word and 50-word adaptive protocol in young normal hearing adults and older adults with hearing loss with the VA-2 talker. Validate the psychometric characteristics of word recognition across dynamic speech levels for young normal hearing adults and older adults with hearing loss with the VA-2 talker.
Speech-In-Noise performance on the AzBio Sentence test for adult monolingual Spanish-speakers, monolingual English-speakers, and Spanish-English bilingual speakers with normal hearing
Principal Investigator Initiated Research Study
To collect and compare performance data on speech perception measures (Az Bio and Hearing in Noise Test [HINT]) in quiet and in noise in normal-hearing adults who are either: (1) monolingual English speakers; (2) monolingual Spanish speakers; or (3) bilingual Spanish/English speakers. Perform group comparisons on performance based on: 1) age 2) language spoken and history of bilingualism. Collect performance data on central auditory processing measures of speech perception in bilingual and monolingual
Spanish speakers 1) Spanish Words-In-Noise (S-WIN).
Effect of Microphone Directionality & Noise Reduction Algorithms on Speech in Noise Recognition in Cochlear Implant Users
Principal Investigator Initiated Research Study
The purpose of this study is two-fold. The first goal in this study is to determine if a specific speech in noise program yields a better speech perception score for cochlear implant users. A second goal is to determine if the test required for this study could help facilitate a new clinical protocol for determining which input processing should be used and testing speech perception in cochlear implant users
at the University of South Florida. The research questions addressed in this project are as follows: 1) Is there a specific speech in noise program that will yield better results when comparing fixed directionality, adaptive directionality, and background noise reduction features?
Word Recognition in Quiet Performance: Effects of the Carrier Phrase
Principal Investigator Initiated Research Study
The primary goal of this study is to compare word recognition performance in quiet with and without a carrier phrase among young healthy adults with normal hearing and older healthy adults with hearing impairment. Both participant groups will undergo word recognition testing using two clinically available word recognition stimuli sets (Swann set and VA Female set). The Swann set has the carrier phrase independently added or removed but does not alter co-articulation, while the carrier phrase for VA Female set was spliced out using digital media software and may influence co-articulation.
Ototoxicity
Our ototoxicity monitoring research—encompassing the STELLAR, SWOG, and TIP studies—aims to improve the early detection and real‑time tracking of treatment‑related side effects in patients undergoing chemotherapy and other anticancer therapies. These medications can lead to significant adverse outcomes, including peripheral neuropathy, hearing loss, and cognitive impairment. Despite the known risks, there remains limited evidence to guide systematic, proactive monitoring during treatment. Through these studies, we are developing and evaluating practical approaches to identify ototoxic changes as early as possible, supporting timely clinical decision‑making, better symptom management, and improved quality of life for patients. This work is essential for reducing preventable treatment‑related disability and advancing safer, more responsive models of cancer care.
The Identification and Quantification of Chemotherapy-Induced Peripheral Neuropathy, Hearing Loss, and Cognitive Impairment
The purpose of this study is to identify, quantify and evaluate the onset and progression of chemotherapy-induced peripheral neuropathy (CIPN), hearing loss (CIHL), and cognitive impairment (CICI). Patients receiving chemotherapy will be recruited and monitored throughout their chemotherapy treatment regiments.
A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy (STELLAR) Study
Sponsor: Orbus Therapeutics
The primary objective of this study is to demonstrate superiority in overall survival (OS) and comparable safety when eflornithine is added to lomustine compared to lomustine alone in patients with anaplastic astrocytoma (AA) that progress/recur after irradiation and adjuvant temozolomide chemotherapy. The ARCT Lab performs to ototoxicity monitoring hearing evaluations throughout the investigational intervention plan.
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Secondary Primary Colorectal Cancers in Patients with Stage o-III Colon or Rectal Cancer Phase III - Preventing Adenomas of the Colon of the Eflornithine and Sundac (SWOG).
To assess whether the combination of eflornithine and sulindac is effective in reducing the three-year event rate (high-risk adenomas and second primary colorectal cancers in patients with previously treated Stage 0-III colon or rectal cancer