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NCT05318417NARecruiting

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

Cochlear

Start Date

8/19/2022

Completion Date

6/1/2027

Summary

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.

Eligibility Criteria

Age Range: 5 years to No maximum

Inclusion Criteria: • Individuals 18 years or older (Group A) Ear to be Implanted: Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \>80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL • Children 5 years to 17 years, 11 months (Group B) Ear to be Implanted: Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \>80 dB HL; Aided CNC score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL * 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 Exclusion Criteria: * 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.

Interventions

DEVICE

The Cochlear™ Nucleus® Cochlear Implant (CI) System

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Conditions

Hearing Loss, UnilateralDeafness, Unilateral

Locations

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