Clinical Trial: Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

Brief Summary: This longitudinal study evaluates the possible benefit of cochlear implantation in the poor ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better hearing ear.

Detailed Summary:

The study will be conducted as a multicenter, prospective, single-arm clinical trial, evaluating the efficacy and safety of cochlear implantation in patients with asymmetric hearing loss. A repeated-measures analysis will be employed whereby patients will act as their own controls. Participants will be recruited from surgeons and audiologists in Otolaryngology departments at the participating sites.

Participants will be evaluated at multiple intervals using a variety of test measures (addressing sound localization, understanding speech in noise, understanding speech in quiet, and quality of life).

Prior to receiving a cochlear implant (CI) in the poor hearing ear, participants will be evaluated as follows:

• Hearing aid (HA) in the better ear alone
• HA in the poor ear alone
• Bilateral HAs

Participants who have not previously used a poor-ear hearing aid or BiCROS hearing aid will complete a 1-2 week trial and be evaluated at the end of the trial. If performance is better with the alternate therapy (bilateral hearing aids or BiCROS hearing aid) than the better ear alone performance and the participant prefers the alternate therapy, the participant will not continue in the study.

Participants who do continue in the study will be evaluated at several post-implant intervals. Post-implant evaluations will occur at 3, 6, 9, and 12 months after initial stimulation of the CI. Participants will be evaluated as follows:

• HA in the better ear alone
• CI in the poor ear alo
  Sponsor: Washington University School of Medicine
  

  Current Primary Outcome: Poor ear alone CNC monosyllabic word understanding in quiet [ Time Frame: Pre-implant and 6 months post-implant ]

  CNC monosyllabic word understanding in quiet with the CI alone compared to pre-implant with a hearing aid.
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Sound localization [ Time Frame: Pre-implant and 6 months post-implant ]
    Sound localization post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.
  • AzBio Sentences at 50 decibels (dB) sound pressure level (SPL) [ Time Frame: Pre-implant and 6 months post-implant ]
    Understanding of sentences at a soft presentation level post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.
  • AzBio Sentences at 60 dB SPL and 4-talker babble at +8 dB signal-to-noise ratio (SNR) [ Time Frame: Pre-implant and 6 months post-implant ]
    Understanding of sentences in noise post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.
  • Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentences with noise to the better ear and with noise to the poor ear [ Time Frame: Pre-implant and 6 months post-implant ]
    Understanding of sentences in noise post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.
  • AzBio Sentences at 60 dB SPL [ Time Frame: Pre-implant and 6 months post-implant ]
    AzBio sentence understanding in quiet with the CI alone compared to pre-implant with a hearing aid.
  • Hearing Handicap Inventory (HHIE) [ Time Frame: Pre-implant and 6 months post-implant ]
    Inventory completed by participant regarding emotional and social consequences of hearing loss.
  • Health Utility Index (HUI3) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant regarding ability/disability across several health dimensions.
  • Speech, Spatial and Sound Qualities (SSQ) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant regarding impact of hearing loss on various listening situations.
  • Speech, Spatial and Sound Qualities (SSQ) [ Time Frame: Pre-implant and 12 months post-implant ]
    Questionnaire completed by participant regarding impact of hearing loss on various listening situations.
  • Glasgow Benefit Inventory (GBI) [ Time Frame: 6 months post-implant ]
    Inventory completed by participant regarding perceived benefit of cochlear implantation.
  • Satisfaction with Amplification in Daily Use (SADL) [ Time Frame: 6 months post-implant ]
    Questionnaire completed by participant regarding satisfaction of bimodal (HA+CI) device use. The original questionnaire wording has been modified for bimodal listeners.
  • Questions from the Communication Profile for the Hearing Impaired (CPHI) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations.
  • Hearing Impaired Impact - Significant Other Profile (HII-SOP) [ Time Frame: Pre-implant and 6 months post-implant ]
    Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other.
  • Number, type and degree of adverse events [ Time Frame: Up through 6 months post-implant ]
    Adverse event information through 6 months post-implant will be summarized by event type, severity/seriousness, and whether related to the device and/or implant procedure
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Washington University School of Medicine
  

  Dates:
  Date Received: February 9, 2017
  Date Started: May 2017
  Date Completion: August 2020
  Last Updated: May 8, 2017
  Last Verified: May 2017