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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 : Recruiting
First Posted : July 15, 2014
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
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).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Study Start Date : April 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Contacts
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Contact: Silke Thode, Ph.D. clinicalresearch@advancedbionics.com
Contact: Madison Gray (661) 362-1794 Madison.Gray@advancedbionics.com

Locations
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United States, District of Columbia
Georgetown University School of Medicine Recruiting
Washington, District of Columbia, United States, 20007
Contact: Silke Thode, PhD       ClinicalResearch@advancedbionics.com   
Principal Investigator: Michael Hoa, MD         
United States, Florida
Tampa Bay Hearing and Balance Center Active, not recruiting
Tampa, Florida, United States, 33606
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Kris Dyer    859-218-2167    Kris.dyer@uky.edu   
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Paula Orr    507-284-1231    orr.paula@mayo.edu   
Principal Investigator: Colin W. Driscoll, MD         
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65201
Contact: Rebecca Schneider, MS    573-882-2549    schneiderri@health.missouri.edu   
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Laura Holden, AuD, CCC-A    314-362-7245    laurakholden@wustl.edu   
Principal Investigator: Richard A. Chole, MD, PhD         
Midwest Ear Institute/St. Luke's Health System Recruiting
Saint Louis, Missouri, United States, 64111
Contact: Sarah Zlomke, AuD, CCC-A    816-932-1671    sking@saint-lukes.org   
Principal Investigator: Robert D. Cullen, MD         
United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Susan Waltzman, PhD    212-263-7567    Susan.Waltzman@nyumc.org   
Principal Investigator: John T Roland, MD         
United States, Oklahoma
Oklahoma Ear Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Geraldine Chissoe       Geraldine-Chissoe@ouhsc.edu   
United States, Tennessee
Vanderbilt Bill Wilkerson Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Ashudee Kirk    615-936-2491    ashudee.kirk@vumc.org   
Principal Investigator: David Haynes, MD         
United States, Texas
Austin Ear, Nose & Throat Clinic Recruiting
Austin, Texas, United States, 78731
Contact: Sara Morton, M.S.Ed., CCC-A    512-836-8786    smorton@austinent.com   
Principal Investigator: James Kemper, MD         
Sponsors and Collaborators
Advanced Bionics
Investigators
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Principal Investigator: Robert D Cullen, MD Midwest Ear Institute, Saint Louis, Missouri
Principal Investigator: Loren J Bartels, MD Tampa Bay Hearing and Balance Center, Tampa, Florida
Principal Investigator: David Haynes, MD Vanderbilt Bill Wilkerson Center, Nashville, Tennessee
Principal Investigator: Richard A Chole, MD, PhD Washington University, Saint Louis, Missouri
Principal Investigator: J Thomas Roland, MD New York University Langone Medical Center, New York, New York
Principal Investigator: Colin LW Driscoll, MD Mayo Clinic Rochester, Rochester, Minnesota
Principal Investigator: Betty Tsai Do, MD Oklahoma Ear Institute, Oklahoma City, Oklahoma
Principal Investigator: Matthew Bush, MD, PhD University of Kentucky Medical Center, Lexington, Kentucky
Principal Investigator: Arnaldo Rivera, MD University of Missouri, Columbia, Missouri
Principal Investigator: James Kemper, MD Austin Ear, Nose & Throat Clinic, Austin, Texas
Principal Investigator: Michael Hoa, MD Georgetown University School of Medicine, Washington, District of Columbia
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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: August 21, 2018
Last Verified: August 2018
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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Hearing Loss
Deafness
Ear Diseases
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs