Back to resultsBenefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Primary Purpose
Hearing Loss, Ear Diseases, Hearing Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HiResolution Bionic Cochlear Implant
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring 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
Eligibility 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
Sites / Locations
- The Silverstein Institute
- Virginia Mason Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HiResolution Bionic Cochlear Implant
Arm Description
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).
Outcomes
Primary Outcome Measures
Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)
The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary.
• Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.
Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front
AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Change in Lateralization Ability Testing (Bilateral Listening Condition)
Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.
Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear
AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.
AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02811549
Brief Title
Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Official Title
Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Bionics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Asymmetrical Hearing Loss, Single-Sided Deafness
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HiResolution Bionic Cochlear Implant
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
HiResolution Bionic Cochlear Implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)
Description
The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.
Time Frame
Baseline and Twelve months
Title
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Description
Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary.
• Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.
Time Frame
Baseline and Twelve months
Title
Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front
Description
AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Time Frame
Baseline and Twelve months
Title
Change in Lateralization Ability Testing (Bilateral Listening Condition)
Description
Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.
Time Frame
Baseline and Twelve months
Title
Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear
Description
AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Time Frame
Baseline to Twelve Months
Title
Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.
Description
AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Time Frame
Baseline to Twelve Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Silverstein Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
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Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
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