Clinical Trial: Cochlear Implants for Adults With Single-sided Deafness

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Cochlear Implantation for Single-Sided Deafness

Brief Summary: 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.

Detailed Summary:
Sponsor: Robert Shannon

Current Primary Outcome:

  • Pure-tone threshold average (dB) [ Time Frame: 6 months post-activation ]
    Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.
  • Hearing in Noise Test (signal-to-noise ratio) [ Time Frame: 6 months post-activation ]
    Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse Events [ Time Frame: 1-month post-implantation ]

Number of unexpected serious adverse events across all 10 subjects.


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: September 26, 2014
Date Started: September 2014
Date Completion: September 2019
Last Updated: April 18, 2017
Last Verified: April 2017