NCT02004535

Brief Summary

The objective of this study is to investigate benefits of binaural hearing for non-traditional cochlear implant candidates (with Asymmetric Hearing Loss). Asymmetric candidates are patients with severe to profound hearing loss in one ear and better hearing in the other ear. (One ear is deaf and the other ear has better hearing and in most cases uses a hearing aid.) The investigators hypothesize that cochlear implantation of the poorer ear provides a functional increase in word and sentence understanding in quiet or noise, perceived benefit, localization ability, and other measures of auditory performance relative to use of the better hearing ear alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

13.3 years

First QC Date

November 26, 2013

Last Update Submit

March 9, 2026

Conditions

Hearing Loss

Keywords

Hearing lossAsymmetric hearing lossCochlear implantation

Outcome Measures

Primary Outcomes (1)

  • Sound localization using a 140 degree, horizontal plane loudspeaker arc

    Sound localization using a 140 degree, horizontal plane loudspeaker arc

    Change from Pre-implant baseline localization at 12 months post-implant

Secondary Outcomes (2)

  • Speech recognition

    Pre-implant and 1, 3, 6, 9, 12, and 24 months post-implant

  • Perceived benefit questionnaire

    Pre-implant and 1, 3, 6, 12, and 24 months post-implant

Other Outcomes (1)

  • Cognitive ability (processing speed, visuospatial working memory, and perceptual effort)

    Pre-implant and 12 months post-implant

Study Arms (1)

Cochlear implantation

EXPERIMENTAL

Cochlear implantation of the ear with severe to profound hearing loss

Procedure: Cochlear Implantation

Interventions

Cochlear ImplantationPROCEDURE

The standard surgical procedure for a cochlear implant will be used. The asymmetric participant will receive the cochlear implant in the deaf ear.

Cochlear implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older at time of surgery
  • The poorer ear (implant ear) will have a severe-to-profound hearing loss and meet current cochlear implant candidacy criteria.
  • The better ear (contralateral ear) will have hearing levels less than current cochlear implant candidacy criteria and stable/non-fluctuating hearing levels for at least the previous year
  • Normal/patent cochlear anatomy
  • Fluent in English
  • Desire to have more functional binaural hearing and willingness to comply with all of the study requirements

You may not qualify if:

  • Medical or psychological conditions that contraindicate undergoing surgery
  • Additional handicaps that would prevent or restrict participation in the audiological evaluations
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Hearing loss of neural or central origin, including auditory neuropathy
  • Chronic and severe tinnitus in the ear to be implanted
  • Unwillingness or inability to comply with all investigational requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Firszt JB, Holden LK, Reeder RM, Cowdrey L, King S. Cochlear implantation in adults with asymmetric hearing loss. Ear Hear. 2012 Jul-Aug;33(4):521-33. doi: 10.1097/AUD.0b013e31824b9dfc.

    PMID: 22441359RESULT

  • Asymmetric hearing loss. Extended abstracts from the Cochlear Science and Research Seminar. Interlaken, Switzerland. February 10-11, 2011. Audiol Neurootol. 2011;16 Suppl 1:1-26. doi: 10.1159/000327759. No abstract available.

    PMID: 21527825RESULT

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeProsthesis Implantation

Study Officials

  • Jill B Firszt, PhD

    Washington University School of Medicine in St. Louis

    PRINCIPAL INVESTIGATOR

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

November 26, 2013

First Posted

December 9, 2013

Study Start

April 1, 2006

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)