Clinical Trial: Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss

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

Official Title: Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss

Brief Summary: The objective of this study is to investigate benefits of binaural hearing for non-traditional cochlear implant candidates (with Asymmetric Hearing Loss). Asymmetric candidates are patients with severe to profound hearing loss in one ear and better hearing in the other ear. (One ear is deaf and the other ear has better hearing and in most cases uses a hearing aid.) The investigators hypothesize that cochlear implantation of the poorer ear provides a functional increase in word and sentence understanding in quiet or noise, perceived benefit, localization ability, and other measures of auditory performance relative to use of the better hearing ear alone.

Detailed Summary:

Multichannel cochlear implants have been highly successful in restoring speech understanding in adults and children who have congenital or acquired bilateral profound or severe-to-profound sensorineural (permanent) hearing loss. As implant technology has continued to develop and post-implant performance of patients has improved, the patient selection criteria has broadened to include patients with less severe hearing loss. Further, results from studies where patients received bilateral cochlear implants have demonstrated not only improved performance but the feasibility of integrating signals from both ears.

In contrast to persons with bilateral severe-to-profound hearing loss, persons who have only one ear with profound or severe-to-profound hearing loss and the other ear with substantially less hearing loss have not, to date, been considered cochlear implant candidates. This is because it has been assumed they will do well enough with a conventional hearing aid in the better ear. A problem with this assumption is that even with an appropriately fit better ear hearing aid, many of these hearing-impaired individuals still experience significant difficulties in speech understanding in their everyday listening environments, along with significant communication handicaps that interfere with their employment and quality of life.

Previous studies that have examined the performance of patients who have more symmetrical hearing loss and who wear a cochlear implant on one ear and a power hearing aid on the other ear, have illustrated that the two inputs can be combined and provide binaural hearing benefits. It is hypothesized in this study that patients with an asymmetrical sensorineural hearing loss may also receive significant binaural benefit from having a cochlear implant on the poorer ear along with an appropriately fit heari
Sponsor: Washington University School of Medicine

Current Primary Outcome: Sound localization using a 140 degree, horizontal plane loudspeaker arc [ Time Frame: Change from Pre-implant baseline localization at 12 months post-implant ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Speech recognition [ Time Frame: Pre-implant and 1, 3, 6, 9, 12, and 24 months post-implant ]
    Speech recognition will be assessed with word and sentence material for the each ear individually as well as bilaterally (both ears together). Testing will be completed in quiet and in the presence of background noise.
  • Perceived benefit questionnaire [ Time Frame: Pre-implant and 1, 3, 6, 12, and 24 months post-implant ]
    Speech, Spatial and Qualities of Hearing scale (SSQ; Gatehouse and Noble,2004) will be completed by participants. The SSQ is a 49-item questionnaire that uses a 10-point rating scale (where a 0 rating reflects least ability and 10 reflects greatest ability) to evaluate the effects of hearing loss in terms of disability and function across three domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing.


Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: November 26, 2013
Date Started: April 2006
Date Completion: July 2018
Last Updated: May 3, 2017
Last Verified: May 2017