Clinical trial NCT03052920: Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Official title: Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: cochlear implant
asymmetric hearing loss
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Midwest Ear Institute
name: House Clinic, Inc.
name: NYU Langone Health
First posted: 2017-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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
  * 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

Primary outcomes:
measure: Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Poor Ear Alone Soundfield Thresholds
timeFrame: Pre-implant and 6 months post-implant
Secondary outcomes:
measure: Change in Sound Localization
timeFrame: Pre-implant and 6 months post-implant
measure: Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL)
timeFrame: Pre-implant and 6 months post-implant
measure: Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR)
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear
timeFrame: Pre-implant and 6 months post-implant
measure: Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Hearing Handicap Inventory (HHIE)
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Health Utility Index (HUI3) Ratings
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant
timeFrame: Pre-implant and 12 months post-implant
measure: Change in Satisfaction With Amplification in Daily Use (SADL)
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Scores on the Communication Profile for the Hearing Impaired (CPHI)
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant
timeFrame: Pre-implant and 6 months post-implant
measure: Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear
timeFrame: Pre-implant and 6 months post-implant
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Clinic
state: California
city: Kansas City
country: United States
facility: Saint Luke's Midwest Ear Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: Washington University School of Medicine
name: Jill B Firszt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sampathkumar R, Kaehne A, Kumar N, Kameswaran M, Irving R. Systematic review of cochlear implantation in adults with asymmetrical hearing loss. Cochlear Implants Int. 2021 Nov;22(6):311-329. doi: 10.1080/14670100.2021.1936363. Epub 2021 Jun 14.