Otology

Jason Brant, M.D.

Virtual Temporal Bone Surgery
Clinical Research – open

The emphasis of this research is to integrate a set of surgical proficiency metrics established by a national consortium into an existing surgical simulation platform towards the goal of providing automated assessment. Concurrently, we will refine the existing simulation system through formative evaluation by our consortium of experts. Our hypothesis is that through the translation of standardized metrics, an automated assessment tool can be generated that is not inferior to expert assessment.

Steven Eliades, M.D.

Cochlear Implants and Voice
Clinical Research – open

The goal of this study is to investigate how well patients with cochlear implants (CIs) are able to use hearing to control their speech. CI patients and normal hearing control subjects are asked to speak into a microphone while their voice is recorded. We perturb what they hear of their voice as they are speaking, and observe how they change their speech to overcome this perturbation. Results for CI patients and controls are compared to determine how well patients are able to control their voices.

Cochlear Implants for Single-Sided Deafness
Clinical Research – open

The goal of this study is to investigate how the auditory system of patients with SSD interprets sound inputs when their hearing in the affected ear is restored using a CI. Electrical potentials from the brain are recorded while participants listen to sounds in one or both ears. Participants with a CI are similarly presented to either the CI, the opposite ear, or both.  We compare the groups to determine how well the auditory system is processing sound information from the implant.

Michael Ruckenstein, M.D.

Meniere’s Disease QOL I
Clinical Research – open

The objectives of this study are to develop a validated quality of life (QOL) indicator that will reflect the impact of this chronic disorder on patients’ quality of life, and to develop a validated QOL indicator that can be used to evaluate efficacy of therapeutic interventions for this disorder.

PANQOL: QOL in Acoustic Neuroma
Clinical Research – open

This study is designed to assess the quality of life of all patients currently being followed for acoustic neuromas by the University of Pennsylvania Department of Otorhinolaryngology. This retrospective chart review will look at longitudinal changes in quality of life in patients having undergone the 3 treatment options for acoustic neuromas (conservative, surgery, stereotactic radiosurgery).

Stimulation Rate for Older Adults with Cochlear Implants
Clinical Research – open

The purpose of this study is to evaluate the effect of lowering the stimulation rate in the older adult population. We hypothesize that decreases in stimulation rate will result in significant improvements in speech perception performance and subjective benefit for MED-EL cochlear implant recipients sixty (60) years of age and older who perform poorly with the default higher stimulation rate.

Meniere’s Disease QOL II
Clinical Research – open

This is an extension of the Meniere’s Disease QOL I protocol. The purpose of that and this new protocol is to develop a validated quality of life (QOL) indicator that will reflect the impact of Meniere’s Disease (a chronic disorder) on a patient’s quality of life.

Hybrid Cochlear Implant Safety and Efficacy
Clinical Research – open

This is a post approval, pre-market study to monitor the long term (5 year) safety and effectiveness of the Hybrid L24 Implant System in a cohort of newly implanted subjects. The estimated study duration is 5-7 years from the time of approval. This is a prospective, multi-center, repeated-measure, single-arm, open label clinical study that targets adults 18 years and older for unilateral use.

Electric-Acoustic Stimulation Extended Follow-Up Post-Approval Study
Clinical Research – open

The purpose of this post-approval study is to evaluate the long-term safety and effectiveness of the MED-EL EAS Cochlear Implant System, which was issued PMA approval by FDA on September 15, 2016.  Up to 68 subjects from the previous US clinical trial will be followed to 60 months post-activation.

Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
Clinical Research – open

The primary objectives of this multi-center study are to evaluate the safety and efficacy of currently available multichannel cochlear implant systems for newly implanted adults with an indication based on open-set sentence recognition that expands criteria currently used by CMS, and to assess the correlation between measures of speech recognition in candidates for cochlear implants and their utility in predicting audiologic and quality of life outcomes after implantation.