Active Studies
Active Studies:
Meniere's Disease
SPI-1005-401: Open-label study of SPI-1005 for the treatment of Ménière's Disease
Description: Sound Pharmaceuticals, Inc., a Seattle-based biopharmaceutical company, has been studying ebselen (aka SPI-1005) for use in Meniere’s disease for over 10 years. Ebselen, thought to have generally anti-inflammatory and neuroprotective properties, mimics the activity of a naturally occurring type of enzyme that helps prevent oxidative damage.
We at the House Ear Institute participated as a site in Sound Pharmaceuticals’ previous placebo-controlled, double-blind Phase III trial, and are currently participating as a site in the company’s open-label trial. The results of the previous Phase III trial showed significant improvements in patient-reported tinnitus, dizziness, vertigo, and aural fullness compared to baseline. Currently, there are no FDA-approved medical treatments for Meniere’s disease; as such, we are proud to have a hand in supporting Sound Pharmaceuticals as they investigate and develop this promising drug.
Funding Source: Sound Pharmaceuticals, Inc.
Principal Investigator: Dr. William Slattery
Adult Hearing Loss
Biomarkers in the Pathogenesis of Sudden Sensorineural Hearing Loss
Description: Sudden sensorineural hearing loss (SSNHL) is a condition in which a person loses a significant degree of hearing, most typically in one ear, over the course of fewer than three days. Oftentimes, the hearing loss occurs all at once. Currently, SSNHL is not well understood. In most cases, the cause of the hearing loss is unknown and, while steroids are the immediate, first line treatment, some people do not experience and recovery of hearing loss following treatment with steroids.
Being able to identify what may cause SSNHL – whether it may be viral, bacterial, immunologic, genetic, or a combination of all of the above – would be a massive step forward in the field. It would also be an important step toward differentiating different types of SSNHL, which are currently grouped together for the most part. For this project, we are collaborating with researchers at Yale University and a life sciences company called Karius. We are currently enrolling patients with sudden sensorineural hearing loss within 14 days prior to presentation in clinic.
Funding Source: The Panda Charitable Family Foundation and House Institute Foundation
Principal Investigator: Dr. William Slattery
Proteomic Study of The Inner Ear
Description: Diseases of the inner ear are mainly diagnosed clinically, and no assays have been established to confirm or rule out different diagnoses (e.g., Meniere’s Disease, vestibular migraine, autoimmune hearing loss, and sudden sensorineural hearing loss). Typically, a biopsy of the inner ear would be unrealistic, as it would result in damaging the delicate structure of and balance of fluids in the inner ear. In the field of neurotology, there are certain surgical procedures (e.g., cochlear implantation, specific approaches for acoustic neuroma removal) that result in complete loss of hearing on the side operated on. These cases provide an excellent and rare opportunity to collect fluid from the inner ear.
In collaboration with world-leading scientists at George Mason University, we are collecting and analyzing this fluid in order to establish biomarkers for various hearing- and vestibular-related conditions. We hope that this work will facilitate diagnostic procedures in the future and give us insight into how these conditions develop.
Funding Source: House Institute Foundation
Principal Investigator: Dr. William Slattery
A Multicenter, Prospective, Open-label Clinical Trial to Evaluate the Safety and Effectiveness of the Perf-Fix Otologic Gel Patch to Aid in the Repair of Chronic Tympanic Membrane Perforation
Description: Tympanogen, a Richmond, VA-based company dedicated to simplifying medical procedures and reducing healthcare costs, is pioneering a non-surgical, non-invasive treatment for eardrum perforations that don’t heal on their own. The current standard option for many patients with chronic and/or non-spontaneously healing eardrum perforations is a surgical intervention called tympanoplasty, which involves general anesthesia and may not be an option for elderly patients.
The House Ear Institute participated as a site for Tympanogen’s recent Perf-FixTM gel-patch clinical trial. The gel-patch can be applied to a patient’s eardrum in less than 20 minutes by a physician in an outpatient setting, and has already shown signs of effectiveness in patients of all ages. If successful, this treatment would make treatment of chronic eardrum perforations significantly more accessible and less costly.
Funding Source: Tympanogen
Principal Investigator: Dr. William Slattery
Hearing Devices (Cochlear Implants/Hearing Aids)
Adaptation and Optimization in Bilateral Cochlear Implants
Description: The aim of this project is to better understand how adaptation affects bilateral integration of spectral patterns in simultaneously or sequentially implanted bilateral cochlear implant users. (PI: Fu; Co-I:Galvin)
Brain plasticity is key to the success of the cochlear implant. This plasticity is important for postlingual adult bilateral cochlear implant users, who must adapt to electric stimulation patterns relative to previous acoustic-hearing experience. The trajectory of adaptation differs between simultaneously implanted patients (who adapt with both implants at the same time) and sequentially implanted patients (who first adapt to the first implant, and then to the second implant). The aim of this study is to better understand how adaptation affects bilateral integration of spectral patterns with electric hearing in simultaneously and sequentially implanted bilateral cochlear implant users. Data from this study will provide empirical evidence regarding the advantages for simultaneous over sequential implantation and guide optimization of bilateral cochlear implant signal processing improve outcomes. (PI: Fu; Co-I: Galvin)
Principal Investigator: Dr. John Galvin
Emotional Communication in Children and Adults with Cochlear Implants
Description: The aim of this project is to better understand how emotional communication is affected by experience-driven plasticity in children and adults. (PI: Chatterjee; Co-Is: Luo, Galvin)
Pitch cues are important for perception and production of emotional speech. However, pitch cues are poorly represented by and perceived with cochlear implants. Early implantation in childhood may offer some advantage, as children with cochlear implants may better learn cues for emotional speech perception and production with their device. Postlingually deaf cochlear implant users may benefit from previous acoustic hearing experience for production of emotional speech. The aim of this study is to better understand how emotion communication is affected by experience-driven plasticity in children and adults. Data from this project may inform optimization of cochlear implant signal processing as well as rehabilitation strategies to improve emotional communication in pediatric and adult cochlear implant patients. (PI: Chatterjee; Co-Is: Luo, Galvin).
Co-Investigator: Dr. John Galvin
Improving Music Perception in Cochlear Implants
Description: The aim of this project is to better understand the source of the “bimodal benefit” for music sound quality with combined acoustic and electric hearing. (Co-PIs: Galvin, Landsberger)
While speech communication is generally good with cochlear implants, music perception and sound quality are generally poor. Despite this poor music quality with the cochlear implant, singlesided deaf cochlear implant users (normal hearing in one ear, cochlear implant in the other ear) often prefer to listen to music with the cochlear implant on. The aim of this project is to better understand the source of this “bimodal benefit” for music sound quality. By controlling the spectral and temporal information to the implanted ear, we can better understand what cues contribute to music sound quality with combined acoustic and electric listening. Data from this project may inform optimization of cochlear implant signal processing to improve music perception in single-sided deaf as well as bilaterally deaf patients. (Co-PIs: Galvin, Landsberger)
Co-Investigator: Dr. John Galvin
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Integration of Acoustic and Electric Hearing
Description: The aim of this project is to better understand factors that contribute to the variability in outcomes with combined acoustic and electric hearing. (PI: Fu; Co-I: Galvin)
Criteria for cochlear implantation have progressively expanded to include increasingly larger amounts of usable acoustic hearing in the non-implanted ear. The benefit of combined acoustic and electric hearing depends on the extent of acoustic hearing, with more benefit when there is less available acoustic hearing. Bimodal benefits also depend on the speech performance difference and frequency mismatch between the acoustic-hearing and cochlear implant ears. The aim of this project is to better understand factors that contribute to the variability in outcomes with combined acoustic and electric hearing. Data from this study may guide optimization of cochlear implant signal processing to promote better integration of acoustic and electric hearing. (PI: Fu; Co-I: Galvin)
Co-Investigator: Dr. John Galvin
Place and Temporal Cues for Pitch in Children and Adults with Cochlear Implants
Description: The aim of this project is to better understand factors that limit pitch perception, perception of emotional speech, and perception of music in pediatric cochlear implant users. (PI: Reiss; Co-Is: Galvin, Chatterjee)
The ability to hear pitch in music and spoken emotion is an important aspect of childhood development. Children with cochlear implants often have difficulties with pitch perception, which in turn affects music and emotion recognition. The aim of this study is to better understand factors that limit pitch perception, perception of emotional speech, and perception of music in pediatric cochlear implant users. The project is the start of a new multi-center collaboration to explore the relationship of early access to acoustic or electric hearing to pitch perception. Data from this study may guide optimization of cochlear implant signal processing to improve pitch perception and provide guidelines for cochlear implantation for children who have residual acoustic hearing. (PI: Reiss; Co-Is: Galvin, Chatterjee).
Co-Investigator: Dr. John Galvin
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Pulse Phase Duration as a Marker of Neural Health
Description: The aim of this project is to better understand loudness growth with relatively short or long pulse phase durations. (PI: Galvin; Co-Is: Landsberger, Bakhos)
Cochlear implants provide hearing by delivering pulses of electrical charge to the implanted electrodes. The loudness of the charge is determined by the pulse amplitude and pulse phase duration. Our previous data suggest great variability in loudness growth with increasing pulse phase duration across individual electrodes and patients, with some association between duration of hearing loss and loudness growth. The aim of this project is to better understand loudness growth with relatively short or long pulse phase duration. We will extend this work to consider broad and focused stimulation modes and relative spread of excitation with increasing pulse amplitude or pulse phase duration. Data from this project may inform optimization of cochlear implant signal processing. (PI: Galvin; Co-Is: Landsberger, Bakhos)
Principal Investigator: Dr. John Galvin
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Acoustic Neuroma/Vestibular Schwannoma (Tumors)
Brain, Nervous System, and Ear Tissue Repository Protocols
Description: In 2020, the House Ear Institute established a biobank of tumor, blood, and cerebrospinal fluid specimens from patients with acoustic neuromas (aka vestibular schwannomas). Acoustic neuromas are noncancerous, usually slow-growing tumors that grow on a nerve connecting the ear to the brain. When these tumors press on the nerve and/or surrounding structures, they can cause one-sided hearing loss, dizziness, tinnitus, and ear fullness.
With our tissue bank, we hope to advance the basic and clinical science of these relatively rare tumors. Analyzing tumor, plasma, serum, and cerebrospinal fluid samples will help us to understand more about how and when these growths occur, and may also provide insight into other related pathologies.
Funding Source: House Institute Foundation
Primary Investigator: Dr. William Slattery
Pediatric Hearing Loss
Using Eye-Tracking to Assess Real-Time Spoken Language Processing in Children
Description: A study examining how different types of background noise affect the language processing efficiency of school-age children with hearing aids and children with normal hearing.
Children with and without hearing loss can struggle to understand speech in noisy environments, which may be due in part to negative effects of auditory maskers (i.e., background noise) on children’s speech processing efficiency. In this project, we are characterizing the development of children’s real-time processing efficiency while listening to speech in different types of noise, as well as comparing these processes in children with normal hearing and children with hearing aids. Findings will inform recommendations for classroom noise management, improve our understanding of the mechanisms underlying listening and spoken language difficulties in children with hearing aids, and support the development of clinical interventions supporting complex listening skills in children with hearing loss.
Funding Source: National Institutes of Health (NIH) / National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Dr. Kelsey Klein
Longitudinal Pediatric Hearing Health Study
Description: A longitudinal study examining various outcomes among a diverse group of children and adolescents with hearing loss.
Technology and early intervention for children with hearing loss have improved tremendously in recent decades. However, we continue to see large variability in children’s long-term outcomes. In this longitudinal study, we are examining outcomes related to speech perception, language, listening-related fatigue, mental health, and quality of life among children and adolescents who are deaf or hard of hearing. Our goal is to identify audiologic, educational, and family- and child-specific factors that support improved outcomes. By including a large and diverse group of children, including children with additional disabilities, children who speak Spanish, and children with hearing loss in only one ear, we will ensure that our findings are relevant to a broad range of children.
Funding Source: House Institute Foundation
Principal Investigator: Dr. Kelsey Klein
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Characterizing the Home Auditory Environments of Children with Hearing Loss
Description: A study that combines in-lab and at-home measurements to better understand how well children with hearing loss can access spoken language at home
Children with hearing loss need consistent access to speech to effectively develop spoken language. When there is a lot of noise, it can be difficult for children with hearing loss to hear and understand speech. In this study, we are using audio recorders that analyze how much speech and noise children are exposed to in order to characterize children’s listening environments at home. We are particularly interested in how social, cultural, and linguistic factors are related to spoken language access for children with hearing loss. The results will support clinicians in providing families more individualized recommendations about how to support their children’s spoken language development at home.
Funding Source: American Speech-Language-Hearing Foundation
Principal Investigator: Dr. Kelsey Klein
For more information, please contact:
Sean Lang, CRC II
slang@hifla.org, (213) 443-8193
Jane Cabison, MSPM, Director of Research Administration
jcabison@hifla.org, (213) 459-5712