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

Not Applicable

Terminated

• Conditions: Ear Diseases; Hearing Loss; Partial Deafness; Otorhinolaryngologic Diseases; Hearing Disorders

• Registration Number: NCT02189798
• Lead Sponsor: Advanced Bionics

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Study Start: 2014-10-21
• Primary Completion: 2022-03-29
• Study Completion: 2022-03-29
• Results First Submitted: 2025-02-12
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Results First Posted: 2025-05-08
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Newly Implanted and Existing Implanted Groups

• Ability to provide informed consent
• 18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor (i.e. Naída family device)
• Postoperative unaided low frequency audiometric hearing thresholds in the treated ear up to 80 dB HL for at least one frequency from 125 - 1000 Hz
• English Language Proficiency
• Willingness to participate in all scheduled procedures outlined in the study protocol

EAS Fitting

Exclusion Criteria

Newly Implanted and Existing Implanted Groups

• Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix® and HiFocus™ 1j electrode
• Exclusive use of a body worn external sound processor
• Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear
• Postoperative unaided low frequency audiometric hearing thresholds in the treated ear exceeding 80 dB HL at each frequency from 125 - 1000 Hz Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Unaided Pure-tone Average (PTA) Hearing Threshold Measurements	Twelve months post device activation	Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet	Up to 12 months post device activation	Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Speech Perception Testing (AzBio) in Noise.	up to 12 months post device activation	Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.

Trial Locations

Locations (11)

Georgetown University School of Medicine; 🇺🇸 Washington, 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; 🇺🇸 Saint Louis, Missouri, United States

Midwest Ear Institute/St. Luke's Health System; 🇺🇸 Saint 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

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