Recruiting

Hearing Loss

Sponsor:

Med-El Corporation

Code:

NCT04506853

Conditions

Hearing Loss, Unilateral

Hearing Loss, Sensorineural

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Interventions

MED-EL Cochlear Implant System

Study Details

Brief summary:

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.

Conditions

Hearing Loss, Unilateral

Hearing Loss, Sensorineural

Study ID

NCT04506853

Start date

Feb 22, 2021

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Study Procedure

Interventions

MED-EL Cochlear Implant System

Cochlear implant and audio processor

Primary outcome measure

  • Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation [ Time Frame: Three years (36 months) post implantation ]

Central Contacts and Locations

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242-1078

Contacts

Camille Dunn, PhD

319-353-8776camille_dunn@uiowa.edu

Principal Investigator:

Camille Dunn, PhD

New York Eye and Ear Infirmary

Recruiting

New York, New York, United States, 10003

Contacts

Samantha Udondem, MPH

347-978-3973samantha.udondem@mountsinai.org

Principal Investigator:

Maura Cosetti, MD

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Kelly Robertson

206-287-6263Kelly.Robertson@virginiamason.org

Principal Investigator:

Daniel Zietler, MD

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Kari Smilsky, M.CI.Sc.

416-480-6100kari.smilsky@sunnybrook.ca

Principal Investigator:

Kari Smilsky, M.CI.Sc.

More Information

Sponsor

Med-El Corporation

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Med-El Corporation on 2025-09-24.