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

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.

Conditions

Hearing Loss, Unilateral, Deafness, Unilateral

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hearing Loss, Unilateral
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Englewood

Rocky Mountain Ear Center, Englewood, Colorado, United States, 80113

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

New York

New York Eye and Ear Infirmary, New York, New York, United States, 10003

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27517

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Dallas

University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery, Dallas, Texas, United States, 75390

Seattle

Virginia Mason Medical Center, Seattle, Washington, United States, 98101

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * English spoken as a primary language
  • * Willing and able to provide written informed consent
  • * Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • * Previous cochlear implantation
  • * Hearing loss of neural or central origin, including auditory neuropathy
  • * Duration of profound sensorineural HL \>10 years per self-report
  • * Active / chronic middle-ear infection; conductive HL in either ear
  • * Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
  • * Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
  • * Evidence of and/or suspected cognitive or developmental concern
  • * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
  • * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
  • * Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation
  • * Pregnant or breastfeeding women
  • * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Ages Eligible for Study

5 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cochlear,

Jillian Crosson, STUDY_DIRECTOR, Cochlear

Study Record Dates

2027-06