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Trial record 1 of 2 for:    Implantation of the HiRes 90K™ Advantage Cochlear Implant with HiFocus™ Mid-Scala
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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

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ClinicalTrials.gov Identifier: NCT02189798
Recruitment Status : Terminated (Thirty-six subjects wore the EAS processor for as long as 84 months without any significant safety issues. Sufficient data gained to support EAS technology development for safe use in subjects with residual low-frequency acoustic hearing sensitivity.)
First Posted : July 15, 2014
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics

Study Description
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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).

Condition or disease Intervention/treatment Phase
Hearing Loss Partial Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Device: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode Device: EAS sound processor Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 21, 2014
Actual Primary Completion Date : March 29, 2022
Actual Study Completion Date : March 29, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Newly Implanted Group
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
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).

Device: EAS sound processor
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.
Experimental: Existing Implanted Group
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
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.
Experimental: EAS Extended Use Arm
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Unaided pure-tone hearing threshold measurements [ Time Frame: Three months ]
    Unaided pure tone hearing threshold measurement in the implanted ear 3 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)

  2. Speech perception testing [ Time Frame: Up to 19 months ]
    Speech perception testing (in quiet and noise) in the treated ear compared to pre-implant speech perception testing (in quiet and noise)

  3. Questionnaire data [ Time Frame: Up to 19 months ]
    Speech, Spatial Qualities (SSQ) questionnaire, Abbreviated Profile of Hearing Aid Benefits (APHAB) and Sponsored Development questionnaires post-implant compared to pre-implant condition


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: Newly Implanted Group:

  • 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

Exclusion Criteria: Newly Implanted Group:

  • 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

EAS Fitting 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189798


Locations
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United States, District of Columbia
Georgetown University School of Medicine
Washington, District of Columbia, United States, 20007
United States, Florida
Tampa Bay Hearing and Balance Center
Tampa, Florida, United States, 33606
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65201
Washington University
Saint Louis, Missouri, United States, 63110
Midwest Ear Institute/St. Luke's Health System
Saint Louis, Missouri, United States, 64111
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
United States, Oklahoma
Oklahoma Ear Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Vanderbilt Bill Wilkerson Center
Nashville, Tennessee, United States, 37232
United States, Texas
Austin Ear, Nose & Throat Clinic
Austin, Texas, United States, 78731
Sponsors and Collaborators
Advanced Bionics
More Information
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Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT02189798    
Other Study ID Numbers: CR0114
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Keywords provided by Advanced Bionics:
Cochlear Implant
HiRes™ 90K Advantage implant
Cochlear Implantation
HiFocus™ Mid-Scala electrode
Listening Benefits
 Adults
Cochlear Implant Benefit
Electrical Stimulation
Electro-Acoustic Stimulation (EAS)
Additional relevant MeSH terms:
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Imidacloprid
Hearing Loss
Deafness
Ear Diseases
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
 Neurologic Manifestations
Nervous System Diseases
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs