Single-Sided Deafness in the Medicare Population

Description

The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.

Conditions

Hearing Loss, Unilateral

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.

Cochlear Implantation in the Single-Sided Deafness in the Medicare Population

Single-Sided Deafness in the Medicare Population

Condition
Hearing Loss, Unilateral
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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)
  • * External or middle ear infection
  • * Suspected cognitive concern
  • * Other medical contraindication for surgery or anesthesia

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Med-El Corporation,

Study Record Dates

2025-07