Ireland
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Active, not recruiting Not applicable

Single-Sided Deafness and Asymmetric Hearing Loss

NCT04506853 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2021-02-22
Last updated
2026-10-20

Condition(s) studied

Hearing Loss, UnilateralHearing Loss, Sensorineural

Investigational drug(s) / intervention(s)

MED-EL Cochlear Implant System

MED-EL Cochlear Implant System: Cochlear implant and audio processor

Study 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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — Three years (36 months) post implantation
    The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.

Trial sites (5)

FacilityCityRegionStatus
University of Iowa Iowa City Iowa
New York Eye and Ear Infirmary New York New York
University of North Carolina Chapel Hill North Carolina
Virginia Mason Medical Center Seattle Washington
Sunnybrook Health Sciences Center Toronto Ontario

More Med-El Corporation trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04506853 on ClinicalTrials.gov ↗ ← All trials in the USA