Clinical Evaluation of a Cochlear Implant Sound Processor

Completed · Not applicable

Conditions studied: Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases

In brief

This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit

Key facts

Study ID

NCT04237207

Run by

Advanced Bionics

People needed

22

Starts

2019-12-17

Expected to finish

2020-10-15

Last updated by the study team

2022-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
• Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Tampa Bay Hearing and Balance Center — Tampa, Florida, United States
• Midwest Ear Institute/St. Luke's Health System — Kansas City, Missouri, United States
• Washington University Medical Center — St Louis, Missouri, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Austin Ear, Nose & Throat Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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