🔎 Trials Near Me

Home › Unilateral Hearing Loss › NCT04506853

Single-Sided Deafness and Asymmetric Hearing Loss

Recruiting

Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study

Who can join

Ages 5 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Med-El Corporation · Participants: 65 · Started: Feb 22, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04506853

Locations in the U.S.

IowaUniversity of Iowa, Iowa City
New YorkNew York Eye and Ear Infirmary, New York
WashingtonVirginia Mason Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.