Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Completed · Not applicable
Conditions studied: Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT03052920
- Run by
- Washington University School of Medicine
- People needed
- 40
- Starts
- 2017-07-28
- Expected to finish
- 2021-03-10
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- English as the native language
- Have a desire for functional binaural hearing
- Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary
- Willingness to comply with all study requirements
- Ability to provide informed consent
- Poor ear (ear to be implanted):
- Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) > 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL)
- Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30%
- Duration of SPHL ≥ 6 months
- Onset of hearing loss ≥ 6 years of age
- Better ear:
- PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL
- Currently using a HA
- Aided word recognition score (CNC Word Test) at 60 dB SPL > 40%
- Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies
You may not qualify if…
- Medical condition that contraindicates surgery
- Actively using an implantable device in the ear to be implanted
- Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted
- Hearing loss of neural or central origin
- Unrealistic expectations related to the benefits and limitations of cochlear implantation
- Unwillingness or inability to comply with all investigational requirements
Where it is running
- House Clinic — Los Angeles, California, United States
- Saint Luke's Midwest Ear Institute — Kansas City, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- New York University School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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