Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial (NCT03052920) | Clinical Trial Compass
CompletedNot Applicable
Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
United States40 participantsStarted 2017-07-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet