The purpose of this investigation is to determine the safety and preliminary efficacy of implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal hearing (NH) ear (termed "single-sided deaf" person, or SSD). The potential subjects will have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The long-term goal of this research program is to determine whether the CI, in combination with the NH ear, may provide improved localization ability and better speech understanding in noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity, compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off, after implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
cochlear implant
Keck School of Medicine of USC
Los Angeles, California, United States
House Clinic
Los Angeles, California, United States
Pure-tone threshold average (dB)
Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.
Time frame: 6 months post-activation
Hearing in Noise Test (signal-to-noise ratio)
Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.
Time frame: 6 months post-activation
Adverse Events
Number of unexpected serious adverse events across all 10 subjects.
Time frame: 1-month post-implantation
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