Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

ID: NCT03052920
Status: Recruiting
Phase: N/A
Start Date: June 13, 2017
First Submitted: February 09, 2017
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine, Midwest Ear Institute, House Clinic, Inc., New York University School of Medicine
Location: United States
Conditions: Hearing Loss
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Study Description

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
Condition or disease Intervention/treatment Phase

Hearing Loss

Device: Cochlear implant
Other Names
Cochlear America Advanced Bionics MED-EL
N/A

Tracking Information

First Submitted DateFebruary 09, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateJune 13, 2017
Anticipated Completion DateAugust 01, 2020
Actual Primary Completion DateFebruary 01, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Poor ear alone CNC monosyllabic word understanding in quiet [Time Frame: Pre-implant and 6 months post-implant]

    CNC monosyllabic word understanding in quiet with the CI alone compared to pre-implant with a hearing aid.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Sound localization [Time Frame: Pre-implant and 6 months post-implant]

    Sound localization post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.

  • 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 post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.

  • AzBio Sentences 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]

    Understanding of sentences in noise post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.

  • Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentences with noise to the better ear and with noise to the poor ear [Time Frame: Pre-implant and 6 months post-implant]

    Understanding of sentences in noise post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition.

  • AzBio Sentences at 60 dB SPL [Time Frame: Pre-implant and 6 months post-implant]

    AzBio sentence understanding in quiet with the CI alone compared to pre-implant with a hearing aid.

  • 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.

  • Health Utility Index (HUI3) [Time Frame: Pre-implant and 6 months post-implant]

    Questionnaire completed by participant regarding ability/disability across several health dimensions.

  • Speech, Spatial and Sound Qualities (SSQ) [Time Frame: Pre-implant and 6 months post-implant]

    Questionnaire completed by participant regarding impact of hearing loss on various listening situations.

  • Speech, Spatial and Sound Qualities (SSQ) [Time Frame: Pre-implant and 12 months post-implant]

    Questionnaire completed by participant regarding impact of hearing loss on various listening situations.

  • Glasgow Benefit Inventory (GBI) [Time Frame: 6 months post-implant]

    Inventory completed by participant regarding perceived benefit of cochlear implantation.

  • Satisfaction with Amplification in Daily Use (SADL) [Time Frame: 6 months post-implant]

    Questionnaire completed by participant regarding satisfaction of bimodal (HA+CI) device use. The original questionnaire wording has been modified for bimodal listeners.

  • Questions from the Communication Profile for the Hearing Impaired (CPHI) [Time Frame: Pre-implant and 6 months post-implant]

    Questionnaire completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations.

  • Hearing Impaired Impact - Significant Other Profile (HII-SOP) [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.

  • Number, type and degree of adverse events [Time Frame: Up through 6 months post-implant]

    Adverse event information through 6 months post-implant will be summarized by event type, severity/seriousness, and whether related to the device and/or implant procedure

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleCochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Official TitleCochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
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

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
40
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Hearing Loss
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Device: Cochlear implant

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
Study Groups/Cohorts
Cochlear Implantation
Cochlear implantation of the poor hearing ear

Study Arms
Experimental Cochlear Implantation
Cochlear implantation of the poor hearing ear
Device : Cochlear implant
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.

Arm Intervention/Treatment
Experimental Cochlear Implantation
Cochlear implantation of the poor hearing ear
Device : Cochlear implant

Recruitment Information

Recruitment Status:Recruiting
Enrollment40
Completion DateAugust 01, 2020
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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03052920
Other Study ID Numbers
201612147
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Midwest Ear Institute
House Clinic, Inc.
New York University School of Medicine
Investigators
Principal Investigator
Jill B Firszt, PhD
Washington University School of Medicine