Frontlight ResearchEarly access
Active, not recruitingNo phase
Single-Sided Deafness and Asymmetric Hearing Loss
Key facts
- Who runs it
- Med-El Corporation
- Where
- Chapel Hill, Iowa City, New York, and Seattle, United StatesSee the 4 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 65 people, planned
- Started
- 22 Feb 2021
- Expected to end
- 21 Dec 2026
- Type of study
- Interventional
- Treatments tested
- MED-EL Cochlear Implant System
- Record updated
- 20 October 2026
Who can take part
- Age
- 5 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Other medical contraindication for surgery or anesthesia
- External or middle ear infection
- 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)
- Suspected developmental or cognitive concern
Where in United States
Also in 1 other country, 1 site
- University of North CarolinaChapel Hill, United States
- University of IowaIowa City, United States
- New York Eye and Ear InfirmaryNew York, United States
- Virginia Mason Medical CenterSeattle, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Study ProcedureOther group
Treatment: MED-EL Cochlear Implant System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
- Record updated
- 20 October 2026