RECRUITING

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Conditions

Hearing Loss, Sensorineural Hearing Loss Hearing Loss, Bilateral

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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 current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).

Official Title

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Quick Facts

Study Start:2021-11-10

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04707885

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:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form. 2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset. 3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets. 4. Limited benefit from conventional amplification in the best aided condition as defined by test scores of: 1. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct) 2. Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct) 5. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted. 6. Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted. 7. Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear. 8. Proficient in English. 9. Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG. 1. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624 2. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala 10. Stated willingness and ability to complete testing and all associated study visits.	1. Previous cochlear implantation. 2. Prelingual onset of hearing loss. 3. Abnormal inner ear anatomy on CT imaging. 4. Auditory neuropathy spectrum disorder. 5. Retrocochlear pathology such as a vestibular schwannoma or stroke. 6. Unwillingness or inability to comply with all investigational requirements including the randomization process. 7. Additional medical, or social barriers that would prevent completion of all study requirements. 8. Medical condition contraindicated for surgery. 9. Device selection of Med El CI (per the patient's selection).

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form.
2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.
4. Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
1. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
2. Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
5. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
6. Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
7. Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.
8. Proficient in English.
9. Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.
1. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
2. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
10. Stated willingness and ability to complete testing and all associated study visits.

1. Previous cochlear implantation.
2. Prelingual onset of hearing loss.
3. Abnormal inner ear anatomy on CT imaging.
4. Auditory neuropathy spectrum disorder.
5. Retrocochlear pathology such as a vestibular schwannoma or stroke.
6. Unwillingness or inability to comply with all investigational requirements including the randomization process.
7. Additional medical, or social barriers that would prevent completion of all study requirements.
8. Medical condition contraindicated for surgery.
9. Device selection of Med El CI (per the patient's selection).

Contacts and Locations

Study Contact

Beth Miles-Markley

CONTACT

614-366-9244

beth.miles-markley@osumc.edu

Meghan Hiss, AuD

CONTACT

meghan.hiss@osumc.edu

Principal Investigator

Oliver Adunka, MD

PRINCIPAL_INVESTIGATOR

Ohio State University

Amanda Ortmann, PhD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

University of Iowa

Iowa City, Iowa, 52242

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Washington University in St. Louis

Saint Louis, Missouri, 63110

United States

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Ohio State University Eye and Ear Institute

Columbus, Ohio, 43210

United States

Vanderbilt University

Nashville, Tennessee, 37232

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Ohio State University

Oliver Adunka, MD, PRINCIPAL_INVESTIGATOR, Ohio State University
Amanda Ortmann, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Date2021-11-10

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2021-11-10

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Hearing Loss, Sensorineural
Hearing Loss
Hearing Loss, Bilateral