Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HiResolution Bionic Cochlear Implant | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiResolution Bionic Cochlear Implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Twelve months |
| 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. | Baseline and Twelve months |
| 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. | Baseline and Twelve months |
| 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. |
Not provided
Not provided
Inclusion Criteria:
General Requirements:
Ear to be Implanted:
Contralateral (non-implanted) ear:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Silverstein Institute | Sarasota | Florida | 34239 | United States | ||
| Virginia Mason Medical Center |
Per protocol, a subject is considered enrolled upon giving written informed consent. After undergoing the ICF process, subjects completed audiometric testing and speech perception testing to determine eligibility to undergo surgical implantation. Subjects that did not meet the audiometric threshold hearing or speech testing inclusion criteria were discontinued at baseline.
Investigators recruited study subjects from their clinical practices. The first patient first visit occurred on November 7, 2016 and last patient last visit occurred on March 25, 2020. Two study sites enrolled a total of 24 subjects in the study. Of the 24 subjects enrolled 15 were deemed eligible to undergo surgical implantation and 14 completed the study. All enrolled subjects provided informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline and Twelve months |
| 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. | Baseline to Twelve Months |
| 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. | Baseline to Twelve Months |
| Seattle |
| Washington |
| 98101 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects determined eligible for implantation were implanted ear had severe to profound sensorineural hearing (SNHL) loss (PTA > 70 dB HL for 500, 1000, 2000, and 4000 Hz) where SNHL duration was > 3 months and ≤10 year. A moderate SNHL of < 70 dB HL PTA at 500, 1000, 2000, and 4000 Hz was also present in the contralateral (non-implanted) ear. The Consonant-Nucleus-Consonant Word (CNC) word recognition score for both ears was 30% (tested in subject's everyday listening condition for that ear).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Audiometric Threshold Testing | Mean | Standard Deviation | dB HL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary outcome measure used in this clinical feasibility study was monosyllabic word recognition with the ear to be implanted in quiet using the CNC word test. Subjects that achieved a CNC word recognition score ≤ 30% in the implanted ear and >30% in the contralateral ear. Subjects are tested using their everyday listening condition for each ear. | Posted | Mean | Standard Deviation | percentage of recognized words | Baseline and Twelve months |
|
|
| |||||||||||||||||||||||||||
| Primary | 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. | 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 non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate. | Posted | Mean | Standard Deviation | change in decibels (db) | Baseline and Twelve months |
| |||||||||||||||||||||||||||||
| Primary | 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. | Speech recognition in noise was measured with the AZBio speech perception test presented in a background of noise in which the target remained at 0° and noise was presented from 0° (speech front). | Posted | Mean | Standard Deviation | percentage of recognized words | Baseline and Twelve months |
| |||||||||||||||||||||||||||||
| Primary | 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. | Lateralization ability was measured as the ability to identify the location of a sound presented from a loudspeaker placed at +/- 45° in front of the subject. Test is performed using the participant's bilateral, everyday listening condition using both ears and reported for all subjects at baseline compared to month12. | Posted | Mean | Standard Deviation | percentage of sentences localized | Baseline and Twelve months |
| |||||||||||||||||||||||||||||
| Primary | 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. | Speech recognition in noise was measured with the AZBio Speech test presented with the participant at 0° and noise was presented at either 90° or 270° dependent on the implanted ear side. | Posted | Mean | Standard Deviation | percentage of recognized words | Baseline to Twelve Months |
| |||||||||||||||||||||||||||||
| Primary | 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. | Speech recognition in noise was measured with the AZBio Speech test presented with the participant at 0° and noise was presented from either 90° or 270° dependent on the contralateral ear side. Higher percentages score represents a better ability to identify speech source location. | Posted | Mean | Standard Deviation | percentage of recognized words | Baseline to Twelve Months |
|
Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).
All adverse events were reported per subject and classified based on type and frequency. Information recorded included onset date, if the AE was serious, categorization, description, course of action taken, status, and relationship to study device or procedure.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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. | 0 | 15 | 0 | 15 | 15 | 15 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complication at implant site | Surgical and medical procedures | Non-systematic Assessment | Implanted ear |
| |
| Mild Tinnitus, intermittent - Left Ear | Ear and labyrinth disorders | Non-systematic Assessment | Non-implanted Ear |
| |
| Moderate Tinnitus, continuous - Right Ear | Ear and labyrinth disorders | Non-systematic Assessment | Implanted Ear |
| |
| Allergy induced asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Anxiety | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Cerumen Impaction | Ear and labyrinth disorders | Non-systematic Assessment | Both implanted and non-implanted ear |
| |
| Granuloma | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Headache | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Imbalance | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Itching in implanted ear | Ear and labyrinth disorders | Non-systematic Assessment | Implanted ear |
| |
| Lightheadedness | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Mild ear pressure | Ear and labyrinth disorders | Non-systematic Assessment | Implanted ear |
| |
| mild head & neck pain post-surgery | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Numbness, discomfort, or pain at or around the pinna | Ear and labyrinth disorders | Non-systematic Assessment | Implanted ear |
| |
| Pain and Anxiety when wearing external device | General disorders | Non-systematic Assessment | Implanted Ear |
| |
| Residual hearing loss with a PTA greater than 30dB | Ear and labyrinth disorders | Non-systematic Assessment | Implanted Ear |
| |
| Sinus Infection | Infections and infestations | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Small scab superior pole of incision line related to the patient's haircut | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Jaw Pain when chewing | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Soreness, Tenderness, or Pain at or around the incision site | General disorders | Non-systematic Assessment | Implanted ear |
| |
| Tongue Numbness | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Transient Pain | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Unsteady Gait | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Severe Tinnitus - Left Ear | Ear and labyrinth disorders | Non-systematic Assessment | Implanted ear |
| |
| Severe Tinnitus - Right ear | Ear and labyrinth disorders | Non-systematic Assessment | Implanted ear |
| |
| Taste Disturbance | General disorders | Non-systematic Assessment |
| ||
| Vertigo or Dizziness | General disorders | Non-systematic Assessment | Systemic Adverse Events only |
| |
| Moderate Tinnitus, continuous - Left Ear | Ear and labyrinth disorders | Non-systematic Assessment | Implanted ear |
| |
| Aural fullness | Ear and labyrinth disorders | Non-systematic Assessment | Implanted ear and Non-implanted Ear |
|
PI agrees to submit any publication to Sponsor at least 30 days before submission. Within 30 days, Sponsor advises PI in writing of any information contained therein which is Confidential Information (other than Study Data) or which may impair availability of patent protection for Inventions.
Sponsor has the right to require PI to remove specifically identified CI and/or to delay the publication for an additional 60 days to enable Sponsor to seek patent protection for Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ankur Kaushal, VP of Global Regulatory Affairs | Advanced Bionics | 661 362 1400 | clinicalresearch@advancedbionics.com |
| Dec 2, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D004427 | Ear Diseases |
| D006311 | Hearing Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
| Pre-Implant PTA (Contralateral Ear) |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|