Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Cochlear implant
- Conditions
- Hearing Loss
- Sponsor
- Washington University School of Medicine
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Change in Poor Ear Alone Soundfield Thresholds
- Status
- Completed
- Last Updated
- last month
Overview
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 Description
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 alone * HA and CI together
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Cochlear Implantation
Cochlear implantation of the poor hearing ear
Intervention: Cochlear implant
Outcomes
Primary Outcomes
Change in Poor Ear Alone Soundfield Thresholds
Time Frame: Pre-implant and 6 months post-implant
Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.)
Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
Time Frame: Pre-implant and 6 months post-implant
Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.)
Secondary Outcomes
- Change in Sound Localization(Pre-implant and 6 months post-implant)
- Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL)(Pre-implant and 6 months post-implant)
- Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant(Pre-implant and 6 months post-implant)
- Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear(Pre-implant and 6 months post-implant)
- Change in Health Utility Index (HUI3) Ratings(Pre-implant and 6 months post-implant)
- Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone(Pre-implant and 6 months post-implant)
- Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant(Pre-implant and 12 months post-implant)
- Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR)(Pre-implant and 6 months post-implant)
- Change in Hearing Handicap Inventory (HHIE)(Pre-implant and 6 months post-implant)
- Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear(Pre-implant and 6 months post-implant)
- Change in Satisfaction With Amplification in Daily Use (SADL)(Pre-implant and 6 months post-implant)
- Change in Scores on the Communication Profile for the Hearing Impaired (CPHI)(Pre-implant and 6 months post-implant)
- Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant(Pre-implant and 6 months post-implant)