COMPLETED

Single-Sided Deafness in the Medicare Population

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-06-27

Study Completion:2025-08-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05250414

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.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

United States

University of North Carolina

Chapel Hill, North Carolina, 27599

United States

Collaborators and Investigators

Sponsor: Med-El Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-27

Study Completion Date2025-08-11

Study Record Updates

Study Start Date2022-06-27

Study Completion Date2025-08-11

Terms related to this study

Additional Relevant MeSH Terms

Hearing Loss, Unilateral