Clinical Trial: Cochlear Implantation in Cases of Single-Sided Deafness

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cochlear Implantation in Cases of Single-Sided Deafness

Brief Summary: The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.

Detailed Summary:

Single-sided deafness (SSD) can be defined as moderate-to-profound sensorineural hearing loss with limited speech perception benefit in one ear and normal hearing in the contralateral ear. Though one ear is within the normal hearing limits, SSD may result in reduced speech perception in noise, variable abilities on localization tasks, increased subjective report of hearing handicap, and reduced quality of life.

This patient population cannot utilize conventional amplification due to the severity of the hearing loss and poor speech discrimination abilities in the affected ear. Current treatment options include: contralateral routing of the signal (CROS) hearing aids, and bone-conduction devices. A CROS hearing aid is a two-part system that includes a microphone/transmitter on the affected ear and a receiver on the normal hearing ear. The microphone/transmitter sends the acoustic signal from the affected ear to the receiver, which is presented to the normal hearing ear. Bone-conduction devices utilize a percutaneous, implanted titanium abutment to send the acoustic signal from the affected side to the normal hearing ear via vibrations. The goal of both of these technologies is to send the signal from the affected side to the normal hearing side, thereby leaving the patient in a unilateral listening condition.

Though CROS hearing aids and bone-conduction devices provide the patient with auditory information from both sides to the better hearing ear, the ability to use binaural cues for speech perception in noise is variable.

It is of interest whether cochlear implantation of the affected ear would benefit the SSD population. A cochlear implant is a two-part system, including the internal electrode array and external speech processor. The internal electrode array is surgically
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

• demonstrate effectiveness of cochlear implantation on speech perception [ Time Frame: Intervals within the first year of device use ]
  Results on recorded speech perception materials (sentence and word lists)
• demonstrate the effectiveness of cochlear implantation on localization [ Time Frame: Intervals within the first year of device use ]
  Subjects will identify noise source from an 11-speaker array with the cochlear implant on versus off
• demonstrate effectiveness of cochlear implantation on subjective benefit [ Time Frame: Intervals within the first year of device use ]
  Subjects will complete subjective questionnaires to indicate perceived benefits of cochlear implantation

Original Primary Outcome: Same as current

Current Secondary Outcome:

• compare speech perception outcomes of cochlear implantation to that of current treatment options [ Time Frame: Intervals within the first year of device use ]
  Results on recorded speech perception materials (sentence and word recognition tasks)
• compare localization abilities of cochlear implantation to that of current treatment options [ Time Frame: Intervals within the first year of device use ]
  Subjects will identify noise source from an 11-speaker array with the device (cochlear implant / bone-conduction device) on versus off
• compare subjective benefit of cochlear implantation to that of current treatment options [ Time Frame: Intervals within the first year of device use ]
  Subjects will indicate their perceived benefits of cochlear implantation/other treatment options on subjective questionnaires

Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: July 22, 2014
Date Started: October 2014
Date Completion: December 2018
Last Updated: September 6, 2016
Last Verified: September 2016