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Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness | Clinical Trials | Clareo Health

TERMINATEDNA

Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness

NCT02189798•Advanced Bionics

View on ClinicalTrials.gov

Summary

The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to provide informed consent
•No previous cochlear implant experience in either ear
•18 years of age or older
•Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the ear to be implanted
•Aided CNC word recognition score up to 50% in ear to be implanted
•Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
•Aided CNC word recognition score up to 80% in the contralateral ear
•English language proficiency
•Willingness to use an ear-level sound processor postoperatively for the duration of the study trial
•Willingness to participate in all scheduled procedures outlined in the protocol
+5 more criteria

Exclusion Criteria

•Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or more in range of 500-1000 Hz in the ear to be implanted
•Congenital hearing loss (for purpose of this study, onset prior to age 2 years\*). \*Based on critical period for speech and language development
•Duration greater than 30 years of severe-to-profound high-frequency hearing loss
•Cochlear malformation or obstruction that would preclude full insertion of electrode array in the ear to be implanted
•Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
•Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
•Active middle-ear disease/infection in the ear to be implanted
•Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator
•Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
•Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix® and HiFocus™ 1j electrode
+3 more criteria

Locations (11)

Georgetown University School of Medicine

Washington D.C., District of Columbia, United States

Tampa Bay Hearing and Balance Center

Tampa, Florida, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

University of Missouri

Columbia, Missouri, United States

Washington University

St Louis, Missouri, United States

Midwest Ear Institute/St. Luke's Health System

St Louis, Missouri, United States

New York University Langone Medical Center

New York, New York, United States

Oklahoma Ear Institute

Oklahoma City, Oklahoma, United States

Vanderbilt Bill Wilkerson Center

Nashville, Tennessee, United States

Key Dates

Start Date

October 21, 2014

Primary Completion Date

March 29, 2022

Completion Date

March 29, 2022

Last Updated

May 8, 2025

Enrollment

ACTUAL participants

Conditions

Hearing LossPartial DeafnessHearing DisordersEar DiseasesOtorhinolaryngologic Diseases

Interventions

HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode

DEVICE

EAS sound processor

DEVICE

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness

Inclusion Criteria

Exclusion Criteria

ListenFuture-Listening for Their Future: Deaf and Hard-of-Hearing Adolescents

MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

Preschool Hearing Screening

Evaluation of Flexible Conductive Hearing Aids

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