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Thirty-five subjects wore the EAS processor for as long as 84 months without significant safety issues. Sufficient data gained to support EAS technology development for safe use in subjects with residual low-frequency acoustic hearing sensitivity.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly Implanted Group | Experimental | 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. |
|
| Existing Implanted Group | Experimental | Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. |
|
| EAS Extended Use Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison) | Twelve months post device activation |
| Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome. | Up to 12 months post device activation |
| Speech Perception Testing (AzBio) in Noise. | Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome. | up to 12 months post device activation |
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Inclusion criteria: Newly Implanted Group:
Exclusion Criteria: Newly Implanted Group:
EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups
EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University School of Medicine | Washington D.C. | District of Columbia | 20007 | United States | ||
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Investigators recruited study subjects from their clinical practices. Thirteen study sites enrolled a total of 67 subjects. Of those enrolled, 35 completed the study main phase (month 12). The first patient first visit occurred on June 30, 2014, and last patient last visit occurred on 11/2/2020 for the main phase of the study. Twenty-four of the subjects that completed month 12 volunteered to enroll in the extended use phase. The last visit of the extended use phase was March 29, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Phase |
|
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| 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 | Sep 26, 2016 |
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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.
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|
| EAS sound processor | Device | 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. |
|
| Tampa Bay Hearing and Balance Center |
| Tampa |
| Florida |
| 33606 |
| United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| University of Missouri | Columbia | Missouri | 65201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Midwest Ear Institute/St. Luke's Health System | St Louis | Missouri | 64111 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Oklahoma Ear Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Vanderbilt Bill Wilkerson Center | Nashville | Tennessee | 37232 | United States |
| Austin Ear, Nose & Throat Clinic | Austin | Texas | 78731 | United States |
| FG001 | 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. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Extended Use Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| 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 | Number | participants |
| ||||||||||||||||
| Unaided low frequency hearing threshold - EAS Baseline | Low-frequency pure tone hearing ability (250-1000 Hz) was tested by playing tones and measuring the softest sounds the subject could hear. For EAS eligibility, candidates needed to hear at least one low-frequency tone at 80 dB HL or better after surgery without a hearing aid. Only those who met this criterion, used the investigational device, and completed the main EAS phase were included in the analysis. | Mean | Standard Deviation | Hertz (Hz) |
|
| 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 | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison) | Analysis includes only subjects who completed up to month 3 using the EAS processor. | Posted | Mean | Standard Deviation | decibles | Twelve months post device activation |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome. | Analysis includes only subjects who completed up to month 12 using the EAS processor. | Posted | Mean | Standard Deviation | Percent words correct | Up to 12 months post device activation |
| |||||||||||||||||||||||||||||||||||||
| Primary | Speech Perception Testing (AzBio) in Noise. | Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome. | Analysis includes only subjects who completed the main phase study using the EAS processor. | Posted | Mean | Standard Deviation | Percent words correct | up to 12 months post device activation |
|
Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation.
Information recorded includes onset date, if the AE is serious, categorization, description, course of action taken, status, and relation to study device or procedure. The number subjects experiencing AEs will be summarized by type and frequency of event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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). 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. | 1 | 49 | 16 | 49 | 24 | 49 |
| EG001 | 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. 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. | 0 | 18 | 0 | 18 | 9 | 18 |
| EG002 | Extended Use Phase - Newly Implanted Group | 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 the Newly Implanted Group. Enrollment was optional and subject to the willingness of the participant and the discretion of the managing clinician. | 0 | 15 | 1 | 15 | 4 | 15 |
| EG003 | Extended Use Phase - Existing Implanted Group | 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 the Existing Implanted Group. Enrollment was optional and subject to the willingness of the participant and the discretion of the managing clinician | 0 | 9 | 0 | 9 | 2 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe inflammation from extensive radiation damage | General disorders | Non-systematic Assessment | Subject hospitalized for treatment. |
| |
| Death | General disorders | Non-systematic Assessment | Subject passed away in their sleep. Event reported by subject's spouse. |
| |
| Fractured left femoral head secondary to fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject hospitalized for treatment. |
| |
| Fractured rib secondary to fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject hospitalized for treatment. |
| |
| Crushed legs secondary to Motor Vehicle Accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject hospitalized for treatment. |
| |
| Hospitalization due to Health Setback | General disorders | Non-systematic Assessment | Subject hospitalized |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Subject hospitalized |
| |
| Complication at Implant Site | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Torn Shoulder Tendon | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Required Surgical Repair |
| |
| Postoperative decrease/loss of residual hearing | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Condition of the Contralateral ear | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Complication at Implant site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Oral/Taste disturbance | General disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Decreased Concentration | General disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Device related/ Programming Problems | Product Issues | Non-systematic Assessment |
| ||
| Parkinson's Disease | Nervous system disorders | Non-systematic Assessment |
| ||
| Ear Irritation/Pain | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Epistaxis | General disorders | Non-systematic Assessment |
| ||
| External/Middle Ear Postoperative Symptom | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Eye Fluttering - Right eye | Eye disorders | Non-systematic Assessment |
| ||
| Facial Edema | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Headaches | General disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Iron Deficiency/Low Hemoglobin count |
| |
| Leaky Heart Valve | Cardiac disorders | Non-systematic Assessment |
| ||
| Lockjaw with pain | General disorders | Non-systematic Assessment |
| ||
| Macular Degeneration | Eye disorders | Non-systematic Assessment |
| ||
| Musculoskeletal injury, sprain or fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Numbness (Implanted Ear) | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Oral/Dental Disturbance | General disorders | Non-systematic Assessment |
| ||
| Pain due to bone fracture from a fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Postoperative decrease/loss of residual hearing | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Nausea after implant surgery in contralateral ear | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Post-operative Pain - Implanted ear | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Postoperative popping noise (Implanted Ear) | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Postoperative Sensation of clogged ear (Implanted Ear) | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Postoperative Sensitivity during testing (Implanted Ear) | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Prediabetes | Endocrine disorders | Non-systematic Assessment |
| ||
| Prostate Dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Renal illness (injury, stones or failure) | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Skin irritation - Implant site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin Irritation (General) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Sleep Deprivation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Somatosensory response to sound at certain frequencies (Bilateral) | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Uterine Cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Surgical Complication - Implanted Ear | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Taste Disturbance | General disorders | Non-systematic Assessment |
| ||
| Tinnitus - Implanted Ear | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Tinnitus - Contralateral Ear | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Tinnitus - Continuous (Bilateral) | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Vertigo or Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Caulfield, Senior VP, Global Quality Assurance and Regulatory Affairs | Advanced Bionics | 6613621400 | clinicalresearch@advancedbionics.com |
| Feb 11, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| 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
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| Desire to explore other commercial technology/Processor Upgrade |
|
| Explanted prior to 24 month visit |
|
| Travel Issues |
|
| No longer perceiving a benefit from acoustic component |
|
| Between 18 and 65 years |
|
| >=65 years |
|
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|
|
|
|
| 6 Month PTA |
|
| 12 Month PTA |
|
Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.
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.
|
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