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Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811549
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : July 22, 2019
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 the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).

Condition or disease Intervention/treatment Phase
Hearing Loss Ear Diseases Hearing Disorders Otorhinolaryngologic Diseases Asymmetrical Hearing Loss Single-Sided Deafness Device: HiResolution Bionic Cochlear Implant Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Actual Study Start Date : November 28, 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HiResolution Bionic Cochlear Implant
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
 Device: HiResolution Bionic Cochlear Implant
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Speech Perception (Implanted Ear only) [ Time Frame: Baseline and Twelve months ]
    CNC word scores compared to preimplant word scores

  2. Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, only) [ Time Frame: Baseline and Twelve months ]
    Unaided audiometric thresholds compared to preimplant

  3. Change in Speech Perception (Bilateral Listening Condition) [ Time Frame: Baseline and Twelve months ]
    AzBio sentence scores in noise twelve months post implantation compared to preimplant bilateral sentence scores

  4. Change in Lateralization Ability Testing (Bilateral Listening Condition) [ Time Frame: Baseline and Twelve months ]
    Lateralization ability compared to preimplantation


Eligibility Criteria
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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:

General Requirements:

  • Ability to provide Informed Consent
  • 18 years of age or older
  • English language proficiency
  • Willingness to participate in all scheduled procedures outlined in the study investigational plan
  • Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study

Ear to be Implanted:

  • Severe-to-profound sensorineural hearing loss (> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
  • CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
  • Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) >3 months and ≤10 years in the ear to be implanted only

Contralateral (non-implanted) ear:

  • Up to a moderate sensorineural hearing loss (<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
  • CNC word recognition score >30% (tested in subject's everyday listening condition for that ear)

Exclusion Criteria:

  • Previous experience with a cochlear implant
  • Cochlear malformation or obstruction (i.e. ossification) 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
  • 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
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): NCT02811549


Locations
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United States, Florida
The Silverstein Institute
Sarasota, Florida, United States, 34239
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Advanced Bionics
Investigators
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Study Director: Silke Thode, PhD Advanced Bionics
More Information
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Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT02811549    
Other Study ID Numbers: CR0314
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Keywords provided by Advanced Bionics:
Cochlear Implant
HiRes™ 90K Advantage Implant
HiFocus™ Mid-Scala electrode
HiFocus™ 1J electrode
HiFocus Helix™ electrode
Cochlear Implantation
 Listening Benefits
Adults
Cochlear Implant Benefit
Electrical Stimulation
HiRes™ Ultra Implant with HiFocus™ Mid-Scala electrode
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Ear Diseases
Hearing Disorders
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases