CompletedNo phase
Single-Sided Deafness in the Medicare Population
Key facts
- Who runs it
- Med-El Corporation
- Where
- Chapel Hill and Iowa City, United StatesSee the 2 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Completed
- People taking part
- 18 people enrolled
- Started
- 27 Jun 2022
- Ended
- 11 Aug 2025
- Type of study
- Interventional
- Treatments tested
- MED-EL Cochlear Implant System
- Record updated
- 31 August 2026
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 65 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
- Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 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 CROS, BI-CROS, 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
- Sudden onset of hearing loss within six months of implantation
- Evidence of non-functional cochlear nerve or other retrocochlear hearing loss
- Evidence of severe cochlear malformation (i.e., common cavity or ossification)
- Suspected cognitive concern
Where in United States
Also in 1 other country, 1 site
- University of North CarolinaChapel Hill, United StatesNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
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
- Cochlear Implantation in the Single-Sided Deafness in the Medicare Population
- Record updated
- 31 August 2026