Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

NCT03052920 | Completed Results DMC FDA Device

• 1 other identifier: 201612147
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Hearing Loss

Keywords

cochlear implant; asymmetric hearing loss

Outcome Measures

Primary Outcomes (2)

• Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet

  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.)

  Pre-implant and 6 months post-implant

• Change in Poor Ear Alone Soundfield Thresholds

  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.)

  Pre-implant and 6 months post-implant

Secondary Outcomes (13)

• 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 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 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 AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone

  Pre-implant and 6 months post-implant

Study Arms (1)

Cochlear Implantation

EXPERIMENTAL

Cochlear implantation of the poor hearing ear

Device: Cochlear implant

Interventions

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.

Also known as: Cochlear America, Advanced Bionics, MED-EL

Cochlear Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Midwest Ear Institute: collaborator
• House Clinic, Inc.: collaborator
• NYU Langone Health: collaborator

Study Sites (4)

House Clinic

Los Angeles, California, 90057, United States

Location

Saint Luke's Midwest Ear Institute

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 34126876 DERIVED

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Results Point of Contact

• Title: Jill B Firszt, PI
• Organization: Washington University in St. Luis

FirsztJ@wustl.edu

314-362-4760

Study Officials

• Jill B Firszt, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 14, 2017
• Study Start: July 28, 2017
• Primary Completion: November 17, 2020
• Study Completion: March 10, 2021
• Last Updated: March 11, 2026
• Results First Posted: October 18, 2021

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)