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 | Terminated Results FDA Device

• 1 other identifier: CR0114
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 11

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).

Conditions

Hearing Loss; Partial Deafness; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases

Keywords

Cochlear Implant; HiRes™ 90K Advantage implant; Cochlear Implantation; HiFocus™ Mid-Scala electrode; Listening Benefits; Adults; Cochlear Implant Benefit; Electrical Stimulation; Electro-Acoustic Stimulation (EAS)

Outcome Measures

Primary Outcomes (3)

• Unaided Pure-tone Average (PTA) Hearing Threshold Measurements

  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)

  Twelve months post device activation

• Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet

  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.

  Up to 12 months post device activation

• Speech Perception Testing (AzBio) in Noise.

  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.

  up to 12 months post device activation

Study Arms (3)

Newly Implanted Group

EXPERIMENTAL

HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor.

Device: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode; Device: EAS sound processor

Existing Implanted Group

EXPERIMENTAL

Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.

Device: EAS sound processor

EAS Extended Use Arm

EXPERIMENTAL

Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in either the Newly Implanted Group or Existing Implanted Group.

Device: EAS sound processor

Interventions

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

HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).

Newly Implanted Group

EAS sound processor DEVICE

Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.

EAS Extended Use Arm; Existing Implanted Group; Newly Implanted Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• No previous cochlear implant experience in either ear
• 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

You may not qualify if:

• 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
• Ability to provide informed consent
• 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
• Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix® and HiFocus™ 1j electrode

Sponsors & Collaborators

• Advanced Bionics: lead

Study Sites (11)

Georgetown University School of Medicine

Washington D.C., District of Columbia, 20007, United States

Location

Tampa Bay Hearing and Balance Center

Tampa, Florida, 33606, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

University of Missouri

Columbia, Missouri, 65201, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Midwest Ear Institute/St. Luke's Health System

St Louis, Missouri, 64111, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Oklahoma Ear Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Vanderbilt Bill Wilkerson Center

Nashville, Tennessee, 37232, United States

Location

Austin Ear, Nose & Throat Clinic

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michelle Caulfield, Senior VP, Global Quality Assurance and Regulatory Affairs
• Organization: Advanced Bionics

clinicalresearch@advancedbionics.com

6613621400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The two main arms are conducted in parallel. The third arm is optional for subjects who complete either of the two main arms using the EAS sound processor.

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 15, 2014
• Study Start: October 21, 2014
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-05

Locations

US (11)