Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

NCT ID: NCT03052920

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-28
• Study Completion Date: 2021-03-10

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

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cochlear Implantation

Cochlear implantation of the poor hearing ear

Group Type: EXPERIMENTAL

Cochlear implant

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cochlear America; Advanced Bionics; MED-EL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Midwest Ear Institute

OTHER

Sponsor Role: collaborator

House Clinic, Inc.

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill B Firszt, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

House Clinic

Los Angeles, California, United States

Saint Luke's Midwest Ear Institute

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

New York University School of Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34126876 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201612147

Identifier Type: -

Identifier Source: org_study_id