RECRUITING

Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

Talk to us

Conditions

Hearing Loss, UnilateralDeafness, Unilateral

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.

Official Title

A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

Quick Facts

Study Start:2022-08-19
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05318417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Previous experience with a current conventional treatment option for unilateral \[SSD\] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required
  2. * English spoken as a primary language
  3. * Willing and able to provide written informed consent
  1. * Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
  2. * Previous cochlear implantation
  3. * Hearing loss of neural or central origin, including auditory neuropathy
  4. * Duration of profound sensorineural HL \>10 years per self-report
  5. * Active / chronic middle-ear infection; conductive HL in either ear
  6. * Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
  7. * Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
  8. * Evidence of and/or suspected cognitive or developmental concern
  9. * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
  10. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
  11. * Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation
  12. * Pregnant or breastfeeding women
  13. * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Contacts and Locations

Study Contact

Laura Lambrecht
CONTACT
303-827-8786
llambrecht@cochlear.com
Jillian Crosson
CONTACT
601-209-8781
jcrosson@cochlear.com

Principal Investigator

Jillian Crosson
STUDY_DIRECTOR
Cochlear

Study Locations (Sites)

Stanford University
Palo Alto, California, 94304
United States
Rocky Mountain Ear Center
Englewood, Colorado, 80113
United States
University of Iowa
Iowa City, Iowa, 52242
United States
New York Eye and Ear Infirmary
New York, New York, 10003
United States
University of North Carolina
Chapel Hill, North Carolina, 27517
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
Dallas, Texas, 75390
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Cochlear

  • Jillian Crosson, STUDY_DIRECTOR, Cochlear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-19
Study Completion Date2027-06

Study Record Updates

Study Start Date2022-08-19
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Hearing Loss, Unilateral
  • Deafness, Unilateral