Single-Sided Deafness and Asymmetric Hearing Loss

Recruiting now · Not applicable

Conditions studied: Hearing Loss, Unilateral, Hearing Loss, Sensorineural

In brief

The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

Key facts

Study ID

NCT04506853

Run by

Med-El Corporation

People needed

65

Starts

2021-02-22

Expected to finish

2026-12-01

Last updated by the study team

2025-09-24

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Five years of age or older at the time of implantation
• Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
• Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear
• Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less
• Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
• Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
• Fluent in English

You may not qualify if…

• Duration of profound hearing loss of 10 years or more
• Absence of cochlear development or non-functionality of cochlear nerve
• Other retrocochlear hearing loss
• Evidence of severe cochlear malformation (i.e., common cavity or ossification)
• External or middle ear infection
• Suspected developmental or cognitive concern
• Other medical contraindication for surgery or anesthesia

Where it is running

• University of Iowa — Iowa City, Iowa, United States (enrolling)
• New York Eye and Ear Infirmary — New York, New York, United States (enrolling)
• Virginia Mason Medical Center — Seattle, Washington, United States (enrolling)
• Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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