Skip to main content
OpenTrials
Completed

NCT Number: NCT03052920

Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

House Clinic, Los Angeles, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cochlear Implant

Device

Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.

Other names: Cochlear America, Advanced Bionics, MED-EL

Primary outcomes

  1. 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.)

  2. 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.)

Secondary outcomes

  1. Change in Sound Localization

    Time frame: Pre-implant and 6 months post-implant

    Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.)

  2. Change in 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 at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.)

  3. Change in AzBio Sentence Scores 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

    Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.)

  4. Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear

    Time frame: Pre-implant and 6 months post-implant

    Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)

  5. Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone

    Time frame: Pre-implant and 6 months post-implant

    Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.)

  6. Change in 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. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.)

  7. Change in Health Utility Index (HUI3) Ratings

    Time frame: Pre-implant and 6 months post-implant

    Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.)

  8. Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant

    Time frame: Pre-implant and 6 months post-implant

    Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)

  9. Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant

    Time frame: Pre-implant and 12 months post-implant

    Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)

  10. Change in Satisfaction With Amplification in Daily Use (SADL)

    Time frame: Pre-implant and 6 months post-implant

    Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.)

  11. Change in Scores on the Communication Profile for the Hearing Impaired (CPHI)

    Time frame: Pre-implant and 6 months post-implant

    The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.)

  12. Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant

    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. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.)

  13. Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear

    Time frame: Pre-implant and 6 months post-implant

    Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • House Clinic, Inc.
  • Midwest Ear Institute
  • NYU Langone Health

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Feb 14, 2017
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.