Ear Diseases, Hearing Disorders, Hearing Loss, Otorhinolaryngologic Diseases
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICENaída Cochlear Implant Q90 sound processor (Naida CI Q90) & software
Control cochlear implant sound processor
DEVICE301-M062 sound processor & software
New cochlear implant sound processor
Sponsors
Advanced Bionics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Ability to provide Informed Consent * 18 years of age or older * Unilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D), including bilaterally implanted subjects that only use one implant in their everyday listening modality * Minimum of 6 months of CI experience * Having used a Naída CI Q70 or a Naída CI Q90 as their primary processor for a minimum of one month * Presently using a current steering strategy * At least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the AzBio in quiet test using the Naída CI Q90 research processor * English language proficiency as determined by the investigator * Willingness to use a BTE processor for the duration of the study ARH Arm Inclusion Criteria * Residual low frequency hearing sensitivity (pure tone average of \< 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear * Willingness to use an in-canal acoustic earhook for the duration of the study 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
* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator * Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Recognition in Quiet | 1 Day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Recognition in Noise | 1 Day | 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. |
| Increased Speech Recognition in Noise | 1 Day | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Aidable Residual Hearing (ARH) Cohort | Electric Only (EO) Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 3 Participants | 9 Participants |
| Age, Continuous | 61.1 years STANDARD_DEVIATION 9.66 | 67.2 years STANDARD_DEVIATION 9.28 | 64.5 years STANDARD_DEVIATION 9.74 |
| Audiometric Threshold Testing and Speech Perception Testing | 12 Participants | 10 Participants | 22 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 2 / 10 | 1 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 |
Outcome results
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.
Time frame: 1 Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EO Cohort | Speech Recognition in Quiet | Baseline AutoSound | 88.31 percentage of correct words | Standard Deviation 5.817 |
| EO Cohort | Speech Recognition in Quiet | Baseline AutoSense | 87.30 percentage of correct words | Standard Deviation 10.214 |
| ARH Cohort | Speech Recognition in Quiet | Baseline AutoSound | 89.39 percentage of correct words | Standard Deviation 10.535 |
| ARH Cohort | Speech Recognition in Quiet | Baseline AutoSense | 88.09 percentage of correct words | Standard Deviation 9.848 |
p-value: 0.001t-test, 2 sided
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.
Time frame: 1 Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EO Cohort | Increased Speech Recognition in Noise | Omnidirectional | 42.93 percentage of correct words recognized | Standard Deviation 30.801 |
| EO Cohort | Increased Speech Recognition in Noise | AutoSense | 76.37 percentage of correct words recognized | Standard Deviation 19.078 |
| ARH Cohort | Increased Speech Recognition in Noise | Omnidirectional | 51.37 percentage of correct words recognized | Standard Deviation 28.604 |
| ARH Cohort | Increased Speech Recognition in Noise | AutoSense | 84.98 percentage of correct words recognized | Standard Deviation 13.108 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 1 Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EO Cohort | Speech Recognition in Noise | AutoSound | 52.95 percentage of correct word responses | Standard Deviation 31.163 |
| EO Cohort | Speech Recognition in Noise | AutoSense | 76.37 percentage of correct word responses | Standard Deviation 19.078 |
| ARH Cohort | Speech Recognition in Noise | AutoSound | 66.04 percentage of correct word responses | Standard Deviation 25.939 |
| ARH Cohort | Speech Recognition in Noise | AutoSense | 84.98 percentage of correct word responses | Standard Deviation 13.108 |
p-value: 0.001t-test, 2 sided