The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).
Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
Georgetown University School of Medicine
Washington D.C., District of Columbia, United States
Tampa Bay Hearing and Balance Center
Tampa, Florida, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
Midwest Ear Institute/St. Luke's Health System
St Louis, Missouri, United States
New York University Langone Medical Center
New York, New York, United States
Oklahoma Ear Institute
Oklahoma City, Oklahoma, United States
Vanderbilt Bill Wilkerson Center
Nashville, Tennessee, United States
...and 1 more locations
Unaided Pure-tone Average (PTA) Hearing Threshold Measurements
Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
Time frame: Twelve months post device activation
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: Up to 12 months post device activation
Speech Perception Testing (AzBio) in Noise.
Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: up to 12 months post device activation
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