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
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit
The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aidable Residual Hearing (ARH) Cohort | Other | Control Device followed by experimental Device. |
|
| Electric Only (EO) Cohort | Other | Control Device followed by experimental Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software | Device | Control cochlear implant sound processor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Recognition in Quiet | The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Recognition in Noise | Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | 1 Day |
Not provided
General Inclusion Criteria:
ARH Arm Inclusion Criteria
EO Arm Inclusion Criteria
• Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125, 250, and 500 Hz) and high frequencies (pure tone average ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the 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 |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| Tampa Bay Hearing and Balance Center |
Not provided
Not provided
Not provided
Not provided
Not provided
After undergoing the Informed Consent Form process, subjects completed audiometric testing and speech perception testing to determine eligibility and assignment to either the electric only (EO) or aidable residual hearing (ARH) cohort. 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 December 17, 2019 and last patient last visit occurred on October 15, 2020. A total of 22 subjects were enrolled; 10 subjects were enrolled in the Electric Only cohort and 12 subjects were enrolled in the Aidable Residual Hearing cohort based on the results of their audiometric testing. All 22 subjects completed the study; there were no withdrawals or losses to follow-up.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Electric Only (EO) Cohort | Control Device followed by experimental Device. Naída Cochlear Implant Q90 (Naída CI Q90) sound processor & software: Control cochlear implant sound processor 301-M062 sound processor & software: New cochlear implant sound processor |
| FG001 | Aidable Residual Hearing (ARH) Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Nov 13, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 301-M062 sound processor & software | Device | New cochlear implant sound processor |
|
| Increased Speech Recognition in Noise | Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | 1 Day |
| Tampa |
| Florida |
| 33606 |
| United States |
| Midwest Ear Institute/St. Luke's Health System | Kansas City | Missouri | 64111 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Austin Ear, Nose & Throat Clinic | Austin | Texas | 78731 | United States |
Control Device followed by experimental Device. Naída Cochlea Implant Q90 (Naída CI Q90) sound processor & software: Control cochlear implant sound processor 301-M062 sound processor & software: New cochlear implant sound processor |
| COMPLETED |
|
| NOT COMPLETED |
|
Subject assigned to ARH cohort were residual low frequency hearing sensitivity (PTA of < 70 dB HL for 125 thru 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1000 thru 8000 Hz) in the implanted ear. EO cohort assigned to subjects with Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125 thru 500 Hz) and high frequencies (PTA ≥ 70 dB HL for 1000 thru 8000 Hz) in the implanted ear
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aidable Residual Hearing (ARH) Cohort | Control Device followed by experimental Device. Naída Cochlear Implant Q90 (Naída CI Q90) sound processor & software: Control cochlear implant sound processor 301-M062 sound processor & software: New cochlear implant sound processor |
| BG001 | Electric Only (EO) Cohort | Control Device followed by experimental Device. Naída Cochlear Implant Q90 (Naída CI Q90) sound processor & software: Control cochlear implant sound processor 301-M062 sound processor & software: New cochlear implant 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 | Three subjects failed ARH baseline and 1 failed EO baseline. | Count of Participants | Participants |
| |||||||||||||||
| Age, Continuous | Three subjects failed ARH baseline and 1 failed EO baseline. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Three subjects failed ARH baseline and 1 failed EO baseline. | 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 | Three subjects failed ARH baseline and 1 failed EO baseline. | Number | participants |
| |||||||||||||||
| Audiometric Threshold Testing and Speech Perception Testing | A sample size of 12 subjects per cohort was calculated based upon the primary efficacy outcomes measure i.e., demonstration of non-inferiority of AutoSense on the M90 process compared to AutoSound on the Q90 processor. The calculations were based on 8 complete subjects per cohort, with a total of 12 subjects enrolled in order to accommodate up to 4 subjects per cohort who may have screen failed or early discontinued. | Four subjects did not meet inclusion criteria and were therefore discontinued at baseline. | Count of Participants | Participants | No |
|
| 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 | Speech Recognition in Quiet | The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | Posted | Mean | Standard Deviation | percentage of correct words | 1 Day |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Speech Recognition in Noise | Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | Posted | Mean | Standard Deviation | percentage of correct word responses | 1 Day |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Increased Speech Recognition in Noise | Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | Posted | Mean | Standard Deviation | percentage of correct words recognized | 1 Day |
|
|
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. The total period is up to 5 weeks.
All device-related and non-device-related adverse events (AEs) was tracked and reported accordingly throughout the study as defined in the investigational plan and in accordance with requirements of an IDE investigation. The number and percent of all subjects experiencing adverse events was summarized by type, status and frequency of event.
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 | EO Cohort | Control Device followed by experimental Device. Naída CI Q90 sound processor & software: Control cochlear implant sound processor 301-M062 sound processor & software: New cochlear implant sound processor | 0 | 10 | 0 | 10 | 2 | 10 |
| EG001 | ARH Cohort | Control Device followed by experimental Device. Naída CI Q90 sound processor & software: Control cochlear implant sound processor 301-M062 sound processor & software: New cochlear implant sound processor | 0 | 12 | 0 | 12 | 1 | 12 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient discomfort | Product Issues | Systematic Assessment | Participant reported sharpness of sound that was sometimes uncomfortable and sound was distorted. |
| |
| Upper Respiratory | Infections and infestations | Systematic Assessment | Subject reported a head cold |
| |
| Sprained ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject twisted ankle playing golf. |
|
Due to clinic closures related to the COVID-19 pandemic, total enrollment in the EO Cohort was 10 subjects instead of 12.
PI agrees to submit any publication to Sponsor at least 30 days before submission. Within 30 days of its receipt, 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, LLC | 661 362 1400 | clinicalresearch@advancedbionics.com |
| Feb 4, 2022 |
| Prot_SAP_000.pdf |
Not provided
| 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
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
|
|
|
|
|